Latest News - Neuro News Affino Atom Generator BIBA Medical Ltd 2014-10-23T11:06:49Z Codman Neuro launches first disposable forceps with dual irrigation 2014-10-22T11:07:00Z 2014-10-22T11:07:00Z <div id="Introduction1" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Codman Neuro has&nbsp;announced the launch of Spetzler Malis dual irrigating disposable non-stick bipolar forceps, the first disposable dual irrigating forceps for neurosurgery. The announcement was made at the 2014 Congress of Neurological Surgeons (CNS) annual meeting.</strong></span></p> </div><div id="Text11" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Spetzler Malis dual irrigating forceps is the first disposable device to have irrigation channels inside both of its branches, offering precise delivery of fluid through each forceps tip for improved and uninterrupted visualisation. The device also provides the same non-stick coagulation performance as the industry leading standard version of the Spetzler Malis disposable bipolar forceps.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The dual irrigation design is ideal for working with arteriovenous malformations and&nbsp;vascular tumours as they keep the tips and vessels moist enhancing their non-stick properties, and the transparent fine tubing provides better visualisation,&rdquo; says neurosurgeon Robert Spetzler, director, Barrow Neurological Institute in Phoenix, Arizona, USA. &ldquo;The Spetzler Malis disposable bipolar forceps line has been designed to be non-stick, low profile, and provide great tactile feedback.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to Codman Neuro, the dual irrigating forceps is the latest addition to the Spetzler Malis forceps product line, following the launch of Spetzler Malis slim non-stick bipolar forceps earlier this year. Spetzler Malis slim forceps have the slimmest profile available on the market and provide access to narrow surgical fields. Standard Spetzler Malis disposable forceps have been available since 2006. This family of forceps features an ergonomic design that provides excellent visualisation and control, which is especially important when operating on deep-seated tumours or vascular structures, and during skull-based neurosurgery.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Spetzler Malis dual irrigating bipolar forceps are single-use devices sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.</span></p></div> FDA and CE mark approval for new CoverEdge surgical leads 2014-10-21T14:26:00Z 2014-10-21T14:26:00Z <div id="ImageMain2" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction2" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Boston Scientific has received US Food and Drug Administration (FDA) and CE mark approval for the CoverEdge 32 and CoverEdge X 32 surgical leads,&nbsp;the world&rsquo;s first 32-contact surgical leads designed to blanket the spinal cord for unprecedented pain coverage. Designed for use with the Precision Spectra spinal cord stimulator system, the CoverEdge surgical leads are powered by the Illumina 3D software, a proprietary, anatomy-based computer model for precise pain targeting.&nbsp;Boston Scientific is introducing the CoverEdge surgical leads at the Congress of Neurological Surgeons (CNS).</strong></span></p> </div><div id="Text12" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Previous surgical leads have delivered pain therapy with a maximum of 16 independent contacts. By offering 32 contacts &ndash; each powered by a dedicated power source &ndash; CoverEdge surgical leads are designed to deliver more focused coverage of the spinal cord for more pain relief. Available in two configurations, the CoverEdge 32 surgical lead features 32 tightly spaced contacts in four columns for precise pain targeting. The CoverEdge X 32 surgical lead offers the broadest span on the market among multi-column paddles.&nbsp;&nbsp;&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;I see the CoverEdge surgical leads as a game changer for patients,&rdquo; says Giancarlo Barolat, medical director of Barolat Neuroscience in Denver, USA.&nbsp;&ldquo;Because it provides greater coverage of the spinal cord, I believe this product will give patients, especially those with low back pain or pain in multiple areas, a better opportunity for relief.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The combination of the CoverEdge surgical leads with the Precision Spectra spinal cord stimulator system and Illumina 3D Software is designed to deliver spinal cord stimulation in new ways. For example, a key challenge in spinal cord stimulation therapy is stimulating the neural target without stimulating undesired areas.&nbsp;By taking into account the conductivity of 3D anatomical structures and physician placement of the spinal cord stimulator leads, the Illumina 3D Software is designed for simple point-and-click pain targeting.&nbsp;&nbsp;</span></p></div> AVP-923 phase II results in Alzheimer’s patients presented at ANA meeting 2014-10-21T12:40:00Z 2014-10-21T12:40:00Z <div id="ImageMain3" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction3" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Avanir Pharmaceuticals has announced that results from the phase II study evaluating AVP-923 for the treatment of agitation in patients with Alzheimer&rsquo;s disease were presented at the 2014 American Neurological Association meeting.</strong></span></p> </div><div id="Text13" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In this study, utilising the two-stage, sequential parallel comparison design (SPCD), AVP-923 showed a clinically meaningful and statistically significant improvement in agitation on the primary endpoint and a majority of the secondary endpoints. Key highlights from the poster were:&nbsp;</span>&nbsp;</p> <ul> <li><span style="font-size: 10pt;">AVP-923 showed a statistically significant benefit on the agitation/aggression domain of the Neuropsychiatric Inventory (NPI) (primary endpoint; p=0.00008)</span></li> <li><span style="font-size: 10pt;">The NPI agitation/aggression score was reduced by 3.3 points from baseline in AVP-923 treated patients at week five (stage 1; p=0.0002 vs. placebo) and was reduced by 2.0 points in stage 2 (p=0.021)</span></li> <li><span style="font-size: 10pt;">The change in the NPI agitation/aggression score corresponds to a mean (SD) reduction from baseline of 47 percent (43.1 percent) for AVP-923 vs. 22% (50.8%) for placebo in Stage 1, and 26% (67.5%) for AVP-923 vs. 6.7% (77.9%) for placebo in Stage 2</span></li> <li><span style="font-size: 10pt;">Treatment benefit with AVP-923 was evident at week one and was sustained for the duration of the 10-week study</span></li> <li><span style="font-size: 10pt;">AVP-923 also demonstrated significant improvements versus placebo on the following outcomes: NPI total score (p=0.014), NPI4A (p=0.001), NPI4D (p&lt;0.001), clinical global impression of change-agitation (p=0.0003), patient global impression of change (p=0.001) and measures of caregiver burden (p&lt;=0.05)</span></li> <li><span style="font-size: 10pt;">AVP-923 was generally safe and well-tolerated and associated with a low rate of discontinuation from the study (11.8%)</span></li> <li><span style="font-size: 10pt;">Treatment with AVP-923 was not associated with cognitive decline or somnolence</span></li> </ul> <p><span style="font-size: 10pt;">&ldquo;Agitation and aggression in Alzheimer&rsquo;s disease are among the most disruptive of dementia-related neuropsychiatric symptoms and leading causes of institutionalisation,&rdquo; says Jeffrey Cummings, director of the Cleveland Clinic Lou Ruvo Center for Brain Health, chair of the study steering committee and a paid member of Avanir Pharmaceuticals Advisory Board. &ldquo;These study results are encouraging for Alzheimer&rsquo;s patients suffering from agitation and their caregivers.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are highly encouraged by these data showing a nearly 50% reduction in agitation for patients treated with AVP-923. In addition, clear improvements in global measures of agitation, as assessed by both clinicians and patients/caregivers, indicate the improvement was deemed clinically meaningful,&rdquo; says Joao Siffert, chief medical officer for Avanir. &ldquo;We are committed to working with regulatory agencies in the United States and the EU with the goal to advance the programme and make the treatment available as early as possible, upon approval, for patients with Alzheimer&rsquo;s disease who have agitation.&rdquo;</span></p></div> Stenting safe and effective for long-term stroke prevention 2014-10-21T12:20:00Z 2014-10-21T12:20:00Z <div id="ImageMain4" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction4" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Using stents to keep neck arteries open is just as effective as invasive neck surgery for long-term prevention of fatal and disabling strokes, reports an international trial led by University College London funded by the Medical Research Council and Stroke Association.</strong></span></p> </div><div id="Text14" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The research paper, published in <a href="" target="_blank"><em>the Lancet</em></a>, was authored by researchers from University College London (UCL), Basel University, Switzerland, the London School of Hygiene &amp; Tropical Medicine, the University Medical Center Utrecht, Netherlands, Sheffield Teaching Hospitals NHS Foundation Trust, and Newcastle University.</span></p> <p><span style="font-size: 10pt;"><br />The study followed 1,713 patients with carotid artery disease, of whom 855 were assigned to stenting and 858 to endarterectomy, for up to 10 years. The median follow-up was 4.2 years. Both techniques were found to be equally good at preventing fatal and disabling strokes, but stented patients were slightly more likely to have minor strokes without long-term effects. The risk of any stroke in five years was 15.2% in the stenting group compared to 9.4% in the endarterectomy group, but the additional strokes were minor and had no impact on long-term quality of life.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;At the moment, stenting is not widely used in the UK due to historical uncertainty over its long-term effectiveness,&rdquo; says study leader Professor Martin Brown from the UCL Institute of Neurology. &ldquo;However, we have now shown that stenting is just as good as endarterectomy for preventing fatal and disabling strokes. We have also shown that the risk of stroke during the procedure is no higher for stenting than for endarterectomy in younger patients. The risks of each procedure are different and will vary depending on the patient, but stenting should be offered as an option to many more patients under the age of 70.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;One of the issues is that there are not many centres in this country that currently offer stenting as an option so the patient choice is not there. Now that we know stenting is effective in the long term, more staff should be trained to carry out the procedure and gain experience. Otherwise there is a vicious cycle where nobody at a centre has stenting experience so patients are only offered endarterectomy and staff cannot learn or observe the procedure. In other countries, stenting is more widespread and the safety of the procedure improves as staff gain experience.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Shamim Quadir, research communications manager at the Stroke Association, says: &ldquo;A transient ischaemic attack, also known as a mini-stroke, can be a warning sign that someone has carotid artery stenosis, and is at risk of having a major stroke. Preventative procedures to treat such carotid artery stenosis are therefore crucial.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Carotid endarterectomy is a common, yet invasive surgery used to treat carotid artery stenosis, and is widely used throughout the UK.&nbsp;Previously, far less was known about the long-term effectiveness of stenting as an alternative procedure.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;These latest research findings suggest that overall, stenting is just as safe, and equally effective for the long-term prevention of fatal and disabling strokes. Both procedures carry their own risks, and these will need to be considered for each individual patient.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This research provides a vital step in providing another viable option which will help people significantly reduce their stroke risk.&rdquo;</span></p></div> Drug-eluting balloon angioplasty shows excellent results for refractory recurrent carotid in-stent restenosis 2014-10-16T11:53:00Z 2014-10-16T11:53:00Z <div id="Introduction5" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Restenosis, the recurrence of narrowing of the arteries after stenting, is a common risk of this endovascular treatment. There are no well-defined guidelines to treat restenosis, but recent studies have shown excellent results with drug-eluting balloon angioplasty in coronary and femoral artery stents. However, few studies have focused on the carotid arteries, which take blood to the neck and head.</strong></span></p> </div><div id="Text15" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">A long-term follow-up study reports on the safety and success of drug-eluting balloon angioplasty in treating patients with carotid in-stent restenosis that has proven refractory to treatment with balloon angioplasty and/or redo stenting. The results of this study are published in the current issue of the <em><a href="" target="_blank">Journal of Endovascular Therapy</a>.</em> The researchers followed nine patients with significant (more than 80%) recurrent restenosis who underwent drug-eluting balloon angioplasty. In this procedure, a drug-eluting balloon is inflated for 60 seconds and delivers the drug paclitaxel, an inhibitor of the exuberant healing process after angioplasty that leads to restenosis.</span></p> <p><span style="font-size: 10pt;"><br />The angioplasty was successful in all 9 patients, with stenosis decreasing from 87% to 6%. These patients had clinical and ultrasound follow-up every three months during the first 24 months after the procedure, then were followed every six months. By approximately 36 months after the drug-eluting balloon angioplasty, only three patients were found to have recurrent in-stent restenosis at 18, 25, and 32 months, respectively, after the initial angioplasty, a far longer interval without restenosis than earlier treatments provided.</span></p> <p><span style="font-size: 10pt;"><br />These three patients underwent another drug-eluting balloon angioplasty procedure and did not experience restenosis at up to14 months after the second procedure. These results show the potential for the drug-eluting balloon treatment to improve outcomes for patients with early recurrent carotid in-stent restenosis.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />In a related commentary article, the authors discuss lessons learned through this research. Their primary advice is not to wait, but to choose drug-eluting balloon angioplasty for treatment after the first failure of conventional endovascular intervention. They also urge practitioners to keep up to date on the ongoing trials of this treatment.</span></p></div> NeuroSigma partners with US Veterans Administration for eTNS trial 2014-10-16T11:33:00Z 2014-10-16T11:33:00Z <div id="ImageMain6" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction6" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroSigma has announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the US Veterans Affairs for a clinical trial to evaluate the benefits of non-invasive, external trigeminal nerve stimulation (eTNS) for patients with traumatic brain injury.</strong></span></p> </div><div id="Text16" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Jean-Philippe Langevin, an expert in neurotrauma and a neurosurgeon at the Veterans Affairs Greater Los Angeles (VAGLA) medical centre, will lead the study as principal investigator.&nbsp;The project will enrol US military veterans with traumatic brain injury in an eight-week treatment protocol, and will examine change in cognitive function and regional brain activity as people receive nightly eTNS treatment at home.</span></p> <p><span style="font-size: 10pt;"><br />Traumatic brain injury is a condition that arises after mechanical injury to the brain. According to the Centers for Disease Control and Prevention, an estimated 5.3 million Americans currently live with traumatic brain injury-related disability, with an annual total cost in 2010 estimated at&nbsp;US$76.5 billion, including&nbsp;US$11.5 billion&nbsp;in direct medical costs and&nbsp;US$64.8 billion&nbsp;in indirect costs including lost wages, lost productivity, and nonmedical expenditures.&nbsp;The Department of Defense has reported approximately 200,000 cases of traumatic brain injury in troops between 2000 and June 2010. While many individuals recover fully, approximately 15 to 34% of individuals with mild or moderate traumatic brain injury have persistent symptoms that may interfere with their return to work or school, including difficulties with memory, decision making, attention, movement, and emotional functioning.&nbsp;These issues not only impact the injured individuals, but also can have lasting effects on their families and communities.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are excited to be working with Dr Langevin and his colleagues on this important project. There is an acute need for more non-invasive traumatic brain injury treatment options, not only for our veterans returning from overseas combat operations but also for the millions of Americans involved in motor vehicle accidents, falls, and sports-related concussions,&rdquo; says Lodwrick M Cook, chairman of NeuroSigma.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Neuroimaging data from PET scans suggest that eTNS can influence the activity of certain brain areas associated with the cognitive functions that are disrupted in traumatic brain injury.&nbsp;This effect may be able to help these individuals overcome their impairments and the purpose of this study is to gather evidence related to this hypothesis,&rdquo; adds Ian A Cook, NeuroSigma&rsquo;s chief medical officer and senior vice president.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We owe it to our veterans to evaluate whether eTNS can help with traumatic brain injury and are delighted to support this important phase I clinical trial by supplying&nbsp;Monarch&nbsp;eTNS systems. &nbsp;We are excited to be adding traumatic brain injury to our pipeline of therapies under development,&rdquo; says Leon Ekchian, NeuroSigma&rsquo;s president and chief executive officer.</span></p></div> First patient enrolled in pilot spinal cord injury trial 2014-10-16T11:20:00Z 2014-10-16T11:20:00Z <div id="Introduction7" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>InVivo Therapeutics has announced that the first subject has been enrolled in the pilot study of its Neuro-Spinal Scaffold for the treatment of complete traumatic spinal cord injury at the Barrow Neurological Institute at St Joseph&rsquo;s Hospital and Medical Center in Phoenix, USA. The objective of the pilot study is to evaluate the safety and feasibility of the Neuro-Spinal Scaffold as well as to gather preliminary evidence of effectiveness.</strong></span></p> </div><div id="Text17" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Nicholas Theodore, chief of Spinal Surgery, Barrow Neurosurgical Institute and medical director of the Neurological Trauma Program, is a principal investigator in this <a href="" target="_blank"><strong>study</strong></a> and implanted the first-ever Neuro-Spinal Scaffold into an acute spinal cord injury patient. &ldquo;I am excited about my participation in this important clinical trial,&rdquo; Theodore says. &ldquo;The surgery and Neuro-Spinal Scaffold implantation went smoothly and the patient is doing well at this time. I look forward to continuing to help evaluate this approach in patients with these devastating injuries.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Mark Perrin, InVivo&rsquo;s chief executive officer, says, &ldquo;This is a major milestone not only for the company, but also for the field of traumatic spinal cord injury. InVivo is striving to provide benefit to the spinal cord injury patient population with such a huge unmet medical need, and this clinical trial is the first step. We look forward to communicating our progress and moving forward. InVivo will be making announcements after each site has joined the study, after each subject is enrolled, and once enrolment is re-opened for subsequent patients. We consider patient privacy of the utmost importance and will thus communicate any interim information according to industry standards. With the exception of dramatically positive or negative results, we will look to communicate progress at appropriate medical or scientific forums.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />As previously stated and per FDA requirements, the company will follow the first enrolled subject for three months before re-opening enrolment.</span></p></div> Delay the Disease Parkinson’s programme gets participants moving again 2014-10-16T11:11:00Z 2014-10-16T11:11:00Z <div id="ImageMain8" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction8" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>OhioHealth &ldquo;Delay the Disease&rdquo;, an evidenced-based fitness programme designed for people with Parkinson&rsquo;s disease, is one of the newest members of the OhioHealth family of neuroscience programmes. The community-based wellness programme is designed to empower those living with Parkinson&rsquo;s disease by optimising their physical function and helping to delay the progression of symptoms associated with Parkinson&rsquo;s disease.</strong></span></p> </div><div id="Text18" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Medicare data show, in Ohio alone, more than 21,000 people are treated for Parkinson&rsquo;s disease each year, with 7,500 new cases diagnosed every year,&rdquo; says Connie Gallaher, OhioHealth System vice president of Neuroscience. &ldquo;With Delay the Disease, OhioHealth is able to bring this extraordinary programme to more Parkinson&rsquo;s patients, giving them the opportunity to help with management of the disease through exercise.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Delay the Disease programme compliments OhioHealth&rsquo;s full continuum of expert neurologists and neurological rehabilitation specialists, with a wellness programme offering fitness classes, Delay the Disease personal training, and instruction available as a book and DVD.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />David Zid and Jackie Russell have been partners in Delay the Disease since 2006. David Zid is certified through ACE as a personal trainer and APG as a functional fitness trainer. Jackie Russell saw the effects of Parkinson&rsquo;s disease through the eyes of a loved one, when her mother-in-law was diagnosed, and has collaborated with David on translating Delay the Disease to DVD and book formats, training new Delay the Disease instructors, and pioneering a &ldquo;Train the Caregiver&rdquo; community education programme.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Delay the Disease is an established programme in central Ohio, with approximately 2000 exercise classes conducted over the past seven years and more than 200 weekly participants. But the programme is not limited to Ohio, with classes held by certified Delay the Disease trainers across the USA.</span></p></div> Neuravi receives US patents for neurovascular clot capture and retrieval 2014-10-15T13:24:00Z 2014-10-15T13:24:00Z <div id="Introduction9" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Neuravi has announced that the US Patent Office has approved two patents covering its therapeutic platform for the endovascular treatment of acute ischaemic stroke.</strong></span></p> </div><div id="Text19" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The granting of US Patent #8,852,205 &ldquo;Clot Retrieval Device for Removing Occlusive Clot from a Blood Vessel&rdquo; and US Patent #8,777,976 B2 &ldquo;Clot Capture Systems and Associated Methods&rdquo; expands Neuravi&rsquo;s US granted portfolio to 33 patents. These new patents disclose unique design elements intended to enable both clot disengagement and capture and so facilitate the protected removal of hazardous clot from the brain. The CE-marked Embotrap revascularisation system incorporates these advanced features into its design.</span></p> <p><span style="font-size: 10pt;"><br />According to David Vale, chief technology officer for Neuravi, the company has established its extensive portfolio by a combination of external licensing and internal R&amp;D. &ldquo;This approach has given us a great combination of very early priority filings on the base technology as well as strong protection on the more advanced third generation features. The extensive Neuravi patent portfolio continues to be strengthened by our R&amp;D team&rsquo;s commitment to developing technologies that tackle some of the most daunting clinical challenges in treating this patient population,&rdquo; says Vale.</span></p> <p><span style="font-size: 10pt;"><br />The Embotrap revascularisation device takes an inside-out approach to rapidly and safely restoring blood flow to the affected brain tissue. The device is designed to trap the clot inside a proprietary structure that the company calls a Stent-Trap while the device restores blood flow to the brain. The Stent-Trap structure is engineered to retain the clot during the retrieval process, and features a multi-dimensional fragment protection zone. Physicians have observed that minimizing distal and new territory embolisation during endovascular stroke therapy may play an important role in patient outcomes.</span></p> <p><span style="font-size: 10pt;"><br />The EmboTrap received CE mark approval in 2013 and is not yet available for use in the United States.</span></p></div> Treeway BV and Leiden Academic Center for Drug Research collaborate on ALS therapy development 2014-10-15T11:51:00Z 2014-10-15T11:51:00Z <div id="Introduction10" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Treeway and Leiden Academic Center for Drug Research (LACDR) at the University of Leiden join forces and form a collaboration focused on the optimisation of clinical trial designs and data-analysis for ALS (Amyotrophic Lateral Sclerosis) through the use of population disease progression models. Furthermore both parties aim to obtain a better understanding of the disease by developing ALS physiology-based disease models and to test the effect of interventions in the different identified pathways.</strong></span></p> </div><div id="Text110" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The scope of this collaboration encompasses two assignments:</span></p> <p><span style="font-size: 10pt;"><br />1. Development of a population disease progression model for ALS. Currently a phase 3 clinical trial with Treeway&rsquo;s drug candidate TW001 is being developed. The availability of a mathematical model characterising both the average as well as individual time course of disease development will enable optimisation of the trial design, as well as a more effective analysis of the study data.</span></p> <p><span style="font-size: 10pt;"><br />2. Development of an in silico ALS physiology-based disease model. This in silico ALS disease model should provide insight in the complex interaction between neurological and immunological processes, and the cell signalling networks in this. The model can be used to test what-if scenarios and explore the impact of interventions via different pathways.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Inez de Greef, chief executive officer of Treeway says, &ldquo;By applying pharmacometric modelling and clinical trial simulations we can streamline our clinical development programmes for new treatments for ALS. In addition, the physiology-based model will provide direction to our discovery efforts. We are glad to work together with professor Piet Hein van der Graaf and his group at LACDR, as they are international leaders in this field.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Professor Piet Hein van der Graaf, director of the LACDR and head of the Department of Pharmacology at the University of Leiden believes the collaboration with Treeway signals an important trend in drug discovery and development: &ldquo;Rare and neglected diseases have been ignored by large pharmaceutical companies due to the limited return on high-risk R&amp;D investment. Therefore, collaborations like this between academics and small entrepreneurial biotech companies will be of vital importance to bring new medicines to patients in areas of high unmet medical need like ALS.&rdquo;</span></p></div> Disputed theory on Parkinson’s origin strengthened 2014-10-15T11:19:00Z 2014-10-15T11:19:00Z <div id="ImageMain11" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction11" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Parkinson&rsquo;s disease is strongly linked to the degeneration of the brain&rsquo;s movement centre. In the last decade, the question of where the disease begins has led researchers to a different part of the human anatomy. In 2003, the German neuropathologist Heiko Braak presented a theory suggesting that the disease begins in the gut and spreads to the brain. The idea has since, despite vocal critics, gained a lot of ground. Researchers at Lund University in Sweden now present the first direct evidence that the disease can actually migrate from the gut to the brain.&nbsp;</strong></span></p> </div><div id="Text111" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The so-called Braak&rsquo;s hypothesis proposes that the disease process begins in the digestive tract and in the brain&rsquo;s centre of smell. The theory is supported by the fact that symptoms associated with digestion and smell occur very early on in the disease.</span></p> <p><span style="font-size: 10pt;"><br />Researchers at Lund University have previously mapped the spread of Parkinson&rsquo;s in the brain. The disease progression is believed to be driven by a misfolded protein that clumps together and &ldquo;infects&rdquo; neighbouring cells. Professor Jia-Yi Li&rsquo;s research team has now been able to track this process further, from the gut to the brain in rat models. The experiment shows how the toxic protein, alpha-synuclein, is transported from one cell to another before ultimately reaching the brain&rsquo;s movement centre, giving rise to the characteristic movement disorders in Parkinson&rsquo;s disease.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We have now been able to prove that the disease process actually can travel from the peripheral nervous system to the central nervous system, in this case from the wall of the gut to the brain. In the longer term, this may give us new therapeutic targets to try to slow or stop the disease at an earlier stage,&rdquo; says Professor Jia-Yi Li, research group leader for&nbsp;Neural Plasticity and Repair&nbsp;at Lund University.</span></p> <p><span style="font-size: 10pt;"><br />The research team will now carry out further studies in which the mechanisms behind the transport of the harmful protein will be examined in detail. The current study suggests that the protein is transferred during nerve cell communication. It is at this point of interaction that the researchers want to intervene in order to put a stop to the further spread of the disease.</span></p></div> Mechanism that repairs brain after stroke discovered 2014-10-13T11:35:00Z 2014-10-13T11:35:00Z <div id="ImageMain12" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction12" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A previously unknown mechanism through which the brain produces new nerve cells after a stroke has been discovered at Lund University and Karolinska Institutet in Sweden. The findings have been published in the journal <a href="" target="_blank"><em>Science</em></a>.</strong></span></p> </div><div id="Text112" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The researchers have shown that following an induced stroke in mice, support cells, so-called astrocytes, start to form nerve cells in the injured part of the brain. Using genetic methods to map the fate of the cells, the scientists could demonstrate that astrocytes in this area formed immature nerve cells, which then developed into mature nerve cells.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This is the first time that astrocytes have been shown to have the capacity to start a process that leads to the generation of new nerve cells after a stroke,&rdquo; says Zaal Kokaia, professor of Experimental&nbsp;Medical Research at Lund University.</span></p> <p><span style="font-size: 10pt;"><br />The scientists could also identify the signalling mechanism that regulates the conversion of the astrocytes to nerve cells. In a healthy brain, this signalling mechanism is active and inhibits the conversion, and, consequently, the astrocytes do not generate nerve cells. Following a stroke, the signalling mechanism is suppressed and astrocytes can start the process of generating new cells.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Interestingly, even when we blocked the signalling mechanism in mice not subjected to a stroke, the astrocytes formed new nerve cells,&rdquo; says Zaal Kokaia. &ldquo;This indicates that it is not only a stroke that can activate the latent process in astrocytes. Therefore, the mechanism is a potentially useful target for the production of new nerve cells, when replacing dead cells following other brain diseases or damage.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The new nerve cells were found to form specialised contacts with other cells. It remains to be shown whether the nerve cells are functional and to what extent they contribute to the spontaneous recovery that is observed in a majority of experimental animals and patients after a stroke.</span></p> <p><span style="font-size: 10pt;"><br />A decade ago, Kokaia&rsquo;s and Lindvall&rsquo;s research group was the first to show that stroke leads to the formation of new nerve cells from the adult brain&rsquo;s own neural stem cells. The new findings further underscore that when the adult brain suffers a major blow such as a stroke, it makes a strong effort to repair itself using a variety of mechanisms.</span></p> <p><span style="font-size: 10pt;"><br />The major advancement with the new study is that it demonstrates for the first time that self-repair in the adult brain involves astrocytes entering a process by which they change their identity to nerve cells.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;One of the major tasks now is to explore whether astrocytes are also converted to neurons in the human brain following damage or disease. Interestingly, it is known that in the healthy human brain, new nerve cells are formed in the striatum. The new data raise the possibility that some of these nerve cells derive from local astrocytes. If the new mechanism also operates in the human brain and can be potentiated, this could become of clinical importance not only for stroke patients, but also for replacing neurons which have died, thus restoring function in patients with other disorders such as Parkinson&rsquo;s disease and Huntington&rsquo;s disease,&rdquo; says Olle Lindvall, senior professor of&nbsp;Neurology.</span></p></div> New Envoy catheters launched 2014-10-11T15:01:00Z 2014-10-11T15:01:00Z <div id="ImageMain13" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction13" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Codman Neuro has announced the Europe, Middle East and Africa launch of the EnvoyDA XB Distal Access Guiding Catheter and the 7F Envoy Guiding Catheter for neurovascular procedures.</strong></span></p> </div><div id="Text113" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;To support evolving treatment techniques and the need for versatile access solutions we have expanded our Envoy guide catheter line to provide interventional neuro-radiologists with choice. The Envoy DA XB and the 7F Envoy have been designed to deliver distinct advantages during neurovascular procedures whilst providing the reliable navigation and stability associated with the Envoy range of guide catheters,&rdquo; says Bertrand L&rsquo;Huillier, director of Codman EMEA.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><strong><br />The Envoy DA XB Guiding Catheter</strong></span></p> <p><span style="font-size: 10pt;"><br />The Envoy DA XB Guiding Catheter enables access to more distal anatomy and is designed to provide additional proximal support of the catheter when more stability is required. The new catheter is part of the Envoy DA Guiding Catheter family designed with a soft &amp; flexible distal segment for easy navigation and ease of placement into the petrous segment. It features a .071-inch inner lumen for smooth advancement of multiple indwelling devices, end-to-end braided construction, a distal 10cm hydrophilic coating, soft distal tip with a recessed metal marker, and BRITE TIP<sup> &nbsp;</sup>technology for enhanced visibility.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The combination of supportive stability and flexible distal accessibility of the Envoy DA XB makes this my preferred guiding catheter in the majority of neurovascular procedures,&rdquo; says Maurits Voormolen, Division of Interventional Neuroradiology at Antwerp University Hospital, Belgium.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><strong><br />7F Envoy Guiding Catheter</strong></span></p> <p><span style="font-size: 10pt;"><br />The 7F Envoy Guiding Catheter is the largest-diameter guiding catheter the company has ever offered, expanding upon the leading 6F Envoy Guiding Catheters, it is the only 7F catheter on the market specifically designed for neuro procedures. With stainless steel end-to-end hybrid braid technology and soft distal BRITE TIP technology, the new catheters are offered in multiple shape configurations to enhance navigation of different anatomies.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The 7F Envoy Guiding Catheter offers a significant increase in stability in comparison to the 6F guiding catheters, and circumvents the need to replace the guiding catheter during the procedure as well as the need for an intermediate catheter. In my opinion, the key advantage is the possibility of using multiple micro-catheters within the large inner lumen as required by the Pressure Cooker Technique or the double balloon remodeling technique, where both remodelling catheters and a third micro-catheter for coiling can be placed through the Envoy 7F.&rdquo; says Ren&eacute; Chapot, Division of Interventional Neuroradiology at Essen University Hospital, Germany.</span></p></div> Neuroscientists claim rare pair of research grants 2014-10-10T11:35:00Z 2014-10-10T11:35:00Z <div id="Introduction14" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>In a rare distinction for one university, neuroimaging world leaders and University of Southern California (USC) Professors Arthur Toga and Paul Thompson will receive two major research centre awards to advance their exploration of the human brain.</strong></span></p> </div><div id="Text114" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Toga and Thompson each will establish a Center of Excellence under a National Institutes of Health initiative to mine discoveries from the vast and exponentially growing amounts of data created by imaging science, genetic sequencing and many other biomedical fields.</span></p> <p><span style="font-size: 10pt;"><br />The awards total US$12 million and US$11 million for Toga and Thompson respectively over four years. NIH is funding several Centers of Excellence, including the two at USC, under its Big Data to Knowledge initiative.</span></p> <p><span style="font-size: 10pt;"><br />The two researchers&rsquo; teams have gathered what they believe to be the world&rsquo;s largest collection of brain scans. The collection is housed at the USC Institute for Neuroimaging and Informatics and continues to double in size every two years. The two centre grants will allow the researchers to move from data collection to large-scale analyses that could point to new treatments for autism, Alzheimer&rsquo;s disease, mental illness and many other neurological diseases and disorders.</span></p> <p><span style="font-size: 10pt;"><br />Toga and Thompson came to USC a year ago as leaders of a massive neuroimaging cluster of 110 faculty, researchers and multidisciplinary staff. Their recruitment was a signature moment in the university&rsquo;s drive to attract scholars with the potential to transform their fields.</span></p> <p><span style="font-size: 10pt;"><br />When the recruitment was announced, USC president C L Max Nikias said: &ldquo;This cluster hire will help us move one step closer to understanding the structure and function of the human brain.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The NIH initiative signals the agency&rsquo;s commitment to invest in the same goal. The university&rsquo;s own Digital USC initiative, established last year by Provost Elizabeth Garrett, supports neuroimaging research as part of a commitment of US$1 billion over 10 years toward gathering, interpreting and applying digital data on a massive scale.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;In receiving substantial grants supporting one of the NIH&rsquo;s priority initiatives, Professors Toga and Thompson and their USC colleagues expand this university&rsquo;s leadership in the areas of neuroscience, informatics, and big data. More important is the potential for consequential research produced within these new centres to influence our basic understanding of the brain and identify causes of brain-related diseases,&rdquo; Garrett says.</span></p> <p><span style="font-size: 10pt;"><br />Toga&rsquo;s NIH award will establish the Big Data for Discovery Science Center, which aims to develop database systems and computational strategies to help scientists and physicians mine complex data about the brain.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The unifying focus of the BDDS Center is to promote a &lsquo;science of discovery,&rsquo;&rdquo; says Toga, who also directs the USC Institute for Neuroimaging and Informatics. &ldquo;Around the globe, we are collecting massive amounts of biomedical data, but the technology to process it all does not exist. We are proposing to create the framework that is essential to truly understand how the brain works and functions.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Thompson will head the ENIGMA Center for Worldwide Medicine, Imaging and Genomics, a global consortium of more than 300 researchers sharing data to study nine major brain diseases. The worldwide effort is developing tools to discover predictive factors in the genome that affect brain development and disease.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;ENIGMA is the largest alliance in the world studying factors that help or harm the brain,&rdquo; says Thompson, who also is director of the USC Imaging Genetics Center. &ldquo;We will develop new computational algorithms to integrate this vast array of data available to us to find biomarkers of mental illness and brain diseases, allowing for better diagnostics and more personalised medical treatment. In a way, we are extending the mathematics currently used for code-breaking and pattern recognition to find patterns in the brain.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The NIH launched the BD2K initiative in 2013 to support research, implementation, and training in data science that would enable biomedical scientists to maximise the use of large datasets in their studies.</span></p> <p><span style="font-size: 10pt;"><br />Toga is a Provost Professor in the Departments of Ophthalmology, Neurology, Psychiatry and the Behavioral Sciences, and Radiology in the Keck School of Medicine of USC, with a joint appointment in the USC Viterbi School of Engineering. In addition to directing the Institute for Neuroimaging and Informatics, he leads the Laboratory of Neuro Imaging, also at USC.</span></p> <p><span style="font-size: 10pt;"><br />Thompson is Associate Dean for Research and Professor of Neurology, Psychiatry, Radiology, Pediatrics and Ophthalmology in the Keck School, with a joint appointment in the USC Viterbi School of Engineering. In addition to directing the USC Imaging Genetics Center, he serves on the faculty of the Institute for Neuroimaging and Informatics and the Laboratory of Neuro Imaging.</span></p></div> First patient treated in US pivotal trial evaluating cerebral protection during TAVI 2014-10-09T16:04:00Z 2014-10-09T16:04:00Z <div id="ImageMain15" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction15" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Claret Medical has announced that the first patient has been successfully treated in its SENTINEL Trial in the United States, a multicentre pivotal trial of the Sentinel Cerebral Protection System (CPS). The landmark SENTINEL Trial is the first prospective, randomised, controlled, blinded trial in the USA to evaluate the role of cerebral protection during transcatheter aortic valve implantation (TAVI).</strong></span></p> </div><div id="Text115" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The first patient was treated at New York and Presbyterian Hospital/Columbia&nbsp;University Medical Center by Susheel Kodali, a national co-principal investigator for the trial. The SENTINEL Trial will evaluate up to 284 patients at up to 15 centres nationwide.</span></p> <p><span style="font-size: 10pt;"><br />The primary endpoints for the <a href=";rank=1" target="_blank"><strong>SENTINEL</strong></a> Trial are the reduction in total new lesion volume as determined by diffusion-weighted magnetic resonance imaging (DW-MRI) and major adverse cardiac and cerebrovascular events (MACCE). A number of secondary endpoints, such as neurocognitive and histopathological outcomes during TAVI, will be compared in the study arms with and without cerebral protection.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Any occurrence of stroke is one too many, and results from this clinical trial may give us the evidence needed to make cerebral protection a standard of care during TAVI, as it is in carotid artery stenting,&rdquo; says Samir Kapadia, director of the Cleveland Clinic&rsquo;s Sones Cardiac Catheterization Laboratories and a national co-principal investigator for the study. &ldquo;By both capturing and removing embolic debris released during TAVI, the Sentinel CPS may offer a unique neuroprotective benefit. We expect the device to demonstrate a similarly significant reduction in the number and size of lesions in the brains of TAVI patients when cerebral protection is used as was recently reported in the CLEAN-TAVI trial.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />At last month&rsquo;s Transcatheter Cardiovascular Therapeutics (TCT) meeting, 30 day results from the <a href=";rank=1" target="_blank"><strong>CLEAN-TAVI</strong></a> randomised, controlled trial studying Claret Medical&rsquo;s cerebral protection system were presented as a Late Breaking Clinical Trial session, demonstrating:</span></p> <ul> <li><span style="font-size: 10pt;">53% reduction in the total volume of new brain lesions and 60% reduction in the number of new brain lesions two days after the TAVI procedure when the Claret Medical cerebral protection system was used</span></li> <li><span style="font-size: 10pt;">24% incidence of the neurological symptoms of ataxia in the control group as compared to 9% in the treatment group protected with the Claret Medical system in a &ldquo;Per Protocol&rdquo; analysis at two days, which reached statistical significance</span></li> <li><span style="font-size: 10pt;">Observed neurological deficit in 28% of all control patients at two days post-procedure when evaluated by a NIHSS (National Institute of Health Stroke Scale) trained specialist in an &ldquo;Intent to Treat&rdquo; analysis, demonstrating that prospective assessment pre- and post-procedure can identify more neurological effects than has been reported to date</span></li> </ul> <p><span style="font-size: 10pt;">Stroke continues to be a devastating complication of TAVI procedures, occurring in approximately two to eight per cent of procedures according to published literature. Recently, new ischaemic brain lesions, or &ldquo;silent&rdquo; infarcts, have been shown to occur in more than 90% of TAVI patients. These lesions have been associated with adverse neurologic and cognitive consequences, and dementia. They have also been shown to increase the risk of stroke by two to four times in future years, according to population-based studies published in the 2013 American Stroke Association/American Heart Association consensus guidelines.</span></p></div> IMRIS intraoperative imaging solutions to be featured at CNS 2014-10-09T15:43:00Z 2014-10-09T15:43:00Z <div id="ImageMain16" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction16" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>IMRIS has announced that use of intraoperative imaging for optimising workflow with neurosurgical focal therapies will be featured in its exhibition space at the Congress of Neurosurgical Surgeons (CNS) meeting (20&shy;&shy;&ndash;22 October, Boston, USA). IMRIS invites meeting attendees to visit booth 442.</strong></span></p> </div><div id="Text116" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Emerging focal therapies such as laser ablation and neuro-navigation combined with intraoperative MRI in the VISIUS Surgical Theatre allow for expanding minimally invasive techniques and accurate placement of tools for improved outcomes. According to the company, IMRIS products provide surgeons on-demand access to real-time, state-of-the-art imaging during procedures in the operating room without moving the patient. VISIUS Surgical Theatres by IMRIS are equipped with either high-field MR or 64-slice computed tomography (CT) that move to the patient on ceiling-mounted rails.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We continue to develop and put into the hands of neurosurgeons cutting edge visualisation which support these growing less invasive treatment options for improving patient outcomes,&rdquo; says Jay D Miller, IMRIS president and chief executive officer. &ldquo;In some of these cases, these innovations are offering patients new hope for conditions once considered inoperable. The VISIUS Surgical Theatre is an ideal platform for neurosurgeons by enabling therapies in the operating room with enhanced surgical planning and assessment without moving the patient.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />IMRIS also designs and manufactures proprietary head fixation devices, horseshoe headrests, imaging coils, and operating room tables for use in this unique and multifunctional intraoperative environment.</span></p></div> Kadimastem approached the FDA regarding its ALS treatment 2014-10-07T15:50:00Z 2014-10-07T15:50:00Z <div id="Introduction17" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Israeli biotechnology company Kadimastem has announced that it has approached the FDA regarding the cellular treatment it is developing for ALS. This is the initial approach the company is making to the FDA. In the framework of talks with the FDA, Kadimastem intends to consolidate a preliminary outline for its continuing trials for this indication.</strong></span></p> </div><div id="Text117" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Recently, the company reported positive results in a pre-clinical trial it conducted. In the trial, the efficacy of injecting support cells (astrocytes), produced by the company in a unique technology, into the spinal fluid of ALS model mice, was tested. This model is highly significant in predicting the treatment&rsquo;s activity in humans.</span></p> <p><span style="font-size: 10pt;"><br />The results of the trial showed an increased life expectancy in the mice treated, as well as a significant improvement of their motor (muscle) function, compared to the untreated mice. The efficacy of the treatment was also demonstrated in other indices indicating a delay in disease onset. Injections into the spinal fluid are standard procedure performed routinely in hospitals around the world. The company found that injections into the spinal fluid enable the even dispersion of cells throughout the central nervous system, thereby establishing the method of cell penetration in future treatment of patients.</span></p> <p><span style="font-size: 10pt;"><br />Professor Michel Revel, the company&rsquo;s chief scientist, notes, &ldquo;This is an important step in the company&rsquo;s progress towards the development of cellular therapy for ALS patients. Kadimastem is developing an industrial product, and is designing the cell production process while ensuring the required safety and reliability regulations. The early contact with the regulatory authorities is vital for the success of the development.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Yossi Ben-Yossef, the company&rsquo;s chief executive officer, notes, &ldquo;Since the publishing of the initial results of the pre-clinical trial, we are operating to advance the process with the FDA. Upon receiving the FDA&rsquo;s feedback, we will pursue the clinical development of cellular treatment for ALS.&rdquo;</span></p></div> ALS Association announces initial commitment of US$21.7 million from Ice Bucket Challenge donations 2014-10-03T16:33:00Z 2014-10-03T16:33:00Z <div id="Introduction18" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>After the generous outpouring of support from people all around the globe due to this summer&rsquo;s Ice Bucket Challenge, the Board of Trustees of The ALS Association has approved an initial expenditure of US$21.7 million in funding to support six programmes and initiatives to expedite the search for treatments and a cure for amyotrophic lateral sclerosis (ALS). Additionally, US$12.5 million in matching donations bring the total commitment to US$34.2 million.</strong></span></p> </div><div id="Text118" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Four of these projects involve global research cooperative alliances that would not have moved forward without this significant funding from The Association, made possible through the generosity of donors worldwide, along with matching gifts.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We recognise the sense of urgency felt by people living with the disease and their families and I want to assure everyone that our number one commitment is to making decisions that get treatments to patients in the fastest way possible,&rdquo; says Barbara Newhouse, president and chief executive officer of The ALS Association. &ldquo;Our roadmap to treatments involves collaboration with other ALS organisations and with industry, university investigators, government agencies, pharmaceutical and biotech companies and other nonprofit organisations committed to the fight against ALS.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />During a 30-day period this summer, The ALS Association received more than US$100 million in donations. Over the last few weeks, The Association has actively convened key stakeholder groups, including a panel of advisors made up of people living with ALS, to provide input into a comprehensive plan that The Association will release in early November after approval from the Board of Trustees.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The bulk of The ALS Association&rsquo;s initial US$21.7 million commitment&mdash;US$18.5 million&mdash;will advance four new cooperative alliances for the next one to three years involving research that has been identified as critical to finding new treatments for ALS: ALS Accelerated Therapeutics (ALS ACT), The New York Genome Center, the Neuro Collaborative, and Project MinE. These projects would not have been possible without Ice Bucket Challenge donations.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />There will be synergies between these four initiatives that will increase the quantity, and most importantly, the value of data openly available to the ALS research community worldwide. The ALS Association will play a pivotal role in coordinating these efforts.</span></p> <p><span style="font-size: 10pt;"><br />Under the leadership of The ALS Association&rsquo;s chief scientist, Lucie Bruijn, the Association has been involved in the planning of each of these new collaborations, and, in each case, has sought the advice and evaluation of leading researchers to assess scientific merit, to gather additional ideas for each project, and to ensure the maximum relevance to future therapies.&nbsp;</span></p> <p><span style="font-size: 10pt;"><strong><br />ALS&nbsp;Accelerated&nbsp;Therapeutics (ALS ACT)</strong></span></p> <p><span style="font-size: 10pt;"><br />ALS ACT is a novel academic-industry partnership to accelerate treatments for people living with ALS, which is able to proceed with a US$10 million commitment from The ALS Association and matching gift of US$10 million from The ALS Finding a Cure Foundation.</span></p> <p><span style="font-size: 10pt;"><br />The combined contributions from The ALS Association and the ALS Finding a Cure Foundation will significantly expedite therapy development. The ALS Finding a Cure Foundation is led by Peter N Foss, Lee Rizzuto and Denis Rizzuto. The foundation was created in April of 2014 and is a tribute to Denis&rsquo; wife, Christie Rizzuto, who was diagnosed with ALS five years ago at age 41. ALS ACT will enact a multi-pronged approach to expediting clinical trials in ALS. Efforts will include (1) developing neuroimaging tools as potential biomarkers for ALS progression, a key unmet need in trials; (2) development of therapeutic approaches to decrease production of misfolded proteins within motor neurons and reverse neuroinflammation, two major contributors to the disease process; (3) a challenge grant programme to overcome key roadblocks in the search for therapies; (4) support for phase IIA pilot clinical trials using biomarkers. Merit Cudkowicz, co-chair of the Northeast ALS Consortium (NEALS) and chief of neurology and the ALS Program at Massachusetts General Hospital (MGH), notes that these efforts will accelerate diagnosis, speed development of new treatments for people with ALS, and remove road blocks to finding a cure for ALS.</span></p> <p><span style="font-size: 10pt;"><br />In addition, ALS ACT will strengthen ongoing collaborative efforts in support of clinical trials, including NeuroBANK, a central repository for clinical research data in ALS, and the NEALS (Northeast ALS Consortium) Biorepository. Initially established through the&nbsp;Translational&nbsp;Research&nbsp;Advancing&nbsp;Therapies for ALS (TREAT ALS) NEALS Clinical Trials Network, NeuroBANK will host, curate, and disseminate proteomic, genomic and clinical data.</span></p> <p><span style="font-size: 10pt;"><br />Investigators:&nbsp;Merit Cudkowicz, Massachusetts General Hospital; Robert J Brown, Jr, University of Massachusetts; Stanley H Appel, Houston Methodist Hospital System; and Clive Svendsen, Cedars-Sinai; Nadeem Ishaque, and Tom Gentile senior vice president General Electric.</span></p> <p><span style="font-size: 10pt;"><strong><br />New York Genome Center (NYGC)</strong></span></p> <p><span style="font-size: 10pt;"><br />The ALS Association and its Greater New York Chapter will match a US$2.5 million gift from The Tow Foundation in support of a new project at the NYGC, which will bring together for the first time a world-class scientific team to further understand the genetic basis of ALS. Recent discoveries have indicated that genes may contribute to a much larger percentage of ALS cases than previously thought. Finding these genes and understanding how they work will allow development of new therapeutic approaches. Under the leadership of Drs Robert Darnell and Hemali Phatnani together with their advisors, including Tom Maniatis and Marc Tessier-Lavigne , the NYGC will spearhead a cooperative and multidisciplinary effort to provide open-source &ldquo;big data&rdquo; to benefit the entire ALS research community.</span></p> <p><span style="font-size: 10pt;"><br />Investigators:&nbsp;Robert B Darnell; Hemali Phatnani; Tom Maniatis; Marc Tessier-Lavigne; Merit Cudkowicz; Robert J Brown, Jr; Virginia Lee; John Q Trojanowski, Alex Sherman; James Berry; Neil Shneider; David Goldstein; and Tom Jessell.</span></p> <p><span style="font-size: 10pt;"><strong><br />Neuro Collaborative</strong></span></p> <p><span style="font-size: 10pt;"><br />The Neuro Collaborative will combine the efforts of three world renowned California labs focused on ALS: Cedars-Sinai in Los Angeles, the University of California San Diego and the Gladstone Institutes, an affiliate of the University of California San Francisco, to develop and expedite therapeutic approaches for ALS. The collaborative, which now has funding to proceed with US$5 million in Ice Bucket Challenge funding from The ALS Association, will focus on the following: (1) development of antisense therapy for the C9orf72 gene, the most common genetic cause of ALS, in partnership with Biogen-Idec and ISIS Pharmaceuticals; (2) gene therapy to down regulate SOD1, the second-most common ALS gene; (3) establishment of a Stem Cell and Motor Neuron Core Facility to create clinical-grade induced pluripotent stem (iPS) cell lines, which will be openly shared with the ALS research community. iPS cells have emerged as a key research tool and potential source of therapeutic cells in ALS.( 4) Using a novel screening tool, identify new targets for drug development and in partnership with the industry these leads will be developed further with the potential of new treatment options in the clinic. The Golden West Chapter of The ALS Association has played a key role in the planning and development of this project.</span></p> <p><span style="font-size: 10pt;"><br />Investigators:&nbsp;Don Cleveland, UCSD; Steven Finkbeiner, the Finkbeiner lab at the Gladstone Institutes; Clive Svendsen, Cedar Sinai Medical Center; and collaborators, Martin Marsala, UCSD; and Brian Kaspar, Children&rsquo;s Hospital and Ohio State University.</span></p> <p><span style="font-size: 10pt;"><strong><br />Project MinE</strong></span></p> <p><span style="font-size: 10pt;"><br />Project MinE&nbsp;is a global collaboration with the goal to sequence the genomes of at least 15,000 people with ALS in an effort to discover new genes that affect ALS, either increasing the risk for the disease or protecting against it. The ALS Association&rsquo;s funding commitment of US$1 million will enable Project MinE to expand to the United States.&nbsp;</span><br /> <br /><span style="font-size: 10pt;"> <br />It has become clear that risk for ALS is likely influenced by variants in multiple genes, each of which is relatively rare. The development of advanced sequencing technologies has dramatically reduced the cost of screening large numbers of individuals for these rare variants. Discovering these variants, and understanding how they contribute to disease, or protect against it, is likely to lead to novel approaches to ALS therapies.</span><br /> <br /><span style="font-size: 10pt;"> <br />US investigators:&nbsp;John Landers, University of Massachusetts, Worcester; Jonathan Glass, Emory University.</span><br /> <br /><span style="font-size: 10pt;"> International partners include the Netherlands, United Kingdom, Ireland, Spain, Portugal and Belgium.</span><br /> <br /><span style="font-size: 10pt;"> <br />In addition to the abovementioned collaborative alliances to drive forward ALS research, The ALS Association&rsquo;s Board of Trustees also approved two other projects to expedite the search for treatments and a cure for the disease through care services and public policy efforts.</span></p> <p><span style="font-size: 10pt;"><strong><br />Grants to Certified Treatment Centers of Excellence</strong></span></p> <p><span style="font-size: 10pt;"><br />The ALS Association and its network of chapters currently partner with 43 ALS Association Certified Treatment Centers of Excellence across the United States. Multiple studies have shown the value to a patient of attending a multidisciplinary clinic, including longer survival, increased quality of life, and improved access to potential therapies. One of the requirements in achieving certification through The ALS Association is for the institution to be actively involved in ALS-related research and to provide information to people living with the disease on research outside of their institution. Participation in clinical trials is imperative to the research process to find treatments for the disease. The Ice Bucket Challenge donations have enabled The Association to increase its annual grants to the centres from the presently budgeted US$12,500 to US$25,000 per centre, which was the funding level pre-2008, for the next three years.</span></p> <p><span style="font-size: 10pt;"><strong><br />Regulatory Guidance to Expedite Drug Development</strong></span></p> <p><span style="font-size: 10pt;"><br />Organisations involved in two other neurological diseases (Alzheimer&rsquo;s and Duchenne Muscular Dystrophy) have seen great benefits in working to develop guidance for companies to help them navigate the regulatory pathway for approval of effective therapies. The enactment of the patient-focused drug development elements of the Food and Drug Administration Safety and Innovation Act (FDASIA) presents a unique opportunity for The ALS Association to help expedite drug development by developing similar guidance for ALS. No such guidance exists today for ALS, which creates uncertainty and risk for what is already a difficult and costly process. By developing this guidance, The ALS Association will be able to build on and strengthen its engagement with the FDA, industry and people with ALS about drug development as a regulatory process, which will reduce obstacles that can slow and limit innovation and access to effective treatments.</span></p></div> IMRIS horseshoe headrest named Life Sciences Alley New Technology Showcase winner 2014-09-30T18:14:00Z 2014-09-30T18:14:00Z <div id="ImageMain19" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction19" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>IMRIS announced that its horseshoe headrest has been selected one of 10 New Technology Showcase Winners by Twin Cities-based Life Sciences Alley (LSA), the USA&rsquo;s largest regional medical industry association. The first MR-safe and CT-compatible horseshoe headrest was introduced in February and will be among the products featured at the LSA Health Technology Leadership Conference on 19 November in Minneapolis, USA.</strong></span></p> </div><div id="Text119" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Our products are the result of a core competency in designing patient-centred intraoperative imaging solutions. Leading paediatric neurosurgeons provided strong insights for developing this product and now those who have adopted it are serving a patient population not previously treated in the VISIUS Surgical Theatre for anticipated improved outcomes,&rdquo; says Jay D Miller, IMRIS president and chief executive officer. &ldquo;We look forward to sharing our headrest and other intraoperative imaging solutions with international industry professionals at the LSA conference.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />For procedures within the VISIUS Surgical Theatre, the horseshoe headrest provides non-pinned patient head support in prone, lateral, and supine positions during head, neck and cervical spine surgeries where use of a head fixation device - a clamp-like device - is not desirable because the skull is too fragile for pinning. These patients may be babies whose skulls are still soft or older patients with weakened skull bones.</span></p> <p><span style="font-size: 10pt;"><br />The headrest also was specially designed for use with the new IMRIS InSitu wireless coil, a sterile, wireless, ultra-lightweight, and disposable imaging coil that eliminates the need to manage cables and heavy imaging coils typically draped and removed between intraoperative scans.</span></p> <p><span style="font-size: 10pt;"><br />Inside a VISIUS Surgical Theatre equipped with either high-field intraoperative MRI (iMRI) or 64-slice intraoperative Computed Tomography (iCT), surgeons have on-demand access to real-time diagnostic quality imaging during the procedure and from the operating room table as the scanner uniquely moves to the patient on ceiling-mounted rails. VISIUS iMRI provides neurosurgeons the ability to assess and decide to perform further resection for removing as much tumour as possible by clearly visualising tumour and healthy brain tissue which otherwise are hard to differentiate.</span></p></div> Collaboration established to advance diagnostic candidate to detect CTE in former NFL players 2014-09-29T17:54:00Z 2014-09-29T17:54:00Z <div id="ImageMain20" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction20" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Aethlon Medical and its diagnostic subsidiary, Exosome Sciences, have announced that a clinical collaboration with the Boston University CTE Center has been established to advance a blood-based diagnostic candidate that could identify Chronic Traumatic Encephalopathy (CTE) in living individuals.</strong></span></p> </div><div id="Text120" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">CTE is a progressive neurodegenerative disorder that has been found at autopsy in former National Football League (NFL) players. At present, CTE can only be diagnosed through post-mortem autopsy. The Boston University CTE Center has been a leading CTE research centre since the disease was first defined.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Aethlon Medical develops targeted therapeutic devices to address infectious disease, cancer and neurodegenerative disorders. Exosome Sciences develops exosome-based solutions to diagnose and monitor cancer and neurodegenerative disorders. Earlier this year, Aethlon disclosed that Exosome Sciences researchers had successfully isolated exosome-based biomarkers transporting tau protein across the blood-brain barrier and into the circulatory system. The hallmark of CTE is an excess of accumulation of tau in the brain.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />In the study, Exosome Sciences researchers are evaluating and defining exosome and exosomal tau populations in blood samples collected from participants enrolled in the DETECT (Diagnosing and evaluating traumatic encephalopathy using clinical tests) study, under the direction of Robert Stern, director of Clinical Research at the Boston University CTE Center.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The DETECT study is the first research project on CTE ever funded by the National Institutes of Health (NIH), with support from the National Institute of Neurologic Diseases and Stroke (NINDS), the National Institute on Aging (NIA), and the National Institute of Child Health and Human Development (NICHD). The ultimate goal of the study is to develop methods, including blood-based tests, that could diagnose CTE during life. The study has enrolled former NFL players (ages 40-69) and same-age &ldquo;control&rdquo; athletes who played non-contact sports.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Our colleagues at the CTE Center are premier thought leaders in the CTE field and have been instrumental in changing how the NFL and other high-risk sports respond to head trauma,&rdquo; states Aethlon Medical chief executive officer, Jim Joyce, who also serves as executive chairman of Exosome Sciences. &ldquo;We are truly grateful for the opportunity to establish a blood-based test that could identify CTE in living individuals.&rdquo;</span></p></div> Medina Medical announces CE mark for its embolisation coil 2014-09-25T16:04:00Z 2014-09-25T16:04:00Z <div id="Introduction21" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Medina Medical has announced that it has received CE mark authorisation for its Embolization Framing Coil for commercial distribution in the European Union.</strong></span></p> </div><div id="Text121" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Medina Embolization Framing Coil is used to treat brain aneurysms using minimally-invasive techniques, and is delivered like other embolization coils through a micro-catheter that has been threaded through blood vessels into the aneurysm. The novel Medina Embolization Framing Coil is designed to occupy space efficiently within an aneurysm.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;After three years dedicated to developing our product, we are so excited to be able to bring our technology to a broader group of patients. Helping patients is our passion. Seeing our technology play even a small part in the treatment of cerebral aneurysms, and knowing that we touched patients&rsquo; lives is what drives us,&rdquo; comments Maria Aboytes, president and co-founder, Medina Medical.</span></p></div> Neuroimaging technique identifies concussion-related brain disease in living brain 2014-09-24T16:21:00Z 2014-09-24T16:21:00Z <div id="ImageMain22" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction22" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>An experimental positron emission tomography (PET) tracer is effective in diagnosing concussion-related brain disease while a person is still alive, according to a case study conducted at the Icahn School of Medicine at Mount Sinai, and at Molecular Neuroimaging in New Haven, USA, and published in the journal <a href="" target="_blank"><em>Translational Psychiatry</em></a>.</strong></span></p> </div><div id="Text122" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Specifically, the study results suggest that an experimental radiolabeled compound called [18 F]-T807, which is designed to latch onto a protein called tau that accumulates in the&nbsp;brain with repetitive blows to the head, can be registered on a PET scanner to effectively diagnose&nbsp;chronic traumatic encephalopathy (CTE). The study results also argue the process can differentiate it from other forms of dementia while the sufferer is still alive. Until now, CTE diagnosis has only been possible by evaluating post-mortem brain tissue.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Our data suggest that PET imaging using the [18F]-T807 tau tracer is an effective method of diagnosing or ruling out chronic traumatic encephalopathy in a living brain,&rdquo; says Samuel Gandy, director of the Center for Cognitive Health and NFL Neurological Care at the Icahn School of Medicine at Mount Sinai, USA. &ldquo;Estimates of the prevalence of CTE have varied wildly, with the most recent figure coming from the National Football League who predicts that one in three NFL players will suffer significant brain damage. We can now begin to test this while the players are still alive. Moreover, we are now equipped to tell prospective athletes of all ages some real data on the risks that accompany sports involving repeated traumatic brain injuries.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Signs of CTE were originally spotted in boxers and retired National Football League (NFL) players. Before their deaths, many of these athletes struggled with symptoms like memory loss, depression, and violent outbursts, and in some cases they became suicidal. The NFL is currently helping to launch large-scale studies of the condition. More recently, the brains of ice hockey players and battlefield veterans exposed to repeated bomb blasts have revealed evidence of CTE.</span></p> <p><span style="font-size: 10pt;"><br />In recent years, scientists have developed radiotracers like [18F]-T807 that attach to protein aggregates and emit high-energy particles called positrons that are registered on a PET scanner. The [18F]-T807 tau tracer selectively binds only to tangles of tau in the brain and not to amyloid proteins associated with Alzheimer&rsquo;s disease, making it superior to other proposed tau tracers to date in terms of CTE detection, according to the study authors.</span></p> <p><span style="font-size: 10pt;"><br />The Mount Sinai case study included the evaluations of two living patients, a retired NFL football player with a history of multiple concussions and a patient with a single, severe traumatic brain injury (TBI). Both patients presented with cognitive decline and suspected Alzheimer&rsquo;s disease. Both were evaluated by a combination of molecular imaging techniques to pinpoint specific brain disease and damage.</span></p> <p><span style="font-size: 10pt;"><br />Brain injury, whether as a result of repeated head trauma or a single, traumatic brain event, may jumpstart a process whereby tau protein, which functions in a healthy brain to help stabilise a nerve cell&rsquo;s protein skeleton, breaks off the skeleton and begins to build up inside nerve cells. The theory is that tangles of tau protein accumulate and cause nerve cell damage in the CTE brain.</span></p> <p><span style="font-size: 10pt;"><br />While various dementias like CTE and Alzheimer&rsquo;s disease share many symptoms, the nature and distribution of brain degeneration in chronic traumatic encephalopathy is distinctive from Alzheimer&rsquo;s disease. CTE is characterised by prominent formation inside nerve cells of structures called tangles, a process called a tauopathy. The dementia of CTE occurs in midlife after a latency period of years or decades after exposure to repetitive head trauma.</span></p> <p><span style="font-size: 10pt;"><br />In this study, led by Gandy, both patients underwent neurologic and neuropsychological assessments by a team of traumatic brain injury and Alzheimer&rsquo;s disease experts. Following this comprehensive evaluation, the experts disagreed as to whether Alzheimer&rsquo;s disease was present in this retired NFL player.</span></p> <p><span style="font-size: 10pt;"><br />Both patients underwent PET imaging with florbetapir, another chemical that is FDA-approved to detect the brain amyloid plaques of Alzheimer&rsquo;s disease during life. In the case of the retired NFL player, who suspected he had Alzheimer&rsquo;s disease and presented to the team at Mount Sinai in hope to participate in a clinical study for Alzheimer&rsquo;s disease, the florbetapir PET scan was negative for cerebral amyloidosis, thereby excluding Alzheimer&rsquo;s disease and the possibility of his engaging in a treatment protocol for his suspected, incorrect Alzheimer&rsquo;s disease diagnosis. He also underwent [18F]-T807 PET imaging that revealed signs of aggregated tau in some temporal areas of his brain.</span></p> <p><span style="font-size: 10pt;"><br />The current study is the first where one technology was able to show both the abnormal accumulation of tau protein in a person that experienced several concussions in the distant past, while at the same time demonstrating that the patient did not have the protein signature seen with Alzheimer&rsquo;s disease.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Although we are just now understanding the clinical impact of PET, our use of tauopathy PET imaging to evaluate the progressive alterations in brain proteins for CTE patients already offers us a powerful new tool for evaluation,&rdquo; says Ken Marek, president and senior scientist at Molecular Neuroimaging (MNI) in New Haven, USA, where the [18F]-T807 imaging was performed. &ldquo;In particular, we can directly measure the accumulation of&nbsp;tau protein&nbsp;we believe associated with the devastating symptoms experienced by patients and their families and evaluate the disease during life in ways that were previously only available to the pathologist&rsquo;s microscope.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />A tauopathy imaging programme at Mount Sinai Hospital is expected to commence in early October 2014.</span></p> <p><span style="font-size: 10pt;">Researchers from the University of Virginia also contributed to the study.</span></p></div> EBS expands commercialisation of Next Wave non-invasive electrical brain stimulation device 2014-09-24T11:17:00Z 2014-09-24T11:17:00Z <div id="Introduction23" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>EBS Technologies has&nbsp;announced that it has opened its first ophthalmologic clinical site in Germany that is offering the use of the EBS&nbsp;Next Wave<em>&nbsp;</em>brain stimulation device designed to expand the visual field of patients with impaired vision caused by glaucoma, stroke and other neurological diseases.</strong></span></p> </div><div id="Text123" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Last week, EBS announced that a clinical study (&ldquo;Brain functional connectivity network breakdown and restoration in blindness&rdquo;) published in the journal&nbsp;<em>Neurology</em>&nbsp;validates non-invasive brain stimulation for restoring partial vision to an impaired eye; the company&rsquo;s&nbsp;Next Wave&nbsp;system is a non-invasive brain stimulation device that is designed to expand the visual field of patients with impaired vision caused by glaucoma, stroke or other neurological disorders. Next Wave is approved for sale in Europe.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Electrical brain stimulation could have the potential to reactivate residual capabilities of brain function,&rdquo; says&nbsp;Carl Erb, a leading German ophthalmologist and renowned glaucoma specialist at the&nbsp;Eye Clinic Wittenberg Platz, Berlin. &ldquo;We expect that Next Wave therapy will be offered to patients at many additional neuroophthalmologic and neurorehabilitation clinics throughout Europe. Consequently, we are pleased that our institution is among those that are pioneering this interesting medical advance.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;There is an overwhelming and unmet clinical need for treating vision impairment caused by a variety of different neurological disorders, such as neuropathy of the optic nerve. Indeed, three out of five persons who are disabled from impaired vision as a result of optic nerve neuropathy, for example, or brain injury or stroke, are potentially treatable with our&nbsp;Next Wavetherapy, which is why we are getting enquiries from patients from not only Europe but also the United States and Asia,&rdquo; says&nbsp;Ulf Pommerening,&nbsp;chief executive officer of EBS Technologies.</span></p></div> Randomised data show gammaCore significantly reduces cluster headache attack frequency 2014-09-24T10:56:00Z 2014-09-24T10:56:00Z <div id="ImageMain24" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction24" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>At the biannual European Headache and Migraine Trust International Conference (EHMTIC) meeting in Copenhagen, more than 900 neurologists and other headache specialists came to hear about the latest advances in managing severe headache conditions, including electroCore&rsquo;s gammaCore therapy. The attendees heard that a large scale randomised clinical trial of the gammaCore therapy in chronic cluster headache not only significantly reduced the number of cluster headache attacks beyond the best available standard of care, but also that patients experienced a greater reduction in number of attacks the longer they stayed on treatment.</strong></span></p> </div><div id="Text124" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Treatment with gammaCore also resulted in meaningful improvements in quality of life and a reduction in the use of traditional rescue medications such as injectable sumatriptan and oxygen. Cluster headache is a condition that affects approximately the same number of people as multiple sclerosis, and is considered by experts to be one of the most painful medical conditions known to medicine. GammaCore&rsquo;s demonstrated effects represent a significant breakthrough in the care of patients with this debilitating condition.</span></p> <p><br /><span style="font-size: 10pt;">More particularly, the Prevention and acute treatment of chronic cluster headache (PREVA) randomised and open label trial data were presented in three poster presentations and at a breakout symposium, highlighting the following key findings:</span></p> <ul> <li><span style="font-size: 10pt;">Patients receiving gammaCore plus standard of care achieved a 43.4% reduction in the number of weekly cluster headache attacks compared with 12.5% (p=0.002) in patients treated with the best available standard of care.</span></li> <li><span style="font-size: 10pt;">Treatment with gammaCore was more effective the longer patients remained on therapy.</span></li> <li><span style="font-size: 10pt;">The quality of life measurements measured by EQ-5-3L VAS&nbsp;and HIT-6&nbsp;were meaningful for those on gammaCore.</span></li> <li><span style="font-size: 10pt;">Patients on gammaCore (in the randomised phase) reduced their use of sub cutaneous sumatriptan and oxygen by &gt;60%.</span></li> <li><span style="font-size: 10pt;">Nearly 64% indicated that they would recommend the use of gammaCore to a family member or friend.</span></li> <li><span style="font-size: 10pt;">56% of patients found treatment with gammaCore very easy to use.</span></li> <li><span style="font-size: 10pt;">Treatment with gammaCore was safe and can be used in combination with drug treatments.</span></li> <li><span style="font-size: 10pt;">Device related adverse events were primarily mild and transient.</span></li> </ul> <p><span style="font-size: 10pt;">Charly Gaul, director of the Migraine and Headache Clinic in K&ouml;nigstein, Germany, who was the principal investigator of the PREVA study, and presented the data from this study during the symposium, comments, &ldquo;This study is one of the few well controlled, randomised studies of any preventative treatment for cluster headache. The ability of electroCore&rsquo;s gammaCore therapy to significantly reduce the number of weekly cluster headaches in these chronic patients suggests it offers an important new option for this extremely painful and difficult to manage condition.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The PREVA trial, which is part of the largest trial program ever carried out in cluster headache, was conducted at ten sites across Europe with 97 patients enrolled. Ninety-three were randomized to participate following the initial baseline data collection. Forty-five of the patients were randomly selected to use gammaCore plus their usual treatment and 48 to the best available standard of care. The baseline data collection period was two-weeks, followed by the four-week randomized phase. All the patients from both arms were asked to continue on active therapy for an additional four-week open label phase.</span></p> <p><br /><span style="font-size: 10pt;">The dosing of the therapy used in the PREVA trial was three, 120-second stimulations, delivered at two time points during each day.</span></p></div> Neuralstem ALS investigator presents long-term follow-up phase I data 2014-09-24T10:02:00Z 2014-09-24T10:02:00Z <div id="ImageMain25" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction25" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Neuralstem has announced that Jonathan D Glass, site investigator at Emory University, presented long-term follow up data on the phase I trial testing NSI-566 human neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS). The presentation, which occurred at the Annual Symposium on ALS of the Foundation Andre-Delambre, in Montreal, Canada, and was not open to the public, covered data up to approximately 1200 days post the stem cell treatment.</strong></span></p> </div><div id="Text125" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Glass reported that patients in the last safety cohort (n=3), who received treatments in both the lumbar and the cervical region with the highest number of cells per injection, all showed significant slowing of the progression of the disease. One patient showed functional improvement from pre-treatment baseline, which is maintained to present day. The other two patients are maintaining the same level of functionality as they had at the baseline for over three years since the stem cell treatment.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The long-term follow up data is very encouraging,&rdquo; says Karl Johe, Neuralstem&rsquo;s chairman and chief scientific officer. &ldquo;In phase I, patients 10, 11, and 12 each received 10 lumbar and five cervical injections, of 100,000 cells each, which was far below the safe maximal dose. Even so, the data shows a significant slowing of the disease progression for over three years. If replicated on a larger scale, this could represent meaningful improvement in quality of life, and lifespan, compared to untreated patients. In our phase II dose escalation trial, we successfully reached the maximal dose planned, which consisted of&nbsp; 20 lumbar and 20 cervical injections of 400,000 cells each, more than ten times the number of stem cells delivered in the highest dose cohort of the phase I trial.&rdquo;&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The progress in this trial is truly groundbreaking,&rdquo; says Glass, who is director of the Emory ALS Center at Emory University, the first site in the trial. &ldquo;It has provided data on the safety of multiple injections and multiple transplantation surgeries in ALS patients, as well as the long- term survival of the transplanted cells in the human spinal cord. This provides a strong foundation for moving ahead with more definitive trials focused on the potential therapeutic efficacy of spinal cord transplantation of neural stem cells for ALS.&rdquo;</span></p></div> Evidence supports deep brain stimulation for obsessive-compulsive disorder 2014-09-23T17:38:00Z 2014-09-23T17:38:00Z <div id="Introduction26" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Available research evidence supports the use of deep brain stimulation for patients with obsessive-compulsive disorder (OCD) who do not respond to other treatments, concludes a review in the October issue of <a href="" target="_blank"><em>Neurosurgery</em></a>, official journal of the&nbsp;Congress of Neurological Surgeons&nbsp;(CNS). </strong></span></p> </div><div id="Text126" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Based on evidence, two specific bilateral deep brain stimulation techniques are recommended for treatment of carefully selected patients with OCD, according to a new clinical practice guideline endorsed by the CNS and the American Association of Neurological Surgeons. While calling for further research in key areas, Clement Hamani of Toronto Western Hospital and co-authors emphasise that patients with OCD symptoms that do not respond to other treatments should continue to have access to deep brain stimulation.</span></p> <p><span style="font-size: 10pt;"><br />Hamani led a multispecialty expert group in performing a systematic review of research on the effectiveness of deep brain stimulation for OCD. Deep brain stimulation&mdash;placement of electrodes in specific areas of the brain, followed by electrical stimulation of those areas&mdash;has become an important treatment for patients with Parkinson&rsquo;s disease and other movement disorders.</span></p> <p><span style="font-size: 10pt;"><br />Although many patients with OCD respond well to medications and/or psychotherapy, 40 to 60% continue to experience symptoms despite treatment. Over the past decade, a growing number of reports have suggested that deep brain stimulation may be an effective alternative in these &ldquo;medically refractory&rdquo; cases.</span></p> <p><span style="font-size: 10pt;"><br />Hamani and colleagues were tasked with analysing the supporting evidence and developing an initial clinical practice guideline for the use of deep brain stimulation for patients with OCD. The review and guideline development process was sponsored by the American Society of Stereotactic and Functional Neurosurgery and the CNS. Out of more than 350 papers, the reviewers identified seven high-quality studies evaluating deep brain stimulation for OCD.</span></p> <p><span style="font-size: 10pt;"><br />Based on that evidence, they conclude that bilateral stimulation (on both sides of the brain) of two brain &ldquo;targets&rdquo;&mdash;areas called the subthalamic nucleus and the nucleus accumbens&mdash;can be regarded as effective treatments for OCD. In controlled clinical trials, both techniques improved OCD symptoms by around 30% on a standard rating scale.</span></p> <p><span style="font-size: 10pt;"><br />That evidence forms the basis for a clinical guideline stating that bilateral deep brain stimulation is a &ldquo;reasonable therapeutic option&rdquo; for patients with severe OCD that does not respond to other treatments. The guideline also notes that there is &ldquo;insufficient evidence&rdquo; supporting the use of any type of unilateral deep brain stimulation target (one side of the brain) for OCD.</span></p> <p><span style="font-size: 10pt;"><br />The review highlights the difficulties of studying the effectiveness of deep brain stimulation for OCD&mdash;because most patients respond to medical treatment, studies of this highly specialised treatment typically include only small numbers of patients. Hamani and co-authors identify some priorities for future research: particularly to identify the most effective brain targets and the subgroups of patients most likely to benefit.</span></p> <p><span style="font-size: 10pt;"><br />Despite the limited evidence base, deep brain stimulation therapy for OCD has been approved by the Food and Drug Administration under a humanitarian device exemption. Hamani and co-authors note that various safeguards are in place to ensure appropriate use, and prevent overuse, of deep brain stimulation for OCD.</span></p> <p><span style="font-size: 10pt;"><br />While research continues, they believe that functional neurosurgeons should continue to work with other specialists to ensure that patients with severe, medically refractory OCD continue to have access to potentially beneficial deep brain stimulation therapy.</span></p></div> ATL1102 phase II trial results published in Neurology 2014-09-23T17:00:00Z 2014-09-23T17:00:00Z <div id="Introduction27" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Antisense Therapeutics has reported the publication of previously generated phase IIa clinical trial data on ATL1102 in the medical journal <a href="" target="_blank"><em>Neurology</em></a>.</strong></span></p> </div><div id="Text127" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The article titled &ldquo;CD49d antisense drug ATL1102 reduces disease activity in patients with relapsing-remitting MS&rdquo;, is currently available online and will be included in the print edition Volume 83, November 11, 2014.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The article highlights the successful outcomes of the Phase IIa clinical trial of ATL1102 in Multiple Sclerosis (MS) patients where in the randomised, double-blind, placebo-controlled study in 77 patients with relapsing-remitting multiple sclerosis (RRMS), ATL1102 met its primary end point after only two months of dosing, showing a significant reduction, by 54.4% (p=0.01) in the cumulative number of new active brain lesions in patients taking ATL1102 compared to placebo.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The efficacy outcomes from this study were viewed to be as good as, or superior to, those achieved with MS drug Tysabri at a similar stage in its clinical development. Tysabri (natalizumab) is a monoclonal antibody drug targeting the VLA-4 receptor (same target as ATL1102). In 2013, Tysabri generated sales in excess of US$1.6 billion. It is regarded as the current efficacy benchmark for the treatment of RRMS. ANP anticipates that ATL1102 could be as potent as Tysabri but potentially safer, cheaper to manufacture, and more conveniently dosed.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Principal investigator of the ATL1102 phase IIa study and lead author of the <em>Neurology</em> publication, Volker Limmroth (professor of Neurology, chairman, Department of Neurology and Palliative Care Medicine Cologne City Hospitals, University of Cologne) says:</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;There are a number of unresolved issues with current MS drugs including the occurrence of neutralising antibodies to the antibody, protein and peptide MS drugs as well as long-term safety concerns with the more recently approved drugs. There is a clear need for more effective and safe drugs for the significant population of MS patients who have relapses and non-stable disease.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The ATL1102 phase IIa trial provides evidence for the first time that antisense oligonucleotides may be used as a therapeutic approach in neuroimmunologic disorders such as MS. ATL1102 was shown to be highly effective in reducing brain lesions in RRMS patients with a quick onset of action and a clinical safety profile that strongly supports its ongoing development as a treatment for this disease.&rdquo;</span></p></div> Nexstim plans an Initial Public Offering on NASDAQ OMX First North 2014-09-23T16:18:00Z 2014-09-23T16:18:00Z <div id="ImageMain28" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction28" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Nexstim has announced its intention to proceed with an Initial Public Offering of Nexstim on NASDAQ OMX First North Finland and NASDAQ OMX First North Sweden (&ldquo;Admission&rdquo;). It is expected that the Admission will occur in the 4<sup>th</sup> Quarter of 2014.</strong></span></p> </div><div id="Text128" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Nexstim has developed a technology which allows a non-invasive targeting of a specific area of the brain with high accuracy. Nexstim has pioneered the technology as a diagnostic tool for brain surgery planning with its Navigated Brain Stimulation (NBS) System. The NBS System is the first and only FDA cleared and CE marked device utilising so-called navigated transcranial magnetic stimulation (nTMS) for mapping of the motor and speech cortices.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Based on the same technology platform the company has developed a device for stroke therapy called Navigated Brain Therapy (NBT), which focuses stimulation on targeted locations in the brain to enhance and accelerate stroke rehabilitation by removing natural barriers for recovery. The NBT System was tested in a phase II proof of concept study in 29 post-acute stroke patients to study the effect on hand and arm function in connection with rehabilitation. The patients were randomised into two groups of which a group of 19 patients received NBT therapy and a group of 10 patients received sham (placebo) treatment. Out of the group receiving NBT treatment, 84% of the patients showed a clinically important improvement in motor function of the upper extremity six months after treatment compared to 50% in the sham group.&nbsp;The difference was statistically significant (p&lt;0.05).</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Nexstim has earlier this year initiated a two-year clinical phase III study at 12 prominent rehabilitation sites in the USA, aiming to demonstrate the effectiveness of the NBT System and to obtain an FDA clearance for marketing the device for post-acute stroke treatment in the USA.</span></p> </div> Multiple sclerosis drug candidate shows new promise 2014-09-22T17:27:00Z 2014-09-22T17:27:00Z <div id="Introduction29" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Positive new data have been released on a drug candidate for relapsing multiple sclerosis that was first discovered and synthesised at The Scripps Research Institute.</strong></span></p> </div><div id="Text129" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to the results from a six-month phase 2 study of 258 multiple sclerosis patients, the drug candidate RPC1063 reduced the annualised relapse rate of participants with multiple sclerosis by up to 53%, compared with placebo. The potential therapy also decreased the emergence of new brain damage seen by magnetic resonance imaging (MRI) by more than 90%.</span></p> <p><span style="font-size: 10pt;"><br />In addition, safety results suggest a favourable risk-benefit profile. More than 98% of patients remained on the drug regimen&mdash;an important metric as existing drugs for multiple sclerosis are often difficult for patients to tolerate.</span></p> <p><span style="font-size: 10pt;">RPC1063 was first discovered by a &ldquo;hit&rdquo; from a National Institutes of Health molecular library during research at Scripps Florida&rsquo;s Molecular Screening Center. The compound was then synthesised and further developed in the laboratories of Scripps California Professors Ed Roberts and Hugh Rosen.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;These data support our labs&rsquo; approach at The Scripps Research Institute that discovery of fundamental mechanisms in chemical biology provides the foundation for intelligent intervention in disease processes,&rdquo; says Rosen. &ldquo;Meeting the needs of patients and their families is our high calling in biomedical science.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Patrick Griffin, chair of the Department of Molecular Therapeutics and director of the Translational Research Institute at Scripps Florida, adds, &ldquo;This development is an exciting outcome resulting from research within the Scripps Florida Molecular Screen Center. We expect many other programmes that Scripps Florida has been involved in will have similar potential to improve human health.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The new RPC1063 findings were presented recently at the MS Boston 2014 meeting.</span></p> <p><span style="font-size: 10pt;"><br />Receptos, a San Diego biopharmaceutical company that licensed the technology from The Scripps Research Institute, is developing RPC1063 for approval by the US Food and Drug Administration. The drug candidate is currently in a phase 3 randomised, double-blind study involving 1,200 relapsing multiple sclerosis patients. The trial is expected to be completed in 2017.</span></p> <p><span style="font-size: 10pt;"><br />The mechanism of RPC1063 (Sphingosine 1-Phosphate Receptor modulation) may also be significant in the treatment of other autoimmune diseases. An ongoing phase 2 study (called Touchstone) for the treatment of moderate-to-severe ulcerative colitis is fully enrolled, with results expected by the end of this year.</span></p></div> Mayo researchers reveal pathway that contributes to Alzheimer’s disease 2014-09-22T17:18:00Z 2014-09-22T17:18:00Z <div id="Introduction30" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers at Jacksonville&rsquo;s campus of Mayo Clinic have discovered a defect in a key cell-signalling pathway they say contributes to both overproduction of toxic protein in the brains of Alzheimer&rsquo;s disease&nbsp;patients as well as loss of communication between neurons &mdash; both significant contributors to this type of dementia.</strong></span></p> </div><div id="Text130" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Their study, in the online issue of&nbsp;<em>Neuron</em>, offers the potential that targeting this specific defect with drugs &ldquo;may rejuvenate or rescue this pathway,&rdquo; says the study&rsquo;s lead investigator,&nbsp;Guojun Bu, Ph.D., a&nbsp;neuroscientist&nbsp;at&nbsp;Mayo Clinic, Jacksonville, Florida, USA.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This defect is likely not the sole contributor to development of Alzheimer&rsquo;s disease, but our findings suggest it is very important, and could be therapeutically targeted to possibly prevent Alzheimer&rsquo;s or treat early disease,&rdquo; he says.</span></p> <p><span style="font-size: 10pt;"><br />The pathway, Wnt signalling, is known to play a critical role in cell survival, embryonic development and synaptic activity &mdash; the electrical and chemical signals necessary for learning and memory. Any imbalance in this pathway (too much or too little activity) leads to disease &mdash; the overgrowth of cells in cancer is one example of overactivation of this pathway.</span></p> <p><span style="font-size: 10pt;"><br />While much research on Wnt has focused on diseases involved in overactive Wnt signalling, Bu&rsquo;s team is one of the first to demonstrate the link between suppressed Wnt signalling and Alzheimer&rsquo;s disease.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Our finding makes sense, because researchers have long known that patients with cancer are at reduced risk of developing Alzheimer&rsquo;s disease, and vice versa,&rdquo; Bu says. &ldquo;What was not known is that Wnt signalling was involved in that dichotomy.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Using a new mouse model, the investigators discovered the key defect that leads to suppressed Wnt signalling in Alzheimer&rsquo;s. They found that the low-density lipoprotein receptor-related protein 6 (LRP6) is deficient, and that LRP6 regulates both production of amyloid beta, the protein that builds up in the brains of Alzheimer&rsquo;s disease patients, and communication between neurons. That means lower than normal levels of LRP6 leads to a toxic buildup of amyloid and impairs the ability of neurons to talk to each other.</span></p> <p><span style="font-size: 10pt;"><br />Mice without LRP6 had impaired Wnt signalling, cognitive impairment, neuroinflammation and excess amyloid.</span></p> <p><span style="font-size: 10pt;"><br />The researchers validated their findings by examining post-mortem brain tissue from Alzheimer&rsquo;s patients &mdash; they found that LRP6 levels were deficient and Wnt signalling was severely compromised in the human brain they examined.</span></p> <p><span style="font-size: 10pt;"><br />The good news is that specific inhibitors of this pathway are already being tested for cancer treatment. &ldquo;Of course, we do not want to inhibit Wnt in people with Alzheimer&rsquo;s or at risk for the disease, but it may be possible to use the science invested in inhibiting Wnt to figure out how to boost activity in the pathway,&rdquo; Bu says.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Identifying small molecule compounds to restore LRP6 and the Wnt pathway, without inducing side effects, may help prevent or treat Alzheimer&rsquo;s disease,&rdquo; he says. &ldquo;This is a really exciting new strategy &mdash; a new and fresh approach.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Researchers from the University of Kentucky, Xiamen University in China, the University of Oklahoma and the Korea Brain Research Institute participated in the study.</span></p></div> CE mark for Vercise deep brain stimulation system for patients with tremor 2014-09-18T16:09:00Z 2014-09-18T16:09:00Z <div id="ImageMain31" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction31" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Boston Scientific has received CE mark approval for the Vercise deep brain stimulation system for the treatment of tremor, including the most common form of this movement disorder known as essential tremor. Tremor is characterised by involuntary and rhythmic shaking, usually associated with difficulty in an activity such as writing or holding and controlling items.</strong></span></p> </div><div id="Text131" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Experts say essential tremor may be as much as 20 times more prevalent than Parkinson&rsquo;s disease.The Vercise deep brain stimulation system is the first system designed to offer precise neural targeting, allowing physicians to customise therapy for patients with essential tremor. It also features a rechargeable battery that can last up to 25 years.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />One of the first commercial implantations of the Vercise deep brain stimulation system for essential tremor was performed at the University Hospital Cologne, Germany, by a team of physicians, led by Veerle Visser Vandewalle, head of the Department of Stereotaxy and Functional Neurosurgery, and Lars Timmermann, neurologist and professor of Neurological Movement Disorders.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Essential tremor can be very debilitating for patients in their day-to-day activities such as writing and eating,&rdquo; says Vandewalle. &ldquo;The Vercise deep brain stimulation system provides advanced tremor care through precise neural targeting that is designed to manage essential tremor symptoms effectively and improve patient quality of life.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The Vercise deep brain stimulation system features multiple independent current control, which gives clinicians the ability to control stimulation precisely for a neural target to help minimise unwanted side effects,&rdquo; says Timmermann.&nbsp;&ldquo;The 25 year battery life may also help reduce the frequency of surgical interventions to replace depleted batteries.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Essential tremor can be a progressive disorder, typically starting on one side of the body, and then gradually affecting both sides. It is most commonly seen in older adults, however the onset of symptoms may occur at any age. The exact cause for essential tremor is unknown, but it is found to be mostly hereditary, where children of a parent who has essential tremor have a 50% chance of inheriting the condition.<sup>&nbsp; </sup></span></p> <p><span style="font-size: 10pt;"><br />&ldquo;With the launch of the Vercise deep brain stimulation system for the treatment of patients with Parkinson&rsquo;s disease in 2012, for dystonia in 2013, and now for tremor, Boston Scientific continues to demonstrate its commitment to provide more access to deep brain stimulation therapy to more patients,&rdquo; says Maulik Nanavaty, president, Neuromodulation, Boston Scientific. &ldquo;We believe this advanced technology can play a critical role in improving the lives of patients who suffer from these devastating conditions.&rdquo;</span></p></div> New mobile apps support education, safety, and adherence needs of seizure patients 2014-09-17T16:44:00Z 2014-09-17T16:44:00Z <div id="Introduction32" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Adherent Health has announced the introduction of patient support apps for two novel medications used in the treatment of seizures and epilepsy, Oxtellar XR (oxcarbazapine extended-release tablets) and Trokendi XR (topiramate extended-release capsules).&nbsp;</strong></span></p> </div><div id="Text132" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Developed under the guidance of epilepsy, neurology, pharmacy, and specialty nurse advisors, these patient support apps, now available in the Mobile Health Library (MHL) system, have been designed to better address the education, safety, and adherence needs of physicians, nurses, and pharmacists in clinical practice. &ldquo;MHL engages both clinicians and patients on their terms, which today for most people means simple, mobile, and private,&rdquo; says Tracy A Glauser, director, Comprehensive Epilepsy Center, Cincinnati Children&rsquo;s Hospital Medical Center, &ldquo;Having the important patient support resources available at your fingertips helps us better address the medication-specific needs of our patients, parents, and caregivers,&rdquo; continues Glauser.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Mobile app adoption rates are high across all medication-taking age groups, with many already using mobile apps on their smartphones or tablets,&rdquo; says Todd Horich, executive director of Marketing, Supernus Pharmaceuticals. &ldquo;Making our education and patient support services also available as apps in Mobile Health Library, helps us better support the treatment needs and communications preferences of clinicians, and of patients prescribed our medications,&rdquo; continues Horich.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;By more simply integrating brand content and services that support safety, education, and medication adherence, MHL apps help address the patient understanding, safe-use, and outcomes attainment needs of physicians, nurses, pharmacists, patients, caregivers, and payers,&rdquo; says Peter Pitts, chief regulatory officer, Adherent Health; chairman, MHL Standards and Practices Board; former FDA associate commissioner.&nbsp;</span></p></div> Lilly and AstraZeneca announce alliance to co-develop potential treatment for Alzheimer’s disease 2014-09-17T10:13:00Z 2014-09-17T10:13:00Z <div id="Introduction33" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Eli Lilly and AstraZeneca have announced an agreement to co-develop and commercialise AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer&rsquo;s disease.</strong></span></p> </div><div id="Text133" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The progression of Alzheimer&rsquo;s disease is characterised by the accumulation of amyloid plaque in the brain. BACE is an enzyme associated with the development of beta-amyloid. Inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />AZD3293 is an oral potent small molecule inhibitor of BACE that has been shown in phase 1 studies to reduce levels of beta-amyloid in the cerebro-spinal fluid of Alzheimer&rsquo;s patients and healthy volunteers. AstraZeneca announced earlier in 2014 its plan to move AZD3293 into registration trials.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Under the terms of the agreement, Lilly will pay AstraZeneca up to US$500 million in development and regulatory milestone payments. Lilly will recognise the initial milestone of US$50 million (pretax), or approximately US$.03 per share (after-tax), as a charge to earnings in the third quarter of 2014.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />AstraZeneca and Lilly aim to progress AZD3293 rapidly into a phase 2/3 clinical trial in patients with early Alzheimer&rsquo;s disease. Lilly will lead clinical development, working with researchers from AstraZeneca&rsquo;s Innovative Medicines Unit for neuroscience, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialisation of AZD3293. The companies will share all future costs equally for the development and commercialisation of AZD3293, as well as net global revenues post-launch.</span></p></div> Covidien begins enrolment in two neurovascular clinical trials 2014-09-16T15:11:00Z 2014-09-16T15:11:00Z <div id="ImageMain34" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction34" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Covidien has announced the start of enrolment in two clinical trials designed to further underscore the safety and effectiveness of the company&rsquo;s advanced neurovascular solutions.</strong></span></p> </div><div id="Text134" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Baptist Medical Center&nbsp;in&nbsp;Jacksonville, Florida, USA, treated the first patient enrolled in the PREMIER Prospective study, an international Investigational Device Exemption (IDE) clinical study to evaluate the&nbsp;Pipeline embolisation device&nbsp;in smaller unruptured intracranial aneurysms. Separately,&nbsp;Baptist Health Lexington&nbsp;in&nbsp;Kentucky, USA, enrolled the first patient in the STRATIS Registry for endovascular stroke devices, which will evaluate the use of all&nbsp;Covidien&nbsp;market-released stroke devices.</span></p> <p><span style="font-size: 10pt;"><br />The PREMIER study will enrol up to 141 patients in 20 global sites and is designed to assess the safety and effectiveness of the Pipeline device in the treatment of unruptured, small and medium wide-necked intracranial aneurysms.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are excited to be the first hospital to enrol a patient in this important study. There is a need for an effective and sustained treatment option for patients with wide neck small or medium intracranial aneurysms,&rdquo; says&nbsp;Ricardo Hanel, neurovascular surgeon with Lyerly Neurosurgery at&nbsp;Baptist Medical Center. &ldquo;Redirecting blood flow away from the aneurysm with the Pipeline device has been shown to reduce aneurysm recurrence and the need for retreatment in large and giant internal carotid artery aneurysms. This study will provide valuable clinical evidence in a new population of aneurysms.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The STRATIS Registry, a prospective, multicentre, non-randomised, observational registry designed to evaluate the use of&nbsp;Covidien endovascular stroke devices in patients diagnosed with an acute ischaemic stroke. Covidien&rsquo;s current endovascular stroke device in the USA is the&nbsp;Solitaire 2 revascularisation device.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The STRATIS Registry will assess mechanical thrombectomy as a treatment option in patients who cannot get access to or are not eligible for IV-tPA - a medication that dissolves blood clots,&rdquo; says&nbsp;Curtis Given, co-director of neurointerventional services at Baptist Health Lexington.&nbsp;&ldquo;It is very important to provide registry data to not only demonstrate the safety of a mechanical thrombectomy procedure on these patients, but also to track the outcomes, so we can compare the results to historical IV-tPA data.&nbsp;In some states, insurance carriers are refusing to reimburse mechanical thrombectomy procedures, so it is vital that we collect the data to show not only safety, but efficacy, in order to ensure that we can continue to provide care to these patients that would otherwise not be offered any treatment for their stroke.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />As many as 60 US sites are expected to participate in the STRATIS Registry, which will enrol up to 1,000 patients to collect clinical outcomes for interventional stroke patients in a real world setting.</span></p></div> Codman Neuro gains exclusive rights to market and promote PulseRider in Europe, the Middle East and Africa 2014-09-09T19:45:00Z 2014-09-09T19:45:00Z <div id="ImageMain35" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction35" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Codman Neuro, part of DePuy Synthes Companies of Johnson &amp; Johnson, has announced that it has reached an exclusive distribution agreement with Pulsar Vascular to market and promote that company&rsquo;s PulseRider in Europe, the Middle East and Africa. PulseRideris a minimally invasive device intended for use with embolic coils in the treatment of unruptured wide-neck intracranial aneurysms originating on or near a bifurcation. The device received initial CE mark approval in Europe in late 2013. The agreement was entered into by one of Codman Neuro&rsquo;s EU affiliated companies.</strong></span></p> </div><div id="Text135" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The announcement was made at the European Society of Minimally Invasive Neurological Therapy (ESMINT) Congress. This distribution agreement marks the latest expansion of Codman Neuro&rsquo;s neurovascular portfolio, which includes a wide range of products for haemorrhagic and ischaemic stroke, cerebral aneurysms and other neurovascular and neurological diseases and conditions. PulseRider is a self-expanding nitinol implant that is used in conjunction with embolic coils to bridge the neck of cerebral aneurysms.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are excited about this new agreement with Pulsar Vascular and the greater access physicians and their patients in Europe will now have to a potentially lifesaving endovascular procedure,&rdquo; says P Laxmin Laxminarain, worldwide president of Codman Neuro. &ldquo;There is a significant unmet clinical need in the treatment of unruptured, wide-neck bifurcation aneurysms, and we hope to help fill it with this innovative device.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Repairing wide-neck intracranial aneurysms is a challenging endovascular procedure&nbsp;and treatment options are extremely limited,&rdquo; says Monika Killer-Oberpfalzer, Paracelsus Medical University Salzburg, Austria. &ldquo;We welcome technology specifically designed to enhance our ability to treat these complex aneurysms more easily with less risk in the hope that more lives can be saved.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />PulseRider is limited to investigational use only in the United States and has not been approved by the US Food and Drug Administration (FDA) for distribution.</span></p></div> IMRIS sterile wireless imaging coil and Monteris laser technologies combine for first time inside a VISIUS Surgical Theatre with iMRI 2014-09-09T19:00:00Z 2014-09-09T19:00:00Z <div id="ImageMain36" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction36" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>IMRIS has announced that the company&rsquo;s InSitu wireless coil and Monteris NeuroBlate laser ablation system have been used together for the first time at a leading United States neuroscience centre. This combination brought improved visualisation and workflow in removing a patient&rsquo;s low-grade glioma brain tumour inside a VISIUS Surgical Theatre.</strong></span></p> </div><div id="Text136" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Using the sterile InSitu wireless coil with the NeuroBlate system&nbsp; streamlines the workflow for transitioning between intraoperative&nbsp; imaging and surgery and provides high-quality MR images for&nbsp; navigation,&rdquo; says Monteris president and chief executive officer John E Schellhorn.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The InSitu Coil is a sterile, wireless, ultra-lightweight and disposable imaging coil that eliminates the need to manage cables and heavy imaging coils typically draped and removed between intraoperative scans. Instead, this coil is secured directly to the sterile field, and provides an open window for direct access to the operative site for the manipulation of the NeuroBlate robotic laser thermotherapy probe or other surgical tools. The NeuroBlate System, a type of laser interstitial thermal therapy (LITT), applies focused energy under MR-guidance to ablate tumours through a minimally invasive approach, while the system&rsquo;s cooling technology helps avoid damage to adjacent&nbsp; healthy tissue.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The InSitu wireless coil enhances the image quality of MR images acquired by the VISIUS iMR scanner. The InSitu Coil remains in a consistent position during the procedure, eliminating the small fluctuations in the MR images that may be caused if using a coil that requires repositioning between scans.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The experience of neurosurgeons has demonstrated that employing MR imaging and software-based visualisation with the Monteris system allows the ablation of targeted tissue using minimally invasive techniques through very small holes in the skull,&rdquo; Schellhorn adds.</span></p></div> Revive SE thrombectomy device approved in China, South Korea and Taiwan 2014-09-08T19:38:00Z 2014-09-08T19:38:00Z <div id="ImageMain37" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction37" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Codman Neuro, part of<em>&nbsp;</em>DePuy Synthes Companies of Johnson &amp; Johnson, has announced regulatory approval from the China Food and Drug Administration (CFDA), South Korea&rsquo;s Ministry of Food and Drug Safety (MFDS), and the Taiwan Food and Drug Administration (TFDA) for the company&rsquo;s Revive SE Thrombectomy Device, a next-generation self-expanding clot removal device intended to restore blood flow in patients with acute ischaemic stroke secondary to intracranial occlusive vessel disease.</strong></span></p> </div><div id="Text137" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Revive SE Device is designed to ease navigation through small and tortuous blood vessels and arteries in the cerebral vasculature. The new device enables rapid restoration of blood flow to the brain during an acute ischaemic stroke.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are pleased to offer the Revive SE device in these countries, which have a high incidence of stroke and an increasing need for new and advanced treatment options,&rdquo; says&nbsp;P Laxmin Laxminarain, worldwide president of Codman Neuro. &ldquo;Codman Neuro continues to expand its presence throughout the world with existing and new solutions that fill clinical needs and improve patient care.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Revive SE Device, which is also available in Europe, features a closed-ended soft distal tip to capture clots and large fragments with minimal trauma, and a narrow and tall strut design to better penetrate and engage more clot.&nbsp;Clinicians may use the Revive SE Device for the non-surgical removal of emboli and thrombi, with aspiration and with the injection or infusion of contrast media and other fluids.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Revive SE Thrombectomy Device is not currently approved for distribution in the United States.</span></p></div> Understanding the brain’s pulse shows promise for managing concussion 2014-09-08T17:57:00Z 2014-09-08T17:57:00Z <div id="Introduction38" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>An article published in the <a href="" target="_blank"><em>Clinical Journal of Sport Medicine </em></a>&mdash; &ldquo;Detection of Concussion Using Cranial Accelerometry&rdquo; by Paul S Auerbach, Jennifer G Baine, Megan L Schott, Amy Greenhaw, Monika G Acharya and Wade S Smith &mdash; has shown that the Jan Medical Nautilus BrainPulse technology has detected a consistent pattern correlated with concussion. This paper provides the first indication that the measurement of brain motion due to pulsatile blood flow can detect physiological changes in the brain correlated with concussion. Out of 84 players enrolled in the Stanford University Medical School Institutional Review Board-approved protocol, BrainPulse detected 10 out of 13 confirmed concussions for a 77% sensitivity; and 79 out of 91 recordings were confirmed to not have a concussion for an 87% specificity.</strong></span></p> </div><div id="Text138" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Paul Lovoi, founder and chief executive officer of Jan Medical, states, &ldquo;While these findings are very encouraging, additional trials will be necessary to establish this technology as an objective measure of concussion, studies that we are currently undertaking.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The study was conducted at a Northern California high school over the course of one football season involving the majority of both the varsity and junior varsity players. All the players were recorded with the BrainPulse at the beginning of the season prior to any potentially concussive contact. Over the course of the season, SCAT2 (Sports Concussion Assessment Tool) was used to assist in the clinical determination of concussion. &ldquo;This new discovery holds promise to provide a more objective measure of concussion so as to allow a safer return to play and the protection of our youth in contact sports,&rdquo; says Wade Smith, vice chair of Neurology at UCSF.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The brain has a normal pulse driven by the cardiac cycle. The impact of this pulse on the skull can in turn be detected and measured. The Nautilus BrainPulse from Jan Medical is designed to measure the normal brain pulse as well as disruptions of the brain pulse. By digitising the signal patterns from headset-mounted sensors measuring the skull&rsquo;s motion, and extracting features from them, algorithms can be developed to identify normal and a variety of abnormal brain pulse patterns. The BrainPulse sensors passively measure the skull in recording sessions that take approximately three minutes to conduct. The entire device itself is portable and provides analysis immediately once the recording session is complete. Lovoi adds, &ldquo;We see evidence that our technology can contribute to a wide range neurological deficits.&rdquo;</span></p></div> Neuravi introduces collaborative clot research initiative at ESMINT 2014-09-08T11:37:00Z 2014-09-08T11:37:00Z <div id="Introduction39" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Neuravi introduced the Neuravi Thromboembolic Initiative (NTI) during a series of workshops on &ldquo;The Science of Clot&rdquo; at the European Society of Minimally Invasive Neurological Therapy (ESMINT) conference in Nice, France. The NTI brings together Neuravi engineers with clinicians and researchers from leading international institutions in an effort to deepen the understanding of the mechanical properties of clot and occlusion dynamics, with the goal of improving the physician&rsquo;s ability to restore flow in acute ischaemic stroke.</strong></span></p> </div><div id="Text139" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The ESMINT conference gathers leaders in minimally invasive neurological therapy from across Europe. &ldquo;One of the goals of ESMINT is to advance the practice of neuro-intervention through the support of research, education and training,&rdquo; observed Laurent Pierot, president of the ESMINT Congress. &ldquo;Currently, there is a growing interest in identifying different clots and in understanding how different clot characteristics may impact treatment in acute ischaemic stroke. The NTI workshops will help in these efforts.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The NTI workshops featured a presentation by Anastasios Mpotsaris, Uniklinik K&ouml;ln, as well as interactive hands-on sessions with engineers exploring clot characterisation, the dynamics of occlusion formation and clot-device interactions and any potential implications for revascularisation.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The NTI represents Neuravi&rsquo;s commitment to advance the treatment of stroke by investing and collaborating in research to unravel the science of stroke occlusion,&rdquo; states Eamon Brady, chief executive officer of Neuravi. &ldquo;We are excited to have this opportunity to both share and learn with the neurointerventional community during these interactive workshops.&rdquo;</span></p></div> Diplomat to distribute Plegridy (peginterferon beta-1a) for treatment of multiple sclerosis 2014-09-04T18:39:00Z 2014-09-04T18:39:00Z <div id="ImageMain40" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction40" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Diplomat has announced that it will distribute Plegridy (peginterferon beta-1a). Manufactured by Biogen Idec, Plegridy was approved on 15 August 2014 by the US Food and Drug Administration for the treatment of relapsing forms of multiple sclerosis (RMS). Plegridy is the only pegylated beta interferon approved for use in RMS and is dosed once every two weeks. Plegridy can be administered subcutaneously with the Plegridy Pen, a new, ready-to-use autoinjector, or a prefilled syringe.</strong></span></p> </div><div id="Text140" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The approval of Plegridy comes as a result of the one of the largest pivotal studies of beta interferon conducted, <a href=";rank=13" target="_blank"><strong>ADVANCE</strong></a>, which included more than 1,500 multiple sclerosis patients. ADVANCE was a two-year, phase 3, placebo-controlled study that evaluated the efficacy and safety of Plegridy administered subcutaneously. The ADVANCE study demonstrated a reduction in relapses, disability progression and the number of multiple sclerosis lesions in comparison to the results with placebo.</span></p></div> GeNeuro phase 2a study reinforces novel approach to treat multiple sclerosis 2014-09-03T18:51:00Z 2014-09-03T18:51:00Z <div id="Introduction41" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>GeNeuro has announced positive results from a one-year, open-label extension of a phase IIa study. GeNeuro tested its monoclonal antibody GNbAC1 in 10 multiple sclerosis patients, nine of which had primary or secondary progressive disease. GNbAC1 targets the MSRV-Env protein expressed by genes of endogenous retroviral origin, which GeNeuro believe plays a critical role in the pathogenesis of multiple sclerosis.</strong></span></p> </div><div id="Text141" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The long-term safety profile of GNbAC1 was confirmed, with excellent tolerability among patients following repeat administration, verifying results of the earlier phase I study. With respect to clinical endpoints, the average Expanded Disability Status Score (EDSS), which measures disease progression, remained stable over one year. MRI analysis revealed that the brain images also remained stable and biomarkers associated with the target showed a consistent decline. These results confirm the safety and tolerability of GNbAC1 and support a positive pharmacodynamic response to the treatment. The positive results of this clinical study represent the successful first step in GeNeuro&rsquo;s phase II programme. A proof-of-concept clinical study to test the efficacy of GNbAC1 in multiple sclerosis will follow in 2015.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Francois Curtin, chief executive officer of GeNeuro states: &ldquo;We are very excited by the potential that GNbAC1 offers as a new avenue to treat multiple sclerosis patients. In addition to confirmation of long-term safety of the monoclonal antibody in patients, we have seen that the cohort of progressive multiple sclerosis patients was stable over one year from both clinical and MRI standpoints. Moreover, there is a clear decrease in the associated biomarkers supporting a positive pharmacodynamic response. This reinforces our conviction that GNbAC1 can completely transform the multiple sclerosis therapeutic landscape.&rdquo; Curtin adds: &ldquo;Preliminary results of this study presented at the American Academy of Neurology earlier this year generated a high level of enthusiasm among clinicians as they see that this treatment could bring new hope to patients as a safe therapy addressing a causal factor of the disease, breaking with the immunosuppressive logic of existing treatments.&rdquo;</span></p></div> National charity unveils big new ambitions for children with brain injury 2014-09-01T17:43:00Z 2014-09-01T17:43:00Z <div id="Introduction42" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The UK&rsquo;s leading charity for children with brain injury has launched a new three-year strategy, outlining ambitious plans to reach thousands more children and families across the UK.</strong></span></p> </div><div id="Text142" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">By 2017, The Children&rsquo;s Trust aims to be reaching 2,500 children living with brain injury every year through a major expansion of its community services. The charity will also undertake significant redevelopment work at its national specialist centre in Tadworth, Surrey and has committed to making greater investments in its online information service, research and campaigning.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Children&rsquo;s Trust, which is celebrating its 30th anniversary this year, provides residential and community-based rehabilitation for children with an acquired brain injury as a result of a serious accident or illness. The charity also runs a special school for children with profound and multiple learning difficulties and provides transitional medical care to children with complex health needs.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Over 40,000 children are estimated to be left with an acquired brain injury every year in the UK.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />One of the key objectives of the new strategy is a major increase in the number of charity-funded partnerships between The Children&rsquo;s Trust and the NHS. Through these partnerships, The Children&rsquo;s Trust embeds their qualified brain injury specialists within major trauma hospitals. Here they provide practical support to families as their child makes the often difficult return to home and school following a brain injury.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Brain injury specialists from the charity have been working at Sheffield Children&rsquo;s Hospital since 2011 and Nottingham Children&rsquo;s Hospital since 2013, supporting more than 500 children and families across South Yorkshire and the East Midlands. As part of their new strategy, The Children&rsquo;s Trust aims to have brain injury specialists in 10 major trauma centres across the UK by 2017, providing support to around 250 children and families in each area every year.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Dalton Leong, chief executive of The Children&rsquo;s Trust, says: &ldquo;Our big new ambitions will see us using our skills and expertise to help even more children with brain injury right across the UK. Never before has there been such an opportunity to increase the expert support available to these children and their families, who are amongst the most vulnerable people in our society. Over the last 30 years, our services have become beacons of specialist rehabilitation, education and care. Our new strategy will enhance these services and expand the vital support we provide to families across the country and online, as well as increasing our research and campaigning activities. We will need more donations and support from the public to turn our ambitions into reality. So I am calling on everyone who wants to make a difference to thousands more children with brain injury to get behind us.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Childhood Brain Injury: Our Big Ambitions, a brochure outlining the details of The Children&rsquo;s Trust&rsquo;s new strategy, is now available to download from</span></p></div> High accuracy for identification of traumatic intracranial haematomas with BrainScope, study says 2014-09-01T17:24:00Z 2014-09-01T17:24:00Z <div id="ImageMain43" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction43" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The publication of an independent, prospective validation study has demonstrated the potential clinical utility of the BrainScope technology for the identification of acute traumatic intracranial haematomas in patients who present to hospital emergency departments.</strong></span></p> </div><div id="Text143" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The results of the study, &ldquo;Identification of hematomas in mild traumatic brain injury using an index of quantitative brain electrical activity&rdquo;, appeared online ahead of print in the <a href="" target="_blank"><em>Journal of Neurotrauma</em></a>, authored by investigators from New York University School of Medicine and The Johns Hopkins University School of Medicine, USA.</span></p> <p><span style="font-size: 10pt;"><br />The technology records brain electrical activity with a handheld, rapid, easy-to-use, non-invasive and non-radiation emitting device, according to BrainScope. The technology utilises advanced signal processing methods and classification algorithms that quantify and characterise features of brain electrical activity associated with traumatic brain injury.</span></p> <p><span style="font-size: 10pt;"><br />In this prospective validation study, ten minutes of brain electrical activity were recorded in 46 adult patients with traumatic haematomas with measureable blood (CT scan positive, &ge;1cc of blood) and 278 head-injured control patients (CT scan negative). The mild presentation of the entire study population is reflected by 97% (313/324) of the patients in the study having a normal Glasgow Coma Scale score of 15 (on a scale of 3&ndash;15), with a mean value of 14.7 for the population with haematomas, and 14.9 for the control group. The volume of blood and distance from recording electrodes were measured by blinded independent experts. A previously derived classification algorithm developed by BrainScope (the &ldquo;TBI-index&rdquo;) was used to identify the probability of a traumatic CT positive lesion in this clinically important independent population.</span></p> <p><span style="font-size: 10pt;"><br />The study reported a sensitivity of 96% to haematomas, which was independent of type of haematoma, blood volume, or distance of the bleed from the recording electrodes on the forehead. Because of the life-threatening risk associated with undetected haematomas, specificity was permitted to be lower (44%) in exchange for extremely high sensitivity. In this study population (n=324), all subjects had been referred for CT scanning by standard clinical practice, of whom 278 were found to be CT negative. These results replicate previously peer-reviewed published findings (Hanley and colleagues, <em>Journal of Neurotrauma</em>, 2013) using the technology in traumatic haematomas, and again importantly demonstrated that the distance and volume restrictions noted with other commercially available methods for detecting traumatic intracranial haematomas were not limitations of BrainScope&rsquo;s technology. These results lend further strong support to the potential enhanced clinical utility of the BrainScope TBI-Index as an important adjunct to acute assessment and triage of clinically important (potentially life-threatening) brain injuries.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Often patients such as those in this study present with very mild symptoms of traumatic brain injury and therefore pose difficult triage decisions upon clinical evaluation. It is not always clear whether the patient might have a clinically important traumatic brain injury (blood in the brain) requiring further clinical evaluation. The ability to determine the likelihood of presence of such injuries non-invasively and without radiation could result in a paradigm shift in the way emergency medicine for TBI is currently practiced,&rdquo; says Michael Singer, president and chief executive officer of BrainScope. &ldquo;This peer-reviewed publication, which independently validated the prior 2013 publication, provides further compelling evidence about the potential for our technology to help assess the existence of brain injuries shortly after injury. Whether in the military or civilian hospital emergency departments, there is a true need for an objective, adjunctive assessment tool for TBI beyond what currently exists. We are highly encouraged by the independent prospective replication of these results.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />BrainScope devices under development for assessment of traumatically-induced head injury and concussion are for investigational use only.</span></p></div> NICE approves Tecfidera (dimethyl fumarate) 2014-08-29T17:11:00Z 2014-08-29T17:11:00Z <div id="ImageMain44" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction44" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Thousands of adults in England and Wales living with the most common type of multiple sclerosis may benefit from a new oral treatment, Tecfidera (dimethyl fumarate), as the National Institute for Health and Care Excellence (NICE) issues the Technology Appraisal Guidance (TAG).</strong> </span>&nbsp;</p> </div><div id="Text144" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">NICE has approved Tecfidera as an option for treating adults with active relapsing remitting multiple sclerosis &ndash; normally defined as two clinically significant relapses in the previous two years &ndash; only if, they do not have highly active or rapidly evolving severe relapsing remitting multiple sclerosis and the manufacturer provides Tecfidera with the discount agreed in the patient access scheme.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The NHS will have a three month period to implement the guidance.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Tecfidera is a new oral treatment, licensed for adult patients with relapsing remitting multiple sclerosis. Tecfidera is taken twice daily with food.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Eli Silber,&nbsp;consultant neurologist at the King&rsquo;s Regional Neurosciences Centre, London, &ldquo;I am pleased that our clinical trials team at King&rsquo;s played a part in confirming the clinical benefits of Tecfidera and I am delighted that NICE has recognised the value of this new oral treatment. Multiple sclerosis is a long-term condition and it is important that patients who are newly diagnosed and starting treatment for the first time have access to new and efficacious treatments. In all multiple sclerosis treatments we are balancing clinically confirmed efficacy with side effects and the studies show that this new drug appears to have a very good risk-benefit profile.&rdquo;<em>&nbsp;</em></span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Ben Turner, consultant neurologist and Honorary Senior Lecturer at Barts and The London NHS Trust says, &ldquo;As the UK chief investigator for Tecfidera&rsquo;s DEFINE study, having seen the obvious benefits of Tecfidera in multiple sclerosis patients I am delighted that people with relapsing-remitting multiple sclerosis will now have access to this new treatment.&nbsp;Tecfidera has been shown to significantly reduce the number of multiple sclerosis relapses and delay disability progression compared to placebo. Also, as shown in the studies, Tecfidera is well tolerated, making it a welcome new treatment option.&rdquo;</span></p></div> Alzheimer’s Prevention Registry reaches recruitment milestone of 40,000 individuals 2014-08-28T16:56:00Z 2014-08-28T16:56:00Z <div id="Introduction45" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The Alzheimer&rsquo;s Prevention Registry has reached a significant milestone in the fight against Alzheimer&rsquo;s by enrolling the 40,000th volunteer interested in participating in major studies of the disease. Championed by Banner Alzheimer&rsquo;s Institute (BAI) and in collaboration with partnering organisations and leading scientists, the online Registry ( aims to accelerate research by connecting healthy individuals who are committed to preventing Alzheimer&rsquo;s with scientists carrying out the studies.</strong></span></p> </div><div id="Text145" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Every person who joins is helping to further research and is bringing us one step closer to unlocking the mysteries of this devastating disease,&rdquo; says Jessica Langbaum, principal scientist at BAI and associate director of the Alzheimer&rsquo;s Prevention Initiative (API). &ldquo;We are excited about the momentum of current prevention research, as many studies begin to recruit and the Registry plays a crucial role in overcoming recruitment barriers.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Registry is unique in that anyone 18 or older with a passion for combating Alzheimer&rsquo;s can be linked to researchers seeking a cure or a new treatment. It was created as part of the API, an international collaborative launched in 2011 to accelerate the pace of research.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Alzheimer&rsquo;s begins developing in the brain long before any symptoms appear - a critical &ldquo;silent&rdquo; period during which scientists believe the disease could be slowed or even stopped. But researchers say that cutting-edge research can be delayed, sometimes by years, because of the difficulty of finding sufficient numbers of volunteers. Clinical trials sometimes need to screen tens of thousands of individuals in order to find the hundreds of participants who fit the trial criteria.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />As Alzheimer&rsquo;s remains the only disease among the top 10 causes of death that has no cure or treatment, the Registry is urgently pushing to accelerate the pace of much-needed research by recruitment both in the USA and internationally. Registry members also receive regular updates on the latest scientific advances, and news and information on overall brain health, Langbaum says.</span></p></div> Aggressive resection should be considered for paediatric epilepsy 2014-08-28T11:31:00Z 2014-08-28T11:31:00Z <div id="ImageMain46" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction46" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Physicians from the University of California, San Francisco, USA, report that resection is safe and effective in children with pharmacoresistant focal epilepsy but seizure outcomes could be improved through aggressive resection in select patients. They add that high-resolution neuroimaging and invasive electrographic studies could be beneficial.</span></strong></p> </div><div id="Text146" style="clear:both; text-align:left"><p>According to the study&rsquo;s lead author, Dario J Englot there is differences in epilepsy type and pathological substrates between children and adults. He explains that because young children have greater neural plasticity and potential for neurological recovery than adults, extremely aggressive resection such as hemispherectomy would be devastating in an adult, adding that critical functions such as language and motor abilities are more likely to improve post-operatively in a young child, due to reorganisation of eloquent cortex.<br /><br />However, they say that, although resection is a tried and tested treatment method, some patients continue to experience seizures post-surgery.<br /><br />Englot and colleagues performed a retrospective cohort study of children and adolescents who underwent focal respective surgery to determine the reasons for surgical failure. They also performed quantitative and qualitative analyses of factors associated with persistent post-operative seizures. The results were published in the <a href="" target="_blank"><em>Journal of Neurosurgery: Pediatrics</em></a>.<br /><br />They reviewed data from 110 patients (115 resections) and found that 76% of patients were free from disabling seizures (Engel Class I outcome) at a mean follow-up of 3.1 years.<br /><br />They say that freedom from seizures was predicted by temporal lobe surgery compared with extratemporal resection, tumour or mesial temporal sclerosis compared with cortical dysplasia or other pathologies and by a lower preoperative seizure frequency.<br /><br />From their findings, it was demonstrated that factors associated with persistent seizures (Engel Class II&ndash;IV outcome) were residual epileptogenic tissue adjacent to the resection cavity (40%), an additional epileptogenic zone distant from the resection cavity (32%), and the presence of a hemispheric epilepsy syndrome (28%).<br /><br />&ldquo;While seizure outcomes in paediatric epilepsy surgery may be improved by the use high-resolution neuroimaging and invasive electrographic studies, a more aggressive resection should be considered in certain patients&rdquo;, Englot <em>et al</em> state.<br /><br />They conclude that aggressive resection should extend to hemispherectomy, if a hemispheric epilepsy syndrome is suspected. Englot told <em>NeuroNews</em>: &ldquo;While it is critical to carefully tailor resections to avoid neurological deficits, it is also true that seizure-freedom is the strongest predictor of quality of life. In our view, an aggressive resection involves maximal removal of tissue that is involved in the epileptogenic zone, while preserving eloquent brain regions to the greatest extent possible. For example, in a child with epilepsy caused by a benign brain tumour (e.g. ganglioglioma), a limited resection might involve lesionectomy alone, while an aggressive resection may include intraoperative interictal electrocorticography to delineate epileptogenic peri-tumoral cortex which should also be removed.&rdquo;<br /><br />They add that the patient should receive counselling on treatment expectations as reoperation may be required in some cases.</p> </div> Highest level evidence indicates better outcomes when using iMRI for brain tumour surgery 2014-08-26T16:37:00Z 2014-08-26T16:37:00Z <div id="ImageMain47" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction47" style="clear:both;"> <p><strong><span style="font-size: 11pt;">In a recently published article in the journal <a href="" target="_blank"><em>Neurosurgery</em></a> the use of VISIUS intraoperative MRI (iMRI) in brain tumour surgery has been proven to result in complete tumour removal in more patients with glioma tumours.&nbsp;</span></strong></p> </div><div id="Text147" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Led by Jin-song Wu, the neurosurgical team at Huashan Hospital at Fudan University in Shanghai, China, conducted the study.</span><br /><br /><span style="font-size: 10pt;">The prospective, parallel, randomised, triple-blind controlled trial design provides the most objective data and therefore highest level evidence to date of the value of iMRI in treating both low and high-grade gliomas. The early results reinforce that high-field iMRI-guided surgery is more effective in achieving complete resection than conventional neuronavigation-guided surgery. Other published studies on high-field iMRI have been mainly retrospective.</span><br /><br /><span style="font-size: 10pt;">&ldquo;iMRI is a practical and valuable asset to increasing the extent of resection for cerebral gliomas, with a specific significant influence for low grade gliomas,&rdquo; Wu says. &ldquo;With trends to statistical significance, these early results are the highest level of iMRI evidence for glioma surgery now available. This leads to more improved overall survivability and quality of life than using conventional neuronavigation.&rdquo;</span><br /><br /><span style="font-size: 10pt;">The low-grade glioma (LGG) subgroup patients who were treated in a VISIUS Surgical Theatre using iMRI had a statistically significant complete resection rate of 82% compared to 43% for the control group of conventional surgery patients. For the high-grade glioma (HGG) patients, 91% of those treated with iMRI had complete resection compared to 73% for the control group. These results are confirmed by volumetric analysis. The LGG subgroup met the endpoint early and that arm of the study stopped enrolling additional patients. The study continues for HGG patients.</span></p> <p><br /><span style="font-size: 10pt;">Jay D Miller, IMRIS CEO and president, notes: &ldquo;Clearly these studies continue to show the benefit of having the level of MR imaging the IMRIS solution provides inside the operating room without moving the patient. We know certain surgeons will not do these types of procedures without being in our surgical suites. In time, use of VISIUS iMRI will develop into a standard of care in these cases.&rdquo;</span><br /><br /><span style="font-size: 10pt;">More than 1,000 patient procedures have been completed using the Fudan University iMRI since its installation in September 2010, the company reports.</span></p></div> US Army funds phase II trial for treatment of PTSD with NeuroSigma eTNS system 2014-08-26T15:57:00Z 2014-08-26T15:57:00Z <div id="ImageMain48" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction48" style="clear:both;"> <p><strong><span style="font-size: 11pt;">NeuroSigma has announced that the US Department of the Army, through the US Army Medical Research and Material Command, has funded a phase II clinical trial at the University of California, Los Angeles (UCLA) aimed at examining the use of external trigeminal nerve stimulation (eTNS) as treatment for post-traumatic stress disorder (PTSD).</span></strong></p> </div><div id="Text148" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Andrew Leuchter, professor of Psychiatry and Biobehavioral Sciences at UCLA and a physician at the Greater Los Angeles Veterans Administration (GLAVA) Health Care System, will lead the study. The phase II clinical trial is expected to enrol 74 subjects to evaluate eTNS as adjunctive therapy under double-blind conditions for military combat veterans who remain symptomatic despite trials of conventional treatments through the GLAVA PTSD program. An earlier phase I clinical trial of eTNS for the adjunctive treatment of PTSD, conducted at UCLA and funded by NeuroSigma, found significant improvements in the severity of PTSD symptoms with eight weeks of nightly eTNS therapy.&nbsp; NeuroSigma will supply eTNS Systems to support the trial.</span><br /><br /><span style="font-size: 10pt;">&ldquo;Despite the best pharmaceutical and psychological treatments for PTSD, many patients still experience symptoms after months and months of trying to get well, with impact on not only on their lives, but also on their families and their communities.&nbsp; Leuchter and his team are to be congratulated for securing competitive federal funding for this rigorous double-blind clinical trial,&rdquo; says Ian Cook, NeuroSigma&rsquo;s chief medical officer and senior vice president. &ldquo;The phase I clinical trial found improvement in PTSD symptom severity and also in measures of depression and quality of life.&nbsp; This phase II trial will evaluate the effects of eTNS on PTSD in a larger group and specifically in combat veterans. We owe it to our veterans to develop new treatments to address their unmet medical needs.&nbsp; A safe, non-invasive neuromodulation treatment may be able to help give them back their lives where other treatments have fallen short.&rdquo;</span><br /><br /><span style="font-size: 10pt;">In August 2012, NeuroSigma received CE mark approval to market NeuroSigma&rsquo;s first trigeminal nerve stimulation product (Monarch eTNS system) in the European Union, for the adjunctive treatment of epilepsy and major depressive disorder (MDD) for adults and children nine years and older. In addition, the Monarch system also received a class II medical device license from Health Canada in April of 2013 allowing NeuroSigma to market the system for treatment of drug-resistant epilepsy (DRE) and MDD for adults and children nine years and older. In April of 2014, NeuroSigma received approval from the Australian Therapeutic Goods Administration (TGA) to market the system in Australia for the adjunctive treatment of DRE in adults and children nine years and older. NeuroSigma is currently offering the system to patients in these jurisdictions with a physician&rsquo;s prescription.</span></p></div> Medtronic acquires Sapiens Steering Brain Stimulation 2014-08-26T12:39:00Z 2014-08-26T12:39:00Z <div id="ImageMain49" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction49" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Medtronic has announced that it has acquired Sapiens Steering Brain Stimulation (Sapiens SBS) for approximately US$200 million in an all-cash transaction.</span></strong></p> </div><div id="Text149" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Sapiens SBS, located in Eindhoven, The Netherlands, is developing a deep brain stimulation system that features an advanced lead with 40 individual stimulation points. This advanced system is designed to allow more precise stimulation of the intended target in the brain and may potentially result in reduced procedure time and fewer stimulation-induced side effects.</span><br /><br /><span style="font-size: 10pt;">Employees at the Eindhoven facility will continue to work toward bringing this technology to market. In the future, the site will serve as a global research and development centre for Medtronic&rsquo;s Neuromodulation business.</span><br /><br /><span style="font-size: 10pt;">Medtronic and Sapiens SBS will work to finalise product development and begin clinical research to integrate these technologies into an expanded portfolio of deep brain stimulation products within Medtronic&rsquo;s Neuromodulation business.</span><br /><br /><span style="font-size: 10pt;">&ldquo;This acquisition broadens our neuroscience leadership position with innovative brain modulation technology that, along with our comprehensive portfolio of deep brain stimulation solutions, may one day transform the way physicians are able to treat patients with neurodegenerative diseases like Parkinson&rsquo;s disease and essential tremor,&rdquo; says Lothar Krinke, vice president and general manager of the Brain Modulation business at Medtronic.</span><br /><br /><span style="font-size: 10pt;">&ldquo;Since 2011, Sapiens SBS employees have worked tirelessly to develop an advanced deep brain stimulation system,&rdquo; says Jan Keltjens, chief executive officer at Sapiens SBS. &ldquo;We are excited to join Medtronic, and look forward to collectively working to bring this and other novel technologies and therapies to neuromodulation patients worldwide that could benefit from them.&rdquo;</span><br /><br /><span style="font-size: 10pt;">Medtronic Neuromodulation business currently includes implantable neurostimulation and targeted drug delivery systems for the management of chronic pain, common movement disorders, spasticity and urologic and gastrointestinal disorders.&nbsp;</span><br /><br /><span style="font-size: 10pt;">More than 115,000 patients worldwide have received Medtronic deep brain stimulation therapy, which is approved in Europe and the USA for the treatment of the disabling symptoms of essential tremor, advanced Parkinson&rsquo;s disease and chronic intractable primary dystonia. The approval in the USA is under a humanitarian device exemption (HDE). In Europe, Canada and Australia, deep brain stimulation therapy is approved for the treatment of refractory epilepsy. It is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder in the European Union and Australia, and in the USA under an HDE.</span><br /><br /><span style="font-size: 10pt;">The transaction is expected to meet Medtronic&rsquo;s long-term financial metrics and does not impact fiscal year 2015 earnings guidance.</span></p></div> Covidien acquires Reverse Medical Corporation 2014-08-22T17:38:00Z 2014-08-22T17:38:00Z <div id="Introduction50" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Covidien&nbsp;has announced that it has acquired&nbsp;Reverse Medical&nbsp;Corporation, a privately held medical device company focused on expanding the management of vascular disease. Financial terms of the transaction were not disclosed.</strong></span></p> </div><div id="Text150" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Covidien is focused on technologies that deliver improved patient care through clinically relevant and economically valuable solutions,&rdquo; says Brett Wall, president, Neurovascular, Covidien. &ldquo;The acquisition of Reverse Medical is complementary to our existing portfolio and will allow us to leverage existing vascular technologies to compete in the worldwide vascular embolisation market, which is growing at a double digit rate.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Covidien will report the Reverse Medical business as part of its Neurovascular product line in the Medical Devices segment. Annualised dilution is not expected to be material.</span></p> <p><span style="font-size: 10pt;"><br />Reverse Medical is currently commercialising its vascular embolisation plugs, MVP Micro Vascular Plug System and UNO Neurovascular Embolisation System. MVP and UNO are self-expanding vessel occlusion devices, which close blood vessels for vascular embolisation. A number of clinical applications require occlusion of the vasculature to rapidly, effectively and safely provide blood flow cessation.</span></p> <p><span style="font-size: 10pt;"><br />Other Reverse Medical products include ReVerse&nbsp;Microcatheter for device delivery and Barrel Vascular Reconstruction Device (VRD), a self-expandable bifurcation aneurysm bridging device. All the devices have received CE Mark approval and are commercially available in Europe. Additionally, MVP-3 and MVP-5 are 510(k) cleared in the USA.</span></p></div> Stemedica International announces pre-clinical data of Alzheimer’s study 2014-08-20T11:00:00Z 2014-08-20T11:00:00Z <div id="Introduction51" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Stemedica International SA, a Stemedica Cell Technologies subsidiary developing stem cell therapies for Alzheimer&rsquo;s disease and dementia, revealed the first results of an intravenous administration of allogeneic, human, ischaemia-tolerant mesenchymal stem cells (itMSCs) in a pre-clinical animal model of Alzheimer&rsquo;s disease. The results demonstrated a greater than 30% decrease in amyloid beta (Abeta) plaques in the brain of transgenic animals treated with Stemedica itMSCs compared to the control group that were treated with lactated Ringer&rsquo;s solution (LRS).</strong></span></p> </div><div id="Text151" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Pre-clinical results show Stemedica International&rsquo;s treatment reduces the amount of plaque as much as the best drug candidates to manage Abeta amyloidosis,&rdquo; says Stemedica International&rsquo;s chief scientist Tristan Bolmont. &ldquo;Most importantly, our itMSC treatment did not result in side effects, such as cerebral amyloid angiopathy and micro-haemorrhages.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />These promising results were achieved during a two-year, intensive, pre-clinical research project supported by a grant from the Swiss Commission for Technology and Innovation (CTI). The research was conducted at the Laboratoire d&rsquo;Optique Biomedicale and headed by professor Theo Lasser at &Eacute;cole Polytechnique F&eacute;d&eacute;rale de Lausanne (EPFL) in Switzerland.</span></p> <p><span style="font-size: 10pt;"><br />The results were presented at the Alzheimer&rsquo;s Association International Conference in Copenhagen, Denmark, on 14 July, 2014. In addition,&nbsp;Bolmont will share the findings during his talk&nbsp;at the Stem Cells Regenerative Medicine Congress 2014 in Boston, Massachusetts, USA.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The combination of safety and efficacy of Stemedica&rsquo;s itMSCs clears the pathway for Stemedica International to file an IND application with the FDA for clinical trials,&rdquo; says Stemedica International&rsquo;s general manager Alexei Lukashev. &ldquo;We hope our stem cell treatment can halt or slow down the progression of Alzheimer&rsquo;s disease and, maybe, have some reverse effect on the damage caused by Alzheimer&rsquo;s disease and other forms of dementia, which the Alzheimer&rsquo;s Disease Institute estimates afflicts more than 44 million people worldwide today.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Only Stemedica International&rsquo;s therapies feature itMSCs that are exclusively licensed from the parent company Stemedica Cell Technologies. Unlike other MSCs &ndash; which are grown under normoxic conditions &ndash; Stemedica&rsquo;s bone-marrow-derived, allogeneic itMSCs are unique because they are grown under hypoxic conditions.&nbsp;<em>In vitro</em>&nbsp;experiments demonstrate cells that are exposed to hypoxic conditions show greater homing and engraftment than cells grown under normoxic conditions. Compared to other MSCs, itMSCs secrete higher levels of growth factors and other important proteins associated with neoangiogenesis and healing.</span></p></div> New dementia research reveals overwhelming demand for “the value of knowing” 2014-08-20T10:50:00Z 2014-08-20T10:50:00Z <div id="Introduction52" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Three out of four people would want to know what kind of neurological disorder they had even if there was no cure, according to new global research from GE Healthcare. An even higher percentage of respondents, 81%, would want to identify an incurable neurological disorder if it affected somebody close to them, with more women (84%) wanting to know than men (76%). The &ldquo;Value of Knowing&rdquo; global survey of 10,000 adults across 10 countries explored perspectives on incurable neurological disorders including Alzheimer&rsquo;s and Parkinson&rsquo;s.</strong></span></p> </div><div id="Text152" style="clear:both; text-align:left"><p><span style="font-size: 10pt;"><strong>Prepared to pay for diagnosis</strong></span></p> <p><span style="font-size: 10pt;"><br />While the overwhelming consensus (94%) is that the government or health insurance providers should cover diagnosis, approximately half (51%) of respondents indicated that they would even be prepared to pay for a diagnosis themselves. This sentiment was particularly prevalent in India and China, where 71% and 83% respectively, said they would be prepared to pay. This was echoed by almost one half of those questioned in Russia and around one-third of respondents in UK, USA and Japan.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;What these statistics tell us is just how strongly people feel about tackling neurological disorders like dementia,&rdquo; says Marc Wortmann, executive director of Alzheimer&rsquo;s disease International. &ldquo;Worldwide, nearly 44 million people have dementia and this number is expected to nearly double in 20 years as the world&rsquo;s population ages. Although there is no cure yet, a timely diagnosis is useful for people with dementia to get access to current treatment, services and support, both medical and non-medical. Governments and healthcare systems need to ensure ready access to the diagnostic tools already available to accurately diagnose disorders such as Alzheimer&rsquo;s and Parkinson&rsquo;s, so that people can manage the symptoms as early as possible.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />When people surveyed were asked why they would want to know, the most common answer (71%) was to start treatment that could help manage the symptoms of the disease. Other reasons included the opportunity to change lifestyle to potentially slow the impact of the illness (66%), and the ability to make informed decisions (62%). Those who would not want to know cited undue worry and the futility of knowing about their disorder without being able to control it.</span></p> <p><span style="font-size: 10pt;"><br />Ben Newton, director of PET Neurology for GE Healthcare, comments, &ldquo;It is understandable that dementia is a frightening topic for people. That said, although there are currently no cures for many neurological disorders, there are symptom-modifying therapies and approaches available if detected early enough. It is interesting to note that the majority of respondents with more experience of a neurological disorder via a loved one for example, said that they would want to know, in spite of there being no cure.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />Recognising the symptoms</strong></span></p> <p><span style="font-size: 10pt;"><br />The research also probed respondents&rsquo; recognition of the possible signs and symptoms of dementia. While a majority recognised memory loss (70%) and disorientation (61%) as signs of dementia, less than half of those surveyed were able to identify other very common symptoms, including language problems, personality, mood and behaviour changes, and loss of initiative.</span></p> <p><span style="font-size: 10pt;"><br />Newton adds, &ldquo;Understanding and knowing all the symptoms of a neurological disorder are critical to helping loved ones who may be showing early signs. Acting early on any concerns may mean patients have access to earlier diagnosis and intervention, which could help to manage and delay the impact of a disorder.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />For decades, GE Healthcare has produced diagnostics scanners, imaging agents and software to help physicians see more clearly inside the brain and aid better patient management. Between 2010 and 2020, GE Healthcare plans to invest over US$500 million in research into neurological disorders. The investment crosses all lines of GE Healthcare and focuses on developing new neurology diagnostic solutions, educating consumers, and expanding research already in progress. Target areas include diagnosing post-traumatic stress disorder, Alzheimer&rsquo;s disease, Parkinson&rsquo;s disease, multiple sclerosis, stroke, concussion and traumatic brain injury.</span></p></div> Utah team invents way to image brains of mice using small needle 2014-08-20T10:38:00Z 2014-08-20T10:38:00Z <div id="Introduction53" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A University of Utah team discovered a method for turning a small, US$40 needle into a 3D microscope capable of taking images up to 70 times smaller than the width of a human hair. This new method not only produces high-quality images comparable to expensive microscopes, but may be implanted into the brains of living mice for imaging at the cellular level.</strong></span></p> </div><div id="Text153" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study appears in the 18 August issue of the journal&nbsp;<a href="" target="_blank"><em>Applied Physics Letters</em></a>.</span></p> <p><span style="font-size: 10pt;"><br />Designed by Rajesh Menon, an associate professor of electrical and computer engineering, and graduate student Ganghun Kim, the microscope technique works when an LED light is illuminated and guided through a fiberoptic needle or cannula. Returned pictures are reconstructed into 3D images using algorithms developed by Menon and Kim.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Unlike miniature microscopes, our approach does not use optics,&rdquo; Menon says. &ldquo;It&rsquo;s primarily computational.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />He says this approach will allow researchers not only to take images far smaller than those taken by current miniature microscopes, but do it for a fraction of the cost.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We can get approximately 1-micron-resolution images that only US$250,000 and higher microscopes are capable of generating,&rdquo; Menon says. &ldquo;Miniature microscopes are limited to the few tens of microns.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Menon hopes to extend the technology in the future so it can see details down to submicron resolutions, compared with the current 1.4 microns. (A micron is a millionth of a metre. A human hair is about 100 microns wide.)</span></p> <p><span style="font-size: 10pt;"><br />The microscope was originally designed for the lab of Nobel Prize-winning U human genetics professor, Mario R Capecchi, whose team will use it to observe the brains of living mice to gain insight into how certain proteins in the brain react to various stimuli. Because the microscope can be assembled so inexpensively and easily go into hard-to-reach places, Menon and Kim expect many other uses for the device.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This microscope will open up new avenues of research,&rdquo; Menon says. &ldquo;Its low-cost, small-size, large field-of-view and implantable features will allow researchers to use this in fields ranging from biochemistry to mining.&rdquo;</span></p></div> New non-invasive technique controls the size of molecules penetrating the blood-brain barrier 2014-08-20T10:20:00Z 2014-08-20T10:20:00Z <div id="Introduction54" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A new technique developed by&nbsp;Elisa Konofagou, professor of biomedical engineering and radiology at Columbia Engineering, has demonstrated for the first time that the size of molecules penetrating the blood-brain barrier (BBB) can be controlled using acoustic pressure&mdash;the pressure of an ultrasound beam&mdash;to let specific molecules through. The&nbsp;study&nbsp;was published in the July issue of the&nbsp;<em><a href="" target="_blank">Journal of Cerebral Blood Flow &amp; Metabolism</a>.</em></strong></span></p> </div><div id="Text154" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This is an important breakthrough in getting drugs delivered to specific parts of the brain precisely, non-invasively, and safely, and may help in the treatment of central nervous system diseases like Parkinson&rsquo;s and Alzheimer&rsquo;s,&rdquo; says Konofagou, whose National Institutes of Health Research Project Grant (R01) funding was just renewed for another four years for an additional US$2.22 million. The award is for research to determine the role of the microbubble in controlling both the efficacy and safety of drug safety through the BBB with a specific application for treating Parkinson&rsquo;s disease.</span></p> <p><span style="font-size: 10pt;"><br />Most small&mdash;and all large&mdash;molecule drugs do not currently penetrate the blood-brain barrier that sits between the vascular bed and the brain tissue. &ldquo;As a result,&rdquo; Konofagou explains, &ldquo;all central nervous system diseases remain undertreated at best. For example, we know that Parkinson&rsquo;s disease would benefit by delivery of therapeutic molecules to the neurons so as to impede their slow death. But because of the virtually impermeable barrier, these drugs can only reach the brain through direct injection and that requires anaesthesia and drilling the skull while also increasing the risk of infection and limiting the number of sites of injection. And transcranial injections rarely work&mdash;only about one in ten is successful.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Focused ultrasound in conjunction with microbubbles&mdash;gas-filled bubbles coated by protein or lipid shells&mdash;continues to be the only technique that can permeate the BBB safely and non-invasively. When microbubbles are hit by an ultrasound beam, they start oscillating and, depending on the magnitude of the pressure, continue oscillating or collapse. While researchers have found that focused ultrasound in combination with microbubble cavitation can be successfully used in the delivery of therapeutic drugs across the BBB, almost all earlier studies have been limited to one specific-sized agent that is commercially available and widely used clinically as ultrasound contrast agents. Konofagou and her team were convinced there was a way to induce a size-controllable BBB opening, enabling a more effective method to improve localised brain drug delivery.</span></p> <p><span style="font-size: 10pt;"><br />Konofagou targeted the hippocampus, the memory centre of the brain, and administered different-sized sugar molecules (Dextran). She found that higher acoustic pressures led to larger molecules accumulating into the hippocampus as confirmed by fluorescence imaging. This demonstrated that the pressure of the ultrasound beam can be adjusted depending on the size of the drug that needs to be delivered to the brain: all molecules of variant sizes were able to penetrate the opened barrier but at distinct pressures, ie., small molecules at lower pressures and larger molecules at higher pressures.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Through this study, we have been able to show, for the first time, that we can control the BBB opening size through the use of acoustic pressure,&rdquo; says Konofagou. &ldquo;We have also learned much more about the physical mechanisms associated with the trans-BBB delivery of different-sized agents, and understanding the BBB mechanisms will help us to develop agent size-specific focused ultrasound treatment protocols.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Konofagou and her&nbsp;Ultrasound Elasticity Imaging Laboratory&nbsp;team plan to continue to work on the treatment of Alzheimer&rsquo;s and Parkinson&rsquo;s in a range of models, and hope to test their technique in clinical trials within the next five years.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;It is frightening to think that in the 21<sup>st</sup>&nbsp;century we still have no idea how to treat most brain diseases,&rdquo; Konofagou adds. &ldquo;But we are really excited because we now have a tool that could potentially change the current dire predictions that come with a neurological disorder diagnosis.&rdquo;</span></p></div> electroCore appoints Piper Jaffray to deal with growing interest from pharma 2014-08-19T10:29:00Z 2014-08-19T10:29:00Z <div id="ImageMain55" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction55" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>electroCore has appointed Piper Jaffray to assist in discussions with pharma companies who are interested in partnering with it on the commercialisation of its breakthrough non-invasive vagus nerve (nVNS) stimulation therapy.</strong></span></p> </div><div id="Text155" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The interest from pharma, medical devices and even technology companies has grown considerably over the last six months,&rdquo; comments chief executive officer and founder JP Errico. &ldquo;We wanted to explore all the opportunities for our future, from partnership to remaining independent. We therefore had discussions with several banks to help us with this process and chose Piper Jaffray. We are under no pressure to do a deal as we are fully funded until 2016. However, as we move from proving that nVNS is a promising treatment for primary headache, to rolling out a sales organisation we wanted to be mindful of all our options.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />electroCore, a US based company, has developed non-invasive Vagus Nerve Stimulation (nVNS) self-administered therapies, which are self-administered by patients for the treatment of multiple conditions in neurology, psychiatry, respiratory and other fields. Initial focus is on primary headache (migraine and cluster headache), with trials continuing in respiratory and gastric motility disorders, depression and anxiety.</span></p> <p><span style="font-size: 10pt;"><br />In Europe, electroCore&rsquo;s nVNS technology has a CE mark for primary headache, bronchoconstriction, epilepsy, gastric motility disorders, and depression and anxiety.&nbsp;It also has regulatory approval for the acute and/or prophylactic treatment of cluster headache, migraine and medication overuse headache in South Africa, India, New Zealand, Australia, Colombia, Brazil and Malaysia, and in Canada for cluster headache. US approval is expected in 2015.</span></p> <p><span style="font-size: 10pt;"><br />electroCore recently reported that its successful funding initiative of US$40 million, announced in April last year, has been oversubscribed by US$10 million by all parties including Merck&rsquo;s Global Health Innovation Fund and private equity groups Easton Capital and Core Ventures. The final tranche of US$15 million of the US$40 million was optional but following discussions between the investors this was not only made compulsory but increased by US$10 million to a total of US$50 million. The company reports having more than US$25 million still at its disposal.</span></p> <p><span style="font-size: 10pt;"><br />electroCore has also recently reported on findings of two of four clinical studies (three against a sham device and one against standard of care), full details of which will be presented at the European headache (EHMTIC) meeting in Copenhagen in mid-September this year on the prevention and treatment of migraine and cluster headache.</span></p> <p><span style="font-size: 10pt;"><br />At the American Headache Society (AHS) in June preliminary results of the US sham controlled pilot study that examined the use of electroCore&rsquo;s non-invasive vagus nerve stimulation therapy (nVNS) in the prevention of chronic migraine were presented showing that the study met its endpoint of safety, and demonstrated a reduction in the number of headache days per month for patients using the active device. The study further suggests that patients who remained on therapy for longer periods of time, may enjoy progressively larger decreases in headache days over the period they are on therapy.</span></p> <p><span style="font-size: 10pt;"><br />Earlier in June electroCore reported preliminary results of a multicentre, randomised, trial across Europe. The trial was found to have met its primary endpoint of statistical significance in reducing the number of cluster headache attacks when compared with the standard of care. During weeks three and four following the beginning of therapy, the number of cluster headache attacks per week was reduced by 46.3% in patients treated with nVNS compared with 12.5% (p=0.002) in patients treated with the best available standard of care.</span></p> <p><span style="font-size: 10pt;"><br />Charly Gaul, director of the Migraine and Headache Clinic K&ouml;nigstein, Germany and the principal investigator of this study comments; &ldquo;This study is one of the few well controlled, randomised studies of any preventative treatment for cluster headache. The ability of electroCore&rsquo;s gammaCore therapy to significantly reduce the number of weekly cluster headaches in these chronic patients suggests it offers an important new option for this extremely painful and difficult to manage condition.&rdquo;</span></p></div> Enrolment in NeuroSTAT phase II study continues 2014-08-18T14:35:00Z 2014-08-18T14:35:00Z <div id="Introduction56" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Enrolment to the ongoing clinical phase IIa study with NeuroVive&rsquo;s drug candidate NeuroSTAT for treating patients with severe traumatic brain injury is continuing, and another two patients have been enrolled. Accordingly, at present, seven of a total of 20 patients have been enrolled in the study.</strong></span></p> </div><div id="Text156" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The enrolment of new patients to the study has taken somewhat longer time than scheduled, but NeuroVive assumes that the ten patients to be treated with a lower dose will have been enrolled by year-end, or during Q1 2015 at the latest. <br /><br />Subsequently, the plan is to conduct interim analysis of data from these first ten patients with the aim of forming an opinion of treatment safety. If there are no safety concerns, the objective is for another ten patients to be enrolled during 2015 with treatment at a higher dose. In addition to planned interim analysis, continuous assessment treatment safety is being conducted. Based on safety assessments of the first patients, treatment with NeuroSTAT at the lower dose is considered to be safe and patient enrolment is continuing as planned.</span></p> <p><span style="font-size: 10pt;"><br />This phase IIa study is an open, non-comparative study involving a total number of 20 patients. Its primary endpoint is to evaluate NeuroSTAT&rsquo;s pharmacokinetics and safety in traumatic brain injury. Secondly, a number of measurements will be conducted, firstly to study NeuroSTAT&rsquo;s efficacy at the mitochondrial level, and to study how biochemical processes are affected by NeuroSTAT post-traumatic brain injury. Traumatic brain injury is a segment subject to a major medical need, where there are no registered pharmaceutical therapies at present.</span></p></div> Plegridy (peginterferon beta-1a) approved in the USA for treatment of multiple sclerosis 2014-08-18T11:15:00Z 2014-08-18T11:15:00Z <div id="ImageMain57" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction57" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Biogen Idec&nbsp;has announced that the US Food and Drug Administration (FDA) has approved Plegridy&nbsp;(peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS).&nbsp;Plegridy, the only pegylated beta interferon approved for use in RMS, is dosed once every two weeks and can be administered subcutaneously with the Plegridy pen, a new, ready-to-use autoinjector, or a prefilled syringe.</strong></span></p> </div><div id="Text157" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Plegridy offers people with MS robust efficacy, a safety profile consistent with the established interferon class, and significantly fewer injections than other beta interferon treatments,&rdquo; says George A Scangos, chief executive officer of Biogen Idec. &ldquo;Plegridy represents the most significant innovation in the interferon class in over a decade, and is the result of our deep commitment to improving the lives of people with MS and those who care for them.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The FDA approval of Plegridy is based on results from one of the largest pivotal studies of beta interferon conducted, ADVANCE, which involved more than 1,500 MS patients. ADVANCE was a two-year, phase 3, placebo-controlled (in year one) study that evaluated the efficacy and safety of PLEGRIDY administered subcutaneously. The analysis for all primary and secondary efficacy endpoints occurred at the end of year one. After the first year, patients on placebo received Plegridy for the duration of the study.</span></p> <p><span style="font-size: 10pt;"><br />In the first year of the ADVANCE clinical trial, Plegridy dosed once every two weeks significantly reduced annualised relapse rate (ARR) at one year by 36% compared to placebo (p=0.0007). Plegridy reduced the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale, by 38% (p=0.0383) compared to placebo. Plegridy also significantly reduced the number of new gadolinium-enhancing [Gd+] lesions by 86% (p&lt;0.0001) and reduced new or newly enlarging T2-hyperintense lesions by 67% (p&lt;0.0001) compared to placebo.</span></p> <p><span style="font-size: 10pt;"><br />The most common adverse reactions were injection site reaction, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, injection site itching and joint pain. The ADVANCE two-year safety data were consistent with safety results observed in year one.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Plegridy is a compelling new treatment option for people living with MS that offers a proven safety profile, strong efficacy and an every two week dosing schedule administered by an innovative delivery system,&rdquo; says Peter Wade, medical director for neurology at the Mandell Center for Comprehensive Multiple Sclerosis Care and Neuroscience Research in Hartford, USA. <br />&ldquo;As a treating neurologist, I believe these attributes will appeal to MS patients who look for less frequent dosing with proven effectiveness.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Plegridy has been recently approved by the European Commission.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;It is always encouraging to have additional treatment options that may help people with MS manage their disease as we move towards our ultimate goal of ending MS forever,&rdquo; says Timothy Coetzee, chief advocacy, services and research officer at the National MS Society.</span></p></div> Low education, smoking, high blood pressure may lead to increased stroke risk 2014-08-18T10:59:00Z 2014-08-18T10:59:00Z <div id="ImageMain58" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction58" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Adult smokers with limited education face a greater risk of stroke than those with a higher education, according to new research in the American Heart Association&rsquo;s journal&nbsp;<em><a href="" target="_blank">Stroke</a>.</em></strong></span></p> </div><div id="Text158" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The combination of smoking and high blood pressure increased stroke risk the most, confirming earlier findings in numerous studies.</span></p> <p><span style="font-size: 10pt;"><br />In a multicentre Danish study, researchers defined lower education as grade school or lower secondary school (maximum of 10 years) education.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We found it is worse being a current smoker with lower education than a current smoker with a higher education,&rdquo; says Helene Nordahl, study lead author and researcher at the Department of Public Health at the University of Copenhagen in Denmark. &ldquo;Targeted interventions aimed at reducing smoking and high blood pressure in lower socioeconomic groups would yield a greater reduction in stroke than targeting the same behaviours in higher socioeconomic groups.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Researchers divided 68,643 adults (30-70 years old) into low, medium and high education levels and assessed&nbsp;smoking&nbsp;and&nbsp;high blood pressure&nbsp;levels. They found:</span></p> <ul> <li><span style="font-size: 10pt;">Sixteen per cent of men and 11% of women were at high-risk of stroke due to low education level, smoking and high blood pressure.</span></li> <li><span style="font-size: 10pt;">Men were more at risk of stroke than women, and the risk of stroke increased with age.</span></li> <li><span style="font-size: 10pt;">Ten per cent of the high-risk men and 9% of the high-risk women had an ischaemic stroke&nbsp;during the study&rsquo;s 14-year follow-up.</span></li> <li><span style="font-size: 10pt;">Smokers with low education had a greater risk of stroke than smokers with high education regardless of their blood pressure.</span></li> </ul> <p><span style="font-size: 10pt;"><br />&ldquo;Universal interventions such as legislation or taxation could also have a strong effect on stroke in the most disadvantaged,&rdquo; Nordahl says. &ldquo;We need to challenge disparities in unhealthy behaviours, particularly smoking.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Researchers were not able to consider differences associated with ethnicity because 98% of the participants were Danes.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The distribution of stroke risk factors may vary across various contexts and study populations,&rdquo; Nordahl says. &ldquo;However, since the most disadvantaged groups are often exposed to a wide number of stroke risk factors, it seems plausible that these people are at higher risk of stroke not only in Denmark, but also in other industrialised countries.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Co-authors are Merete Osler; Birgitte Lidegaard Frederiksen; Ingelise Andersen; Eva Prescott; Kim Overvad; Finn Diderichsen; and Naja Hulvej Rod. Author disclosures are on the manuscript.</span></p> <p><span style="font-size: 10pt;"><br />The Danish Cancer Society funded the study.</span></p></div> IMRIS intraoperative imaging moving system and coils patents granted in Japan 2014-08-14T09:42:00Z 2014-08-14T09:42:00Z <div id="ImageMain59" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction59" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>IMRIS has announced the granting of three patents by the Japanese patent office related to key technology currently integrated into its intraoperative MRI (iMRI) solution within the VISIUS Surgical Theatre. The patents cover control of effective MR imaging using a movable system; imaging coils where clarity is maintained when used while in position during X-ray use; and other components related to using both MR and X-ray imaging in the same environment.</strong></span></p> </div><div id="Text159" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;These patents validate and protect our unique technologies in the territories where we do business,&rdquo; says Meir Dahan, IMRIS chief technology officer and executive vice president of Research and Development. &ldquo;Our intraoperative imaging solutions overcome great challenges in moving a diagnostic quality magnet into multiple locations and then lining it up to produce high quality images while competitor systems are fixed to the floor in a single position.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The covered technology is utilised in VISIUS Surgical Theatres which are hybrid operating room suites with iMRI where a diagnostic quality scanner moves to the patient using ceiling-mounted rails. VISIUS iMRI hybrid ORs may also include X-ray angiography systems where both types of imaging are desired. The fully integrated suites provide neurosurgeons on-demand access to high resolution images - before, during and after procedures without moving the patient from the OR table for truly intraoperative imaging and improved treatment outcomes.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />During brain tumour procedures, serial scanning gives the surgeon the ability to assess results and perform further resection to remove as much tumour as possible. Clinical studies indicate a link between more complete removal of some types of tumours and longer life expectancy and quality of life. IMRIS also develops and manufactures proprietary intraoperative CT systems, head fixation devices, imaging coils, and OR tables for use in this unique and multifunctional intraoperative environment.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;As the leader in image guided therapy solutions, these patents provide us significant coverage and recognition for our intellectual property in these markets for years to come,&rdquo; says Jay D Miller, IMRIS president and chief executive officer. &ldquo;By finding ways to improve the vision and precision the surgeon has available, we are working towards mitigating risks and improving the outcomes for neurosurgical patients and lowering the total cost for the health care system.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />IMRIS currently has one hospital customer with VISIUS iMRI in Japan at the University of Tsukuba in Ibaraki, with a second pending installation at Yaminashi University Hospital, Chuo.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The company also recently received several updated patents from administrations in Canada, the United States and European Union.</span></p> </div> Written emergency stroke care protocols may improve hospital performance 2014-08-06T12:54:00Z 2014-08-06T12:54:00Z <div id="ImageMain60" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction60" style="clear:both;"> <p><strong><span style="font-size: 11pt;">New data presented at the Society of NeuroInterventional Surgery (SNIS) 11th Annual Meeting in (28 &ndash;31, Colorado Springs, USA) helps prove that written care protocols can significantly improve the overall emergency care pathway for stroke.&nbsp;&nbsp;</span></strong></p> </div><div id="Text160" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The data reported was from a study by Vanderbilt University Medical Center, Tennessee, USA.</span><br /><br /><span style="font-size: 10pt;">Over the last decade, an accumulation of evidence has affirmed that, for stroke, reducing the time that elapses from patient presentation to treatment is critical to procedural success and improved patient outcomes. Accordingly, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the regulating agency that certifies Primary and Comprehensive Stroke Centres, requires that these institutions establish written care protocols to guide performance in the emergency care of acute ischaemic stroke, a press release from SNIS states.</span><br /><br /><span style="font-size: 10pt;">The study details a 2012 initiative by VUMC, an Advanced Certification Comprehensive Stroke Center, to significantly revise its stroke care protocol. &ldquo;Our ultimate goal was to develop an enhanced protocol that eliminates variability in our process, streamlines care to achieve necessary efficiencies, and improves time delays to improve the potential for better patient outcomes,&rdquo; said J Mocco, associate professor of Neurosurgery, Vanderbilt University Medical Center.</span><br /><br /><span style="font-size: 10pt;">The new protocol specifies three phases of activities involved in patient assessment and treatment decisions, as well as corresponding communication to relevant physicians at every phase. Specific measurements that map to the three phases include: time from patient arrival to CT scanning; time from patient arrival to neurology evaluation of diagnostics; and time from patient arrival to treatment with intravenous tissue plasminogin activator (IV tPA). Data was obtained over four separate three-month time periods pre- and post-protocol for comparison (pre-implementation of protocol: January&ndash;March 2012, and post-implementation of protocol: August&ndash;October, 2012; January&ndash;March, 2013; and September &ndash; November, 2013). &ldquo;These categories had been measured as part of our original protocol," continued Mocco, "however, we saw an opportunity to focus attention on some of the sub-processes within each that typically do not command attention, but, if addressed, could make a meaningful difference in quality improvement and the overall result.&rdquo;</span><br /><br /><span style="font-size: 10pt;">Post-implementation of the protocol, an analysis across all categories showed notable progress, with average time from patient arrival to CT scanning decreasing from 40.4 to 13 minutes; average time from patient arrival to neurology evaluation of diagnostics decreasing from 34.3 to 8.3 minutes; and average time from patient arrival to IV tPA treatment decreasing from 67.6 to 46.5 minutes.&nbsp; The latter means that VUMC has successfully met the JCAHO-stipulated metric of 60 minutes for "patient arrival to IV tPA."</span></p> <p><span style="font-size: 10pt;">"The success of this new protocol can truly be attributed to a multidisciplinary effort on the part of all of our physicians and other clinicians who work within the always complex and dynamic environment of emergency stroke care with ever-changing variables, all for the purpose of providing the best care for our stroke patients," said Scott Zuckerman, a senior neurosurgery resident who helped plan and lead the implementation of the protocol.</span><br /><br /><span style="font-size: 10pt;">Mocco added, &ldquo;First and foremost, it illustrates the value of customised written protocols that consider all of the nuances associated with any one hospital&rsquo;s emergency stroke care process. Ours is certainly not a one-size fits all solution. Every stroke centre has to tailor its protocols to its own culture and resources.&nbsp; But, ultimately, we hope our experience will be of benefit to other stroke centres that are considering or just beginning a written protocol initiative to fulfill their mission of offering the highest standard of stroke care to their patients.&rdquo;</span></p></div> NeuroPace RNS system receives approval from CMS for new Technology Add-On Payments 2014-08-06T11:18:00Z 2014-08-06T11:18:00Z <div id="ImageMain61" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction61" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroPace has announced that the Centers for Medicare &amp; Medicaid Services (CMS) has approved New Technology Add-on Payments (NTAP) for the RNS system, the world&rsquo;s only commercially available implantable closed-loop responsive neurostimulator system. The NTAP programme recognises new technologies that provide substantial clinical improvement over existing therapies, and is designed to support timely access to innovative technologies for Medicare beneficiaries.</strong></span></p> </div><div id="Text161" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">NeuroPace received premarket approval (PMA) from the US Food and Drug Administration (FDA) for the RNS system in November 2013. It is approved as a treatment for adults with partial onset seizures with one or two seizure onset zones whose seizures have not been controlled with two or more antiepileptic drugs.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are grateful CMS recognises the substantial benefits the RNS system has provided to patients and the need for patients who suffer from uncontrolled seizures to have access to this therapy,&rdquo; says Frank Fischer, chief executive officer at NeuroPace. &ldquo;Epilepsy centres have moved quickly since PMA approval to make the RNS system available. To date, 35 Comprehensive Epilepsy Centers that meet all the qualifications for the highest level of epilepsy care have completed required training and are able to implant the RNS system.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Approximately 2.3 million adults in the United States have active epilepsy, and one-third live with seizures because existing therapies have not provided seizure control. Many people with uncontrolled seizures have or are eligible for Medicare disability benefits. Approval of the NTAP will significantly improve patient access to this new technology.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />As a closed-loop system, the RNS System monitors the brain&rsquo;s own signals, interprets those signals, provides stimulation when needed, and then assesses the brain&rsquo;s response. The breakthrough aspect of the RNS system is its advanced detection and stimulation capabilities. This is unlike all other existing neurostimulation therapies, which continuously or intermittently stimulate the brain without determining the need for treatment or monitoring the response.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The RNS system has been evaluated in three clinical trials, including a prospective, randomised, double-blinded, sham stimulation controlled pivotal study. Results of the clinical trials demonstrate that the substantial clinical improvements experienced by patients over the short- and long-term are durable over many years of therapy. At this time, some patients have been treated with the RNS system for over ten years, and more than 1,500 patient years of experience with responsive neurostimulation have been accumulated to date.</span></p></div> Accenture and Philips announce proof of concept app for ALS patients 2014-08-05T11:49:00Z 2014-08-05T11:49:00Z <div id="Introduction62" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Royal Philips and Accenture have announced that they have developed proof of concept software connecting a wearable display to Emotiv Insight Brainware that could ultimately give more independence to patients with amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. Affecting more than 400,000 people per year, ALS, also known as Lou Gehrig&rsquo;s disease, impairs brain and spinal cord nerve cells, gradually diminishing voluntary muscle action. Late-stage patients often become totally paralysed while retaining brain functions.</strong></span></p> </div><div id="Text162" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This proof of concept exemplifies how people, devices, data and technology could be brought together quickly to connect beyond the hospital walls in a way that can potentially help improve the quality of life for patients, wherever they are in their journey,&rdquo; says Jeroen Tas, chief executive officer, Healthcare Informatics Solutions and Services for Philips. &ldquo;Philips will continue to collaborate with innovative technology companies such as Accenture to explore new wearable and sensor solutions that change peoples&rsquo; lives and create a healthier future.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><strong><br />How it works</strong></span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />When a wearable display and the Emotiv Insight Brainware, which scans EEG brainwaves, are connected to a tablet, users can issue brain commands to control Philips products including Philips Lifeline Medical Alert Service, Philips SmartTV (with TP Vision), and Philips Hue personal wireless lighting. The tablet also allows control of these products using eye and voice commands. In both cases, a person could communicate preconfigured messages, request medical assistance, and control TVs and lights. Accenture and Philips developed the software that enables the integration and interaction between these multiple technologies.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The proof of concept application demonstrates how existing technology could be used to transform the quality of life for ALS patients. When patients lose muscle control and eye tracking ability, they can still potentially operate the Philips suite of connected products in their home environment through brain commands. The Emotiv technology uses sensors to tune in to electric signals produced by the wearer&rsquo;s brain to detect, in real-time, their thoughts, feelings and expressions. The wearable display provides visual feedback that allows the wearer to navigate through the application menu.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Accenture Technology Labs in San Jose, California, USA collaborated with the Philips Digital Accelerator Lab in the Netherlands to create the software to interact with the Emotiv Insight Brainware and the wearable display. Fjord, a design consultancy owned by Accenture Interactive, designed the display&rsquo;s user interface.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This proof of concept shows the potential of wearable technology in a powerful new way &mdash;helping people with serious diseases and mobility issues take back some control of their lives through digital innovation,&rdquo; says Paul Daugherty, Accenture&rsquo;s chief technology officer. &ldquo;It is another demonstration of how Accenture and Philips, collaborating with other technology innovators, seek to improve the lives of people with healthcare challenges.&rdquo;</span></p></div> GE Healthcare’s Signa PET/MR 510(k) pending at FDA 2014-08-05T11:32:00Z 2014-08-05T11:32:00Z <div id="ImageMain63" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction63" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>GE Healthcare has announced that the first integrated, simultaneous, time-of-flight (TOF) capable, whole body Signa PET/MR is 510(k) pending at the US Food and Drug Administration. Powered by simultaneous image acquisition from GE&rsquo;s latest 3.0 Tesla magnetic resonance (MR) technology and innovative positron emission tomography (PET) technology, the Signa PET/MR represents a new chapter in helping clinicians achieve improved scan efficiency that may lead to more effective treatment paths for clinicians to offer their patients, particularly for oncology, neurology, and cardiology.</strong></span></p> </div><div id="Text163" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">MR is excellent for imaging soft tissue as well as functional and morphological details. PET enables clinicians to visualise cellular activity and metabolism. When these two powerful tools are combined, clinicians may be able to see early cellular changes that can be accurately mapped onto MR images. With this knowledge, clinicians may be able to shorten the time between diagnosis and treatment, in addition to offering the convenience of simultaneous PET and MR scans for patients. Research systems are installed at Stanford University, University of California San Francisco, and University of Zurich.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are excited about Signa PET/MR because of its clinical and research potential,&rdquo; says Andrei H Iagaru, associate professor of Radiology and co-chief of the Division of Nuclear Medicine and Molecular Imaging at Stanford University Medical Center. &ldquo;We have been using the system for research and we are able to explore novel things in areas like neurology and oncology, as well as in paediatrics in the future. Additionally, it is more convenient for the patient due to simultaneous scanning. We can also initiate innovative, complex research; simultaneity allows us to do functional neuro imaging, cardiac imaging, and musculoskeletal imaging that we haven&rsquo;t been able to do before. Time-of-flight offers improved image quality in PET/MR and with the increased detector sensitivity, it may lead to future improvements in dose reduction.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Signa PET/MR features GE&rsquo;s new, exclusive MR-compatible silicon photomultiplier detector (SiPM) technology. This new digital detector is characterised by its enhanced sensitivity; it is up to three times more sensitive than conventional PET technology. It also features fast coincidence timing resolution enabling TOF reconstruction. With TOF reconstruction, the arrival times of each coincident pair of photons are more precisely detected, and the time difference between them is used to localise the PET signal accurately. TOF leads to improved PET image quality with higher structural detail and improved signal-to-noise ratio. The Signa PET/MR is designed to be fully upgradable from a Discovery MR750w 3.0T.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We have received extremely positive feedback from our installations of the research PET/MR systems,&rdquo; says Richard Hausmann, president and chief executive officer of GE Healthcare MR. &ldquo;Our research partners are very excited by the performance of the system and the potential of this new technology. We are proud to bring the first TOF-capable, simultaneous PET/MR system, pending FDA clearance, to market.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br /><br />Signa PET/MR is 510(k) pending at FDA. Not available for sale in the United States. Not yet CE marked. Not available for sale in all regions.</span></p></div> AcuteCare Telemedicine and Colleton Medical Center partner to improve patient access to specialised neurological care 2014-08-05T10:40:00Z 2014-08-05T10:40:00Z <div id="Introduction64" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>AcuteCare Telemedicine&nbsp;continues to expand its presence in the Southeastern region with the addition of new client hospitals. Following the announcement of its partnership with&nbsp;Emory John&rsquo;s Creek,&nbsp;Colleton Medical Center&nbsp;(CMC) in Walterboro, South Carolina, USA recently introduced AcuteCare Telemedicine&rsquo;s leading specialists to their dedicated staff of medical professionals and patients. AcuteCare Telemedicine in collaboration with the&nbsp;South Atlantic Division of HCA&nbsp;worked to bring teleneurology services to Colleton Medical Center.</strong></span></p> </div><div id="Text164" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Colleton recently debuted a&nbsp;robot named ELVIS, an acronym for &ldquo;Early Neurological Intervention That&rsquo;s Successful.&rdquo; AcuteCare Telemedicine can remotely consult with doctors and patients through ELVIS. While the robot is currently located in the emergency department, &ldquo;It can be used throughout the entire facility,&rdquo; reports Colleton Medical Center Emergency Department director Christy Judy. As a result, AcuteCare Telemedicine is standing by 24 hours a day anywhere they are needed throughout CMC. Connecting hospital-based medical professionals with off-site specialists through the use of new telecommunication technologies is improving access of specialised care for patients in smaller, regional hospitals and medical centres.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Attracting and recruiting medical specialists is an ongoing challenge for smaller, regional hospitals who must balance the needs of their patients with the financial realities of healthcare in this demanding economy,&rdquo; says Matthews Gwynn, director and founder of the Stroke Center of Northside Hospital and AcuteCare Telemedicine chief executive officer. &ldquo;Having the ability to consult with a neurologist remotely for treatment of stroke and other neurological maladies is allowing these hospitals to meet the needs of the patients in the communities they serve. AcuteCare Telemedicine is extremely proud to associate the South Atlantic Division of HCA and the Colleton Medical Center.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Brad Griffin, chief executive officer of Colleton Medical Center, is also very pleased with Colleton&rsquo;s new relationship with AcuteCare Telemedicine. &ldquo;This is our first venture with telemedicine and the experience is proving to be very positive for both the patients and our team of medical professionals at Colleton,&rdquo; he says. Griffin reports that the hospital staff has found their experience with AcuteCare Telemedicine to be very comforting, easy to work with, and very professional. He sees Colleton&rsquo;s first telemedicine venture as just the beginning and is looking forward to expanding the utilisation of telemedicine to other medical specialties.</span></p></div> NeuroDerm announces eligibility for European Union centralised procedure for ND0612H 2014-08-04T11:01:00Z 2014-08-04T11:01:00Z <div id="ImageMain65" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction65" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroDerm&nbsp;has announced that the European Medicines Agency (EMA) has deemed ND0612H, its product candidate offering continuous delivery of levodopa/carbidopa (LD/CD) treatment for advanced Parkinson&rsquo;s disease, eligible for a European Union marketing authorisation application procedure (&ldquo;centralised procedure&rdquo;). According to EMA guidelines, the EMA can allow products for which the centralised procedure is not mandatory to use that procedure, if the EMA considers that it constitutes a significant therapeutic, scientific or technical innovation.&nbsp;&nbsp;</strong></span></p> </div><div id="Text165" style="clear:both; text-align:left"><p style="margin: 0cm; margin-bottom: .0001pt; line-height: 16.0pt; background: white;"><span style="font-size: 10pt; font-family: Helvetica, sans-serif; color: #464646;">ND0612H is a high-dose form of liquid LD/CD drug delivered continuously through subcutaneous administration by a belt pump. ND0612H is designed to significantly reduce motor complications in advanced Parkinson&rsquo;s disease patients by maintaining steady, high levodopa plasma levels in a convenient manner, to replace current treatments that require highly invasive surgery associated with serious side effects.</span></p> <p style="margin: 0cm; margin-bottom: .0001pt; line-height: 16.0pt; background: white;"><span style="font-size: 10pt; font-family: Helvetica, sans-serif; color: #464646;"><br /> &ldquo;The eligibility for the centralised procedure in the European Union confirms the innovation underlying ND0612H,&rdquo; says&nbsp;Oded Lieberman, NeuroDerm&rsquo;s chief executive officer. &ldquo;It also means that ND0612H will be able to benefit from the more streamlined access to the EU market inherent in this regulatory route. NeuroDerm wishes to bring ND0612H into the market as quickly as possible and make a dramatic change in the lives of Parkinson&rsquo;s disease patients.&rdquo;</span></p> <p style="margin: 0cm; margin-bottom: .0001pt; line-height: 16.0pt; background: white;"><span style="font-size: 10pt; font-family: Helvetica, sans-serif; color: #464646;"><br /> ND0612L, NeuroDerm&rsquo;s low dose drug form for moderate stage Parkinson&rsquo;s patients, has successfully completed phase I and IIa studies. It is currently undergoing a phase II double-blind, randomised, placebo-controlled study supported by a grant from The Michael J Fox Foundation for Parkinson&rsquo;s Research.</span></p></div> Final patient treated in Neuralstem phase II ALS stem cell trial 2014-08-04T10:53:00Z 2014-08-04T10:53:00Z <div id="ImageMain66" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction66" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Neuralstem has announced that the final patient was treated in its phase II trial using NSI-566 spinal cord-derived neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig&rsquo;s disease). The multicentre phase II trial treated 15 ambulatory patients in five different dosing cohorts. The first 12 patients received injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function, in escalating doses ranging from five injections of 200,000 cells per injection, to 20 injections of 400,000 cells each. The final three patients in the trial received both cervical and lumbar injections, for a total of 40 injections of 400,000 cells each, or a total of 16 million cells transplanted. In contrast, the final three patients in the phase I trial received the maximum 15 injections of 100,000 cells each, for a total of 1.5 million cells. The trial will continue until six months past the final surgery, at which point the data will be evaluated.</strong></span></p> </div><div id="Text166" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;We are all extremely pleased to have completed the transplantations in this historic phase II trial," says principal investigator, Eva Feldman, director of the A Alfred Taubman Medical Research Institute and director of Research of the ALS Clinic at the University of Michigan Health System. &ldquo;By early next year, we will have six-month follow up data on the last patients who received what we believe will be the maximum safe tolerated-dose for this therapy. We look forward to seeing what the data tell us about safety and efficacy of this approach. It is also worth noting that we will have completed this phase II trial within a year, roughly.&nbsp; I would like to thank Parag Patil,&nbsp; and my collaborators at Emory, John Glass and Nick Boulis, and at Mass General, Merit Cudkowicz and Larry Borges, for helping us reach this goal.&rdquo; Feldman is an unpaid consultant to Neuralstem.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The completion of phase II of this important clinical research programme is a major milestone, demonstrating that patients can tolerate the transplantation of high doses of cells and multiple spinal cord injections,&rdquo; says site principal investigator, Jonathan D Glass, director of the Emory ALS Center. &ldquo;From both a clinical and scientific perspective, I think we are now ready to move forward toward a true therapeutic trial to test the efficacy of this surgical approach for slowing the course of ALS.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We would like to express our thanks to all of the doctors and medical staff who made this possible, as well as the patients and their families. Without their bravery, none of this would have happened,&rdquo; says Karl Johe, Neuralstem&rsquo;s chairman of the Board and chief scientific officer. &ldquo;With this landmark trial, the first to transplant stem cells in this volume and through so many injections along the length of the human spinal cord, we hope to establish the dose that is both safe and which may be optimal for treatment. We are excited about the collection and analysis of the final data and look forward to advancing to our next trial.&rdquo;</span></p></div> Codman launches new Envoy guiding catheters 2014-08-01T15:25:00Z 2014-08-01T15:25:00Z <div id="ImageMain67" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction67" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Codman Neuro, part of&nbsp;DePuy Synthes Companies of Johnson &amp; Johnson, has announced the launch of the Envoy<sup>&nbsp;</sup>DA XB distal access guiding catheter and the 7F Envoy&nbsp;guiding catheter for neurovascular procedures.</strong></span></p> </div><div id="Text167" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The announcement was made at the Society of NeuroInterventional Surgery (SNIS) 11th Annual Meeting, where Codman Neuro is featuring the new catheters alongside its portfolio of neurovascular solutions, which include microcoils, vascular reconstruction devices and the full line of Envoy guiding catheters.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Each of these new catheters provides reliable navigation and stability, and offers distinct advantages during neurovascular procedures,&rdquo; says Ajit S Puri, Division of Neurointerventional Surgery at University of Massachusetts Memorial Medical Center. &ldquo;The Envoy DA XB guiding catheters provide the reliable navigation associated with the standard Envoy guiding catheter, but in addition, offer distal catheter position in tortuous vascular segments. The 7F Envoy guiding catheter has an inner lumen that accommodates and navigates multiple interventional devices without friction. It also has great support and optimal lumen for use with most carotid stents.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><strong><br />The Envoy DA XB guiding catheter</strong></span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Envoy DA XB guiding catheter enables access to more distal anatomy and is designed to provide additional proximal support of the catheter when more stability is required. The new catheter is part of the Envoy DA&nbsp;guiding catheter&nbsp;family designed with a flexible distal segment for navigation to distal anatomy. It features end-to-end braided construction, a distal 10cm hydrophilic coating, soft distal tip with a recessed metal marker, and Brite Tip<sup>&nbsp; </sup>technology for enhanced visibility.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The Envoy DA guiding catheter with its soft flexible distal segment and .071-inch inner lumen allows for ease of placement into the petrous segment, as well as additional inner lumen, for smooth&nbsp;advancement when using multiple devices such as a balloon and microcatheter,&rdquo; says Gaurav&nbsp;Gupta, director, Cerebrovascular and&nbsp;Endovascular Neurosurgery, Rutgers Robert Wood Johnson Medical School. &ldquo;In addition, it works very well with intermediate catheters providing excellent stability as you place these devices in distal anatomy.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><strong><br />7F Envoy guiding catheter</strong></span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The 7F Envoy guiding catheter is the largest-diameter guiding catheter the company has ever offered, expanding upon&nbsp;the 6F Envoy guiding catheters. With stainless steel end-to-end hybrid braid technology and soft distal Brite Tip technology, the new catheters are offered in multiple shape configurations to navigate and treat different anatomy.</span></p></div> SNIS Foundation bestows first grant award for cutting-edge neurointerventional research 2014-08-01T15:06:00Z 2014-08-01T15:06:00Z <div id="Introduction68" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The SNIS Foundation recognised its first Seed Grant awardee with US$25,000 to fund a translational research project. The first award since the Foundation&rsquo;s inception in 2011, the gift was presented at the Society of NeuroInterventional Surgery (SNIS) 11th Annual Meeting in Colorado Springs, USA.</strong></span></p> </div><div id="Text168" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Representing physicians who specialise in neurointerventional approaches to neurovascular conditions, SNIS formed the SNIS Foundation, in part, to ensure investment in scientific research and discovery that enables practitioners to provide the highest level of care to patients who can benefit from neurointerventional treatment. The Seed Grant is a one-year gift that enables young investigators to conduct pilot projects that address a specific hypothesis and generate preliminary data in preparation for major grant applications to corporations, foundations and governmental agencies.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The first recipient, Daniel Cooke, assistant professor of Radiology and Biomedical Imaging at the University of California, San Francisco, USA, was awarded the grant for his innovative work in facilitating first-time evaluation of endothelial cells harvested from devices utilised in neurointerventional procedures to treat ruptured and unruptured aneurysms. By obtaining these tissue samples during a standard procedure, and analysing genetic expression at the single cell level, Cooke and his team aim to advance neurointervention by utilising their study of endothelial cells to offer insights into the mechanisms of aneurysm formation, evolution, and in some cases, rupture.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This is exciting and innovative work worthy of continued exploration and support from the SNIS Foundation,&rdquo; says Lee Jensen, professor of Radiology, Neurology and Neurological Surgery at University of Virginia Health System and chair of the SNIS Foundation. &ldquo;The applications for the first SNIS Foundation Seed Grant were very strong, but Cooke&rsquo;s work stood out as the kind of research that could have meaningful implications for our overall approach to neurointerventional aneurysm treatment.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />All Seed Grant proposals were reviewed and ranked by a multi-disciplinary panel, including interventional neuroradiologists, endovascular neurosurgeons, and interventional neurologists. For this first award, it is noteworthy that the chosen grant was the top choice of all panellists.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Three additional grants are expected to be awarded in the next six months. The SNIS Foundation will fund these and future grants with private donations as well as select fundraisers sponsored by the Foundation.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;After three years of growing the Foundation, it is exciting to realise our goal of funding meaningful research work that aligns with our overall mission,&rdquo; says Jensen.&nbsp; &ldquo;This is a milestone moment in the life of the SNIS Foundation and SNIS, and instrumental to the growth of our neurointerventional specialty.&rdquo;</span></p> </div> New technology may improve visualisation of the brain during stroke treatment 2014-08-01T14:53:00Z 2014-08-01T14:53:00Z <div id="Introduction69" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>New technology in the form of a magnetically-assisted remote-controlled catheter (MARC) which could allow physicians to see and assess brain tissue more clearly while treating a stroke may hold promise, according to study authors who released their findings at the Society of NeuroInterventional Surgery (SNIS) 11th Annual Meeting in Colorado Springs, USA.</strong></span></p> </div><div id="Text169" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The findings stand to advance the field of neurointervention. Neurointerventionists typically accomplish this approach by manually directing the catheter and visualising its progress under standard X-ray guidance.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />With MARC, study authors sought to understand if a remote-controlled catheter under Magnetic Resonance Imaging (MRI) guidance could more effectively accomplish manoeuvring through complex vessel anatomy, which would ultimately allow improved visualisation of the brain tissue affected during a stroke. &ldquo;Given that MRI is the gold standard by which we determine brain tissue viability, it is exciting that we potentially now have new MRI-compatible technology that enables us, while treating a stroke, to make real-time assessments about whether brain tissue is dead or alive,&rdquo; says Steven Hetts, lead study author and associate professor of Radiology at the University of California, San Francisco, USA. &ldquo;The implications are numerous, including improved medical decision-making, which would naturally result in optimising patient safety and clinical outcomes.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />To assess the performance of MARC, Hetts and his colleagues aimed to determine mean procedure times and success data for a custom, clinical-grade MARC prototype under MRI guidance as compared to a manually-navigated catheter, under both MRI and conventional x-ray guidance - each procedure utilising a cryogel vascular model designed to simulate the main and branch blood vessels in a living human. The MRI-guided procedures were performed at 1.5T (magnetic field strength of a standard clinical MRI scanner) using a balanced steady-state free precession sequence in the type of clinical MRI scanner available in most hospitals.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Results showed that MARC was clearly visible under MRI guidance and was used to successfully complete 192 (80%) of 240 total turns around blood vessels as compared to the manually- directed catheter under both MRI and x-ray guidance, at 144 (60%) of 240 total turns and 119 (74%) of 160 total turns, respectively. MARC also was faster than the manually directed catheter under MRI, with a mean procedure time of 37 seconds per turn as compared to 55 seconds, but comparable to the manually directed catheter under X-ray guidance which required a mean of 44 seconds for each turn. When assessing the time required to navigate the various angles of branch vessels at turns of 45&deg;, 60&deg;, and 75&deg;, MARC proved to be faster than the manually-directed catheter under MRI guidance.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Given that the success of neurointerventional stroke treatment is directly tied to how fast and accurately physicians can eliminate the impact of a clot and restore blood flow to viable portions of the brain, technology that facilitates this objective stands to be transformative,&rdquo; says Hetts. &ldquo;By proving that MRI-guided neurointervention could be more effective than current standard approaches to stroke treatment, we are taking a significant step forward in the advancement of our field.&rdquo;</span></p></div> Los Angeles medical team performs California’s first auditory brainstem implant surgery on toddler 2014-08-01T12:39:00Z 2014-08-01T12:39:00Z <div id="ImageMain70" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction70" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A Los Angeles team of scientists and surgeons from Keck Medicine of the University of Southern California (USC),Children&rsquo;s Hospital Los Angeles&nbsp;(CHLA) and Huntington Medical Research Institutes (HMRI) reported that sound registered in the brain of a deaf Canadian boy for the first time after doctors activated a hearing device that had been surgically implanted in his brainstem.</strong></span></p> </div><div id="Text170" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Auguste Majkowski, 3, is the first child in the United States to undergo an auditory brainstem implant (ABI) surgery in a US Food and Drug Administration (FDA)-approved trial supported by a National Institutes of Health (NIH) clinical trial grant. On 12 June, six weeks after surgery at CHLA, the device was activated with positive results at the Department of Otolaryngology &ndash; Head &amp; Neck Surgery clinic at Keck Medicine of USC.</span></p> <p><span style="font-size: 10pt;"><br />Auguste&rsquo;s surgery, device activation and future behavioural study are part of a five-year clinical trial in which 10 devices will be implanted in deaf children under the age of five and studied over the course of three years. The Los Angeles study, co-led by audiologist Laurie Eisenberg, and surgeon Eric Wilkinson, is the only in the United States to be supported by the NIH.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Our Los Angeles-based team has been at the forefront of ABI technology development since it came into use in the late 1970s for adults, so it is especially gratifying to help break the &lsquo;sound barrier&rsquo; once again; this time, for children who previously could not hear,&rdquo; says Eisenberg, a Keck School of Medicine of USC otolaryngology professor. &ldquo;Surgeons outside the United States have been doing ABI surgeries in children for 10 years, but there has never been a formal safety or feasibility study under regulatory oversight. Our team is writing the manuals for all the procedures for this technology, and we have a top-notch multidisciplinary team in place to carry out the research.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The surgical team that performed the operation at Children&rsquo;s Hospital included Wilkinson, HMRI research scientist and neurotologist at House Clinic; HMRI research scientist and House Clinic neurosurgeon Marc Schwartz, and paediatric neurosurgeon&nbsp;Mark D Krieger, Billy and Audrey Wilder chair, Division of Neurosurgery&nbsp;at CHLA. Attending the surgery was also Vittorio Colletti, of the University of Verona Hospital, Verona, Italy, who has performed the most ABI surgeries on children overseas and is a collaborator on the study.</span></p> <p><span style="font-size: 10pt;"><br />The study&rsquo;s goal is to establish safety and efficacy protocols for the surgery and subsequent behavioural mapping procedures that doctors in the United States can then later utilise once the surgery is approved for children in the USA.</span></p> <p><span style="font-size: 10pt;">&ldquo;Hundreds of children in the USA can benefit from ABI surgery,&rdquo; says Krieger, who also is associate professor of clinical neurosurgery at the Keck School of Medicine of USC. &ldquo;These children would otherwise never hear or develop verbal speech in their lives.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Auguste was the first child accepted into the Los Angeles study. Thirty-six days after the May 6 surgery at CHLA, his parents watched as audiologists Margaret Winter, and Jamie Glater, from the USC Center for Childhood Communication activated the device implanted in Auguste&rsquo;s brainstem. When Winter delivered tiny pulses of electric current to the electrodes in his brain, the toddler lifted his head indicating he heard a sound.</span></p> <p><span style="font-size: 10pt;"><br />Auguste has been deaf since birth. At 22 months, he underwent a bilateral cochlear implant, which uses electrodes to stimulate auditory nerves, but the device did not help him hear because he does not have a cochlear, or hearing, nerve. Auguste travelled with his parents, Sophie and Christophe, from Montreal to Los Angeles to participate in the clinical trial. The NIH grant covers the costs of the device, procedure and subsequent testing. To qualify for participation, patients must show that standard treatment such as hearing aids and cochlear implants have been ineffective.</span></p> <p><span style="font-size: 10pt;"><br />During the six-hour surgery in May, doctors made an incision by Auguste&rsquo;s right ear and removed his right cochlear implant before implanting the ABI device on his brainstem. The ABI device has external and internal parts. The external parts, which consist of a processor with a microphone and transmitter, transform sound into electrical signals and transmit the signals to an internal receiver that is part of the electrode array. The electrode array is placed on the cochlear nucleus of the brainstem. The procedure is considered revolutionary because it stimulates neurons directly at the human brainstem, bypassing the inner ear entirely.</span></p> <p><span style="font-size: 10pt;"><br />The young children who had ABIs implanted outside the United States now have the potential to understand speech, but, in the United States, the device is FDA-approved for use only in patients 12 years or older with neurofibromatosis type II, an inherited disease that causes a non-malignant brain tumour on the hearing nerve. It has shown limited effectiveness in adults, however, and scientists believe that the device would be more effective in young children, when their brains are more adaptable. The clinical trial will attempt to prove that this surgery is safe in young children and allow researchers to study how the brain develops over time and how it learns to hear sound and develop speech.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The children in this study are under five years of age,&rdquo; says Keck School of Medicine of USC Professor Robert V Shannon, an investigator for the trial and leading scientist in the development of ABI technology since 1989. &ldquo;When a child is born, their ear is hard-wired for sound but the brain has to learn how to perceive sound and speech from the information coming up the hearing pathway. If the ear is not providing sound information to the brain, the hearing part of the brain does not develop properly. The ABI provides sound to these pathways so they grow and develop with the child.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />After the devices are implanted, the Los Angeles-based researchers will study how the brain develops over time as it incorporates sound and speech. If the clinical trial is successful, children across the United States will be able to benefit from surgical and audiology techniques and safety and efficacy protocols developed in the study.</span></p></div> Medtronic completes acquisition of Visualase 2014-07-28T14:54:00Z 2014-07-28T14:54:00Z <div id="Introduction71" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Medtronic has announced that it has completed the acquisition of Visualase, a&nbsp;privately held company based in Houston, USA, that develops and markets an FDA-approved MRI-guided laser and image guided system for minimally invasive neurosurgeries, including surgical thermal ablation.</strong></span></p> </div><div id="Text171" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Medtronic will add Visualase&rsquo;s MRI-guided laser ablation system to its portfolio of therapies for treating neurological conditions within its Surgical Technologies business and will integrate the technology into its broader neuroscience offerings. The acquisition of Visualase is another example of Medtronic&rsquo;s ongoing investment in technology and commitment to innovation across the entire surgical care continuum as the company strives to become the partner of choice for neurosurgeons and neuroscience centres around the world.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are excited about this opportunity to add Visualase&rsquo;s complementary technology and expertise to our neurosurgical solutions portfolio, which includes intra-operative imaging, surgical navigation, powered instruments and cerebrospinal fluid (CSF) management,&rdquo; says Mark Fletcher, senior vice president and president, Medtronic Surgical Technologies. &ldquo;The Visualase laser ablation technology gives neurosurgeons a minimally invasive option to precisely target and treat small areas of tissues. We are the recognised leader in high technology solutions for specialties such as neurosurgery, spinal surgery and orthopaedics. This acquisition broadens our strong and growing portfolio of innovative surgical products and represents entries into new areas such as surgical thermal ablation.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The transaction with Medtronic is critical to ensure more patients have access to our beneficial technology,&rdquo; says William Hoffman, chief executive officer of Visualase. &nbsp;&ldquo;We are proud of the MRI-guided laser ablation technology and other products we have developed and their impact on the well-being of patients. Medtronic is clearly committed to the area of minimally invasive neurosurgery and we look forward to working as a team to innovate in this area.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The all-cash transaction of up to US$105 million includes an initial payment of US$70 million plus additional payments of up to US$35 million which are contingent upon the achievement of specific milestones.&nbsp;Medtronic had previously invested in Visualase and held an ownership stake in the company prior to completion of the acquisition.&nbsp;Net of this ownership stake, the initial payment is approximately US$64 million.&nbsp;Medtronic expects the net impact from this transaction to be neutral to fiscal year 2015 earnings and accretive thereafter, and for this transaction to be consistent with the company&rsquo;s disciplined focus on long-term returns.&nbsp;</span></p></div> IMRIS receives CE mark for integrating latest generation MR scanners within VISIUS surgical theatre 2014-07-28T12:13:00Z 2014-07-28T12:13:00Z <div id="ImageMain72" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction72" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>IMRIS has announced that it has obtained regulatory CE mark for integrating the next generation MRI core technology into the VISIUS surgical theatre allowing for sales and marketing in the European Union.</strong></span></p> </div><div id="Text172" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">This newest imaging technology, based on the Siemens Aera 1.5T(tesla) and Skyra 3.0T MRI scanners, helps IMRIS deliver even better image quality, faster 3D image acquisition, and improved ease-of-use and workflow during surgical procedures using intraoperative MRI (iMRI). The company received United States Food and Drug Administration (FDA) approval for these advancements in February 2014.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These high-field intraoperative scanner options will give a hospital&rsquo;s clinical team state-of-the-art applications and image quality that increase productivity,&rdquo; says IMRIS president and chief executive officer Jay D Miller. &ldquo;We bring the latest and unequaled imaging technology into the operating room where it can make the most difference - during the surgery. More and more neurosurgical centres are using image guidance with VISIUS iMRI for an expanding list of conditions and procedures and adjunctive interventions beyond brain tumour resections, such as laser ablation for tumours and epilepsy using stereotactic tools, deep brain stimulation (DBS) and other minimally-invasive techniques that are designed to improve patient outcomes.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Inside a VISIUS surgical theatre equipped with high-field iMRI, surgeons have on-demand access to real-time data and state-of-the-art imaging during the procedure as the scanner uniquely moves on ceiling-mounted rails.</span></p></div> NeuroPace RNS system will play key role in DARPA’s RAM programme 2014-07-24T12:33:00Z 2014-07-24T12:33:00Z <div id="ImageMain73" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction73" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroPace has announced its partnership with the Defense Advanced Research Projects Agency (DARPA) Restoring Active Memory (RAM) teams at the University of Pennsylvania and the University of California, Los Angeles (UCLA), USA to develop new treatments for memory deficits using neurostimulation.</strong></span></p> </div><div id="Text173" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The RNS system is the world&rsquo;s only commercially available implantable closed-loop responsive neurostimulator system. NeuroPace received premarket approval (PMA) from the US Food and Drug Administration (FDA) for the RNS System in November 2013. It is approved as a treatment for adults with partial onset seizures with one or two seizure onset zones whose seizures have not been controlled with two or more antiepileptic drugs.</span></p> <p><br /><span style="font-size: 10pt;">Through the DARPA RAM research, NeuroPace and other collaborators will gain fundamental knowledge regarding the restoration of memory. The company believes this research may expand the clinical applications of the RNS system beyond the treatment of epilepsy, as well as provide the understanding necessary to inform the development of future devices that expand the capabilities of responsive neurostimulation. This collaborative effort will advance the field of brain research and closed-loop neurostimulation applications. A portion of the DARPA project will involve epilepsy patients implanted with the RNS system at seven Comprehensive Epilepsy Centers and will be led by Barbara Jobst, professor of Neurology at Dartmouth, and Martha Morrell, chief medical officer at NeuroPace and clinical professor of Neurology at Stanford University. A separate part of the project will begin with epilepsy patients implanted with the RNS system at UCLA with Itzhak Fried serving as the principal investigator.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Using the RNS system, we will be able to immediately explore ways in which brain stimulation can restore memory function in patients with epilepsy. Insights derived from these early studies will help to guide future research in patients with other neurological disorders that result in memory loss,&rdquo; says Michael Kahana, principal investigator at the University of Pennsylvania.</span></p> <p><br /><span style="font-size: 10pt;">As a closed-loop system, the RNS system monitors the brain&rsquo;s own signals, interprets those signals, provides stimulation when needed, and then assesses the brain&rsquo;s response. The breakthrough aspect of the RNS system is its advanced detection and stimulation capabilities. This is unlike all other existing neurostimulation therapies, which continuously or intermittently stimulate the brain without determining the need for treatment or monitoring the response.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The RNS system is the only commercially available product that continuously monitors the brain&rsquo;s electrical signals, delivers stimulation only when needed and then monitors the response,&rdquo; says Frank Fischer, chief executive officer at NeuroPace. &ldquo;This capability is critical to the research phase of projects like the DARPA RAM programme. Restoring active memory could improve the lives of so many. We are thrilled to be a part of this programme and hope to be part of similar brain research and product development projects in the future.&rdquo;</span></p></div> Plegridy (peginterferon beta-1a) approved in the EU for treatment of multiple sclerosis 2014-07-23T12:51:00Z 2014-07-23T12:51:00Z <div id="Introduction74" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Biogen Idec&nbsp;has announced that the European Commission has granted marketing authorisation for Plegridy&nbsp;(peginterferon beta-1a) as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). Plegridy is dosed once every two weeks and is administered subcutaneously with the Plegridy pen, a new ready-to-use autoinjector, or a prefilled syringe.</strong></span></p> </div><div id="Text174" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Plegridy, the only pegylated interferon approved for use in relapsing-remitting multiple sclerosis, has been proven to significantly reduce important measures of disease activity, including number of relapses, MRI brain lesions, and disability progression.</span></p> <p><br /><span style="font-size: 10pt;">The European Commission approval of Plegridy is based on results from one of the largest pivotal studies of a beta interferon conducted, <a href=";rank=13" target="_blank"><strong>ADVANCE</strong></a>, which involved more than 1,500 patients with relapsing forms of multiple sclerosis.</span></p> <p><br /><span style="font-size: 10pt;">In the ADVANCE clinical trial, Plegridy, dosed once every two weeks, significantly reduced annualised relapse rate (ARR) at one year by 36% compared to placebo (p=0.0007).</span></p> <p><br /><span style="font-size: 10pt;">Plegridy reduced the risk of sustained disability progression confirmed at 12 weeks by 38% (p=0.0383) and at 24 weeks by 54% (p=0.0069, post-hoc analysis). In addition, the number of gadolinium-enhancing [Gd+] lesions was significantly reduced by 86% (p&lt;0.0001) compared to placebo.</span></p> <p><span style="font-size: 10pt;"><br />Results over two years of ADVANCE confirm that its robust efficacy was maintained beyond the placebo-controlled first year of the study.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The safety and efficacy that Plegridy has demonstrated, combined with its less frequent dosing schedule offers multiple sclerosis patients an option to put their treatment in the background for longer stretches of time,&rdquo; says Bernd C Kieseier, Heinrich-Heine&nbsp;Universit&auml;t, Dusseldorf.</span></p> <p><br /><span style="font-size: 10pt;">The safety and tolerability profile of peginterferon beta-1a observed in ADVANCE&nbsp;was consistent with that of established multiple sclerosis interferon therapies. The most commonly reported adverse drug reactions with peginterferon beta-1a treatment (incidence &ge;10% and at least 2% more frequent on peginterferon beta-1a than on placebo) were injection site reaction, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, injection site itching, and joint pain.</span></p> <p><br /><span style="font-size: 10pt;">Plegridy is the fifth therapy to be offered by Biogen Idec to people living with multiple sclerosis.</span></p></div> US$1 million Career Development Award grant for glioblastoma research with ThermoDox and HIFU 2014-07-22T10:14:00Z 2014-07-22T10:14:00Z <div id="Introduction75" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Celsion Corporation has announced that its ongoing collaboration with Costas Arvanitis of Brigham and Women&rsquo;s Hospital, a teaching affiliate of&nbsp;Harvard Medical School, has been expanded through the recent award of a&nbsp;US$1 million&nbsp;Career Development Award from the National Institutes of Health&rsquo;s Center for Biomedical Imaging and Bioengineering (NIBIB).</strong></span></p> </div><div id="Text175" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The grant will support preclinical studies evaluating ThermoDox, the company&rsquo;s heat-activated liposomal encapsulation of doxorubicin, in combination with High Intensity Focused Ultrasound (HIFU), for the treatment of brain tumours. The grant, titled &ldquo;Controlled Delivery and Release of Chemotherapy in Brain Tumours with FUS&rdquo; provides on average of&nbsp;US$200,000&nbsp;in annual funding for five years, and will be used to advance preclinical development of ThermoDox for the treatment of brain cancers, including glioblastoma multiforme, under the company&rsquo;s&nbsp;January 2014&nbsp;collaboration with Brigham and Women&rsquo;s Hospital, Harvard Medical School.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This peer-reviewed grant award builds upon our ongoing collaborative work to explore treatments for brain tumours,&rdquo; says Costas D Arvanitis, Brigham and Women&rsquo;s Hospital,&nbsp;Harvard Medical School. &ldquo;Delivering chemotherapeutic agents across the blood-brain barrier is particularly challenging, but in recent years we have discovered that this could be achieved using focused ultrasound, including enhanced delivery of liposomal doxorubicin.&nbsp;We are hopeful that this grant will allow us to determine the potential utility of a promising therapeutic application for one of the most insidious cancers - glioblastoma.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Glioblastoma is a highly aggressive and deadly form of brain cancer for which there are few treatment options,&rdquo; says&nbsp;Michael H Tardugno, Celsion&rsquo;s president and chief executive officer.&nbsp;&ldquo;Working with a prominent cancer research group like Dr Arvanitis and his team, combined with the financial support of the NIH, will help accelerate the research required to elucidate the potential of ThermoDox combined with HIFU in this difficult to treat cancer, and provide a path forward for larger, more comprehensive phase II studies.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">If promising results are obtained from these phase I studies, a phase II grant application will be submitted to include more comprehensive studies of ThermoDox and HIFU for the treatment of glioblastoma multiforme brain tumours.</span></p></div> Study links enzyme to Alzheimer’s disease 2014-07-21T15:54:00Z 2014-07-21T15:54:00Z <div id="ImageMain76" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction76" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Unclogging the body&rsquo;s protein disposal system may improve memory in patients with Alzheimer&rsquo;s disease, according to a study from scientists at Kyungpook National University in Korea published in&nbsp;<a href="" target="_blank"><em>The Journal of Experimental Medicine</em></a>.</strong></span></p> </div><div id="Text176" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In Alzheimer&rsquo;s disease, various biochemical functions of brain cells go awry, leading to progressive neuronal damage and eventual memory loss. One example is the cellular disposal system, called autophagy, which is disrupted in patients with Alzheimer&rsquo;s disease, causing the accumulation of toxic protein plaques characteristic of the disease. Jae-sung Bae and colleagues had earlier noted that the brains of Alzheimer&rsquo;s disease patients have elevated levels of an enzyme called acid sphingomyelinase (ASM), which breaks down cell membrane lipids prevalent in the myelin sheath that coats nerve endings. But whether increased acid sphingomyelinase directly contributes to Alzheimer&rsquo;s disease (and if so, how) was unclear.</span></p> <p><span style="font-size: 10pt;"><br />The group now finds that these two defects are linked. In mice with Alzheimer&rsquo;s disease-like disease, elevated acid sphingomyelinase activity clogged up the autophagy machinery resulting in the accumulation of undigested cellular waste. Reducing levels of acid sphingomyelinase restored autophagy, lessened brain pathology, and improved learning and memory in the mice. Provided these results hold true in humans, interfering with acid sphingomyelinase activity might prove to be an effective way to slow&mdash;and possibly reverse&mdash;neurodegeneration in patients with Alzheimer&rsquo;s disease.</span></p></div> Scientists find new clues to brain’s wiring 2014-07-21T15:40:00Z 2014-07-21T15:40:00Z <div id="ImageMain77" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction77" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>New research provides an intriguing glimpse into the processes that establish connections between nerve cells in the brain. These connections, or synapses, allow nerve cells to transmit and process information involved in thinking and moving the body.</strong></span></p> </div><div id="Text177" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Reporting online in&nbsp;<a href="" target="_blank"><em>Neuron</em></a>, researchers at Washington University School of Medicine in St Louis have identified a group of proteins that programme a common type of brain nerve cell to connect with another type of nerve cell in the brain.</span></p> <p><span style="font-size: 10pt;"><br />The finding is an important step forward in efforts to learn how the developing brain is built, an area of research essential to understanding the causes of intellectual disability and autism.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We now are looking at how loss of this wiring affects brain function in mice,&rdquo; says senior author Azad Bonni, the Edison Professor of Neurobiology and head of the Department of Anatomy and Neurobiology at the School of Medicine.</span></p> <p><span style="font-size: 10pt;"><br />Bonni and his colleagues are studying synapses in the cerebellum, a region of the brain that sits in the back of the head. The cerebellum plays a central role in controlling the coordination of movement and is essential for what researchers call procedural motor learning, which makes it possible to move our muscles at an unconscious level, such as when we ride a bicycle or play the piano.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The cerebellum also regulates mental functions,&rdquo; Bonni says. &ldquo;So, impairment of the wiring of nerve cells in the cerebellum may contribute to movement disorders as well as cognitive problems including autism spectrum disorders.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />His new results show that a complex of proteins known as NuRD (nucleosome remodelling and deacetylase) plays a fairly high supervisory role in some aspects of the cerebellum&rsquo;s construction. When the researchers blocked the NuRD complex, cells in the cerebellum called granule cells failed to form connections with other nerve cells, the Purkinje neurons. These circuits are important for the cerebellum&rsquo;s control of movement coordination and learning.</span></p> <p><span style="font-size: 10pt;"><br />Bonni and his colleagues showed that NuRD exerts influence at the epigenetic level, which means it controls factors other than DNA that affect gene activity. For example, NuRD affects the configurations of molecules that store DNA and that can open and close the coils of DNA like an accordion, making genes less or more accessible. Changing the accessibility of genes changes their activity levels. For instance, cells cannot frequently make proteins from genes in a tightly packed coil of DNA.</span></p> <p><span style="font-size: 10pt;"><br />NuRD also alters tags on the proteins that store DNA, decreasing the chances that the gene will be used. Among the genes deactivated by NuRD are two that control the activity of other genes involved in the wiring of the cerebellum.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This tells us that the NuRD complex is very influential&mdash;not only does it affect the activity of genes directly, it also controls other regulators of multiple genes,&rdquo; Bonni says.</span></p></div> Making a mental match: Pairing a mechanical device with stroke patients 2014-07-18T12:24:00Z 2014-07-18T12:24:00Z <div id="ImageMain78" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction78" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The repetitive facilitation exercise is one of the most common rehabilitation tactics for stroke patients attempting to regain wrist movement. Stroke hemiparesis individuals are not able to move that part of their body because they cannot create a strong enough neural signal that travels from the brain to the wrist.</strong></span></p> </div><div id="Text178" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">With repetitive facilitation exercise, however, patients get a mental boost. They are asked to think about moving. At the same time, a practitioner flexes the wrist. The goal is to send a long latency response from the stretch that arrives in the brain at the exact time the thought happens, creating a neural signal. The result is a strong, combined response that zips back to the forearm muscles and moves the wrist.</span></p> <p><span style="font-size: 10pt;">It all happens in a span of approximately 40 to 60 milliseconds.&nbsp;</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;Timing is everything. When the window is that small, it is not easy for two people to match each other,&rdquo; says Georgia Institute of Technology master&rsquo;s graduate Lauren Lacey.</span></p> <p><br /><span style="font-size: 10pt;">That&rsquo;s why Lacey and a team of fellow Georgia Tech researchers created&nbsp;a mechanical device that takes people out of the process, replacing them with accurate computers. Their functional MRI-compatible hemiparesis rehab device creates a long latency stretch reflex at the exact time as a brain signal.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;It&rsquo;s kind of like trying to fill a bucket with water,&rdquo; explains Minoru Shinohara, an associate professor in Georgia Tech&rsquo;s Human Neuromuscular Physiology Lab. &ldquo;Stroke individuals can only mentally fill it halfway. The machine pours in the rest to make it full.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">So far, the research team has worked only with healthy individuals in their study. Study participants lie on a bed with the arm extended beneath a pneumatic actuator tendon hammer. In order to simulate the weak signal created by hemiparesis individuals to move their wrist, a transcranial magnetic stimulator (TMS) is placed on the heads of these healthy individuals at a 45-degree angle. Milliseconds after the hammer taps the wrist&rsquo;s tendon, the TMS creates a weak signal in the motor cortex. The responses overlap, produce and send a strong signal back to the arm, and the wrist moves.</span></p> <p><br /><span style="font-size: 10pt;">The team has successfully varied the timing of the transcranial magnetic stimulator signal and speed of the hammer to strike faster or slower depending on how much of a boost is needed to complement the brain signal. Now that the researchers have proven the viability of the transcranial magnetic stimulator-actuator system, they will next work with stroke individuals.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The device is designed to adapt to people whether they are hyper, normo or hyporeflexive,&rdquo; says Lacey, who graduated in spring with a master&rsquo;s degree from the George Woodruff School of Mechanical Engineering.</span></p> <p><br /><span style="font-size: 10pt;">Also, because the machine is MRI-compatible, it will allow the team to study what is happening in the brain during rehab, opening the door for robotics.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Once we fully understand what is happening mentally and physiologically, we should be able to create a robot that can reproduce successful rehabilitative exercises such as repetitive facilitation exercise,&rdquo; says Jun Ueda, an associate professor in the School of Mechanical Engineering. &ldquo;It appears that the timing is the critical piece of this exercise. Robots are great at timing, so the results are very promising for robotics.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The Georgia Tech team was assisted by researchers at Japan&rsquo;s Kagoshima University, Kazumi Kawahira, Megumi Shimodozono and Yong Yu, who originally performed clinical studies of conventional repetitive facilitation exercise. The device was presented at the&nbsp;Design of Medical Devices Conference&nbsp;in Minneapolis, Minnesota, USA this spring.</span></p> <p><br /><span style="font-size: 10pt;">This research was partially supported by the National Science Foundation (NSF) under sub-award EEC 0540834. Any conclusions expressed are those of the principal investigator and may not necessarily represent the official views of the NSF.</span></p></div> JAMA study: Stroke risk and death rates fall over past two decades 2014-07-18T11:57:00Z 2014-07-18T11:57:00Z <div id="ImageMain79" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction79" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Fewer Americans are having strokes and those who do have a lower risk of dying from them finds a new study led by Johns Hopkins Bloomberg School of Public Health researchers.</strong></span></p> </div><div id="Text179" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study found a 24% overall decline in first-time strokes in each of the last two decades and a 20% overall drop per decade in deaths after stroke. However, the decline in stroke risk was concentrated mainly in the over-65 set, with little progress in reducing the risk of strokes among young people. In contrast, the drop in stroke-related deaths each decade was primarily found among those under age 65, with mortality rates holding firm in older people.</span><br /> <br /><span style="font-size: 10pt;"> A report on the results is published in the July 16 issue of the&nbsp;<a href="" target="_blank"><em>Journal of the American Medical Association</em>&nbsp;(<em>JAMA</em>)</a>.</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;We can congratulate ourselves that we are doing well, but stroke is still the number four cause of death in the United States,&rdquo; says study co-author Josef Coresh, a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health. &ldquo;This research points out the areas that need improvement. It also reminds us that there are many forces threatening to push stroke rates back up and if we do not address them head-on, our gains may be lost.&rdquo;</span><br /> <br /><span style="font-size: 10pt;"> Coresh says he worries what the future of stroke will look like as the obesity epidemic, which began in the 90s, matures. As millions more are diagnosed with hypertension and diabetes &ndash; which often go hand-in-hand with obesity -- they will face increased risk for stroke.</span><br /> <br /><span style="font-size: 10pt;"> For their analysis, researchers used results from the Atherosclerosis Risk in Communities (ARIC) study, a prospective study of 15,792 residents of four US communities who were between the ages of 45 and 64 when the study began in the late 1980s. In this analysis, they followed 14,357 participants who were free of stroke in 1987, looking specifically for all stroke hospitalisations and deaths between then and the end of 2011.</span><br /> <br /><span style="font-size: 10pt;"> Seven per cent of the study sample (1,051) had a stroke over that period. Of those, 10% died within 30 days, and 21%, 40% and 58% died within one year, five years and by the end of the study in 2011. Each decade, the number of deaths occurring within 10 years of a stroke was reduced by roughly eight deaths per 100 cases. The decrease was not across the board. Instead it was primarily the result of stroke victims under the age of 65 surviving longer. While they varied by age, the results were similar across race and gender, a finding that researchers were heartened to discover since a previous study suggested African-American stroke rates were not improving.</span><br /> <br /><span style="font-size: 10pt;"> The researchers found that the decrease in stroke incidence and mortality is partly due to more successful control of risk factors such as blood pressure, smoking cessation and the wide use of statin medications for controlling cholesterol. However, an increase in diabetes likely acted in the opposite direction, pushing up stroke rates, though to a lesser extent. Stroke severity and improvements in treatment likely also impacted the data, though the study could not measure the exact role they played.</span><br /> <br /><span style="font-size: 10pt;"> The age disparities in outcomes suggest areas where physicians and researchers may want to focus in the future to prevent strokes in those under 65 and reduce deaths in those over 65.</span><br /> <br /><span style="font-size: 10pt;"> Nearly 800,000 Americans suffer strokes each year; of those, about 600,000 are first-time strokes. &ldquo;Stroke is not only one of the main causes of death, but a leading cause of long-term disability in adults. Therefore, prevention is the best strategy,&rdquo; says study leader Silvia Koton, a visiting faculty member at the Bloomberg School and incoming nursing department chair at Tel Aviv University.</span><br /> <br /><span style="font-size: 10pt;"> National data show that the number of death certificates listing stroke as the underlying cause of death has decreased for a long time. However, only research studies such as this one can distinguish whether the decline is due to a reduction in the number of strokes or whether people are just living longer after having them, researchers say. In this study, researchers also confirmed the occurrence of each stroke by reviewing each medical chart using uniform criteria. Researchers focused on deaths from all causes because following a stroke, many patients die from other causes including heart disease and pneumonia.</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;Since rates are not equally falling across the board, physicians and policymakers need to pay closer attention to specific subgroups,&rdquo; Koton says. &ldquo;These data are also helpful in monitoring the results of how we care for people of all ages, hopefully helping them even before they have a stroke.&rdquo;</span><br /> <br /><span style="font-size: 10pt;"> The ARIC study is supported by contracts with the National Institutes of Health&rsquo;s National Heart, Lung, and Blood Institute as well as NHLBI grants.</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;Stroke Incidence and Mortality Trends in US Communities, 1987 to 2011,&rdquo; was written by Silvia Koton; Andrea L.C. Schneider; Wayne Rosamond; Eyal Shahar; Tingying Sang; Rebecca Gottesman; and Josef Coresh.</span></p></div> ROADSTER trial studying new path to carotid revascularisation completes patient enrolment 2014-07-18T11:02:00Z 2014-07-18T11:02:00Z <div id="ImageMain80" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction80" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Silk Road Medical has announced the completion of enrolment in its pivotal <a href=";rank=1" target="_blank"><span style="color: #000080;">ROADSTER</span></a> study. The trial was the first of its kind to study the treatment of carotid artery stenosis by placing a stent via direct access to the common carotid artery in the neck in an entirely new minimally invasive procedure. The device under study is the company&rsquo;s Enroute transcarotid neuroprotection system which incorporates proven surgical principles to protect the brain from a stroke during carotid angioplasty and stenting, and features a mechanism to divert dangerous debris away from the brain by temporarily reversing blood flow. Data from the trial will be used to support 510(k) clearance of the Enroute transcarotid neuroprotection system as well as pre-market approval of the Enroute transcarotid stent system.</strong></span></p> </div><div id="Text180" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The Enroute transcarotid neuroprotection system was designed to reduce the excess stroke risk of a carotid stent procedure, while at the same time minimising the surgical risks of an open carotid artery surgery known as carotid endarterectomy,&rdquo; says Sumaira Macdonald an expert in the field of carotid artery disease and Silk Road Medical&rsquo;s chief medical officer. &ldquo;Until now, carotid stents were typically placed via the femoral artery approach, which is about three feet from the culprit carotid stenosis, and requires navigation of catheters and other instruments through often hostile territory, increasing the risk of stroke during or immediately after the procedure,&rdquo; she says. &ldquo;We know that carotid stents are effective in preventing strokes in the long term, but we need a safer way to deliver them. The Silk Road procedure moves the access point to within inches of the stenosis to avoid at-risk steps and provides a surgically-inspired method of protecting the brain throughout the simplified procedure.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">By contrast, the gold standard carotid endarterectomy procedure requires a large incision in the neck and a surgery that carries some risk of nerve damage, bleeding, scarring and infection. The Silk Road procedure is designed to reduce these surgical risks as well. &ldquo;Historically, there has not been a safe and effective minimally invasive procedure that could hold up to the clinical outcomes established by carotid endarterectomy. This new procedure may be it,&rdquo; says Richard Cambria, chief, Division of Vascular and Endovascular Surgery at Massachusetts General Hospital and The Robert R Linton MD Professor of Vascular and Endovascular Surgery at the Harvard Medical School. &ldquo;The results from our centre will be announced at the VEITH Symposium.&rdquo; Cambria serves as the National co-principal investigator for the ROADSTER trial.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The ROADSTER trial included an elite, multi-disciplinary group of physicians across the US and Europe with vast experience in treating carotid disease,&rdquo; says Christopher Kwolek, director of the Vascular and Endovascular training programme at Massachusetts General Hospital, chief of Vascular Surgery at Newton Wellesley Hospital, and National co-principal investigator for the ROADSTER trial. &ldquo;Similar to important endovascular innovations in aortic aneurysms and peripheral arterial disease, this new minimally invasive procedure will be an important step forward in the treatment of carotid artery disease for the vascular specialist.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Erica Rogers, chief executive officer for Silk Road Medical, comments, &ldquo;We believe the ROADSTER data will support clearance and approval of our planned marketing applications with the FDA. We are grateful for the collaboration of our investigators who allowed this study to complete enrolment on time. We are quite eager to present the full results of the study in the near future.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Both the Enroute transcarotid neuroprotection system and stent system have been granted CE mark approval. The Enroute transcarotid neuroprotection system is limited by United States law to investigational use. The Enroute transcarotid stent system is not currently available in the United States.</span></p></div> Stroke inpatient rehabilitation facilities yield better neurological outcomes than skilled nursing facilities 2014-07-17T09:38:00Z 2014-07-17T09:38:00Z <div id="ImageMain81" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction81" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A demographic analysis has revealed that an association exists between discharge disposition and National Institutes of Health Stroke Scores (NIHSS) at 90-day follow-up. Patients discharged to an inpatient rehabilitation facility were found to have more favourable outcomes compared with those sent home or to a skilled nursing facility. According to the authors, this study is the first to examine the role of discharge disposition in an acute stroke treatment trial in the modern era.</strong></span></p> </div><div id="Text181" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Rishi Gupta (Wellstar Neurosurgery, Marietta, USA) and others evaluated the demographic data from the SENTIS (The safety and efficacy of NeuroFlo technology in ischemic stroke) trial to determine the impact of stroke severity and discharge disposition on 90-day outcomes in US patients&mdash;the results were published in the <a href="" target="_blank"><em>Journal of NeuroInterventional Surgery</em></a>.</span></p> <p><br /><span style="font-size: 10pt;">The <a href=";rank=1" target="_blank"><strong>SENTIS</strong></a> trial, originally published in the <a href="" target="_blank"><em>American Journal of Neuroradiology</em></a> in 2013, was a multicentre, prospective, randomised controlled trial that evaluated the safety and effectiveness of the NeuroFlo catheter (CoAxia) in stroke patients compared to standard medical therapy. In the trial, it was found that there were consistent reductions in all-cause and stroke-related mortality in the NeuroFlo-treated patients. Although the results showed that treatment with NeuroFlo was safe, it was also demonstrated that there was not a benefit of doing so when compared to standard medical therapy. Therefore, Gupta and colleagues analysed NIHSS from days one and four, discharge disposition and 90-day modified Rankin Score to investigate whether discharge disposition to home or acute rehabilitation is associated with a clinical favourable outcome from the SENTIS data.</span></p> <p><br /><span style="font-size: 10pt;">Of the 292 patients, 153 (52.1%) were discharged to an inpatient rehabilitation facility, 11 (38%) to home and 28 (9.6%) to a skilled nursing facility.</span></p> <p><br /><span style="font-size: 10pt;">Two out of the 28 patients discharged to a skilled nursing facility achieved a 90-day modified Rankin Score of &le;2 compared with the 60/153 patients in the inpatients rehabilitation facility (OR 8.39, 95% CI 1.92 to 36.64, p=0.0047).&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to Gupta <em>et al,</em> these results show that an association between outcomes and discharge disposition remains after adjustments for age and admission NIHSS.</span></p> <p><br /><span style="font-size: 10pt;">They add that three of the 50 patients with NIHSS of &ge;14 at four days achieved modified Rankin Scored of 0&ndash;2 at 90 days.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This analysis shows that discharge to an inpatient rehabilitation facility is associated with better neurological outcomes than discharge to a skilled nursing facility. Additionally, patients with NHISS of &ge;14 at day four are unlikely to achieve independent function.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Co-author Samir R Belagaje, assistant professor, Neurology and Rehabilitation Medicine, Emory University School of Medicine, USA, spoke to <em>NeuroNews</em> and shed light on the implications of the findings of the study for the future.</span></p> <p><span style="font-size: 10pt;"><strong><br />How could these findings be applied to patient care after stroke in the future?</strong></span></p> <p><br /><span style="font-size: 10pt;">Our results reinforce the concept that care of patients with stroke must be optimised in all phases of their care and not just the acute phase. In the real world, neurologists and other healthcare practitioners should try to get their patients to their acute rehabilitation (inpatient rehabilitation) whenever possible and when their patients are unable to go home immediately. In the research world, our research helps with the design of future clinical trials of acute stroke intervention by pointing out the importance of the discharge disposition and possibly standardised. Our data may also point to further examination of the decision process in determining which patients go to inpatient rehabilitation facility vs. skilled nursing facility and help get more patients to an inpatient rehabilitation facility to improve their overall outcome.</span></p> <p><span style="font-size: 10pt;"><strong><br />Would discharging all patients to an inpatient rehabilitation facility be cost-effective?</strong></span></p> <p><br /><span style="font-size: 10pt;">We do not have any data at this point to clearly say one way or another. It is probably not cost-effective as there are some patients who, because of their stroke severity, simply do not make the improvements to justify the resources in terms of therapists and the intensity of therapy. They would do the same with less intensity as provided in a skilled nursing facility.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Furthermore, there are some patients because of their age, stroke severity, or other medical comorbidities are unable to tolerate the intensity of the inpatient facility rehabilitation and could actually do worse. This would result in more acute hospitalisations, longer stays in facilities, and worsened outcomes all of which would add further costs making this strategy less cost-effective.</span></p></div> Banner Alzheimer’s Institute partners with Novartis in new study of Alzheimer’s prevention treatments 2014-07-16T15:19:00Z 2014-07-16T15:19:00Z <div id="Introduction82" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers from the Banner Alzheimer&rsquo;s Institute (BAI) have announced a partnership with Novartis in a pioneering medical trial to determine whether two investigational anti-amyloid drugs&mdash;an active immunotherapy and an oral medication&mdash;can prevent or delay the emergence of symptoms of Alzheimer&rsquo;s in people at particularly high risk for developing the disease at older ages.</strong></span></p> </div><div id="Text182" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The five-year APOE4 trial will involve more than 1,300 cognitively healthy older adults, ages 60&nbsp;to 75<em>,&nbsp;</em>at high risk of developing symptoms of&nbsp;Alzheimer&rsquo;s because they inherited two copies of the apolipoprotein E (APOE4) gene&mdash;one from each parent. About 2% of the world&rsquo;s population carries two copies of this gene and one in four people carry one copy of the APOE4 gene, which is strongly linked to late-onset Alzheimer&rsquo;s.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We are taking clinical trials to a critical new stage,&rdquo; says Pierre N Tariot, study director for BAI, an arm of Banner Health, one of the largest non-profit healthcare systems in&nbsp;the United States. &ldquo;This approach shifts the research paradigm from trying to reverse disease damage to attacking and preventing its cause, years before symptoms could surface.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The trial&mdash;subject to regulatory authority approval&mdash;will begin in 2015 at approximately 60 sites in&nbsp;Europe&nbsp;and North America, including BAI&rsquo;s headquarters in&nbsp;Phoenix, Arizona, USA.</span></p> <p><br /><span style="font-size: 10pt;">The active immunotherapy is aimed at triggering the body&rsquo;s immune system to produce antibodies that attack different forms of the amyloid protein, which many researchers have suggested plays a critical role in the development of Alzheimer&rsquo;s. The oral medication is a BACE (beta-secretase1) inhibitor, designed to prevent the production of different forms of the amyloid protein.</span></p> <p><br /><span style="font-size: 10pt;">The two drugs, which will be tested separately, are intended to stop the accumulation of amyloid. The drugs are being introduced even before amyloid accumulates in some of the participants&rsquo; brains. The trial will increase the chance of finding treatments that will prevent, slow or delay the loss of memory and other cognitive abilities associated with Alzheimer&rsquo;s.</span></p> <p><br /><span style="font-size: 10pt;">Study participants will be recruited via multiple venues, including the Alzheimer&rsquo;s Prevention Registry website created by BAI in 2012. The registry currently has more than 37,000 potential volunteers and is aiming to recruit more than 250,000.</span></p> <p><br /><span style="font-size: 10pt;">Volunteers who meet the study criteria will be asked to mail a sample of their genetic material (such as a cheek swab) to a laboratory. The volunteers will learn the results of that test in the context of possibly enrolling in the trial.</span></p> <p><br /><span style="font-size: 10pt;">Volunteers who are selected for the API APOE4 study will receive genetic counselling. &ldquo;We are keenly aware of the extreme sensitivity and emotional impact of disclosing genetic information,&rdquo; Langbaum says.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;There are no guarantees that any of these investigational treatments will prevent the clinical onset of Alzheimer&rsquo;s disease,&rdquo; says Eric M Reiman, one of the study directors for BAI. &ldquo;But we are grateful for these opportunities to find out.&rdquo;</span></p></div> Worldwide Alzheimer’s and dementia epidemic grows 2014-07-15T15:41:00Z 2014-07-15T15:41:00Z <div id="ImageMain83" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction83" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>While the global epidemic of Alzheimer&rsquo;s disease continues to grow, new data on lower incidence in the &ldquo;youngest old&rdquo; from developed countries in Europe&nbsp;and&nbsp;the United States&nbsp;suggest the possibility of reducing risk and/or preventing the disease, according to the results of several research studies announced at the Alzheimer&rsquo;s Association International Conference2014 (AAIC&nbsp;2014) in&nbsp;Copenhagen, Denmark. Scientists suggest higher education levels and more aggressive treatment of cardiovascular disease may be key.</strong></span></p> </div><div id="Text183" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Pointing in the other direction, researchers reported at AAIC 2014 that incidence and prevalence of Alzheimer&rsquo;s in developing countries such as&nbsp;Colombia, and large regions of&nbsp;Asia&nbsp;and&nbsp;Africa, may be severely underreported. They also raise questions about the effects of the growing incidence of obesity and diabetes in developed countries, both of which are associated with increased risk of cognitive decline and dementia.</span></p> <p><span style="font-size: 10pt;">For clarity following are the definitions of prevalence and incidence:</span></p> <ul> <li><span style="font-size: 10pt;">Prevalence &ndash; the number or proportion of cases of a disease in a population. (ie., How many people have Alzheimer&rsquo;s disease in the USA right now?)</span></li> <li><span style="font-size: 10pt;">Incidence &ndash; the number of new cases of a disease in a population over a given time. (ie., How many new cases of Alzheimer&rsquo;s are there this year in&nbsp;Denmark?)</span></li> </ul> <p><span style="font-size: 10pt;">&ldquo;The good news is that recent trends in developed countries in&nbsp;Europe&nbsp;and the USA suggest that reduction and possibly even prevention of Alzheimer&rsquo;s disease might be possible &ndash; but, at the same time, we must acknowledge the growing worldwide epidemic,&rdquo; says&nbsp;Maria Carrillo, Alzheimer&rsquo;s Association vice president of Medical and Scientific Relations. &ldquo;We must continue efforts to halt this terrible scourge that devastates families and economies.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;According to new data reported at AAIC 2014, Alzheimer&rsquo;s and dementia incidence and prevalence in developing countries may be much higher than previously thought, and rising rates of obesity and diabetes pose an unknown but potentially serious threat to cognitive health throughout the world. Many questions remain, and the only way we can get the answers is through more research,&rdquo; Carrillo says.</span></p> <p><br /><span style="font-size: 10pt;">There are hints in the literature that engaging in more challenging mental activities, such as higher levels of education or intellectually demanding occupations, may increase cognitive reserve and thereby reduce the risk of developing Alzheimer&rsquo;s or another dementia.</span></p> <p><span style="font-size: 10pt;"><strong><br />Review of recent data suggests fewer new cases of Alzheimer&rsquo;s in&nbsp;the United States&nbsp;and&nbsp;Europe<br /> <br /> </strong>Worldwide prevalence of Alzheimer&rsquo;s disease is projected to increase in the decades ahead as the planet&rsquo;s population ages, but recently published studies from&nbsp;the United States,&nbsp;the Netherlands,&nbsp;Sweden, and&nbsp;England suggest a decline in incidence or prevalence of dementia (or both) in those countries, according to a review of recent research conducted by&nbsp;Kenneth Langa of the&nbsp;University of Michigan&nbsp;and the VA Ann Arbor Center for Clinical Management Research, and reported at a plenary session at AAIC 2014.</span></p> <p><span style="font-size: 10pt;"><br />Langa observed from the studies that a number of factors, especially rising levels of education and more aggressive treatment of cardiovascular risk factors such as hypertension and high cholesterol, may be leading to improved brain health and consequent decline of numbers of new cases of Alzheimer&rsquo;s disease and dementia in certain countries or regions of the world.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Whether this trend will continue in the face of rising levels of obesity and diabetes, and whether it is also true in low- and middle-income countries, are key unanswered questions,&rdquo; says Langa. &ldquo;The answers will have enormous implications for the extent of the future worldwide impact of Alzheimer&rsquo;s disease and dementia in the decades ahead.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />Extent of dementia in&nbsp;Asia&nbsp;and Sub-Saharan Africa may be severely underestimated<br /> <br /> </strong>In 2009, Alzheimer&rsquo;s Disease International (ADI) published data on global prevalence of dementia based on a review of 154 worldwide studies and United Nations (UN) population projections. Alzheimer&rsquo;s Disease International carried out an update on that data for the&nbsp;December 2013&nbsp;G8 Dementia Summit in&nbsp;London, focusing primarily on new evidence from&nbsp;Asia and Sub-Saharan Africa, and presented the results at AAIC 2014.</span></p> <p><span style="font-size: 10pt;"><br />Based on a meta-analysis of Chinese and Sub-Saharan African studies combined with the latest UN population projections, Alzheimer&rsquo;s Disease International concluded that the 2009 estimates of worldwide Alzheimer&rsquo;s disease were too low. Alzheimer&rsquo;s Disease International now estimates that 44.35 million people in the world were living with dementia in 2013, significantly up from the earlier estimate of 36 million people living with dementia in 2010. They project that the number will rise to 75.62 million in 2030 &mdash; 15% higher than the 2009 estimate &mdash; and 135.46 million in 2050, which is 17% higher than the 2009 Alzheimer&rsquo;s Disease International estimate.</span></p> <p><br /><span style="font-size: 10pt;">Specifically in the two focus regions, the researchers found that dementia prevalence increased for&nbsp;East Asia from about 5% to about 7%, and in Sub-Saharan African regions from a range of roughly 2 to 4% to 4.76%.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Dementia, including Alzheimer&rsquo;s disease, is one of the biggest global health challenges facing our generation,&rdquo; says&nbsp;Marc Wortmann, executive director, Alzheimer&rsquo;s Disease International. &ldquo;As more and better data becomes available, the effect we&rsquo;ve seen is a reduction in the variation of prevalence between world regions.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;In addition, newly available data suggests that the current burden and future impact of the global dementia epidemic has been underestimated, particularly for the&nbsp;Asia&nbsp;and Sub-Saharan Africa. Especially in light of these revised estimates, there is an urgent need to develop policies to face this disease in all countries of the world, and to enhance our efforts in finding a cure or treatment that can delay the onset of dementia,&rdquo; Wortmann adds.</span></p> <p><span style="font-size: 10pt;"><strong><br />New sases of dementia decline over three decades in the Framingham Heart Study<br /> <br /> </strong>At AAIC 2014,&nbsp;Claudia L Satizabal of&nbsp;Boston University School of Medicine&nbsp;and colleagues reported on the results of a study of dementia trends among participants in the Framingham Heart Study, an ongoing, long-term (since 1948), multi-generational cardiovascular health study of residents of&nbsp;Framingham, Massachusetts, USA, to which dementia tracking has been added since 1975.</span></p> <p><span style="font-size: 10pt;"><br />Framingham Study participants undergo comprehensive assessments for cardiovascular risk factors every two to four years, and remain under intensive surveillance for dementia and stroke. Study researchers defined four non-overlapping five-year time windows (epochs) across the past three decades, each beginning with a baseline examination, and studied new cases of dementia among all dementia-free participants age 60 and older.</span></p> <p><br /><span style="font-size: 10pt;">After adjusting for age at entry and gender, the researchers found that compared with the first epoch, the second epoch had a 22% reduction in new cases of dementia, the third had a 38% reduction, and the fourth had a 44% reduction. The reduction was strongest in participants between age 60 and 69.</span></p> <p><br /><span style="font-size: 10pt;">The researchers found the decrease in dementia incidence was greatest in women across all epochs, while men showed a more gradual decrease over time. The decreasing trend in dementia incidence was true for individuals with a higher educational level, defined as having a high school diploma, whereas individuals without a high school diploma did not appear to benefit from this reduction.</span></p> <p><br /><span style="font-size: 10pt;">During that 30-year time period, the researchers observed among the participants a substantial improvement in educational achievement, better management of blood pressure, higher levels of HDL cholesterol, and a considerable decline in smoking, heart disease and stroke across the same epochs. However, an increasing trend in obesity and diabetes was seen in this population.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These reductions in age-specific rates of new cases of dementia in the Framingham Study participants might be partly explained by the beneficial trends we observed in educational attainment and heart health risk factors,&rdquo; says Satizabal. &ldquo;This leads us to cautious optimism that some cases of dementia may be preventable. However, one of the limitations of this work is that the&nbsp;Framingham&nbsp;sample is largely of European descent. Additional studies are needed in populations of different racial and ethnic backgrounds.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />In&nbsp;Colombia, dementia and Alzheimer&rsquo;s disease might be underestimated by up to 50%<br /> <br /> </strong>To date,&nbsp;Colombia&nbsp;has had only one study, known as EPINEURO, which attempted to estimate the country&rsquo;s dementia prevalence from representative samples of the population 20 years ago. Using updated population estimates and prevalence estimates published in the international literature,&nbsp;Yuri Takeuchi of Universidad Icesi (Colombia) and colleagues estimated the number of people with dementia, and especially Alzheimer&rsquo;s disease, in&nbsp;Colombia&nbsp;by stage of the disease. The results were reported at AAIC 2014.</span></p> <p><br /><span style="font-size: 10pt;">The researchers created three models for Alzheimer&rsquo;s prevalence in the country, each using different projections for the proportion of people with mild, moderate, and severe disease, and different theoretical assumptions on the transitions between stages. They found that the number of people with Alzheimer&rsquo;s in Colombia&nbsp;could be as much as 220,000 in 2015, and 260,000 in 2020. The scientists calculate that current estimates for Alzheimer&rsquo;s disease and other dementias in&nbsp;Colombia&nbsp;might be too low by as much as 50%. (The prevalence estimate of dementia for&nbsp;Colombia&nbsp;in people over 65 used in the study was 6%, according to Takeuchi.)</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;To our knowledge, this is the first attempt to model and estimate dementia prevalence by stage of disease in the developing world; it is certainly the first attempt in&nbsp;Colombia,&rdquo; says Takeuchi. &ldquo;The fastest growth in ageing is happening in developing countries such as&nbsp;Colombia. This has profound implications not only for older people themselves, but for their households, social and community infrastructure, and social policy. These estimations by stage of disease are key information for policymakers because both the social burden and social costs are substantially different depending on the stage of disease.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />Dementia in&nbsp;Germany&nbsp;declined between 2007 and 2009<br /> <br /> </strong>Gabriele Doblhammer of the German Center for Neurodegenerative Diseases (DZNE) and colleagues conducted a study exploring short-term dementia trends in&nbsp;Germany, and reported the results at AAIC 2014.</span></p> <p><br /><span style="font-size: 10pt;">The research is based on claims data from the largest public health insurance company in&nbsp;Germany&nbsp;which covers about one-third of the total population aged 50+ and more than half of the oldest-old. The data include complete records of the inpatient and outpatient services, including dementia diagnosis. The complete insured population of roughly five million people at risk of dementia and about 600,000 dementia cases was used to study the prevalence; a 2.5% sample was the basis for the incidence study.</span></p> <p><br /><span style="font-size: 10pt;">The researchers found that between 2007 and 2009, the total number of people with dementia decreased significantly among German women age 74 to 85. Dementia prevalence in 2009 was 3.6% lower than in 2007 and 1.8% lower than in 2008. Over that period, new cases of dementia decreased significantly for both men and women.</span></p> <p><br /><span style="font-size: 10pt;">According to the researchers, over the last decade there was reduction in new cases of cerebrovascular disease in&nbsp;Germany&nbsp;and a &ldquo;better treatment of vascular risk factors such as high blood pressure, hypercholesterolemia, and diabetes mellitus.&rdquo; Among the elderly, increasing levels of education and wealth also were observed.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This was the first study to explore dementia trends in&nbsp;Germany,&rdquo; says Doblhammer. &ldquo;The ageing of the babyboomers and the increasing life expectancy will lead to more dementia cases in old age. It is necessary to explore the modifiable risk factors of dementia in order to prevent the occurrence of the disease. In addition, more research is needed whether the increasing obesity epidemic and related diseases, such as the metabolic syndrome, may counterbalance the positive trends we are observing today,&rdquo; the researchers add.</span></p></div> C2N expands partnership with Washington University School of Medicine 2014-07-15T15:11:00Z 2014-07-15T15:11:00Z <div id="ImageMain84" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction84" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>C<sub>2</sub>N Diagnostics has announced that it has expanded its partnership with Washington University School of Medicine (WUSM) in St Louis, USA. The objective of this collaboration is to commercialise a clinical blood test for detecting the earliest stages of Alzheimer&rsquo;s disease as well as mild cognitive impairment. Under terms of the agreement, C<sub>2</sub>N has acquired the exclusive worldwide commercial license rights to a suite of technologies developed in the laboratories of professors Randall Bateman and David Holtzman in the Department of Neurology at WUSM.</strong></span></p> </div><div id="Text184" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The licensed technologies build upon the Stable Isotope Labelling Kinetics (SILK) platform pioneered at WUSM and already marketed by C<sub>2</sub>N. The new technologies enable a novel approach to measure the metabolism of brain-derived proteins implicated in Alzheimer&rsquo;s disease and mild cognitive impairment. For the first time, instead of analysing Alzheimer&rsquo;s disease proteins in cerebrospinal fluid, it is now possible to detect the same metabolic markers in patients&rsquo; blood samples.</span></p> <p><br /><span style="font-size: 10pt;">This capability has implications for the advancement of new treatments, early prevention, and personal wellness. Alzheimer&rsquo;s is now one of the major global healthcare concerns. Approximately 44 million people currently have clinical Alzheimer&rsquo;s disease. Millions more have mild cognitive impairment that places them at high risk for progression to clinical Alzheimer&rsquo;s disease. The number of cases of Alzheimer&rsquo;s disease and mild cognitive impairment are expected to increase sharply in the years ahead due to the aging baby boomer population.</span></p> <p><br /><span style="font-size: 10pt;">Pharmaceutical companies developing new drugs targeting Alzheimer&rsquo;s disease increasingly recognise that early intervention provides the greatest chance of halting or reversing disease progression. Biomarkers are needed to detect this early pathology, which can begin at least 15 years before the onset of any clinical symptoms. At the same time, dynamic biomarkers, like those offered by the SILK platform, may also track treatment responses during the pre-symptomatic stages of disease.</span></p> <p><br /><span style="font-size: 10pt;">Since 2008, C<sub>2</sub>N has applied the SILK-A&beta;&nbsp;test to measure the kinetics of beta-amyloid in cerebrospinal fluid. The test has served as a primary endpoint in clinical drug studies to demonstrate target engagement and guide dose selection. The SILK-A&beta;&nbsp;isoforms test is also highly sensitive to identifying people with brain amyloidosis (one of the earliest indicators of Alzheimer&rsquo;s disease), even before amyloid deposits are seen with brain imaging. Still, the more invasive nature of cerebrospinal fluid sampling has impeded the full potential of the SILK-A&beta;&nbsp;method.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;With a simplified SILK-A&beta;&nbsp;test available through blood sampling, we now have an opportunity to validate a unique therapeutic and diagnostic marker,&rdquo; states Joel B Braunstein, chief executive officer of C<sub>2</sub>N. &ldquo;We plan to achieve this validation by collaborating with pharmaceutical companies that are testing their compounds in phase 2 and phase 3 clinical studies, as well as by participating in natural history studies tracking the progression of Alzheimer&rsquo;s disease. If successful, we expect to be able to offer a reliable and informative screening test that is also convenient for patients.&rdquo;</span></p></div> St Jude Medical announces definitive agreement to acquire NeuroTherm 2014-07-14T16:48:00Z 2014-07-14T16:48:00Z <div id="Introduction85" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>St Jude Medical has announced that it has signed a definitive agreement to acquire privately held&nbsp;NeuroTherm, a manufacturer of interventional pain management therapies, for approximately&nbsp;US$200 million&nbsp;in cash.</strong></span></p> </div><div id="Text185" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">NeuroTherm is a global leader in the treatment of spinal pain using radiofrequency ablation (RFA), a segment of the chronic pain market in which&nbsp;St Jude Medical does not currently participate. The company expects to complete this transaction by the end of the third quarter, subject to customary closing conditions. NeuroTherm is expected to add approximately&nbsp;US$10 million to US$15 million&nbsp;to St Jude Medical&rsquo;s 2014 sales. Excluding acquisition-related expenses, this transaction will be neutral to St Jude Medical&rsquo;s consolidated earnings per share in 2014 and accretive thereafter on a GAAP basis.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;NeuroTherm&rsquo;s radiofrequency ablation products are an ideal complement to St Jude Medical&rsquo;s chronic pain portfolio, providing our global sales force with additional interventional pain therapies that offer potential relief to patients earlier in the chronic pain continuum,&rdquo; says&nbsp;Michael T Rousseau, chief operating officer of&nbsp;St Jude Medical. &ldquo;As the only medical device manufacturer with both RFA and spinal cord stimulation, this acquisition will enable us to offer more treatment options to patients worldwide who suffer from the debilitating effects of chronic pain.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />NeuroTherm&rsquo;s flagship technology is a multi-lesion radiofrequency generator that allows real-time temperature monitoring and enables continuous delivery of energy to each site designed to ensure complete treatment of each targeted spinal nerve. The company&rsquo;s products are available in over 65 countries.</span></p> <p><br /><span style="font-size: 10pt;">Christopher R von Jako, president and chief executive officer of NeuroTherm says, &ldquo;St Jude Medical&rsquo;s global leadership in chronic pain represents an excellent opportunity to bring NeuroTherm&rsquo;s radiofrequency ablation technologies to more pain specialists and patients. We are proud of the business that NeuroTherm has built and thank our employees and shareholders for their commitment to developing innovative interventional pain management therapies. We see a promising future with&nbsp;St Jude Medical&nbsp;that combines our products with a leading pain franchise and further develops the underpenetrated global market for chronic pain.&rdquo;</span></p></div> Looking back on 40 years of the Glasgow Coma Scale 2014-07-14T15:58:00Z 2014-07-14T15:58:00Z <div id="ImageMain86" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction86" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A group of leading brain injury specialists look back on 40 years of the Glasgow Coma Scale and outline the continuing role of the scale in research and clinical practice, in a new <a href="" target="_blank">Personal View</a> published in <em><a href="" target="_blank">The Lancet Neurology</a>.</em>&nbsp;&nbsp;&nbsp;</strong></span></p> </div><div id="Text186" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Personal View is published on the 40<sup>th</sup> anniversary of the Glasgow Coma Scale&rsquo;s introduction in a 1974 <em>Lancet</em> article.&nbsp;Since this seminal publication, the Glasgow Coma Scale has provided a practical method for bedside assessment of impairment of conscious level, the clinical hallmark of acute brain injury. The scale was designed to be easy to use in clinical practice in general and specialist units and to replace previous ill-defined and inconsistent methods. Forty years later, the Glasgow Coma Scale has become an integral part of clinical practice and research worldwide.</span></p> <p><br /><span style="font-size: 10pt;">The paper&rsquo;s lead author is Professor Graham Teasdale, of the University of Glasgow, UK, one of the authors of the original paper introducing the scale.&nbsp;Teasdale and colleagues examine the extent to which the original aspirations of the authors have been fulfilled, address some myths and misapprehensions about the scale, examine criticisms, and outline the continuing role of the scale in research and clinical practice.</span></p> <p><span style="font-size: 10pt;">A <em>Lancet Neurology </em>podcast interview with Professor Teasdale is available <a href="" target="_blank"><span style="color: #800000;"><strong>here</strong></span></a>.</span></p></div> Potential Alzheimer’s disease risk factors and risk reduction strategies become clearer 2014-07-14T10:48:00Z 2014-07-14T10:48:00Z <div id="Introduction87" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Participation in activities that promote mental activity, and moderate physical activity in middle age, may help protect against the development of Alzheimer&rsquo;s disease and dementia in later life, according to new research reported at the Alzheimer&rsquo;s Association International Conference&nbsp;2014 (AAIC&nbsp;2014) in&nbsp;Copenhagen, Denmark.</strong></span></p> </div><div id="Text187" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Research reported at AAIC 2014 also showed that sleep problems &ndash; especially when combined with post-traumatic stress disorder (PTSD) &ndash; may increase dementia risk in veterans. Additionally, in a population of people age 90 and older, high blood pressure was seen to help protect against cognitive decline. This is counter intuitive as heart health risk factors, including hypertension, are generally considered to elevate risk of Alzheimer&rsquo;s and other dementias.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Determining more specifically the factors that raise and lower risk of Alzheimer&rsquo;s disease and other dementias is an essential component in our battle against the Alzheimer&rsquo;s epidemic,&rdquo; says&nbsp;Heather Snyder, Alzheimer&rsquo;s Association director of Medical and Scientific Operations. &ldquo;We are now getting a more clear idea of the opportunities for risk reduction through behaviour changes and other health factors. We are learning that Alzheimer&rsquo;s risk and protective factors may change over the course of our lives.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These studies from AAIC 2014 underscore the need to fund larger, longer-term studies in different and diverse populations to enable us to develop helpful &rsquo;prescriptions&rsquo; for lifestyle change &ndash; for example, which foods to eat and avoid, how much physical activity and what types &ndash; and to learn more specifically about how Alzheimer&rsquo;s and dementia risk factors change as we age,&rdquo; Snyder adds.</span><br /><br /></p> <p><span style="font-size: 10pt;"><strong>Cognitively stimulating activities are associated with greater brain volumes and higher cognitive test scores</strong></span></p> <p><br /><span style="font-size: 10pt;">Prior studies have suggested that participation in activities that stimulate thought, new ideas, new memories, and that challenge us mentally may encourage brain health as we age and possibly reduce risk of cognitive impairment and dementia. The mechanisms underlying this possible effect are not currently well understood.</span></p> <p><br /><span style="font-size: 10pt;">At AAIC 2014,&nbsp;Stephanie Schultz, and colleagues at the Wisconsin Alzheimer&rsquo;s Institute and the Wisconsin Alzheimer&rsquo;s Disease Research Center reported on the results of a study of 329 cognitively normal middle-aged adults (mean age=60.3 years, 69% women) enrolled in the Wisconsin Registry for Alzheimer&rsquo;s Prevention. Forty per cent of the participants were positive for the APOe4 gene and 74% had a parental family history of Alzheimer&rsquo;s, both of which are known to increase the risk for developing Alzheimer&rsquo;s.</span></p> <p><br /><span style="font-size: 10pt;">These at-risk adults reported their current engagement in cognitively-stimulating activities using the Cognitive Activity Scale (CAS), underwent MRI brain imaging, and completed a comprehensive battery of neurocognitive tests. The CAS consists of 10 items that ask individuals how often they participate in various cognitive activities, such as reading books and going to museums. The scientists focused on CAS-Games, which is a single item on the scale that asks participants how often they play games such as cards, checkers, crosswords or other puzzles.</span></p> <p><br /><span style="font-size: 10pt;">After controlling for factors known to influence brain volume and cognitive test scores, such as age and gender, the researchers found that a higher self-reported frequency of game playing was significantly associated with greater brain volume in several regions involved in Alzheimer&rsquo;s disease (such as the hippocampus) and with higher cognitive test scores on memory and executive function.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Our findings suggest that, for some individuals, engagement in cognitively stimulating activities, especially those involving games such as puzzles and cards, might be a useful approach for preserving brain structures and cognitive functions that are vulnerable to Alzheimer&rsquo;s disease,&rdquo; says Schultz. &ldquo;More detailed studies of specific cognitive activities, including games, would help further our understanding of how an active, healthy lifestyle may help delay the development of Alzheimer&rsquo;s.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />Moderate exercise in middle age is associated with decreased risk of dementia</strong></span></p> <p><br /><span style="font-size: 10pt;">Of the growing body of research concerning lifestyle and brain health, and also the possibility of reduced risk of Alzheimer&rsquo;s and other dementias, perhaps the strongest and most consistent evidence exists for regular physical activity.</span></p> <p><br /><span style="font-size: 10pt;">Yonas E Geda, and colleagues at the Mayo Clinic investigated the relationship between timing of exercise (mid-life/50-65 vs late-life/70 and above) and risk of new cases of dementia in 280 older adults (median age=81) with mild cognitive impairment from the Mayo Clinic Study of Aging, and reported on their findings at AAIC 2014.</span></p> <p><br /><span style="font-size: 10pt;">A person with mild cognitive impairment has a slight but noticeable and measurable decline in cognitive abilities, including memory and thinking skills. These changes are serious enough to be noticed by the individuals experiencing them or to other people, but they are not severe enough to interfere with daily life or independent function. People with mild cognitive impairment are at an increased risk of developing Alzheimer&rsquo;s disease.</span></p> <p><br /><span style="font-size: 10pt;">Study participants completed a questionnaire on the frequency and intensity of exercise during their lifetime. After following the participants for about three years, the researchers found that a history of moderate physical exercise in middle age was associated with a significantly decreased risk of mild cognitive impairment progressing to dementia. (The association did not hold for either light or vigorous exercise in middle age, or for any level of physical activity in late life.)</span></p> <p><br /><span style="font-size: 10pt;">In a second study reported at AAIC, the researchers looked at the timing of physical exercise and the risk of new cases of mild cognitive impairment. The study participants were 1,830 older adults with normal cognition from the Mayo Clinic Study of Aging. Participants underwent neurological evaluations, cognitive tests, and a self-reported questionnaire about physical exercise habits in mid-life and late-life, and were followed for an average of 3.2 years. The scientists observed that light physical exercise in mid-life and late-life were associated with decreased risk of incident mild cognitive impairment. Additionally, vigorous mid-life as well as moderate late-life physical exercise were associated with decreased risk of incident mild cognitive impairment.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;In our studies, we found that physical exercise at various levels, especially in mid-life, is beneficial for cognitive function,&rdquo; Geda says. &ldquo;These are intriguing results, but they are not yet conclusive. More research is needed to determine the extent and nature of physical activity in protecting against MCI and dementia.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />Poor sleep is associated with higher dementia risk in veterans; PTSD more than doubles that risk</strong></span></p> <p><br /><span style="font-size: 10pt;">It is known that sleep disturbance is a risk factor for cognitive decline and dementia, but this association has not been carefully investigated in older veterans. At AAIC 2014,&nbsp;Kristine Yaffe of the&nbsp;University of California, San Francisco&nbsp;and colleagues reported on the results of a retrospective study of sleep disturbance and dementia among 200,000 veterans age 55 and older, 96.5% of whom were male.</span></p> <p><br /><span style="font-size: 10pt;">The researchers examined eight years of the veterans&rsquo; medical records. After controlling for variables such as gender, income, education, and health status, they found that veterans who had a diagnosis of non-specific sleep disturbance, apnoea, or insomnia at baseline had a 30% increased risk of dementia compared with veterans with no diagnosed sleep problems. They also found that veterans with both PTSD and sleep disturbance had an 80% increased risk of dementia.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This is the first investigation into the link between sleep disturbance and dementia in a large cohort of older, mostly male veterans,&rdquo; says Yaffe. &ldquo;Further research is needed to clarify the role of sleep disturbance as either a risk factor for, or an early symptom of, dementia among veterans, and in other populations as well.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />In people 90 and older, late onset hypertension may protect against dementia</strong></span></p> <p><br /><span style="font-size: 10pt;">While hypertension during midlife is considered to increase risk for Alzheimer&rsquo;s and other dementia, there is emerging research evidence suggesting that its role in dementia risk may change over time, and may instead help protect against dementia in people age 90 and over, known as the &ldquo;oldest old.&rdquo;&nbsp;Maria Corrada of the&nbsp;University of California, Irvine&nbsp;and colleagues investigated the relationship between risk of dementia, age of the onset of hypertension, and blood pressure measurements in the oldest old, and reported the results at AAIC 2014.</span></p> <p><br /><span style="font-size: 10pt;">The researchers followed 625 participants every six months for up to ten years in The 90+ Study, an ongoing longitudinal study of people age 90 and older. At enrolment, participants did not have dementia and were 93 years old on average; 69% were female. The researchers found that participants with a hypertension onset age of 80 to 89 years had a significantly lower risk of developing dementia compared with participants with no history of hypertension. Participants with onset at age 90 or older had an even lower dementia risk.</span></p> <p><br /><span style="font-size: 10pt;">The investigators also found that people with blood pressure levels in the hypertensive range had a significantly lower risk of developing dementia compared to people with blood pressure in the normal range.&nbsp; The association was independent of whether participants were taking medications that treat hypertension.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;In our study, high blood pressure is not a risk factor for dementia in the oldest old, but just the opposite,&rdquo; says Corrada. &ldquo;Developing hypertension at older ages may be beneficial for maintaining intact cognition through mechanisms related to cerebral perfusion or to vascular or other pathologies. It is important to understand these mechanisms, because recommendations for healthy blood pressure in the oldest old may turn out to differ from those in younger people.&rdquo;</span></p></div> Cataract surgery improves not only vision but cognition and quality of life in dementia patients 2014-07-14T10:25:00Z 2014-07-14T10:25:00Z <div id="Introduction88" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Cataract surgery for people with Alzheimer&rsquo;s disease and other dementias not only improves vision but can slow decline in cognition and improve quality of life for both people with the disease and their caregivers, according to clinical trial results reported at the Alzheimer&rsquo;s Association International Conference&nbsp;2014 (AAIC) in&nbsp;Copenhagen, Denmark.</strong></span></p> </div><div id="Text188" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This study supports the Alzheimer&rsquo;s Association view that people with dementia retain, and benefit from, full healthcare treatment,&rdquo; says&nbsp;Maria Carrillo, Alzheimer&rsquo;s Association vice president of Medical and Scientific Relations. &ldquo;Too common attitudes such as, &lsquo;There&rsquo;s no need for extra care&rsquo; or &lsquo;Why put them through all of that&rsquo; are not justified and are bad medical practice.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Appropriate thoughtfulness and restraint are necessary when considering surgery or other procedures for people with Alzheimer&rsquo;s or another dementia. However, we should not assume that medical procedures cannot be pursued or are too risky. As these new results show, improving sensory abilities, for example, can provide benefits in a variety of ways &ndash; for people with Alzheimer&rsquo;s and also for their caregivers from whom unnecessary burden can be lifted,&rdquo; Carrillo says.</span></p> <p><br /><span style="font-size: 10pt;">At AAIC 2014,&nbsp;Alan J Lerner, of&nbsp;Case Western Reserve University&nbsp;and University Hospitals Case Medical Center, and colleagues reported interim results from an ongoing clinical trial to determine the effects of cataract removal on several measures of visual ability, cognitive measures, and quality of life in people with dementia. Study participants are recruited from dementia and ophthalmology clinics at University Hospitals Case Medical Center and MetroHealth Medical Center in&nbsp;Cleveland, Ohio, USA, and are divided into two groups: (1) immediate surgery following recruitment and (2) delayed or refused surgery. Vision and cognitive status, mood, and capability to complete daily activities are evaluated at baseline and six months after recruitment, or six months after surgery.</span></p> <p><br /><span style="font-size: 10pt;">Preliminary analysis of results from 20 surgical and eight non-surgical participants showed that the surgical group had significantly improved visual acuity and quality of life, reduced decline in memory and executive functioning, and improvements in behavioural measures compared with the non-surgical group. Levels of perceived burden for caregivers of people in the surgical group also showed improvement.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These preliminary results indicate that improved vision can have a variety of benefits for people with dementia and their loved ones, both visual and non-visual,&rdquo; says Lerner. &ldquo;Our findings need to be verified in a larger study, but they suggest the need to aggressively address dementia co-morbidities such as vision-impairing cataracts, while balancing safety and medical risks.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;If the results hold up, it will significantly affect how we treat cataracts in individuals with dementia. Other interventions to offset sensory loss &ndash; including vision and hearing &ndash; may help improve quality of life for people with dementia and their caregivers,&rdquo; Lerner adds.</span></p></div> New data shows combination therapy is more effective than monotherapy in removing beta-amyloid plaques from the brains of mice 2014-07-14T09:59:00Z 2014-07-14T09:59:00Z <div id="Introduction89" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Eli Lilly and Company has announced results from its non-clinical study in genetically engineered mice examining combination therapy with the murine version of the beta-amyloid antibody N3pG and beta-secretase inhibitor BACE (LY2811376). Data results found that combination therapy was more effective in removing clumps of amyloid-beta protein in the brain &ndash; a component that is thought to lead to Alzheimer&rsquo;s disease &ndash; than use of one therapy. These data were presented at the Alzheimer&rsquo;s Association International Conference 2014 (AAIC 2014) in&nbsp;Copenhagen, Denmark&nbsp;by&nbsp;Ron DeMattos, research fellow in the Neuroscience Division at Eli Lilly and Company.&nbsp;</strong></span></p> </div><div id="Text189" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This non-clinical study demonstrates that by simultaneously targeting two different steps in the beta-amyloid disease process, researchers can slow the progression of Alzheimer&rsquo;s disease pathology in genetically engineered mice,&rdquo; says DeMattos. &ldquo;These results may have a significant impact on the future of Alzheimer&rsquo;s disease therapies as they support the clinical rationale for using future testing of combination therapy against the a-beta protein in the clinical practice.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Alzheimer&rsquo;s disease, the most common form of dementia, causes progressive decline in memory and other aspects of cognition. A number of new investigational mechanisms for the treatment of Alzheimer&rsquo;s disease are currently in development. One type of investigational mechanism, called beta-secretase inhibitors, aims to block the body&rsquo;s ability to produce beta-amyloid protein, a possible component that leads to Alzheimer&rsquo;s disease. The other type of investigational drug is called a beta-amyloid antibody, which targets the removal of the beta-amyloid protein. </span><span style="font-size: 10pt;">Compounds that are thought to work through these mechanisms have been studied in clinical trials on their own; however, most of the trials have not shown significant treatment effects. Therefore, many believe that multiple steps of the beta-amyloid deposition process need to be simultaneously targeted in order to remove significant quantities of the beta-amyloid pathology.</span></p> <p><br /><span style="font-size: 10pt;">The non-clinical study results showed that when used on their own (as monotherapies), the beta-secretase inhibitor and the N3pG beta-amyloid antibody removed approximately 50% of the clumps of amyloid-beta protein, whereas the combination therapy resulted in an even more substantial 86% removal. Additionally, combination therapy significantly lowered deposited A&beta;1-42 75 percent relative to the time zero controls. Histological analyses indicated that the BACE inhibitor monotherapy resulted in removal of diffuse deposits of beta-amyloid, the antibody monotherapy resulted in removal of cored plaques, and the combination therapy removed both the diffuse deposits and cored plaques. Multiple different types of biochemical analyses confirmed that the combination treatment was superior to the monotherapy treatments.&nbsp;</span></p> <p><span style="font-size: 10pt;"><strong><br />Study Methods<br /> <br /></strong>Aged PDAPP transgenic mice (17-19 months) were randomised into the following five cohorts: 1) time zero control, 2) large and small molecule compound controls, 3) plaque-specific A&beta; antibody (anti-A&beta;p3-x), 4) BACE inhibitor, and 5) A&beta; antibody + BACE inhibitor. The aged mice were treated for four months with either a beta-secretase inhibitor or the N3pG beta-amyloid antibody, or the combination of the two drugs. Effectiveness of the treatments was determined by measuring the amount of beta-amyloid protein remaining in the brains of the mice.</span></p></div> Post-concussion ‘return to play’ decision for footballers should be made solely by doctors, says new editorial 2014-07-14T09:47:00Z 2014-07-14T09:47:00Z <div id="Introduction90" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>An editorial published in <em><a href="" target="_blank">The Lancet Neurology</a>&nbsp;</em>calls for sports authorities to take into consideration the long-term neurological problems that repeated concussions can cause.</strong></span></p> </div><div id="Text190" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Cerebral concussion is the most common form of sports-related traumatic brain injury, and the long-term effects of repeated concussions may include dementia, amyotrophic lateral sclerosis, and other neurological disorders, say the journal editors.</span></p> <p><br /><span style="font-size: 10pt;">However, what is perhaps more concerning, is that even when the symptoms of concussion are delayed, or if they come and go quickly, neurological damage can remain without detection. This can lead to footballers, such as Uruguayan defender &Aacute;lvaro Pereira during the 2014 FIFA World Cup, overruling doctors&rsquo; advice to be substituted and returning to play after sustaining a head injury.</span></p> <p><br /><span style="font-size: 10pt;">The journal editors argue that the decision for players to return to a game after sustaining a concussion should be made only by healthcare professionals, and &ldquo;should surely be taken out of the hands of those with a vested interest in the player&rsquo;s performance.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">According to the journal editors, &ldquo;Many sporting organisations now acknowledge the potentially serious consequences of mild traumatic brain injury and have drawn up new protocols to protect athletes who sustain a head injury. However FIFPro, the world players&rsquo; union, has called for an investigation of concussion protocols and return-to-play standards following Pereira&rsquo;s injury.&rdquo;</span></p></div> Cinnamon may be used to halt the progression of Parkinson’s disease 2014-07-11T16:50:00Z 2014-07-11T16:50:00Z <div id="Introduction91" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Neurological scientists at Rush University Medical Center have found that using cinnamon, a common food spice and flavouring material, can reverse the biomechanical, cellular and anatomical changes that occur in the brains of mice with Parkinson&rsquo;s disease. The results of the study were recently published in the June 20 issue of the&nbsp;<a href="" target="_blank"><em>Journal of Neuroimmune Pharmacology</em></a>.</strong></span></p> </div><div id="Text191" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Cinnamon has been used widely as a spice throughout the world for centuries,&rdquo; says Kalipada Pahan, study lead researcher and the Floyd A Davis professor of neurology at Rush. &ldquo;This could potentially be one of the safest approaches to halt disease progression in Parkinson&rsquo;s patients.&rdquo;</span></p> <p><span style="font-size: 10pt;">&ldquo;Cinnamon is metabolised in the liver to sodium benzoate, which is an FDA-approved drug used in the treatment for hepatic metabolic defects associated with hyperammonemia,&rdquo; says Pahan. It is also widely used as a food preservative due to its microbiocidal effect.</span></p> <p><br /><span style="font-size: 10pt;">Chinese cinnamon (Cinnamonum cassia) and original Ceylon cinnamon (Cinnamonum verum) are two major types of cinnamon that are available in the USA.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Although both types of cinnamon are metabolised into sodium benzoate, by mass spectrometric analysis, we have seen that Ceylon cinnamon is much more pure than Chinese cinnamon as the latter contains coumarin, a hepatotoxic molecule,&rdquo; says Pahan.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Understanding how the disease works is important to developing effective drugs that protect the brain and stop the progression of Parkinson&rsquo;s disease,&rdquo; says Pahan. &ldquo;It is known that some important proteins like Parkin and DJ-1 decrease in the brain of Parkinson&rsquo;s disease patients.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The study found that after oral feeding, ground cinnamon is metabolised into sodium benzoate, which then enters into the brain, stops the loss of Parkin and DJ-1, protects neurons, normalises neurotransmitter levels, and improves motor functions in mice with Parkinson&rsquo;s disease.</span></p> <p><br /><span style="font-size: 10pt;">This research was supported by grants from National Institutes of Health.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Now we need to translate this finding to the clinic and test ground cinnamon in patients with Parkinson&rsquo;s disease. If these results are replicated in Parkinson&rsquo;s disease patients, it would be a remarkable advance in the treatment of this devastating neurodegenerative disease,&rdquo; says Pahan.</span></p></div> Northwestern Medicine enrols first participant in study of device to treat brain aneurysms 2014-07-11T16:22:00Z 2014-07-11T16:22:00Z <div id="ImageMain92" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction92" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Northwestern Medicine&nbsp;is participating in a multicentre US clinical trial to evaluate the safety and effectiveness of the Microvention FRED flow diversion system (Flow Re-Direction Endoluminal Device) for the treatment of wide-necked intracranial aneurysms.&nbsp;The trial involves inserting a&nbsp;small, metallic mesh tube via a micro-catheter into the blood vessel across the entrance to the aneurysm. The device contains the flow of blood within the tube to keep it away from the aneurysm. This causes the aneurysm to clot and minimises the chance of rupture.</strong></span></p> </div><div id="Text192" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Bernard R Bendok, a neurological surgeon at Northwestern Memorial, performed&nbsp;the first surgery on 12 March. The patient was released from the hospital three days later and continues to recover.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Historically, large aneurysms are particularly difficult to treat,&rdquo; says Bendok, who is also a professor of neurological surgery, radiology and otolaryngology at&nbsp;Northwestern University Feinberg School of Medicine.&nbsp;&ldquo;This new device system may offer additional benefits over first generation flow diversion devices because it can be partially deployed, retrieved and accurately repositioned or redeployed to ensure the most precise placement.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The results of this national trial could change the way large aneurysms are treated in a way that is a huge benefit to the patient,&rdquo; Bendok adds. &ldquo;Not only is this safer, it is less invasive, which drastically cuts recovery time. We&nbsp;are thrilled to offer participation in this study to our patients.&rdquo;</span></p></div> NIH funds phase II trial for treatment of ADHD with Monarch eTNS system 2014-07-11T16:08:00Z 2014-07-11T16:08:00Z <div id="Introduction93" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroSigma has announced that the US National Institutes of Health (NIH) has awarded&nbsp;UCLA&nbsp;a grant that funds a phase II 90-subject paediatric clinical trial at the&nbsp;University of California, Los Angeles&nbsp;(UCLA) focused on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) with NeuroSigma&rsquo;s Monarch external trigeminal nerve stimulation (eTNS) system.</strong></span></p> </div><div id="Text193" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">James McGough, professor of Psychiatry and Biobehavioral Sciences at&nbsp;UCLA, will lead the study as principal investigator, with&nbsp;Sandra Loo, associate professor, as co-principal investigator. Their earlier phase I trial of eTNS for the treatment of ADHD, funded by NeuroSigma, found significant improvements in the severity of ADHD symptoms with eight weeks of nightly eTNS therapy.&nbsp;This phase II clinical trial will evaluate eTNS as monotherapy, under double-blind conditions, in up to 90 children, ages eight to 12, in a four week randomised clinical trial conducted at UCLA.&nbsp;NeuroSigma will provide eTNS systems to&nbsp;UCLA&nbsp;in support of the trial.&nbsp;Neither McGough nor Loo has any affiliation with NeuroSigma.</span></p> <p><span style="font-size: 10pt;"><br />ADHD usually arises in childhood.&nbsp;The US Center for Disease Control and Prevention (CDC) has reported national survey findings that approximately 11% of children ages four to 17 have been diagnosed with the disorder, and that about one in five high school boys will receive this diagnosis during childhood.&nbsp;Symptoms include difficulty paying attention in school, at play, or in the home, a reluctance to take on tasks that require sustained mental effort, being easily distracted, exhibiting physical hyperactivity, and engaging in impulsive behaviours.&nbsp;These symptoms may interfere with social, school, or work functioning.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;I am very pleased that the NIH has funded this extremely important phase II clinical trial in ADHD.&nbsp;Millions of parents seek alternatives to drug treatment for their children with ADHD that are safe and non-invasive,&rdquo; says Leon Ekchian, NeuroSigma&rsquo;s president and chief executive officer.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;McGough and Loo are to be congratulated for receiving this grant, particularly at a time when the NIH budget is under pressure to fund only the most promising lines of investigation. NIH awards represent one of the most stringent forms of peer review in biomedical science,&rdquo; notes&nbsp;Ian Cook, NeuroSigma&rsquo;s chief medical officer and senior vice president.&nbsp;&ldquo;Besides showing safety of eTNS in children, their phase I study found a significant impact on the clinical symptoms of ADHD, and substantial improvements on sleep as well as several objective computer-based measures of cognitive performance.&nbsp;We look forward to confirming these results in this phase II clinical trial under double-blind controlled conditions. A neuromodulation treatment option for ADHD could avoid concerns about the exposure of children to the psychostimulant medications that are the current first-line treatments.&rdquo;&nbsp;</span></p></div> New US patent for Barrel vascular reconstruction device 2014-07-11T15:32:00Z 2014-07-11T15:32:00Z <div id="Introduction94" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Reverse Medical Corporation has announced that the United States Patent Office has notified the company that a new patent has issued entitled &ldquo;Protuberant Aneurysm Bridging Device and Method of Use&rdquo;. This new patent grants six claims surrounding the use of the company&rsquo;s Barrel vascular reconstruction device technology platform.</strong></span></p> </div><div id="Text194" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Reverse Medical Barrel vascular reconstruction device represents a proprietary technology designed specifically for treating complex intracranial bifurcation artery anatomy. The Barrel design is unique, essentially reducing the neck size of wide-neck bifurcation aneurysms, enabling traditional coil embolisation, a craft already mastered by the neuro interventionalist, while maintaining patency of all involved vasculature.</span></p> <p><br /><span style="font-size: 10pt;">Commenting on this new patent, Reverse Medical chief technology officer Brian Strauss says, &ldquo;This patent solidifies our intellectual property foundation of unique means for treating wide-neck bifurcation aneurysms, and along with our other issued patents and pending applications, provides us with broad protection for our innovative device portfolio for treating a variety of neuro and peripheral vascular conditions.&rdquo;</span></p></div> High stress, hostility, depression linked with increased stroke risk 2014-07-11T09:50:00Z 2014-07-11T09:50:00Z <div id="ImageMain95" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction95" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Higher levels of stress, hostility and depressive symptoms are associated with significantly increased risk of&nbsp;stroke&nbsp;or transient ischaemic attack in middle-age and older adults, according to new research in the American Heart Association journal&nbsp;<em><a href="" target="_blank">Stroke</a>.</em></strong></span></p> </div><div id="Text195" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">A transient ischaemic attack is a stroke caused by a temporary blockage of blood flow to the brain.</span></p> <p><br /><span style="font-size: 10pt;">Researchers investigated how psychological factors might influence risk for chronic disease, using data from the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing study on cardiovascular disease risk factors in participants living in six US cities.</span></p> <p><br /><span style="font-size: 10pt;">More than 6,700 adults (ages 45-84; 53% women) completed questionnaires assessing chronic stress, depressive symptoms, anger and hostility over two years. Participants were 38.5% white, 27.8% African-American, 11.8% Chinese and 21.9% Hispanic. All were free of cardiovascular disease at the start of the study.</span></p> <p><br /><span style="font-size: 10pt;">In follow-up for an additional 8.5 to 11 years, 147 strokes and 48 transient ischaemic attacks occurred.</span></p> <p><br /><span style="font-size: 10pt;">Compared to people with the lowest psychological scores, those with highest scores were:</span></p> <ul> <li><span style="font-size: 10pt;">86% more likely to have a stroke or transient ischaemic attack for high depressive symptoms.</span></li> <li><span style="font-size: 10pt;">59% more likely to have a stroke or transient ischaemic attack for the highest chronic stress scores.</span></li> <li><span style="font-size: 10pt;">More than twice as likely to have a stroke or transient ischaemic attack for the highest hostility scores.</span></li> </ul> <p><span style="font-size: 10pt;">No significant increased risk was linked to anger.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;There is such a focus on traditional risk factors &mdash; cholesterol levels, blood pressure, smoking and so forth &mdash; and those are all very important, but studies like this one show that psychological characteristics are equally important,&rdquo; says Susan Everson-Rose, study lead author and associate professor of medicine at the University of Minnesota in Minneapolis, USA.</span></p> <p><br /><span style="font-size: 10pt;">These associations noted in the study were significant even when researchers accounted for age, race, sex, health behaviours and other known risk factors of stroke.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Given our ageing population, it is important to consider these other factors that might play a role in disease risk. Stroke is a disease of the elderly predominantly, and so learning more about things that can influence risk for stroke as people age is important.&rdquo;</span></p> <p><span style="font-size: 10pt;">Researchers measured chronic stress in five domains: personal health problems, health problems of others close to the participant, job or ability to work, relationships and finances.</span></p> <p><br /><span style="font-size: 10pt;">They assessed depressive symptoms with a 20-question scale and analysed anger with a 10-item scale that captured the extent and frequency of experiencing that emotion. Hostility, which is a negative way of viewing the world, was measured by assessing a person&rsquo;s cynical expectations of other people&rsquo;s motives.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;One thing we did not assess is coping strategies,&rdquo; Everson-Rose says. &ldquo;If someone is experiencing depressive symptoms or feeling a lot of stress or hostility, we don&rsquo;t know how they manage those, so it&rsquo;s possible that positive coping strategies could ameliorate some of these associations or effects,&rdquo; she says. &ldquo;We did not inquire about coping. I would say that is one of the tasks for future studies.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Researchers did not identify potential racial and ethnic differences or sex differences in the observed associations, but were not able to fully examine such differences due to the smaller numbers of strokes in some groups.</span></p> <p><br /><span style="font-size: 10pt;">Co-authors are Nicholas Roetker; Pamela Lutsey; Kiarri Kershaw; W T Longstreth Jr; Ralph Sacco; Ana Diez Roux; Alvaro Alonso. Author disclosures are on the manuscript.</span></p> <p><br /><span style="font-size: 10pt;">The National Heart, Lung, and Blood Institute funded the study.</span></p></div> Less-invasive technique repairs life-threatening condition 2014-07-10T10:14:00Z 2014-07-10T10:14:00Z <div id="Introduction96" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A patient who underwent a less-invasive technique to repair an arteriovenous fistula was able to return to work just two weeks after surgery.</strong></span></p> </div><div id="Text196" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">What enabled the patient, Bill Abt to recover so quickly and painlessly was a less-invasive surgical technique performed by Loyola University Medical Center neurosurgeon William W Ashley, Jr.</span></p> <p><br /><span style="font-size: 10pt;">The less-invasive technique Ashley performed was an endovascular treatment. He inserted a catheter in an artery in the groin, then guided the catheter up past the heart and through the carotid artery into the brain. Once the catheter reached the fistula, Ashley injected a liquid polymer that immediately solidified. This effectively sealed off the fistula to prevent a possible rupture.</span></p> <p><br /><span style="font-size: 10pt;">The case began when Abt consulted a physician about tinnitus (chronic ringing in his ear). The physician ordered a scan, which detected the arteriovenous fistula.</span></p> <p><br /><span style="font-size: 10pt;">Normally, arteries and veins are separate, with arteries transporting high-pressure blood from the heart to the body&rsquo;s organs, and veins carrying low-pressure blood back to the heart. But in Abt&rsquo;s case, an artery in his brain was directly connected to a vein. Consequently, high-pressure blood was shooting into the vein -- like a fire hose connected to a garden hose. The thin-walled vein, not designed to withstand such pressure, ballooned outward and was at risk of rupturing. Blood leaking from such a rupture could have caused a debilitating or fatal stroke.</span></p> <p><br /><span style="font-size: 10pt;">Christopher Loftus, chair of the Department of Neurological Surgery presented the case to a multidisciplinary cerebrovascular conference. Loftus led the discussion as physicians carefully examined the risks and benefits of all options, including traditional open surgery, the less-invasive endovascular treatment or no treatment at all. Loftus decided to bring Ashley in on the case.</span></p> <p><br /><span style="font-size: 10pt;">Abt underwent the less-invasive endovascular treatment on a Friday. He went home the next day, and began working from home the following week. The second week, he returned to work as senior vice president for administration and business at Carthage College in Kenosha, USA.</span></p></div> Treating oxygen-deprived newborns with hypothermia improves survival without brain damage in later childhood 2014-07-10T09:34:00Z 2014-07-10T09:34:00Z <div id="ImageMain97" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction97" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The cooling of newborn babies suffering from perinatal asphyxia &ndash; a lack of oxygen at the time of birth &ndash; significantly increases their chance of survival without brain damage to later childhood (age six to seven years), according to a Medical Research Council (MRC) funded clinical trial.</strong></span></p> </div><div id="Text197" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study, published in the&nbsp;<a href="" target="_blank"><em>New England Journal of Medicine</em></a>, found that 51.7% of infants treated with hypothermia survived with an IQ of 85 or above, which is considered to be within the normal range, compared to 39.4% of those treated with standard care. Cooling significantly reduced the chance of oxygen-deprived children suffering from cerebral palsy and other moderate/severe disabilities. The children also showed improved motor functioning. However, the authors observed that there was no difference in mortality rate &ndash; reported to be around 30% of children enrolled in the trial &ndash; between the standard care and hypothermia-treated groups.</span></p> <p><span style="font-size: 10pt;"><br />The trial, led jointly by the National Perinatal Epidemiology Unit (NPEU) at the University of Oxford and Imperial College London, is the largest study of its kind and the first study to show improved brain function in children treated using this method in later life<strong>. </strong>Before this trial, there was limited information on the beneficial effect of cooling after asphyxia beyond the age of 18 months. This work is important because it demonstrates that the improvements observed in brain function are not just temporary.</span></p> <p><span style="font-size: 10pt;"><br />The <a href="" target="_blank"><strong>MRC TOBY</strong></a> trial (Total body hypothermia) involved newborn babies of at least 36 weeks gestation that suffered from a lack of oxygen at birth. The children were randomly assigned into two groups within six hours of delivery, and either treated with standard care or standard care plus hypothermia, when their body temperature was reduced to 33.5˚C for 72 hours. After that time, they were slowly returned to a normal body temperature of 37˚C.</span></p> <p><span style="font-size: 10pt;"><br />The current research is part of the follow up <a href="" target="_blank"><strong>TOBY Children Study</strong></a> that aimed to find out if there were any differences in the health of the children, treated with or without cooling, in later life. The scientists tested the children&rsquo;s mental abilities and performance at school, looked at parent and teacher reports on behaviour and investigated the presence and severity of any disabilities that resulted from oxygen deprivation.</span></p> <p><span style="font-size: 10pt;"><br />Following oxygen deprivation a number of processes are set off in the brain, which lead to brain cell death and permanent neurological damage. Hypothermia interrupts these processes to reduce brain injury and has consistently been shown to improve outcomes at 18 months. This study now confirms treatment with cooling is safe and effective, and that the benefits persist in the long term. The treatment has been endorsed by the National Institute for Health and Care Excellence (NICE) and adopted into clinical practice in the NHS; it has the advantage of being relatively simple and inexpensive to carry out.&nbsp;These new findings support its general use in neonatal clinical practice.</span></p> <p><span style="font-size: 10pt;"><br />Denis Azzopardi, of King&rsquo;s College London and lead author of the study, says: &ldquo;This study is important as it confirms improved brain function persisting into middle childhood with cooling treatment and it is a proof of the concept that treatment following oxygen deprivation at birth can be effective.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Brenda Strohm, research nurse and TOBY trial coordinator at the NPEU, University of Oxford, says: &ldquo;We are indebted to all the families who took part in the TOBY Trial and then the TOBY Children Study; their contribution to these two important studies has made a real difference to neonatal care.&rdquo;&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;While corresponding with the families over the years, I have shared many happy stories of achievement and success as well as moments of sadness and loss; this is a privilege which adds a special dimension to my role of study co-ordinator. Thanks to our latest research, now when a baby is treated with cooling, families can be more fully informed about what might lie ahead, not only in the coming months but in the next few years too.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Hugh Perry, chair of the MRC Neurosciences and Mental Health Board, says: &ldquo;This study is a great example of how research can change people&rsquo;s lives. Although major advances have been made in how childbirth is managed, approximately two out of every 1,000 newborn infants suffer from a lack of oxygen around the time of birth. Prior to the introduction of cooling therapy there were no approved, specific treatments that reduced the risk of brain injury long-term following asphyxia.<strong>&rdquo;</strong></span></p></div> Advances in trigeminal nerve stimulation featured at European congress on epileptology 2014-07-09T14:49:00Z 2014-07-09T14:49:00Z <div id="Introduction98" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroSigma has announced top-line summaries of presentations made at the 11th European Congress on Epileptology in&nbsp;Stockholm, Sweden, related to the use of external trigeminal nerve stimulation (eTNS) in epilepsy.</strong></span></p> </div><div id="Text198" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Sean Slaght reported an update of observational findings in on-going adjunctive treatment with eTNS of adults at&nbsp;Kings College&nbsp;London, UK.&nbsp;In a group of 13 real-world, care-seeking patients with drug resistant epilepsy, who completed at least 12 weeks of nightly use of the Monarch eTNS system, they observed a median reduction in seizure frequency of 38%. The Kings College London researchers additionally reported on significant improvement in quality of life, mood, and sleep metrics.</span></p> <p><br /><span style="font-size: 10pt;">In the first-ever use of eTNS in paediatric patients with drug resistant epilepsy, Slaght reported preliminary findings on seven children, age 10 to 17, treated with this non-invasive, adjunctive therapy. Three children (43% of the group) reported a 50% or more reduction of their seizure frequency after 18 weeks.</span></p> <p><br /><span style="font-size: 10pt;">Observational findings were also presented by Jos&eacute; Serratosa, from the Fundaci&oacute;n Jim&eacute;nez D&iacute;az University Hospital,&nbsp;Madrid, Spain.&nbsp;In a group of eight adult patients treated with eTNS, 25% experienced a decrease in seizures of over 90%.</span></p> <p><br /><span style="font-size: 10pt;">Consistent with earlier phase I and II trials conducted in&nbsp;the United States, the European groups reported an absence of serious adverse events.</span></p> <p><span style="font-size: 10pt;"><br />Other investigators from Kings College London reported data on measures of cortical excitability in five adult drug resistant epilepsy patients undergoing eTNS treatment for 18 weeks. Brief magnetic pulses were used to assess cortical function before and after a course of treatment, in an effort to evaluate the mechanism of action of eTNS.&nbsp;&nbsp;Adam Pawley presented work conducted with Mark Richardson&nbsp;at Kings College London.&nbsp;Measures of cortical excitability consistently decreased with use of eTNS, implicating potential effects on signalling in both GABA<sub>A</sub>- and GABA<sub>B</sub>-mediated circuits. Other antiepileptic therapies have previously been shown to reduce measures of cortical excitability.</span></p> <p><br /><span style="font-size: 10pt;">Christianne Heck from the&nbsp;University of Southern California&nbsp;(USC),&nbsp;Los Angeles, chaired a satellite symposium, &ldquo;Trigeminal Nerve Stimulation (TNS): Neuromodulation for the 21st Century.&rdquo; This session introduced TNS to a large number of epileptologists attending the Congress and provided them with both background neurobiological data and clinical results.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The experience at these leading European epilepsy centres bears out the safety profile we have seen in the USA for eTNS, and provides confirmatory evidence of the effects of eTNS on seizures, mood, sleep, and quality of life,&rdquo; says&nbsp;Christopher DeGiorgio, NeuroSigma&rsquo;s vice president of Neurology and the professor of Neurology who first investigated eTNS for drug resistant epilepsy at the&nbsp;University of California, Los Angeles&nbsp;(UCLA).&nbsp;&ldquo;Millions of people living with epilepsy are still having seizures despite the best medication treatment available, often facing cognitive side effects from multiple antiepileptic drugs and the disease itself.&nbsp;eTNS may become an important tool to address this unmet medical need.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;While these studies were of modest size, the researchers conducting these independent effectiveness evaluations are in the vanguard in providing important data that complement the findings from controlled clinical trials. These findings provide us with confidence in the design of the pivotal trial in drug resistant epilepsy that we are preparing to commence. &nbsp;Further, the work with cortical excitability elucidates another biological mechanism by which eTNS may achieve its anticonvulsant effect, and builds on the data showing acute changes in regional brain activity observed with PET scanning at&nbsp;UCLA,&rdquo; adds&nbsp;Ian Cook, chief medical officer and senior vice president at NeuroSigma.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">NeuroSigma provided eTNS Systems to the investigators&rsquo; institutions, but was otherwise uninvolved in the conduct of the research at either Kings College London or the Fundaci&oacute;n Jim&eacute;nez D&iacute;az University Hospital.</span></p></div> Brainlab announces launch of Right.Brain Foundation 2014-07-09T14:26:00Z 2014-07-09T14:26:00Z <div id="ImageMain99" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction99" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Brainlab has announced the launch of the Right.Brain Foundation, which will provide medical technology and education to selected hospitals and public institutions in Southeast Asia, Africa, Central and South America.</strong></span></p> </div><div id="Text199" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Countries were reviewed carefully and selected based on several criteria including: per capita income, reliable energy supply, adequately trained healthcare professionals; keeping in mind the distribution of wealth, political stability and safety of the country as well as where patients may be able to benefit the most from providing treatment.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We understand and acknowledge the World Health Organisation&rsquo;s principles for a good medical equipment donation,&rdquo; says Stefan Vilsmeier, president and chief executive officer, Brainlab. &ldquo;The Right.Brain Foundation, which provides the equipment and trained personnel to the hospitals in need, also includes personnel training at the local hospital level. This helps further their education, provide hope for their country, and raise the bar in academic achievements for residents and studying physicians.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The Right.Brain Foundation purpose, &ldquo;Together we provide medical technology to create opportunities for a better world,&rdquo; dovetails perfectly with the Brainlab vision to increase access to and consistency of treatment for patients everywhere. Brainlab is committed to supporting Right.Brain by providing on-point, frugal technologies that will make the most impact in the countries to be served. The technology that will be loaned to the hospitals is Kick Purely Navigation, a robust, reliable and minimalist image guided surgery system that is compact and can be easily shipped. Engineered with focused functionality, Kick is small but powerful and supports and advances neurosurgery efforts in developing countries.</span></p> <p><br /><span style="font-size: 10pt;">Right.Brain will partner with hospitals and physicians in North America and Europe, building an exchange programme to help teach the physicians in developing countries how to use the technology effectively. Furthermore, Brainlab employees will volunteer their vacation time to Right.Brain to provide additional on-site training and support to the local hospitals.</span></p> <p><br /><span style="font-size: 10pt;">Beyond time donations, Brainlab employees are also encouraged to give to Right.Brain via a variety of opportunities such as frequent flyer-mile donations, monetary donations at the Brainlab Open House on Friday, 11 July, 2014 in Feldkirchen, Germany and merchandise available at where 20% of the proceeds will be donated to the Right.Brain Foundation. In the near future, Brainlab will extend support opportunities to current business partners to further the mission of Right.Brain with additional technologies, training and education.</span></p> <p><br /><span style="font-size: 10pt;">The inaugural Right.Brain project will take place at the Calmette Hospital in Phnom Pehn, Cambodia. For this operation, Right.Brain will cooperate closely with La Cha&icirc;ne de l&rsquo;Espoire, a French foundation which is locally based and will ensure a smooth integration of Brainlab technology and help ensure the mission&rsquo;s success.</span></p> <p><br /><span style="font-size: 10pt;">This announcement is the culmination of a passionate idea long held by Brainlab Founder and chief executive officer, Stefan Vilsmeier and just the beginning of the company&rsquo;s social impact journey. This year, as the company celebrates 25 years of medical technology innovation, Brainlab expands its reach beyond the 80 countries currently served to include developing countries in need of the right medical technology to make a difference.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This mission has been 25 years in the making; it extends beyond the walls of our corporate offices and the hospitals we traditionally serve.&rdquo; Vilsmeier adds. &ldquo;This project is unlike any other effort in which Brainlab has participated. Right.Brain will bring technology into underserved areas, connect experienced surgeons and staff with those in need of training and support and most importantly, help patients in need. In five years, we hope to have 80% of the countries using some type of surgical navigation and more patients benefiting from neurosurgical care.&rdquo;</span></p></div> InspireMD announces completion of CGuard CARENET trial 2014-07-09T10:13:00Z 2014-07-09T10:13:00Z <div id="ImageMain100" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction100" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>InspireMD has announced that it has concluded enrolment in its CARENET (Carotid embolic protection study using MicroNet) clinical trial. The multi-specialty trial is assessing the peri-procedural safety and efficacy of CGuard systems in the treatment of carotid lesions. The acute procedural performance of the CGuard device was 100% successful for all of the 30 patients enrolled in the trial.</strong></span></p> </div><div id="Text1100" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Thirty patients were enrolled at four sites across Europe and will be followed up using traditional assessments post-procedure and at 30 days to include MACE (death, stroke, MI), and ipsilateral stroke (31 days to one year).&nbsp; In addition, DW-MRI (Diffusion Weighted Magnetic Resonance Imaging) is being done pre and post procedure and at 30 days, as well as ultrasound examination at 30 days and one year on every patient.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The proprietary CGuard carotid embolic protection system uses the same MicroNet technology featured on the MGuard and MGuard Prime coronary embolic protection systems. The MicroNet technology is a single fibre knitted mesh wrapped on an open cell stent platform designed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods. This technology seeks to protect patients from plaque debris and blood clots breaking off and which can lead to life threatening strokes. The size, or aperture, of the MicroNet &rsquo;pore&rsquo; is only 150-180 microns in order to maximise protection against the potentially dangerous plaque and thrombus within the carotid artery.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;I am excited that enrolment in the CGuard CARENET study has just been completed. I have treated many patients with carotid artery disease over the years and the unique CGuard embolic protection system with MicroNet has changed the way I think about treating these challenging patients,&rdquo; states Joachim Schofer, from the Hamburg University Cardiovascular Center, in Hamburg, Germany. &ldquo;The experience that we have gained using the CGuard device has given us a sense of confidence in regards to new technology options when treating these patients. The small pore size of the MicroNet technology allows excellent blood flow while trapping potentially harmful plaque debris and thrombus. The CGuard technology provides an elegantly simple solution for embolic protection that has not been available in the past. I look forward to reviewing and analysing all of the CARENET data over the next several weeks and sharing the results soon afterward.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The completion of the CGuard CARENET trial on schedule with 100% procedural success rate is an important milestone for InspireMD,&rdquo; states Alan Milinazzo, president and chief executive officer of InspireMD, &ldquo;Our investigators have done a wonderful job throughout this trial, and their feedback on the CGuard has been very positive and informative. The initial results support our belief that the MicroNet technology may deliver life-saving benefits to patients with carotid artery disease and revolutionise the way the carotid stenting procedures are performed. We are looking forward to analysing the data from the CARENET trial and sharing the results in mid-September at the upcoming TCT conference.&rdquo;</span></p></div>