Latest News - Neuro News Affino Atom Generator BIBA Medical Ltd 2015-01-27T14:22:46Z Siemens Healthcare and IMRIS bring hybrid ORs to Sahlgrenska University Hospital in Sweden 2015-01-27T11:08:00Z 2015-01-27T11:08:00Z <div id="ImageMain1" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction1" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>IMRIS has announced that a VISIUS Surgical Theatre with intraoperative MRI (iMRI) will be integrated among four hybrid operating suites Siemens Healthcare recently sold to Sahlgrenska University Hospital, Sweden, in an example of growing cooperation between IMRIS and Siemens Healthcare.</strong></span></p> </div><div id="Text11" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This represents the close and progressing global collaboration IMRIS has with Siemens Healthcare to bring advanced imaging to the operating environment,&rdquo; said IMRIS president and chief executive officer Jay D Miller. &ldquo;Already many of the top neuroscience centres around the world are making intraoperative MR their standard of care.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Sahlgrenska University Hospital, one of the largest hospital systems in northern Europe, is associated with the Sahlgrenska Academy at the University of Gothenburg in Gothenburg, Sweden. This sale involves both radiology and MRI systems in four hybrid operating rooms for the hospital&rsquo;s new imaging centre with clinical opening planned in 2016.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The benefit for the patient is obvious with minimally invasive surgery, since he or she can leave the hospital much sooner,&rdquo; said Johan M&auml;lsj&ouml;, Head of Division of Imaging and Therapy at Siemens Healthcare in Sweden. &ldquo;This is also beneficial for the hospital which needs to manage its resources carefully. Siemens Healthcare sees a strong trend in this and expects an increasing demand for similar solutions.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The VISIUS iMRI will feature a two-room suite where a diagnostic quality MR travels to the patient using ceiling-mounted rails. The fully integrated suite allows the scanner to move between an operating room (OR) and a diagnostic room, providing neurosurgeons on-demand access to high resolution images before, during and after procedures without moving the patient from the OR table. Published studies have demonstrated that access to advanced imaging technology during procedures leads to improved precision and patient outcomes and reduced returns to surgery, particularly for neurosurgical conditions.</span></p></div> Medtronic completes acquisition of Covidien 2015-01-27T09:41:00Z 2015-01-27T09:41:00Z <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>Medtronic has successfully completed the previously-announced acquisition of Covidien. Under the terms of the acquisition agreement, Medtronic Inc and Covidien plc are now combined under Medtronic plc.</strong></span></p> </div><div id="Text12" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The culmination of this acquisition marks a significant milestone in our industry, creating a company uniquely positioned to alleviate pain, restore health and extend life for more patients around the world. We can now bring together the extensive and innovative capabilities of both Medtronic and Covidien with an underlying objective to solve healthcare&rsquo;s biggest challenge &ndash; expanding access and improving clinical outcomes, while lowering costs,&rdquo; says Omar Ishrak, chairman and chief executive officer of Medtronic.</span></p> <p><br /><span style="font-size: 10pt;">Covidien and Medtronic Inc shares have now ceased trading on the New York Stock Exchange. The cash-and-stock transaction is valued at approximately US$49.9bn, based on Medtronic&rsquo;s closing stock price of US$75.59 per share on 26 January 2015. Under the terms of the transaction, each ordinary share of Covidien outstanding as of the closing has been converted into the right to receive US$35.19 in cash and 0.956 of an ordinary share of Medtronic plc. Each share of Medtronic Inc common stock outstanding as of the closing has been converted into the right to receive one ordinary share of Medtronic plc.</span></p> <p><br /><span style="font-size: 10pt;">Medtronic plc has its principal executive offices in Ireland, where both companies have a longstanding presence. The company&rsquo;s operational headquarters will continue to be based in Minneapolis, USA.</span></p></div> Stem cell transplantation shows potential for reducing disability in multiple sclerosis patients 2015-01-27T09:25:00Z 2015-01-27T09:25:00Z <div id="Introduction3" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Results from a preliminary study indicate that among patients with relapsing-remitting multiple sclerosis, treatment with nonmyeloablative hematopoietic stem cell transplantation (low intensity stem cell transplantation) was associated with improvement in measures of disability and quality of life, according to a study in the <em><a href="">Journal of the American Medical Association</a>.</em></strong></span></p> </div><div id="Text13" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Fifty per cent of patients with multiple sclerosis are unable to continue employment after 10 years of&nbsp;diagnosis or are unable to walk after 25 years. Despite an annual cost of approximately US$47,000 per patient to treat multiple sclerosis, no therapy approved by the US Food and Drug Administration (FDA) has been shown to significantly reverse neurological disability or improve quality of life.</span><br /><br /></p> <p><span style="font-size: 10pt;">Multiple sclerosis is thought to be an immune&shy;mediated disorder of the central nervous system. Autologous haematopoietic stem cell transplantation (HSCT) is a form of immune suppression, which unlike standard immune-based drugs, is designed to reset rather than suppress the immune system. Richard K Burt of the Northwestern University Feinberg School of Medicine, Chicago, USA, and colleagues studied the association of nonmyeloablative HSCT with neurological disability and other clinical outcomes in patients with relapsing-remitting multiple sclerosis (defined as acute relapses followed by partial or complete recovery and stable clinical manifestations between relapses; n=123) or secondary-progressive multiple sclerosis (defined as a gradual progression of disability with or without superimposed relapses; n=28) treated between 2003 and 2014.</span><br /><br /></p> <p><span style="font-size: 10pt;">Outcome analysis was available for 145 patients with an average follow-up of 2.5 years. On the&nbsp;Expanded Disability Status Scale (EDSS) score, there was significant improvement in 41 patients (50% of patients tested at two years) and in 23 patients (64% of patients tested at four years). &ldquo;To our knowledge, this is the first report of significant and sustained improvement in the EDSS score following any treatment for multiple sclerosis,&rdquo; the authors write.</span><br /><br /></p> <p><span style="font-size: 10pt;">Receipt of HSCT was also associated with improvement in physical function, cognitive function and quality of life. There was also a reduction in the volume of brain lesions associated with multiple sclerosis seen on MRI images. Four-year relapse-free survival was 80% and progression-free survival was 87%.</span><br /><br /></p> <p><span style="font-size: 10pt;">Patient selection is important in determining outcome, the researchers write. &ldquo;In the post hoc analysis, the EDSS score did not improve in patients with secondary-progressive multiple sclerosis or in those with disease duration longer than 10 years.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The authors note the results are limited because this was an observational study without a control group. &ldquo;Definitive conclusions will require a randomised trial; however, this analysis provides the rationale, appropriate patient selection, and therapeutic approach for a randomised study.&rdquo;&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Stephen L Hauser, University of California, San Francisco, USA, writes that the study by Burt <em>et al</em>, taken together with other available evidence, enables several conclusions to be made with reasonable confidence. &ldquo;First, autologous HSCT does not appear to be effective against established progressive forms of the condition and, absent new data, additional trials of these protocols are probably not indicated for patients with progressive multiple sclerosis. Second, immunosuppressive regimens that include HSCT appear to be effective against the relapsing-remitting form of multiple sclerosis, at least over several years of observation. However, it is by no means clear that the beneficial effects result from the infusion of stem cells rather than from the conditioning regimen. Given the availability of highly effective FDA-approved therapies against relapsing-remitting multiple sclerosis, it would seem reasonable to use these proven monotherapies in the clinical setting before considering complex HSCT regimens.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Hauser continues, &ldquo;Third, the mechanism of action of autologous HSCT in MS needs to be clarified. Fourth, it is important to remember that multiple sclerosis is a chronic disease, usually arising in young adults and lasting throughout the lifespan. Many important disability-related outcomes take many years or decades to develop. To understand the role of any therapy, and especially an intensive regimen with uncertain long-term risk, very long follow-up periods are required to meaningfully assess if the disease has indeed been rebooted over the long term, and also to increase confidence that these therapies have not caused undue harm.&rdquo;</span></p></div> Medtronic’s pending acquisition of Covidien approved by Irish High Court 2015-01-26T12:11:00Z 2015-01-26T12:11:00Z <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>Medtronic and Covidien have announced that the Irish High Court has sanctioned the Covidien scheme of arrangement pursuant to which Medtronic will acquire Covidien under a new holding company incorporated in Ireland to be named Medtronic plc.&nbsp;</strong></span></p> </div><div id="Text14" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">With the Court&rsquo;s approval of the scheme of arrangement, Medtronic and Covidien anticipate that the transaction, which will result in Medtronic and Covidien becoming wholly owned subsidiaries of Medtronic plc, will close.</span><br /><br /></p> <p><span style="font-size: 10pt;">The transaction is anticipated to close on 26 January 2015, with ordinary shares of Medtronic plc expected to begin trading on the New York Stock Exchange on January 27, 2015.</span></p></div> Interleukin 4 may assist in developing treatment for central nervous system injuries 2015-01-23T14:43:00Z 2015-01-23T14:43:00Z <div id="ImageMain5" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction5" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers have identified a beneficial immune response that occurs after injury to the central nervous system. By harnessing this response, researchers may be able to develop new and better treatments for brain and spinal cord injuries, and tools to predict how patients will respond to treatment, thus improving treatment of degenerative conditions.</strong></span></p> </div><div id="Text15" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The newly-discovered immune response occurs independently of the process that typically spurs the immune system into action. In this process, the body identifies and attacks antigens such as bacteria and viruses. &ldquo;What we have shown is that the injured central nervous system talks to the immune system in a language that has not been previously recognised in this context,&rdquo; said Jonathan Kipnis, Department of Neuroscience at the UVA School of Medicine and director of the Center for Brain Immunology and Glia. &ldquo;It sends danger signals and activates the immune system very rapidly. These danger signals cause immune cells to produce a molecule called interleukin 4, which happens to be indispensable for immune mediated neuroprotection after central nervous system trauma.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Interleukin 4 helps protect the body&rsquo;s neurons and promote their regeneration, whereas uncontrolled inflammation can destroy them. As such, understanding how the body responds to damage to the central nervous system is critically important.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Once CNS neurons die, they are gone for life. They don&rsquo;t come back. So I think the central nervous system has evolved along with the immune system to respond in this protective fashion,&rdquo; explained UVA&rsquo;s James T Walsh, the lead author of the paper outlining the discovery. &ldquo;[The immune system in the central nervous system] has to be very metered with how it responds. It cannot attack everything like it does in a lot of other tissues, because it causes a lot of collateral damage. You really need the right kind of response. It can be a double-edged sword. The immune system can cause damage to the central nervous system, but it can also be beneficial, and we are showing here how it is beneficial.&rdquo;</span></p></div> Nevro receives FDA approvable letter for Senza spinal cord stimulation system 2015-01-23T09:49:00Z 2015-01-23T09:49:00Z <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>Nevro has received a letter from the US Food and Drug Administration (FDA) informing the company of the approvability of its premarket approval application (PMA) for the Senza spinal cord stimulation system.</strong></span></p> </div><div id="Text16" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to the approvable letter, approval of the PMA is subject to satisfaction of regulatory inspections and audits of manufacturing facilities, methods and controls for Senza to ensure compliance with the FDA&rsquo;s Quality System Regulation, as well as finalisation of the product&rsquo;s labelling with the FDA.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We are working to satisfy the conditions of approval and anticipate initial commercial availability in the USA by mid-2015", said&nbsp;Michael DeMane, chairman and chief executive officer of Nevro.</span></p> <p><br /><span style="font-size: 10pt;">Leonardo Kapural, the lead investigator of the <a href="">SENZA-RCT study</a>, presented the study results at the Groundbreaking Clinical Trial Results plenary session of the recent North American Neuromodulation Society Meeting (11&ndash;14 December, 2014, Las Vegas, USA). The Senza system is commercially available in&nbsp;Europe&nbsp;and&nbsp;Australia&nbsp;where over 2,500 patients have been treated to date.</span></p></div> Link discovered between protective effects of cooling on the brain and prevention of neurodegeneration 2015-01-15T15:14:00Z 2015-01-15T15:14:00Z <div id="ImageMain7" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction7" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers at the Medical Research Council (MRC) Toxicology Unit have identified a protective mechanism that activates when body temperature is lowered, initiating a process that prevents the loss of brain cells and the connections between them.</strong></span></p> </div><div id="Text17" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The MRC team discovered that this protective process may be defective in neurodegenerative diseases such as Alzheimer&rsquo;s, contributing to the death of brain cells in these disorders. By simulating the effects of cooling in mice, the scientists have revealed a possible new target for drugs that could protect against neurodegeneration.</span><br /><br /></p> <p><span style="font-size: 10pt;">It has long been known that during hibernation, where a mammal&rsquo;s core temperature cools to well below normal body temperature, synapses are depleted.&nbsp;This allows the animal to enter a state of torpor, allowing the animal to survive without nutrition for weeks or months.&nbsp;As the animal comes out of hibernation and warms up, connections between brain cells are reformed and the number of synapses once again rises, restoring normal brain activity.</span><br /><br /></p> <p><span style="font-size: 10pt;">In humans, hypothermia is known to protect the brain. For example, people have survived hours after a cardiac arrest with no brain damage after falling into icy water. Artificially cooling the brains of babies that have suffered a loss of oxygen at birth is also used to protect against brain damage.&nbsp;</span><br /><br /></p> <p><span style="font-size: 10pt;">Cooling and hibernation lead to the production of a number of different proteins in the brain known as cold-shock proteins. One of these, RBM3, has been associated with preventing brain cell death, but it has been unclear how it affects synapse degeneration and regeneration.&nbsp;Knowing how these proteins activate synapse regeneration might help scientists find a way of preventing synapse loss, without the need for actual cooling.</span></p> <p><span style="font-size: 10pt;">In this study, researchers reduced the body temperature of healthy mice to 16-18 degrees Celsius &ndash; similar to the temperature of a hibernating small mammal &ndash; for 45 minutes. They found that the synapses in the brains of these mice, which do not naturally hibernate, also dismantled on cooling and regenerated on re-warming.</span><br /><br /></p> <p><span style="font-size: 10pt;">The team then repeated the cooling in mice bred to reproduce features of neurodegenerative diseases (Alzheimer&rsquo;s and prion disease) and found that the capacity for synapse regeneration disappeared as the disease progressed, accompanied by a disappearance of RBM3 levels.</span></p> <p><span style="font-size: 10pt;">When the scientists artificially boosted levels of the RBM3 protein they found that this alone was sufficient to protect the Alzheimer and prion mice, preventing synapse and brain cell depletion, reducing memory loss and extending lifespan.</span><br /><br /></p> <p><span style="font-size: 10pt;">The researchers were therefore able to conclude that RBM3 &ndash; and perhaps other cold-shock proteins &ndash; affects the ability of neurons to regenerate synapses in neurodegenerative diseases, which is essential to prevent synapse loss during disease progression. The pathway could be a useful target for drugs so that brain cells could be preserved without the need for cooling.</span><br /><br /></p> <p><span style="font-size: 10pt;">Giovanna Mallucci, who led the research team, said: &ldquo;We have known for some time that cooling can slow down or even prevent damage to brain cells, but reducing body temperature is rarely feasible in practice: it is unpleasant and involves risks such as pneumonia and blood clots. But, by identifying how cooling activates a process that prevents the loss of brain cells, we can now work towards finding a means to develop drugs that might mimic the protective effects of cold on the brain.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Hugh Perry, chairman of the MRC&rsquo;s Neurosciences and Mental Health Board, which funded the research, said: &ldquo;The neuroprotective pathway identified in this study could be an important step forward. We now need to find something to reproduce the effect of brain cooling. Just as anti-inflammatory drugs are preferable to cold baths in bringing down a high temperature, we need to find drugs which can induce the effects of hibernation and hypothermia.&rdquo;</span></p></div> Ischaemic micro-lesions associated with flow-diverting stents in treatment of intracranial aneurysms 2015-01-12T16:53:00Z 2015-01-12T16:53:00Z <div id="Introduction8" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The use of flow-diverting stents to treat intracranial aneurysms appears safe and highly successful. Recently, however, there have been reports of ischaemic complications occurring in brain territories supplied by the parent artery in which the stent is placed and in brain regions fed by small arterial branches whose ostia are covered by the stent.</strong></span></p> </div><div id="Text18" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">To determine the extent of these ischaemic complications and their implications on clinical outcomes in patients who receive flow-diverting stents, researchers from Dupuytren University Hospital in Limoges, France, conducted a prospective single-centre study in which 38 patients (seven male and 31 female) received flow-diverting stents to treat 49 intracranial aneurysms from 1 January 2012 &ndash; 1 July, 2013. Forty aneurysms (82%) were specifically treated using flow-diverting stents, rather than coils or clips, because the aneurysms were considered anatomically challenging.</span><br /><br /></p> <p><span style="font-size: 10pt;">Technical difficulties occurred during insertion of the flow-diverting stent in five patients, but nevertheless, treatment was deemed a technical success in all 49 aneurysms. Diffusion-weighted imaging was performed 24 hours before each procedure as well as 14&ndash;48 hours and three months after treatment. Clinical status and imaging findings before and after treatment were compared in patients who received flow-diverting stents, and these data were also compared with similar data in patients who underwent coil embolisation of aneurysms during the same time period. The authors, Christina Iosif and colleagues, report and discuss their findings in a new paper, &ldquo;Diffusion-weighted imaging&ndash;detected ischaemic lesions associated with flow-diverting stents in intracranial aneurysms: safety, potential mechanisms, clinical outcome, and concerns,&rdquo; published online, ahead of print, in the&nbsp;<em><a href="">Journal of Neurosurgery</a></em>.</span><br /><br /></p> <p><span style="font-size: 10pt;">In this study diffusion-weighted imaging (DWI) was used to identify ischaemic micro-lesions. Hyperintense areas&mdash;bright &lsquo;spots&rsquo;&mdash;on the patients&rsquo; DWI studies represented these lesions. These DWI spots were recorded with respect to their number, location, and size.</span><br /><br /></p> <p><span style="font-size: 10pt;">Within 48 hours after the flow-diversion procedure, 35 patients (92.1%) were found to harbour at least one ischaemic micro-lesion; one patient had as many as seven micro-lesions. In total 84 new lesions were identified on DWI during this period. In most cases the micro-lesions were clinically silent; however, in five cases they were clinically relevant, with permanent deficits occurring in three cases (7.8%)&ndash;&ndash;slight disability in one patient and moderate disability in two patients. Three late-occurring micro-lesions were identified by DWI during the follow-up period. All three were clinically silent.</span><br /><br /></p> <p><span style="font-size: 10pt;">The researchers compared the high incidence of clinically silent ischaemic micro-lesions in patients who underwent flow diversion (86.9% of patients) with the incidence of these lesions in a comparison group of similar patients who underwent aneurysm coiling (35% of patients). The difference between the two groups was statistically significant (p=0.04). The authors state this reveals &ldquo;an increased embolic tendency with this type of device [that is, the flow-diverting stent], probably due to its mechanical properties and to the technical manipulations during the procedures.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">In this study DWI spots that appeared early during the follow-up period were mostly located in tissue distal to the artery harbouring the treated aneurysm; the authors believe that these spots suggest ischaemic embolic micro-lesions that were a consequence of treatment. Other DWI spots appeared later in the follow-up period, but only in territories fed by arterial branches whose ostia were jailed (that is, covered) by flow-diverting stents; the authors state that these ischaemic events were primarily caused by haemodynamic factors, rather than embolic factors, and were due to a present, but inadequately developed, collateral arterial network competing for the perfusion of the brain territory of the jailed branches. As a new perfusion equilibrium is established, either by recruiting collateral arterial network or by arterial remodelling of the branch, symptoms usually regress.</span><br /><br /></p> <p><span style="font-size: 10pt;">An additional item investigated in this study was whether the location of an intracranial aneurysm treated with a flow-diverting stent has an effect on the number and clinical relevance of ischaemic events. They researchers found no statistical difference between the number of clinically relevant complications and associated outcomes in patients with aneurysms located above or below the circle of Willis.</span><br /><br /></p> <p><span style="font-size: 10pt;">In summary, the authors state that the number of clinically silent ischaemic lesions detected on DWI was much higher than they anticipated. Nevertheless, given the low permanent complication rate, they believe that the flow-diversion technique is safe and effective, and can be used both above and below the circle of Willis. The authors do caution, however, that in cases in which the flow-diverting stent may, of necessity, cover the entrance of an arterial branch, such as can occur in locations above the circle of Willis, the collateral blood supply should be examined carefully to predict whether late-occurring ischaemic micro-lesions may occur.</span><br /><br /></p> <p><span style="font-size: 10pt;">Iosif said: &ldquo;The early appearance of embolic DWI lesions after flow-diverting stents have been placed in intracranial locations in patients receiving appropriate anticoagulation therapy, although very frequent, seems to be free of clinical significance. When considering jailing a side arterial branch, special care should be taken to the competition of flow that may exist in the brain territory supplied by this branch. When an indirect collateral supply is present, due to the pial anastomotic network, the extent of the supply seems to determine whether late-occurring DWI lesions will appear during the jailed branch remodelling process. This study is the first step to understanding the complex haemodynamic mechanisms governing side branch behaviour after insertion of a flow-diverting stent. Further laboratory and clinical research is mandatory to fully elucidate these mechanisms in order to arrive at the point where most consequences of jailing a side branch can be predicted during therapeutic strategy decision-making.&rdquo;</span></p></div> InVivo Therapeutics announces reopening of enrolment for ongoing pilot trial 2015-01-12T16:39:00Z 2015-01-12T16:39:00Z <div id="ImageMain9" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction9" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>InVivo Therapeutics has reopened subject enrolment for the company&rsquo;s <a href="">ongoing pilot trial</a> of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. To date, there have been no reported serious safety events with the study&rsquo;s first subject, and InVivo has been cleared by the Data Safety Monitoring Board (DSMB) to move forward with the study.</strong></span></p> </div><div id="Text19" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">As specified in the study protocol, the DSMB is a committee of independent clinical research experts charged with examining the safety data accumulated during the trial.<br /><br /></span></p> <p><span style="font-size: 10pt;">Mark Perrin, InVivo&rsquo;s chief executive officer, said: &ldquo;Since enrolling the first subject, we have increased the number of clinical sites from three to six, putting us in a much better position to enrol the second subject. Although we cannot predict when subjects will present, we anticipate enrolling our second subject more quickly than our first.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">Perrin continued: &ldquo;As we have already announced, once the second subject is enrolled, the Food and Drug Administration (FDA) will require only 30 days of safety data for that subject, rather than 90 days, before reopening enrolment. Barring any significant safety issues, we anticipate reopening the study for concurrent enrolment of subjects three through five about two months after the second subject is enrolled. In parallel, we are taking full advantage of a previous FDA approval and are making significant progress to increase the number of participating clinical sites up to 20.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">This is the company&rsquo;s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption pilot study has been approved by the FDA and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialisation under a Humanitarian Device Exemption.</span></p></div> PulseRider safe and effective in early USA experience 2015-01-08T16:47:00Z 2015-01-08T16:47:00Z <div id="ImageMain10" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction10" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Initial experience with PulseRider (Pulsar Vascular) has shown the device to be safe and effective as an adjunct in the treatment of bifurcation aneurysms arising at the basilar apex or carotid terminus according to a report of the first three cases in the USA published in the <em><a href="" target="_blank">Journal of NeuroInterventional Surgery</a></em>.</span></strong></p> </div><div id="Text110" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In June of 2014, the US Food and Drug Administration (FDA) approved an investigational device exemption (IDE) for the PulseRider, allowing Pulsar Vascular to begin a multicentre clinical trial in support of a humanitarian device exemption to evaluate the PulseRider for US approval for wide neck aneurysms at or near a bifurcation of the basilar tip or carotid terminus. PulseRider is currently only available in the USA in the context of the Adjunctive neurovascular support of wide-neck aneurysm embolization and reconstruction (ANSWER) clinical trial.</span></p> <p><span style="font-size: 10pt;"><br />The first three cases were done by physicians from the Medical University of South Carolina, Charleston, USA. Alejandro Spiotta <em>et al</em> explain that patients were pretreated the evening before the procedure with clopidogrel and aspirin and then maintained on daily doses thereafter. All cases were performed under general endotracheal anaesthesia. An appropriately sized PulseRider device was deployed across the neck of the aneurysm. A microcatheter was then navigated over a 0.014 inch microwire through the device into the aneurysm. In these first three cases, complete occlusion of the aneurysm was achieved without intraprocedural complications.</span></p> <p><span style="font-size: 10pt;"><br />The authors report: &ldquo;In our early experience we have found [PulseRider&rsquo;s] use to be simple and safe, being readily delivered in a standard method very similar to other available stents, making the procedure more familiar to an operator new to the device.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Confirming the safety and effectiveness of the device in their first experiences, they conclude that the PulseRider &ldquo;represents a useful addition to the armamentarium of the neuroendovascular specialist&rdquo;.</span></p></div> Non-invasive EEG reveals depolarisations 2015-01-08T12:09:00Z 2015-01-08T12:09:00Z <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>New research at the University of Cincinnati Neuroscience Institute has shown that spreading depolarisations can be measured by the placement of electroencephalograph (EEG) electrodes on the scalp. Head of the research team, Jed Hartings (research associated professor, Department of Neurosurgery, University of Cincinnati Neuroscience Institute, USA) speaks to <em>NeuroNews</em> about the discovery and its potential to change current practice.</strong></span></p> </div><div id="Text111" style="clear:both; text-align:left"><p><span style="font-size: 10pt;"><strong>What were the findings of your research? How was it conducted?</strong></span></p> <p><span style="font-size: 10pt;"><br />We know how to identify spreading depolarisations from intracranial EEG recordings, that is, by placing electrodes directly on the brain. In this study, we wanted to know whether these waves could be observed with non-invasive EEG recordings from scalp electrodes. So what we did is combine the techniques &ndash; measure EEG both invasively and non-invasively &ndash; and then compare the non-invasive scalp data with confirmed spreading depolarisations identified invasively.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />What we found, in a series of 18 patients, is that the majority of spreading depolarisations had clear manifestations in the scalp EEG recordings. Typically, the spreading depolarisations were observed as reduced amplitudes of the scalp-recorded brain waves. These depressions developed over about 10 minutes and lasted about 30 minutes before recovery. When spreading depolarisations occurred continuously, repeating every 20-30 minutes, they maintained a continuous suppression of the scalp EEG that could last hours to more than a day.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><strong><br />How will this discovery change current practice? </strong></span></p> <p><span style="font-size: 10pt;"><br />The clinical science of spreading depolarisation is in a relatively early stage of development, but progress in recent years has been solid, and it is accelerating. Evidence increasingly shows that spreading depolarisations, or certain patterns of them, are causally related to development of brain lesions and contribute to poor outcomes. This is a major breakthrough, since there has never been a method to look inside the black box of the injured brain and measure a mechanism of developing damage.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Still, significant advances are needed before this emerging field translates to clinical practice. We need to better understand the clinical significance of different patterns of spreading depolarisations, and we need to make information from monitoring more easily accessible at the bedside. Then there is the big question: what can we do to treat and prevent these events? What is the optimal treatment protocol once they are detected?&nbsp; These questions will take years to answer, and the answers will be refined over decades.&nbsp;&nbsp; &nbsp;</span></p> <p><span style="font-size: 10pt;"><strong><br />How will the placement of EEG electrodes on the scalp work to measure depolarisations?</strong></span></p> <p><span style="font-size: 10pt;"><br />EEG techniques for measuring depolarisations would likely be very similar to current practice. In fact, the EEG recordings in our study were performed using clinically standard techniques. This is one reason it was so surprising to find evidence of spreading depolarisations in our data. The evidence has been there all along. The data just have to be viewed and analysed the right way to recognise these events.</span></p> <p><span style="font-size: 10pt;"><br />To optimise the technique, minor changes to current clinical practice might be necessary. We need to explore, for instance, whether a certain type of electrode picks up these signals better than other types, and modifications to EEG amplifier hardware could also enhance detection. Software for displaying the data would need to be modified to identify spreading depolarisations in real-time at the bedside. We need to be able to view trends in EEG activity over long time periods.&nbsp;</span></p></div><div id="Text211" style="clear:both; text-align:left"><p><span style="font-size: 10pt;"><strong>Why was this discovery not made sooner? How exactly was the discovery made?</strong></span></p> <p><span style="font-size: 10pt;"><br />It is incredible that spreading depolarisations were discovered in 1944 &ndash; 70 years ago - and only now are we learning how to see them in patients with methods that have been used clinically for decades. It is not because depolarisations are uncommon &ndash; they occur in about half of patients with severe brain trauma. Most likely, we did not see them sooner because we were not looking at the data with enough perspective. Customary practice is to analyse brain waves on the scale of seconds. But to see these events, the scale needs to be hours. As an analogy, you could describe a forest by walking through it and focusing on individual leaves, branches, and trees. But you would get a very different picture by describing the flow of terrain &ndash; hilltops, streams, and valleys &ndash; from, say, a satellite view. We are just now learning how to analyse this landscape view of brain activity.&nbsp; &nbsp;&nbsp;&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><strong>What is the next step in the development of non-invasive EEG? Is there currently a device in use or, if not, are there any plans to develop one?</strong></span></p> <p><span style="font-size: 10pt;"><br />Moberg Research, in Ambler, Pennsylvania, USA, is a company that specialises in neurointensive care monitoring and has decades of experience in EEG recordings. They have taken an active interest in spreading depolarisations, and see this as a growth area in clinical neurophysiology. Currently they are developing a new EEG amplifier with advanced features designed to optimise detection of spreading depolarisations. It should be available next year, and we are quite excited about it.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Apart from the hardware, a lot of work still needs to be done in signal processing and data display to develop software that will make all of this information readily available to clinicians at the bedside. We are still at a point where EEG recordings are analysed by specialists off-line to identify these events.&nbsp; That is not very helpful for patients, but I am confident that bedside applications will be a reality in the future. It is a very solvable problem.&nbsp;&nbsp; &nbsp;&nbsp;</span></p></div> Publication demonstrates high accuracy for identification of acute stroke 2015-01-07T11:56:00Z 2015-01-07T11:56:00Z <div id="Introduction12" style="clear:both;"> <p><strong><span style="font-size: 11pt;">BrainScope Company has announced the publication of an independent study that demonstrated the potential clinical utility of its traumatic brain injury technology to identify acute stroke in the hospital Emergency Department setting. The results of this study, &ldquo;Identification of Acute Stroke Using Quantified Brain Electrical Activity&rdquo; were published in the peer-reviewed journal&nbsp;<em>Academic Emergency Medicine</em>&nbsp;authored by investigators from University Hospitals Case Medical Center, New York University School of Medicine, and The Johns Hopkins University School of Medicine, USA.</span></strong></p> </div><div id="Text112" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In this publication, BrainScope&rsquo;s handheld, rapid, easy-to-use, non-invasive, and non-radiation emitting investigational device was used to evaluate potential acute stroke patients in hospital Emergency Departments. BrainScope&rsquo;s proprietary traumatic brain injury algorithms are based on advanced signal processing of brain electrical activity for classification of traumatic brain injury, developed on a large population of head injured patients with mild presentation to the Emergency Department. Using a BrainScope traumatic brain injury algorithm on an independent cohort of stroke patients, this study prospectively demonstrated high sensitivity (92%) for the identification of acute stroke (haemorrhagic and ischaemic).</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Every year, 15 million people worldwide suffer a stroke. Nearly six million die and another five million are left permanently disabled. Stroke is the second leading cause of disability, after dementia. Complicating rapid triage are conditions presenting which clinically mimic stroke. The ability to detect the presence of such injuries non-invasively and without radiation could result in a paradigm shift in the way emergency medicine for stroke is currently practiced,&rdquo; states Edward Michelson, Associate Professor of Medicine and Emergency Medicine, Case Western Reserve University School of Medicine.</span></p> <p><span style="font-size: 10pt;"><br />The study included 48 acute stroke patients presenting to hospital Emergency Departments participating in the study and a control group of patients presenting with stroke-like symptoms (&ldquo;stroke mimics&rdquo;) but who did not experience a stroke. Study sites included: Bellevue Hospital Center, New York; University Hospitals Case Medical Center, Cleveland; William Beaumont Medical Center, Royal Oak; and Washington University, St. Louis, all USA. </span><br /> <br /><span style="font-size: 10pt;"> Sensitivity to stroke was 92%, specificity to stroke mimics was 50% and Negative Predictive Value (NPV) was 94%. Of particular interest was a group of ischaemic stroke patients who were initially negative for stroke on computerised tomography of the head (CT-) but later found to be positive on magnetic resonance imaging (MRI+). Eighty per cent of these CT-/MRI+ ischaemic strokes were correctly identified as positive using the BrainScope traumatic brain injury algorithm at the time the CT scan result was negative. The ability of a classification algorithm based on brain electrical activity to detect CT normal patients who are having ischaemic events may improve triage by increasing the number of treatment-eligible patients at a critical time in the care continuum. Considering that stroke-mimics routinely receive CT scans, the specificity of the traumatic brain injury algorithm suggests it may aid in better allocation of resources and a decrease in unnecessary radiation exposure.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Despite a small population and the use of a classification algorithm derived without the benefit of &lsquo;training&rsquo; it on a population of stroke and stroke mimic patients, this data suggests the potential clinical utility of this technology as an adjunct to acute assessment of stroke,&rdquo; states Leslie Prichep, director of the Quantitative Neurophysiological Brain Research Laboratories and Professor of Psychiatry at the NYU School of Medicine, USA.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;While we as a company have fully focused our development efforts on traumatic brain injury and concussion, this peer-reviewed publication provides initial compelling evidence about the potential for our overall technology platform to assess the existence of stroke shortly after it occurs,&rdquo; says Michael Singer, president and chief executive officer of BrainScope. &ldquo;We are highly encouraged by the results of this study and will continue to look for opportunities to expand our capabilities in stroke, which is of course a substantial worldwide clinical need.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Results from independent clinical studies utilising BrainScope&rsquo;s technology have been published through 15 articles in leading peer-reviewed brain injury and emergency medicine journals such as&nbsp;<em>Journal of Neurotrauma</em>,&nbsp;<em>Brain Injury</em>,&nbsp;<em>Academic Emergency Medicine,</em>&nbsp;<em>The Journal of Head Trauma Rehabilitation</em>&nbsp;and&nbsp;<em>The American Journal of Emergency Medicine.</em></span></p></div> Update regarding coverage of VNS Therapy system in treatment-resistant depression 2015-01-06T11:38:00Z 2015-01-06T11:38:00Z <div id="Introduction13" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Cyberonics has announced the receipt of a decision from the Departmental Appeals Board (DAB) of the Department of Health and Human Services in the USA.</span></strong></p> </div><div id="Text113" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The decision concludes that the record regarding the VNS Therapy System for treatment-resistant depression is complete and adequate to support the 2007 National Coverage Determination (NCD).&nbsp; The Centers for Medicare &amp; Medicaid Services (CMS) concluded in the 2007 NCD that coverage for the treatment-resistant depression indication is not reasonable and necessary. The decision also clarifies that CMS and its contractors will allow coverage of maintenance services - including replacement of the implanted VNS Therapy device upon battery expiration - for beneficiaries who began receiving VNS Therapy prior to May 4, 2007.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;While we acknowledge the importance of clarity for beneficiaries already benefiting from VNS Therapy, we are disappointed with this decision and disagree with the position taken by CMS. We believe that the total body of evidence presents a compelling rationale for access to the VNS Therapy System in a very ill subpopulation of Medicare beneficiaries,&rdquo; says Dan Moore, Cyberonics president and chief executive officer. &ldquo;The company is evaluating options for challenging the DAB decision.&rdquo;</span></p></div> Can exercise help people with Parkinson’s disease? 2015-01-02T11:30:00Z 2015-01-02T11:30:00Z <div id="Introduction14" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Exercise may help people with Parkinson&rsquo;s disease improve their balance, ability to move around and quality of life, even if it does not reduce their risk of falling, according to a new study published in the online issue of&nbsp;<a href="" target="_blank">Neurology</a>, the medical journal of the American Academy of Neurology.</span></strong></p> </div><div id="Text114" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">For the study, 231 people with Parkinson&rsquo;s disease either received their usual care or took part in an exercise programme of 40 to 60 minutes of balance and leg strengthening exercises three times a week for six months. This minimally-supervised exercise programme was prescribed and monitored by a physical therapist with participants performing most of the exercise at home. On average, 13% of the exercise sessions were supervised by a physical therapist.</span></p> <p><span style="font-size: 10pt;"><br />Falling is a common problem for people with Parkinson&rsquo;s, with 60% falling each year and two-thirds of those falling repeatedly. &ldquo;The resulting injuries, pain, limitations of activity and fear of falling again can really affect people&rsquo;s health and well-being,&rdquo; says study author Colleen G Canning of the University of Sydney in Australia.</span></p> <p><span style="font-size: 10pt;"><br />Compared to those in the control group, the number of falls by participants who exercised was reduced in those with less severe Parkinson&rsquo;s disease, but not in those with more severe disease. For those with less severe disease a 70% reduction in falls was reported in those who exercised compared to those who did not.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;These results suggest that minimally supervised exercise programmes aimed at reducing falls in people with Parkinson&rsquo;s should be started early in the disease process,&rdquo; Canning says.</span></p> <p><span style="font-size: 10pt;"><br />Overall, those who took part in the exercise programme performed better on tests of ability to move around and balance, had a lower fear of falls and reported better overall mood and quality of life.</span></p> <p><span style="font-size: 10pt;"><br />The study was supported by the Australian National Health and Medical Research Council and the Harry Secomb Foundation.</span></p></div> Stem cell transplants for Parkinson’s disease edging closer 2015-01-02T11:21:00Z 2015-01-02T11:21:00Z <div id="Introduction15" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A major breakthrough in the development of stem cell-derived brain cells has put researchers on a firm path towards the first ever stem cell transplantations in people with Parkinson&rsquo;s disease. A new study presents the next generation of transplantable dopamine neurons produced from stem cells. These cells carry the same properties as the dopamine neurons found in the human brain.</strong></span></p> </div><div id="Text115" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The experiments, performed in rat models of Parkinson&rsquo;s disease, reveal that the latest version of stem cell-derived dopamine cells fully mimic the characteristics and function of the dopamine neurons that are lost in Parkinson&rsquo;s disease. The potentially unlimited supply of transplantable cells, sourced from stem cell lines, opens the door to clinical application on a much broader scale. The results are published in the leading journal in the field,&nbsp;<a href="" target="_blank">Cell Stem Cell</a>.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This study shows that we can now produce fully functioning dopamine neurons from stem cells. These cells have the same ability as the brain&rsquo;s normal dopamine cells to not only reach but also to connect to their target area over longer distances. This has been our goal for some time, and the next step is to produce the same cells under the necessary regulations for human use. Our hope is that they are ready for clinical studies in about three years,&rdquo; says Malin Parmar, who led the study conducted at Lund University and at MIRCen in Paris as part of the EU networks NeuroStemCell and NeuroStemcellRepair.</span></p> <p><span style="font-size: 10pt;"><br />Brain cell transplants with foetal dopamine cells obtained from human embryos have already been performed on a few occasions, with varying results. In the past decade, the EU network TRANSEURO has been working hard to get a new and improved trial underway. That moment is now here. In the coming months a small number of patients will be transplanted with foetal cells in Lund, Sweden and Cambridge, UK.</span></p> <p><span style="font-size: 10pt;"><br />The foetal dopamine cells that will be used within TRANSEURO, however, carry some restrictions. Firstly, there is the ethical concern of taking tissue from aborted foetuses. There is also the issue of availability of foetal cells, which is often scarce. The logistics surrounding the gathering of cells for any specific transplantation is partly down to luck and circumstance. These concerns will be resolved as the stem cell-derived dopamine cells become available in the clinic, making the treatment accessible for larger patient groups.</span></p> <p><span style="font-size: 10pt;"><br />The collaborative efforts within EU networks NeuroStemcellRepair and TRANSEURO have put cell therapy on a faster track towards reaching patients. Getting stem cells to become functioning dopamine neurons, the method of delivering them to a specific target, and learning how to get them to integrate in the brain, are all extremely complicated processes. The sharing of ideas and data has been integral to the success of these networks, explains Professor Elena Cattaneo, coordinator for NeuroStemcellRepair.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Collaborative research of this nature is so much more than the results it produces, especially if we consider its potential for expanding the boundaries of knowledge and dissolving cultural barriers. From this perspective, basic research and collaboration among nations stand out once more as something the scientific community should never distance itself from.&rdquo;</span></p></div> Stroke falls to No. 5 cause of death in USA 2014-12-31T11:11:00Z 2014-12-31T11:11:00Z <div id="Introduction16" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Stroke&nbsp;has dropped from the USA&rsquo;s fourth-leading cause of death to No. 5, according to new federal statistics. It is the second time since 2011 that stroke has dropped a spot in the mortality rankings.</strong></span></p> </div><div id="Text116" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to the&nbsp;Centers for Disease Control and Prevention report released recently, stroke swapped positions with unintentional injuries, which killed 1,579 more people than stroke in 2013.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The fact that the&nbsp;death rate&nbsp;is declining from this terrible and devastating disease is gratifying news,&rdquo; says American Heart Association president Elliott Antman. &ldquo;These statistics are a tribute to the many courageous survivors, healthcare professionals, researchers, volunteers and everyone else committed to fighting stroke.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Still, far too many people are still dying from stroke, and too many people are suffering greatly from this disease,&rdquo; says Antman, a professor of medicine and Associate Dean for Clinical/Translational Research at Harvard Medical School and a senior physician in the Cardiovascular Division of the Brigham and Women&rsquo;s Hospital in Boston, USA.</span></p> <p><span style="font-size: 10pt;"><br />The stroke death rate dropped slightly, from 36.9% in 2012 to 36.2% in 2013. While the death rate from heart disease dropped somewhat between 2012 and 2013, it remains the No. 1 cause of death in the nation. Cancer is the second-leading cause of death, followed by chronic lower respiratory diseases.</span></p> <p><span style="font-size: 10pt;"><br />The decline in stroke deaths may be due in part to improvements in&nbsp;treatment&nbsp;and&nbsp;prevention, says Ralph Sacco, past president of the American Heart Association and chairman of neurology at the University of Miami Miller School of Medicine.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;There are more&nbsp;stroke centres&nbsp;now operating in the USA, and the acute care of stroke is improving,&rdquo; says Sacco, who in 2010 became the first neurologist to be named American Heart Association president. &ldquo;However, although mortality from stroke is dropping, we know that the number of people having strokes in the USA is rising each year due to the aging of our population and other signs that strokes have increased in younger groups.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Indeed, despite the lower death rate, 432 more people died from stroke in 2013 than in 2012, the report found.</span></p> <p><span style="font-size: 10pt;">Stroke also remains a leading cause of disability in the USA. In fact, the number of people having strokes &ndash; often with painful and debilitating after-effects &ndash; remains a major cause of concern. &ldquo;Stroke is more disabling than it is fatal,&rdquo; says Sacco.</span></p> <p><span style="font-size: 10pt;"><br />And that is why the American Heart Association remains committed to working with survivors, chief executive officer Nancy Brown says.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;There is a great deal to be done on behalf of stroke survivors, who very often face highly debilitating consequences in the aftermath of this severe cardiovascular event,&rdquo; she says. &ldquo;We are committed to standing by their side as we continue striving for new breakthroughs in stroke prevention, treatment and rehabilitation.&rdquo;</span></p></div> NeuroMetrix to showcase Quell wearable pain relief technology 2014-12-30T12:31:00Z 2014-12-30T12:31:00Z <div id="ImageMain17" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction17" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroMetrix will unveil and demonstrate Quell, a novel wearable pain relief device at the 2015 International Consumer Electronics show (CES) 6-9 January in Las Vegas, USA. NeuroMetrix will also be one of an exclusive group that will participate in CES Unveiled, the official press event of CES.</strong></span></p> </div><div id="Text117" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Quell utilises NeuroMetrix&rsquo;s proprietary non-invasive neurostimulation technology to provide relief from chronic pain, such as due to diabetes, sciatica, fibromyalgia, and degenerative knee conditions. The advanced wearable device is lightweight and can be worn during the day while active, and at night while sleeping. It has been cleared by the FDA for treatment of chronic pain without a prescription. Users of the device will also have the option of using their smartphone to automatically track and personalize their pain therapy. The company expects Quell to be available for purchase by consumers in the second quarter of 2015.</span></p></div> Stem cell transplants may halt progression of multiple sclerosis 2014-12-30T11:02:00Z 2014-12-30T11:02:00Z <div id="ImageMain18" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction18" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Three-year outcomes from an ongoing clinical trial suggest that high-dose immunosuppressive therapy followed by transplantation of a person&rsquo;s own blood-forming stem cells may induce sustained remission in some people with relapsing-remitting multiple sclerosis (RRMS). The trial is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and conducted by the NIAID-funded&nbsp;Immune Tolerance Network (ITN).</strong></span></p> </div><div id="Text118" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Three years after the treatment, called high-dose immunosuppressive therapy and autologous hematopoietic cell transplant or HDIT/HCT, nearly 80% of trial participants had survived without experiencing an increase in disability, a relapse of MS symptoms or new brain lesions. Investigators observed few serious early complications or unexpected side effects, although many participants experienced expected side effects of high-dose immunosuppression, including infections and gastrointestinal problems. The three-year findings are published in the 29 December 2014, online issue of <em><a href="" target="_blank">JAMA Neurology</a></em>.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These promising results support the need for future studies to further evaluate the benefits and risks of HDIT/HCT and directly compare this treatment strategy to current MS therapies,&rdquo; says NIAID director Anthony S Fauci. &ldquo;If the findings from this study are confirmed, HDIT/HCT may become a potential therapeutic option for people with this often-debilitating disease, particularly those who have not been helped by standard treatments.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">In the study, researchers tested the effectiveness of HDIT/HCT in 25 volunteers with RRMS who had relapsed and experienced worsened neurological disability while taking standard medications. Doctors collected blood-forming stem cells from participants and then gave them high-dose chemotherapy to destroy their immune systems. The doctors returned the stem cells to the participants to rebuild and reset their immune systems.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Notably, participants did not receive any MS drugs after transplant, yet most remained in remission after three years,&rdquo; says Daniel Rotrosen, director of NIAID&rsquo;s Division of Allergy, Immunology and Transplantation. &ldquo;In contrast, other studies have shown that the best alternative MS treatments induce much shorter remissions and require long-term use of immunosuppressive drugs that can cause serious side effects.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The study researchers plan to follow participants for a total of five years, recording all side effects associated with the treatment. Final results from this and similar studies promise to help inform the design of larger trials to further evaluate HDIT/HCT in people with MS.</span></p> <p><br /><span style="font-size: 10pt;">The work was sponsored by NIAID, NIH, and conducted by the ITN (contract number N01 AI015416) and NIAID-funded statistical and clinical coordinating centres (contract numbers HHSN272200800029C and HHSN272200900057C). The identifier for the study High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT-MS) is&nbsp;<a href="">NCT00288626</a>.</span></p></div> Longer cooling, lower temperature no improvement for infant oxygen deprivation 2014-12-24T12:03:00Z 2014-12-24T12:03:00Z <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>The standard treatment for newborns whose brains were deprived of oxygen appears to work better than proposed alternatives, according to a study from a National Institutes of Health research network. The standard treatment involves lowering an infant&rsquo;s body temperature by about six degrees Fahrenheit for 72 hours. Attempts to improve on this treatment by further lowering body temperature or increasing the duration of cooling were of no additional benefit, the researchers concluded.</strong></span></p> </div><div id="Text119" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Oxygen deprivation&nbsp;before, during, and just after birth may result from a number of causes, including compression of the umbilical cord, loss of blood from a tear in the placenta or a tear in the womb.&nbsp;A previous study&nbsp;found that lowering an infant&rsquo;s body temperature after oxygen deprivation could reduce the risk of death or disability.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Preliminary studies in animals suggested that lowering body temperature and increasing the duration of cooling might provide additional benefits,&rdquo; says study author Rosemary Higgins, programme scientist for the&nbsp;Eunice Kennedy Shriver National Institute of Child Health and Human Development&rsquo;s&nbsp;Neonatal Research Network, which conducted the study. &ldquo;Although the results are disappointing, they do show the need to test any modification of a treatment &mdash; no matter how promising it may appear &mdash; before putting it into practice.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Support for the study also was provided by NIH&rsquo;s National Center for Advancing Translational Sciences, and was published in the <em>Journal of the American Medical Association</em>.</span></p> <p><span style="font-size: 10pt;"><br />Oxygen deprivation in newborns, also known as neonatal hypoxic-ischaemic encephalopathy (HIE), is estimated to occur in 1 to 2 of every 1,000 live births in the developed world, according to the World Health Organisation. Survivors may develop long-term disabilities, such as&nbsp;intellectual impairment&nbsp;or&nbsp;cerebral palsy.</span></p> <p><span style="font-size: 10pt;"><br />Infants assessed as having HIE were randomly assigned to one of four treatments:</span></p> <ul> <li><span style="font-size: 10pt;">Lowering body temperature to 92.3 degrees for three days (the standard treatment)</span></li> <li><span style="font-size: 10pt;">92.3 degrees for five days</span></li> <li><span style="font-size: 10pt;">89.6 degrees for three days</span></li> <li><span style="font-size: 10pt;">89.6 degrees for five days</span></li> </ul> <p><span style="font-size: 10pt;">The current study was confined to the time period that the infants spent in the hospital.</span><br /><span style="font-size: 10pt;"> <br />The researchers are observing the children as they grow and will report disability rates in a subsequent publication.</span></p> <p><span style="font-size: 10pt;"><br />Although the differences in survival rates between the groups were not great enough to be statistically significant, infants receiving the standard treatment had a slightly higher survival rate than did the infants in the other groups. Only 7% of infants receiving the standard treatment died.</span></p> <p><span style="font-size: 10pt;"><br />The researchers noted that survival rates for infants in all the groups in the current study were higher than the survival rate for the cooled infants in the original study showing that cooling could benefit infants would HIE. That study, published in 2005, established newborn cooling as&nbsp;the standard treatment&nbsp;for HIE. In that study, 19% percent of the cooled infants died &mdash; an improvement in the survival rate compared to the then-standard treatment.</span></p> <p><span style="font-size: 10pt;"><br />The researchers are not sure why the death rate was so much lower in the current study than in the original study. It is possible that the increase in survival may be due to overall improvements in newborn care in the last decade, Shankaran says.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Our study indicates that physicians won&rsquo;t get a better outcome by making infants a little bit cooler for a little bit longer,&rdquo; Higgins says.</span></p> <p><span style="font-size: 10pt;"><br />The researchers&rsquo; had planned to enrol 726 infants into the study. However, an independent committee that was monitoring the data undertook a statistical analysis indicating that there was less than a 2% chance of finding a benefit to longer or deeper cooling. Taking this analysis into consideration, along with the slightly higher survival rate of infants receiving the standard treatment, the researchers ended the study after only 364 infants had been enrolled.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;It looked like it would not be worth continuing the study, because the likelihood of benefit appeared to be really very low,&rdquo; says the study&rsquo;s first author, Seetha Shankaran of the Children&rsquo;s Hospital of Michigan in Detroit, USA.</span></p></div> Alcyone Lifesciences appoints Michael Rogawski to Clinical and Scientific Advisory Board 2014-12-24T11:25:00Z 2014-12-24T11:25:00Z <div id="Introduction20" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Alcyone Lifesciences has announced the appointment of Michael Rogawski of the University of California, Davis, USA to its clinical and scientific advisory board.</strong></span></p> </div><div id="Text120" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Throughout his career, Rogawski has been in the forefront of bringing novel and effective treatment for hard to treat seizures and epilepsy,&rdquo; says PJ Anand, founder and chief executive officer, Alcyone Lifesciences. &ldquo;His research continues to drive significant advancement in the field and we look forward to his contribution to Alcyone.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Alcyone&rsquo;s technology platform is unique in that it has the potential to significantly improve certain seizure and epileptic conditions and offer new possibilities to help patients with this debilitating condition. I am looking forward to working with the talented Alcyone team,&rdquo; says Rogawski.</span></p> <p><span style="font-size: 10pt;"><br />Rogawski is an internationally recognised expert on treatments for seizures and epilepsy. He is currently professor of neurology and member of the Center for Neuroscience at the University of California, Davis. Until 2006, he was senior investigator and chief of the Epilepsy Research Section at the National Institute of Neurological Disorders and Stroke. Rogawski&rsquo;s research encompasses cellular neurophysiological studies of ion channels and animal seizure models. He was the first to investigate convection-enhanced delivery of anti-seizure agents in the treatment of epilepsy. In recognition of his research contributions, Rogawski received the NIH Director&rsquo;s Award and the Epilepsy Research Award from the American Society for Pharmacology and Experimental Therapeutics. He presented the William G Lennox Lecture of the American Epilepsy Society. <br /><br />Rogawski received his bachelor&rsquo;s degree in biophysics from Amherst College, and MD and PhD in pharmacology from Yale. After serving as a postdoctoral fellow in the Laboratory of Neurophysiology at NINDS, he completed residency training in neurology at Johns Hopkins.</span></p></div> Seventy-one teams to compete in NIH Neuro Startup Challenge 2014-12-24T11:17:00Z 2014-12-24T11:17:00Z <div id="ImageMain21" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction21" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>More than 70 teams composed of 568 students and entrepreneurs have been accepted to compete in the&nbsp;<a href="">Neuro Startup Challenge</a>,&nbsp;an open innovation competition designed to bring promising brain-related inventions to market. The challenge has teams competing&nbsp;to commercialise 16 National Institutes of Health-conceived and -developed inventions&nbsp;involving&nbsp;therapeutics, diagnostics, prognostics, and medical devices for a range of brain diseases.</strong></span></p> </div><div id="Text121" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;We are thrilled about the high quality teams from 96 universities that have entered the challenge,&rdquo; says Richard Merkin, founder and chief executive officer of the Heritage Provider Network (HPN). In addition to post-docs, PhDs, law and business students, team leaders have added venture capitalists, clinical research outsourcing organisations, law firms and serial entrepreneurs on their teams to increase their probability of success. Each team required a seasoned entrepreneur as well as two graduate students.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The challenge was launched in August 2014 by HPN&nbsp;in collaboration with&nbsp;NIH&nbsp;and the&nbsp;Center for Advancing Innovation.&nbsp;The teams selected to come into the challenge are from universities, research institutes, and hospitals from the United States and abroad. More than 20% of the teams are from outside the USA. In addition to deliverables due at the end of each of the three phases of the challenge, teams will participate in 40 rigorous, entrepreneurship and start-up training sessions.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The first phase of the challenge requires the teams to develop elevator speeches, a 350-word executive summary outlining potential commercial products and a company vision. These products will be posted on public voting website from 12-16 January, 2015, to be voted upon by the public.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Winners of the elevator speech phase will move on to compete in the second phase of the competition in which teams will develop a 10-page business plan and 20-minute &ldquo;live&rdquo; pitch presented to a panel of judges. Winners of the business plan phase will receive US$2,500 per team provided by the Heritage Provider Network, and will move on to phase three of the competition, the start-up phase. The start-up phase requires the remaining teams to launch their start-ups, including incorporating their business, applying for licenses, and raise seed funding.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This is an excellent model for commercialising NIH technologies, while also providing real-world, hands-on experience in creating start-up businesses to all of the Challenge participants and creating the next generation of entrepreneurs,&rdquo; says Joseph M Conrad III, NCI Technology Transfer Specialist and NIH Coordinator for the Neuro Startup Challenge.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Center for Advancing Innovation (CAI) evaluated the teams who wanted to enter the challenge on more than 40 criteria.&nbsp;&ldquo;We wanted the teams that were accepted into the challenge to look like successful start-ups; therefore we rigorously evaluated the teams based on criteria that VCs, foundations and others would use to provide funding,&rdquo; says Rosemarie Truman, founder and chief executive officer of CAI. &ldquo;Based on the extraordinary effort the teams have devoted so far, I expect novel, creative and differentiating approaches to the elevator speech phase and invite people who have an interest neuroscience to vote and provide constructive feedback.&rdquo;&nbsp;</span></p></div> CHMP recommends approval of Xadago to treat Parkinson’s disease in the EU 2014-12-19T11:37:00Z 2014-12-19T11:37:00Z <div id="Introduction22" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Newron Pharmaceuticals and its partner Zambon has announced that the EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve the use of Xadago (safinamide) as add-on to L-dopa alone or in combination with dopamine agonists, entacapone, amantadine, and/or anticholinergics, for the treatment of patients with mid-late stage Parkinson&rsquo;s disease experiencing motor fluctuations despite being stabilised on &lsquo;Standard of Care&rsquo;.</strong></span></p> </div><div id="Text122" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">C Warren Olanow, Henry P and Georgette Goldschmidt, professor and chairman Emeritus of the Department of Neurology and Professor of Neuroscience at the Mount Sinai School of Medicine, states: &ldquo;Safinamide is the first NCE to be approved for the treatment of Parkinson&rsquo;s disease in the past 10 years. In a two year double blind study, the product demonstrated rapid onset of efficacy (within two weeks) and benefit with respect to improvements in &lsquo;ON and OFF Time&rsquo; without an increase in dyskinesia. This was maintained for the two year duration of the trial when used as an add-on treatment to Parkinson&rsquo;s disease patients with L-dopa-induced motor fluctuations, compared with Standard of Care. No other agent has demonstrated this duration of benefit in a double blind trial.</span></p> <p><span style="font-size: 10pt;"><br />Safinamide&rsquo;s effects are dependent upon pharmacological mechanisms that are not shared with other Parkinson&rsquo;s disease drugs. These effects include its dual mechanism of highly selective, reversible inhibition of MAO-B, and state and use-dependent blockade of sodium channels that inhibit glutamate release, implicated in causing dyskinesia. Preclinical experiments and data from a large number of dyskinetic patients enrolled in a placebo controlled clinical study indicate that safinamide also has the potential to improve L-dopa induced dyskinesia in Parkinson&rsquo;s disease patients.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Fabrizio Stocchi, professor of Neurology, director of the Parkinson&rsquo;s Disease and Movement Disorders Research Centre, and Institute for Research and Medical Care IRCCS San Raffaele, Rome, who has been involved with safinamide trials from the beginning, says: &ldquo;The benefits of safinamide were demonstrated as adjunctive treatment for fluctuating patients on top of L-dopa alone or in combination with other Parkinson&rsquo;s disease medications. Safinamide demonstrated significantly improved motor fluctuations, Parkinsonism, Quality of Life and Activities of Daily Living without any increase in &lsquo;ON Time with troublesome dyskinesia&rsquo;.</span></p> <p><span style="font-size: 10pt;"><br />My experience in treating Parkinson&rsquo;s disease patients with safinamide in Rome over the last 10 years, as well as my review of all the data indicate that safinamide is extremely well tolerated even over long periods of time. Safinamide does not require any specific medical monitoring, dietary restrictions, or particular precautions because the risk of drug interactions is very low.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The CHMP&rsquo;s positive opinion on Xadagowill now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The final decision will be applicable to all 28 European Union member countries, as well as Iceland, Liechtenstein and Norway.</span></p> <p><span style="font-size: 10pt;"><br />The EU filing was based on results of a comprehensive development programme comprising over 300 preclinical studies and 37 clinical studies performed in over 30 countries worldwide, with over 3,000 subjects treated, and safinamide&rsquo;s safety being documented in &gt;1,100 patients for one year, &gt;500 patients for two years, &gt;220 patients for &gt;three years, and &gt;160 patients for four years.</span></p></div> MR CLEAN: Better outcomes with intervention in ischaemic stroke patients 2014-12-18T10:00:00Z 2014-12-18T10:00:00Z <div id="ImageMain23" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction23" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>For the first time, the Multicentre randomised clinical trial of endovascular treatment for acute ischaemic stroke in the Netherlands (MR CLEAN) has shown better outcomes in favour of intervention in patients with acute ischaemic stroke.</strong></span></p> </div><div id="Text123" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The long-awaited study was released online by the <em>New England Journal of Medicine (NEJM)</em> yesterday. MR CLEAN, a pragmatic, phase 3 clinical trial, compared intra-arterial treatment (intra-arterial thrombolysis, mechanical treatment, or both) plus usual care (which could include intravenous administration of alteplase) with usual care alone (control group) in patients with acute ischaemic stroke and a proximal intracranial arterial occlusion of the anterior circulation that was confirmed on vessel imaging.</span><br /><br /></p> <p><span style="font-size: 10pt;">Study authors, Diederik Dippel <em>et al</em>, report that between December 2010 and March 2014, 500 patients with acute ischaemic stroke caused by an intracranial occlusion in the anterior circulation artery were randomised in 16 Dutch centres. Initiation of intra-arterial treatment had to be possible within six hours after stroke onset. Eligible patients had an occlusion of the distal intracranial carotid artery (M1 or M2), or anterior cerebral artery (A1 0r A2), established with computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital-subtraction angiography (DSA), and a score of 2 or higher on the National Institutes of Health Stroke Scale (NIHSS). All patients underwent clinical assessment at baseline, after 24 hours, and at five to seven days or at discharge if earlier.</span><br /><br /></p> <p><span style="font-size: 10pt;">According to the study, 233 patients (46.6%) were assigned to the intervention group and 267 patients (53.4%) were assigned to the control group. Actual intra-arterial therapy (with or without mechanical thrombectomy) was performed in 196 of the 233 patients in the intervention group. Mechanical treatment was performed in 195 of the 233 patients. Retrievable stents were used in 190 patients (81.5%), and other devices were used in five patients. Additional intra-arterial thrombolytic agents were given to 24 patients. Intra-arterial thrombolytic agents were used as monotherapy in one of the 233 patients. No intervention was given in 37 patients.</span><br /><br /></p> <p><span style="font-size: 10pt;">The authors report that the results show a shift in the distribution of the primary-outcome scores in favour of the intervention. &ldquo;The shift toward better outcomes in favour of the intervention was consistent for all categories of the modified Rankin scale, except death. The absolute between-group difference in the proportion of patients who were functionally independent (modified Rankin score, 0 to 2) was 13.5 percentage points (95% CI, 5.9 to 21.2) in favour of the intervention (32.6% vs. 19.1%), with an adjusted odds ratio of 2.16 (95% CI, 1.39 to 3.38).&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">In terms of secondary outcomes, the results show that intervention was also more favourable: &ldquo;The NIHSS score after five to seven days was, on average, 2.9 points lower in the intervention group than the control group.&rdquo; Additionally, an absence of residual occlusion at the target site was more common in the intervention group than in the control group.&rdquo;</span></p></div><div id="Text223" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Dippel <em>et al</em> conclude, &ldquo;Our results show that patients with acute ischaemic stroke caused by a proximal intracranial arterial occlusion of the anterior circulation have a benefit with respect to functional recovery when intra-arterial treatment is administered within six hours after stroke onset. This treatment leads to a clinically significant increase in functional independence in daily life by three months, without an increase in mortality. Our findings stand in clear distinction to those of recent randomised, controlled trials that failed to show a benefit of intra-arterial treatment.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Comparing this study to the Interventional management of stroke III trial (IMS III), the authors say that the cohort is similar to IMS III, in which intravenous alteplase alone was compared with intravenous altepase plus intra-arterial treatment. They say, &ldquo;Approximately 90% of patients in each treatment group of MR CLEAN received intravenous alteplase; however, in the IMS III trial, patients had to be enrolled and undergo randomisation within 40 minutes after the start of intravenous alteplase. This requirement may have led to the inclusion of more patients who had a favourable response to intravenous alteplase than in MR CLEAN, which had a median time from the start of intravenous alteplase to randomisation that was considerably longer than the maximum time in the IMS III trial. It is likely that intra-arterial treatment will not alter the natural history of acute ischaemic stroke in the absence of a proximal arterial occlusion&hellip;. Our study benefited from the widespread availability of retrievable stents, which were used in 82% of the patients in the intervention group. These devices were recently shown to be superior to the first-generation Merci device for both revascularisation and clinical outcomes.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Commenting on the results, Dippel told <em>NeuroNews</em> that going forward, &ldquo;the challenge for the future will be to identify all patients who are eligible for this treatment: those with an occlusion who can be treated within six hours, and transfer them quickly to an intervention centre.&rdquo;</span></p></div> Brainlab multiple metastases planning software available in the USA 2014-12-18T09:30:00Z 2014-12-18T09:30:00Z <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>Brainlab has announced 510(k) clearance for two software modules for radiation oncologists and neurosurgeons. Adaptive Hybrid Surgery and Automatic Brain Metastases Planning software by Brainlab are now available in the USA after successful clinical use in several international markets.</strong></span></p> </div><div id="Text124" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Brainlab&rsquo;s Adaptive Hybrid Surgery helps physicians to balance surgical risk with radiosurgical toxicity for multi-disciplinary treatment of skull-base tumours. A complete set of automated tools enables analysis of adjuvant radiosurgery at any time, while planning and performing a surgical resection. Elements Intraoperative Structure Update captures residual tumour volumes based on points acquired inside the resection cavity. An intuitive traffic light display provides comprehensive information about tumour coverage and critical dose constraints for calculated treatment plans.</span><br /><br /></p> <p><span style="font-size: 10pt;">The Automatic Brain Metastasis Planning software introduces the market to technology that consistently and rapidly generates radiosurgery plans for the efficient treatment of multiple metastases. This breakthrough technology allows clinicians to plan and treat multiple brain metastases with time and dose efficiencies while helping to minimise exposure to healthy surrounding tissue. Treatment delivery and planning time can be reduced drastically, even for as many as 10 metastatic tumours in the brain.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We expect [our new software&rsquo;s] capabilities, efficiency and usability to help change the way certain life-threatening diseases are treated,&rdquo; comments Stefan Vilsmeier, president and chief executive officer of Brainlab.</span></p></div> American Academy of Neurology calls for more research on medical marijuana for brain diseases 2014-12-18T09:00:00Z 2014-12-18T09:00:00Z <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>The American Academy of Neurology (AAN) is calling for more research on the use of medical marijuana for brain, spine and nervous system disorders.</strong></span></p> </div><div id="Text125" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The current medical marijuana legislation being passed by policymakers across the country, which promotes marijuana-based products as treatment options for various brain and nervous system disorders, is not supported by high-level medical research,&rdquo; says position statement author Anup Patel, with Nationwide Children&rsquo;s Hospital in Columbus, Ohio, and a member of the AAN. &ldquo;There may be some safety concerns for marijuana-based products, especially for long-term use in patients with these diseases, as to date it has not been well-studied.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The AAN supports the reclassification of marijuana-based products by the federal government from their current status as a Schedule I drug to improve access for study of marijuana or cannabinoids under approved research protocols.</span><br /><br /></p> <p><span style="font-size: 10pt;">The AAN does not advocate for the legalisation of marijuana-based products for use in brain and nervous system disorders at this time, Patel states, as further research is needed to determine the benefits and safety of such products. This is especially important in the cases of people with underlying brain disorders and in children whose developing brains may be more vulnerable to the toxic effects of marijuana, according to the position statement.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We recognise that there may be potential use for these agents in the treatment of some brain and nervous system disorders, but there is not sufficient evidence to make any definitive conclusions regarding the effectiveness of marijuana-based products for many neurologic conditions at this time,&rdquo; Patel says.</span><br /><br /></p> <p><span style="font-size: 10pt;">In March 2014, the AAN published a guideline on complementary alternative therapies, such as medical marijuana, to treat multiple sclerosis.&nbsp;In April 2014, the AAN published a systematic review on the efficacy and safety of medical marijuana in selected brain and nervous system disorders, such as epilepsy, Parkinson&rsquo;s disease, multiple sclerosis and Tourette syndrome.</span></p> <p><span style="font-size: 10pt;">The position statement also notes that many cannabis preparations used in studies are not available in the USA. &ldquo;It is not appropriate to extrapolate the results of trials of standardised preparations to other, non-standardised, non-regulated cannabis products that may be commercially available in states with laws supporting the use of medical marijuana,&rdquo; Patel comments.</span></p></div> Cyberonics reports positive results from AspireSR generator vagus nerve stimulation studies 2014-12-17T15:36:00Z 2014-12-17T15:36:00Z <div id="Introduction26" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Cyberonics announced new results from two multi-site clinical studies of the AspireSR generator, <a href=";rank=1">E-36</a> and <a href=";rank=1">E-37</a>, at the American Epilepsy Society Annual Meeting (AES; 5&ndash;9 December, Seattle, USA).&nbsp;</strong></span></p> </div><div id="Text126" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Investigators presented results from the European E-36 study and the US E-37 study, which assessed the acute impact of the AspireSR generator on seizure duration and termination, as well as the long-term evaluation of safety, clinical benefit of the automatic stimulation feature, and quality of life. Assessments of seizure severity and quality of life were made using validated scales scored by patients, and physicians.</span><br /><br /></p> <p><span style="font-size: 10pt;">The acute impact of the AspireSR generator on seizure duration and termination was evaluated during the Epilepsy Monitoring Unit stay period experienced by all patients in both studies. Seizure activity was recorded using concurrent video-electroencephalography (EEG) and electrocardiogram (ECG) monitoring. Patients in both studies experienced termination of seizures as well as reduced seizure duration during automatic stimulation compared to historical controls.</span><br /><br /></p> <p><span style="font-size: 10pt;">During three- and six-month follow-up, patients in both studies experienced clinically significant reduction in several key components of seizure activity compared to baseline, including overall seizure severity, movements that could result in harm, and various aspects of post-ictal recovery.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These clinical results show that the AspireSR vagus nerve stimulation (VNS) therapy system is safe and effective for detecting and reducing the burden of seizures in patients with drug-resistant epilepsy,&rdquo; says Paul A J M Boon, professor and chairman of the Department of Neurology and director, Institute for Neuroscience, Ghent University Hospital. &ldquo;The AspireSR generator shows a similar clinical benefit to the manual magnet-activated stimulation provided by the existing VNS therapy systems, but with added convenience to both the patient and caregiver.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;More than 60% of patients receiving VNS therapy report benefits from manual magnet activation, yet not all patients can use this feature during a seizure as the result of the disabling effects of the seizure, cognitive impairment, seizures that occur during sleep, or seizures that occur without an aura,&rdquo; adds Robert Fisher, director of the Stanford Epilepsy Center, Palo Alto, USA. &ldquo;The AspireSR generator delivers programmed VNS therapy with the addition of automatic stimulation based upon the increased heart rate that accompanies many seizures. This feature can provide the acute stimulation benefit to more patients with drug-resistant epilepsy.&rdquo;<br /><br />The AspireSR generator is investigational in the USA and not approved for commercial use. The device has attained the CE mark and is&nbsp;available in an increasing number of European countries.<br /></span></p></div> Stroke treatment in England varies widely by location 2014-12-17T11:08:00Z 2014-12-17T11:08:00Z <div id="ImageMain27" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction27" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>New figures released by the Health and Social Care Information Centre (HSCIC) show that the treatment of stroke patients in England varies widely depending on where patients live.</strong></span></p> </div><div id="Text127" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Of the 68,800 patients admitted to hospital with stroke during 2013-14, 41,200 (60%) were admitted to an acute stroke unit within four hours of arrival at hospital. This figure varied by clinical commissioning group (CCG), from 22% of patients in NHS Wyre Forest CCG to 85% of patients in NHS Hillingdon CCG.</span></p> <p><br /><span style="font-size: 10pt;">In 71 of the 2,114 CCGs across the country, less than 55% of patients were admitted to a stroke unit within four hours of admission to hospital and in 13 CCGs, this figure was less than 40%. No CCGs were able to ensure that 90% or more of their patients were admitted to a stroke unit within four hours of admission to hospital.</span></p> <p><br /><span style="font-size: 10pt;">The report, &ldquo;<a href="">CCG Outcomes Indicator Set, December 2014</a>&rdquo;, shows two further indicators which examine stroke at CCG level &ndash; people who have had an acute stroke who receive thrombolysis and people who have had an acute stroke who spend 90% or more of their hospital stay on a stroke unit.</span></p> <p><br /><span style="font-size: 10pt;">The report also shows that in 2013-14:</span></p> <ul> <li><span style="font-size: 10pt;">Nationally, 84% of people spent 90% or more of their stay on a stroke unit and this was exceeded in more than half of CCGs (53%)</span></li> <li><span style="font-size: 10pt;">In three CCGs, less than 70% of patients spent 90% or more of their stay on a stroke unit</span></li> <li><span style="font-size: 10pt;">NHS Corby CCG had the lowest rate of stroke patients spending 90% or more of their stay on a stroke unit (66%), whereas NHS Ealing CCG had the highest rate (95%).</span></li> </ul> <p><span style="font-size: 10pt;">HSCIC chair, Kingsley Manning, says: &ldquo;It is important that patients suffering a stroke receive appropriate care as soon as possible. I am sure health professionals and those responsible for delivering care for stroke patients will use this report to identify how improvements in treatment can be made, such as how quickly patients are admitted to a stroke unit.&rdquo;</span></p></div> First trial of oral anticoagulant to prevent recurrent stroke due to a blood clot of undetermined source 2014-12-15T11:36:00Z 2014-12-15T11:36:00Z <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>The first patient has been enrolled in the <a href="">RE-SPECT ESUS</a> phase III study to investigate the efficacy and safety of dabigatran etexilate (Boehringer Ingelheim) for the prevention of recurrent embolic stroke of undetermined source (ESUS). <a href="">RE-SPECT ESUS</a>&nbsp;aims to include 6,000 patients in 35 countries.</strong></span></p> </div><div id="Text128" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Patients who experience an ESUS are at increased risk of another stroke.&nbsp;These recurrent strokes can lead to potentially devastating consequences and are associated with high rates of morbidity and mortality.&nbsp;The currently available treatment options to prevent recurrent stroke following ESUS offer only limited efficacy.&nbsp;There is also limited knowledge and data available to guide treatment decisions in these patients, resulting in a considerable unmet need.</span><br /><br /></p> <p><span style="font-size: 10pt;">Professor Hans-Christoph Diener, professor of neurology and chairman of the Department of Neurology, University of Essen, Germany, says: &ldquo;This trial investigates the safety and efficacy profile of dabigatran etexilate versus acetylsalicylic acid in patients with embolic strokes of undetermined source. These patients are at high risk of a recurrent embolic stroke. Embolic strokes of undetermined sources make up a quarter of all strokes and are caused by blood clots, which travel into the brain via large blood vessels.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Boehringer Ingelheim hopes that the <a href="">RE-SPECT ESUS</a> (Randomised&nbsp;evaluation in&nbsp;secondary stroke&nbsp;prevention&nbsp;comparing the thrombin inhibitor dabigatran etexilate versus acetylsalicylic acid in&nbsp;embolic&nbsp;stroke of undetermined&nbsp;source) study aims to include 6,000 patients from study sites in Asia, Europe, North and South America. It is part of Boehringer Ingelheim&rsquo;s clinical trial programme, RE-VOLUTION. Also including the recently announced <a href="">RE-CIRCUIT</a> and <a href="">RE-DUAL PCI</a> studies, the entire programme will involve over 60,000 patients globally.</span></p></div> Acorda initiates phase 3 trial of CVT-301 in Parkinson’s disease 2014-12-12T11:20:00Z 2014-12-12T11:20:00Z <div id="Introduction29" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Acorda Therapeutics has enrolled its first patient in a phase 3 study of CVT-301 for the treatment of &ldquo;off&rdquo; episodes in Parkinson&rsquo;s disease. &ldquo;Off&rdquo; episodes are characterised by a re-emergence of Parkinson&rsquo;s disease symptoms such as tremor, muscle stiffness and impaired ability to move.</strong></span></p> </div><div id="Text129" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">CVT-301 is a novel, self-administered inhaled therapy designed to provide rapid, reliable delivery of a precise dose of levodopa (L-dopa) through the lungs to return people with Parkinson&rsquo;s disease to an &ldquo;on&rdquo; state, when a patient&rsquo;s symptoms are adequately controlled.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;About 350,000 people with Parkinson&rsquo;s disease in the USA experience &ldquo;off&rdquo; episodes, which can be exceptionally disruptive, impacting their lives on a daily basis, even multiple times per day. We believe CVT-301 has the potential to be an important treatment for people experiencing &ldquo;off&rdquo; episodes,&rdquo; says&nbsp;Enrique Carrazana, Acorda Therapeutics&rsquo; chief medical officer.</span></p> <p><br /><span style="font-size: 10pt;">The multicentre, double blind, randomised trial is expected to enrol approximately 345 participants across three arms: 50mg, 35mg, or placebo. These are the same doses used in the phase 2b study. The primary outcome measure is improvement on the Unified Parkinson&rsquo;s Disease Rating Scale (UPDRS) Part III after administration of CVT-301.</span></p> <p><br /><span style="font-size: 10pt;">Positive results from the CVT-301 phase 2b study were presented at the 2014 American Academy of Neurology Annual Meeting. In this study, participants receiving CVT-301 showed a statistically significant and clinically important reduction in average UPDRS Part III motor score versus placebo across time points beginning at 10 and up to 60 minutes post-administration (p &lt; 0.001). Both doses of CVT-301 were well tolerated, with no increase relative to placebo in troublesome or non-troublesome dyskinesias during &ldquo;on&rdquo; periods. There were no serious adverse events in the trial, and the incidence of drug-related adverse events was similar between treatment groups. The CVT-301 inhaler was shown to be easily self-administered in the &ldquo;off&rdquo; state.</span></p></div> Memory lapses among highly educated may signal higher stroke risk 2014-12-12T11:02:00Z 2014-12-12T11:02:00Z <div id="ImageMain30" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction30" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>People with a high level of education who complain about memory lapses have a higher risk for stroke, according to new research in the American Heart Association journal <a href=""><em>Stroke</em></a>.</strong></span></p> </div><div id="Text130" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Studies have shown how stroke causes memory complaints,&rdquo; says Arfan Ikram, associate professor of neuroepidemiology at Erasmus University Rotterdam in the Netherlands. &ldquo;Given the shared underlying vascular pathology, we posed the reverse question: &lsquo;Do memory complaints indicate an increased risk of strokes?&rsquo;&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">As part of the Rotterdam Study (1990-93 and 2000-01), 9,152 participants 55 or older completed a subjective memory complaints questionnaire and took the Mini-Mental State Examination (MMSE).&nbsp;By 2012, 1,134 strokes occurred: 663 were ischemic, 99 haemorrhagic and 372 unspecified.</span></p> <p><span style="font-size: 10pt;">Subjective memory complaints were independently associated with a higher risk of stroke, but a higher MMSE score was not. Furthermore, those with memory complaints had a 39% higher risk of stroke if they also had a higher level of education. The finding is comparable to the association between subjective memory complaints and Alzheimer&rsquo;s disease among highly educated people.</span></p> <p><span style="font-size: 10pt;">&ldquo;Given the role of education in revealing subjective memory complaints, we investigated the same association but in three separate groups: low education, medium education and high education,&rdquo; Ikram says. &ldquo;We found that the association of memory complaints with stroke was strongest among people with the highest education. If in future research we can confirm this, then I would like to assess whether people who complain about changes in their memory should be considered primary targets for further risk assessment and prevention of stroke.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers categorised level of education into three groups: low education &ndash; primary education only; intermediate education &ndash; primary education plus some higher education, lower vocational education, intermediate vocational education, or general secondary education; and high education &ndash; higher vocational education or university training.</span><br /><br /></p> <p><span style="font-size: 10pt;">The study results apply evenly to men and women. With more than 95% of study participants being Caucasians living in Rotterdam, future studies could include more racially diverse groups.</span></p></div> First US patients receive Genzyme’s Lemtrada following FDA approval 2014-12-05T14:37:00Z 2014-12-05T14:37:00Z <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>Genzyme has announced that the first US patients have initiated treatment with Lemtrada&nbsp;(alemtuzumab) in the commercial setting following its FDA approval for the treatment of patients with relapsing forms of multiple sclerosis (MS).&nbsp;</strong></span></p> </div><div id="Text131" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Christopher LaGanke, founder of North Central Neurology Associates in Cullman, USA, wasthe first physician to initiate patient treatment in the US.</span></p> <p><span style="font-size: 10pt;"><br />Lemtrada has a dosing and administration schedule of two annual treatment courses. The first treatment course is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.</span></p> <p><span style="font-size: 10pt;"><br />The FDA approval of Lemtrada was based on two pivotal randomised phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif&nbsp;(high-dose subcutaneous interferon beta-1a) in patients with relapsing remitting MS who were either new to treatment (<a href="">CARE-MS I</a>) or who had relapsed while on prior therapy (<a href=";rank=2">CARE-MS II</a>).</span></p> <p><span style="font-size: 10pt;"><br />In <a href="">CARE-MS I</a>, Lemtrada was significantly more effective than interferon beta-1a at reducing annualised relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In <a href=";rank=2">CARE-MS II</a>, Lemtrada was significantly more effective than interferon beta-1a at reducing annualised relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada compared to those given interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up.</span></p> <p><span style="font-size: 10pt;"><br />Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.</span></p></div> Images of brain after mild stroke predict future risk 2014-12-05T09:19:00Z 2014-12-05T09:19:00Z <div id="ImageMain32" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction32" style="clear:both;"> <p><strong><span style="font-size: 11pt;">A&nbsp;CT scan&nbsp;of the brain within 24 hours of a mild, non-disabling stroke&nbsp;can predict when patients will be at the highest risk of another stroke or when symptoms may worsen, according to new research published in the American Heart Association journal <a href=""><em>Stroke</em></a>.</span></strong></p> </div><div id="Text132" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;All patients should get a CT scan of their brain after a transient ischaemic attack&nbsp;(TIA) or non-disabling stroke,&rdquo; says Jeffrey J Perry, co-senior author of the study and associate professor of emergency medicine at the University of Ottawa in Canada. &ldquo;Images can help healthcare professionals identify patterns of damage associated with different levels of risk for a subsequent stroke or help predict when symptoms may get worse.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Of 2,028 patients who received CT scans within 24 hours of a TIA or non-disabling stroke, 814 (40.1%) had brain damage due to ischaemia. Compared to patients without ischaemia, the probability of another stroke occurring within 90 days of the initial episode was:</span></p> <ul> <li><span style="font-size: 10pt;">2.6 times greater if the CT image revealed newly damaged tissue due to acute ischaemia;</span></li> <li><span style="font-size: 10pt;">5.35 times greater if tissue was previously damaged (chronic ischaemia) in addition to acute ischaemia;</span></li> <li><span style="font-size: 10pt;">4.9 times greater if any type of small vessel damage occurred in the brain, such as narrowing of the microangiopathy, in addition to acute ischaemia;</span></li> <li><span style="font-size: 10pt;">8.04 times greater if acute and chronic ischaemia occurred in addition to microangiopathy.</span></li> </ul> <p><span style="font-size: 10pt;">While 3.4% of the patients in the study group had a subsequent stroke within 90 days, 25% of patients with CT scans showing all three types of damage to their brain had strokes.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;During the 90-day period, and also within the first two days after the initial attack, patients did much worse in terms of experiencing a subsequent stroke if they had additional areas of damage along with acute ischemia,&rdquo; says Perry, who is also a senior scientist at the Ottawa Hospital Research Institute.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These findings should prompt physicians to be more aggressive in managing patients with TIA or non-disabling stroke who are diagnosed with acute ischaemia, especially if there is additional chronic ischaemia and/or microangiopathy.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Measures to avert a new stroke might include cardiac monitoring or medications to lower blood pressure, treat high cholesterol or prevent blood clots. The researchers are assessing how to incorporate the study&rsquo;s findings into stroke risk scores that rely on symptoms along with patient factors such as age and the presence of high blood pressure or diabetes.</span></p></div> Spinal Modulation completes enrolment of Axium neurostimulator US pivotal trial 2014-12-03T11:42:00Z 2014-12-03T11:42:00Z <div id="ImageMain33" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction33" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Spinal Modulation has completed enrolment of the <a href="">ACCURATE study</a>, a randomised, controlled pivotal clinical trial designed to evaluate the safety and efficacy of the company&rsquo;s Axium neurostimulator system.</strong></span></p> </div><div id="Text133" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Axium system is a targeted form of spinal cord stimulation, which uses an implantable medical device to deliver mild electrical pulses that mask or interrupt pain signals as they travel from the periphery to the brain. Unlike traditional spinal cord stimulation devices, Axium uniquely targets the dorsal root ganglion, a neural structure within the spine that has been shown to play a critical role in the development and maintenance of chronic pain.</span></p> <p><br /><span style="font-size: 10pt;">The <a href="">ACCURATE</a> study enrolled 152 patients at 22 centres throughout the USA. This represents the largest neuromodulation study to be conducted in patients suffering from nerve injuries or complex regional pain syndrome to date.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Approximately 10-50% of patients who undergo common procedures like hernia repair, knee surgery, and other lower limb surgeries will suffer from chronic pain resulting from nerve injury. These conditions have historically been difficult to treat with currently available technology,&rdquo; says Timothy Deer, co-study lead and chief executive officer and president of the Center for Pain Relief in Charleston, West Virginia. &ldquo;Results from prior European studies have been promising, and we are hopeful that the <a href="">ACCURATE</a> trial will continue to substantiate the effectiveness of this therapy for our patients.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Investigators will present the <a href="">ACCURATE</a> trial design at the 18<sup>th</sup>&nbsp;Annual North American Neuromodulation Society (NANS) meeting in Las Vegas, Nevada, December 11 &ndash; 14, 2014. Clinical outcomes from Europe and Australia, where the Axium system is commercially available, will also be presented.</span></p></div> Eli Lilly and Company and AstraZeneca initiate early Alzheimer’s disease pivotal clinical trial 2014-12-01T14:27:00Z 2014-12-01T14:27:00Z <div id="Introduction34" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Eli Lilly and Company and AstraZeneca have announced enrolment of the first patient into AMARANTH, a phase II/III study of an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer&rsquo;s disease.&nbsp;</strong></span></p> </div><div id="Text134" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">AZD3293, also known as LY3314814, has been shown in phase I studies to reduce levels of amyloid-beta in the cerebro-spinal fluid of Alzheimer&rsquo;s patients and healthy volunteers. 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. The study will investigate the safety and efficacy of AZD3293/ LY3314814 compared with placebo in the treatment of early Alzheimer&rsquo;s disease.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Our AstraZeneca partners share our determination to find answers for this condition that shatters lives. We are pleased that the first patient enrolment in AMARANTH comes fewer than three months since we announced our alliance,&rdquo; says Phyllis Ferrell, global brand development leader for Alzheimer&rsquo;s disease at Lilly.</span></p> <p><br /><span style="font-size: 10pt;">Samantha Budd, vice president and head of translational science in AstraZeneca&rsquo;s Neuroscience Innovative Medicines Unit says: &ldquo;We believe that BACE inhibitors have the potential to target one of the key drivers of this devastating disease. Together with Lilly, we have unique expertise that will allow us to evaluate the potential of AZD3293 as a treatment for Alzheimer&rsquo;s patients.&rdquo;</span><br /><br /><span style="font-size: 10pt;">AstraZeneca and Lilly announced an alliance earlier in 2014 for the development and commercialisation of AZD3293/ LY3314814. Under the agreement, Lilly will lead clinical development, working with researchers from AstraZeneca&rsquo;s Neuroscience Innovative Medicines Unit, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialisation of the molecule and will share all future costs equally for development and commercialisation, as well as net global revenues post-launch. &nbsp;</span></p></div> IMRIS completes SYMBIS surgical system human factors study 2014-12-01T12:50:00Z 2014-12-01T12:50:00Z <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>IMRIS has successfully completed the human factors study for the SYMBIS surgical system &ndash; the validation used to support the product&rsquo;s 510(k) submission to the US Food and Drug Administration (FDA).&nbsp;</strong></span></p> </div><div id="Text135" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This is a significant step leading to our goals of merging intraoperative imaging with robotics,&rdquo; saysIMRIS president and chief executive officer Jay D Miller. &ldquo;By finding ways to enhance the vision and precision of surgery through technology, we are working towards improving the outcomes for patients with neurological disorders at lower costs for the healthcare system.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Over the past eight years, the FDA has been actively working with companies to apply the science of human factors &ndash; understanding how humans interact physically and psychologically with a device &ndash; to medical device development.</span></p> <p><br /><span style="font-size: 10pt;">The human factors study provided a neurosurgeon&rsquo;s perspective on how well use-related risks were mitigated by the IMRIS design team, when the SYMBIS surgical system is used by neurosurgeons. The study physicians were asked to perform a planned simulated procedure without any outside intervention. Throughout the study, the subject&rsquo;s interaction with the system was observed for any use-related errors.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The human factors study was not only an opportunity for IMRIS to validate the performance of the SYMBIS system with real users,&rdquo; Miller explains, &ldquo;we also captured the voice of the customer on how surgeons perceive the current system, as well as the future clinical applications where robotics in neurosurgery can provide both clinical and economic value.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The SYMBIS human factors study involved a diverse group of 18 neurosurgeons of varying demographics and range of neurosurgical experience. Subjects were recruited from nine leading neurosurgical centres in the USA &ndash; including three centres that do not currently have a VISIUS surgical theatre with intraoperative MRI (iMRI).</span></p> <p><br /><span style="font-size: 10pt;">One of the study subjects, neurosurgeon William Broaddus of Richmond, VA, comments:&nbsp;&ldquo;After working with the SYMBIS System as a human factors study subject, I see this technology as an exciting platform for major advances in neurosurgical practice.&rdquo;</span></p></div> Philips launches DoseWise Portal radiation dose management software 2014-12-01T12:20:00Z 2014-12-01T12:20:00Z <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>Royal Philips&nbsp;has introduced the DoseWise Portal, a comprehensive radiation dose management software solution aimed at managing radiation exposure risk to patients and their caregivers.&nbsp;</strong></span></p> </div><div id="Text136" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Announced at the 100<sup>th</sup><span class="apple-converted-space">&nbsp;</span>annual meeting of the Radiological Society of<span class="apple-converted-space">&nbsp;</span><span class="xn-location">North America (RSNA; 30 November</span>&ndash;5 December, Chicago, USA), the Philips DoseWise Portal enables health care providers to proactively record, analyse and monitor imaging radiation dose for patients and clinicians across multiple diagnostic settings.</span></p> <p><br /><span style="font-size: 10pt;">While the risk of radiation exposure through imaging scans is thought to be low, and the diagnostic rewards generally outweigh those risks, the industry has committed to reducing radiation exposure through improvements in technology and user training. Computer tomography (CT) scans are of most concern, with a higher average diagnostic radiation dose per scan and nearly 68 million performed annually in the USA.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Dose management is a critical issue, and the reality is that sometimes the higher radiation dose of a CT is necessary for a particular patient to in order reach a definitive diagnosis, in the shortest time, and at the lowest cost,&rdquo; says<span class="apple-converted-space">&nbsp;</span><span class="xn-person">Gene Saragnese</span>, executive vice president and chief executive officer of Philips Imaging Systems. &ldquo;Philips DoseWise Solutions return a measure of control to patient care, arming clinicians and informing patients with the tools, training and insights they need in order to ask the right questions regarding&nbsp;radiation dose.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The company says that Philips DoseWise Solutions include a comprehensive portfolio of products and services including<span class="apple-converted-space">&nbsp;</span>ClarityIQ,<span class="apple-converted-space">&nbsp;</span>IMR<span class="apple-converted-space">&nbsp;</span>and<span class="apple-converted-space">&nbsp;</span>DoseAware that empower health care providers with both the data and support they need to implement a broad and comprehensive dose management strategy.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Philips DoseWise is the first integrated, holistic solution that integrates staff and patient dose protecting both patients and clinicians and helping us to comply with critical new dose management standards and regulations,&rdquo; comments<span class="apple-converted-space">&nbsp;</span><span class="xn-person">Christoph Wald</span>, executive vice chair, Department of Radiology at Lahey Hospital and Medical Center in<span class="apple-converted-space">&nbsp;</span><span class="xn-location">Burlington</span>, USA.&nbsp;</span></p></div> Same regions in brain are vulnerable to both Alzheimer’s and schizophrenia 2014-11-27T12:40:00Z 2014-11-27T12:40:00Z <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>In the largest study of its kind, researchers have found a specific network of brain regions that is not only more vulnerable to unhealthy ageing, for example, Alzheimer&rsquo;s disease, but also to disorders that emerge in young people, such as schizophrenia.</strong></span></p> </div><div id="Text137" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The international team, led by Medical Research Council funded researcher Gwena&euml;lle Douaud, at the Oxford University Functional MRI of the Brain Centre, also discovered that, in healthy people, these parts of the brain are the last to develop and the first to show signs of neurodegeneration. The research has been published in the journal <em><a href="">Proceedings of the National Academy of Sciences</a></em>.</span></p> <p><br /><span style="font-size: 10pt;">The network of nerve cells in the brain, consisting of mainly higher-order regions that coordinate information coming from different senses, develops in late adolescence or early adulthood and is associated with both intellectual ability and long-term memory. These mental abilities become significantly impaired in, respectively, people with schizophrenia or those with Alzheimer&rsquo;s.</span></p> <p><br /><span style="font-size: 10pt;">The University of Oxford team used MRI scans to look at changes in the brain structure of 484 healthy people, ranging in age from 8 to 85 years. Uniquely, the researchers used a data-driven approach to study these age-related changes, in which instead of looking for a particular pattern of brain change over the lifespan in a specific location of the brain, they analysed all the imaging data to see what patterns were revealed.</span></p> <p><br /><span style="font-size: 10pt;">The imaging data showed a specific network within the grey matter linking mostly higher order regions of the brain. This network was found to develop later than the rest of the brain, and was the first to degenerate in older age.</span></p> <p><br /><span style="font-size: 10pt;">The findings fit with a retrogenesis theory of brain change across the lifespan which dates back to the 1880s. It proposes that brain capacity declines in reverse order to the way in which it develops, both in human developmental terms and in evolutionary terms. This study is the first to demonstrate this theory in the grey matter on a large scale using complex, data-driven image analysis techniques.</span></p> <p><br /><span style="font-size: 10pt;">Although it has been known for some time that grey matter declines with age, this study revealed one specific network that was more vulnerable to age-related neurodegeneration. The researchers compared this network, identified from MRI data of healthy subjects&rsquo; brains, with the pattern of grey matter damage observed in the scans of people suffering from Alzheimer&rsquo;s and from schizophrenia. As the researchers found striking similarities between the three, and could relate the network to key symptoms of both diseases, they suggest that these areas of the brain likely play a crucial role in the emergence of these two very different disorders.</span></p> <p><br /><span style="font-size: 10pt;">Research has shown previously that these higher-order regions are not as developed in the brains of chimpanzees and other primates. In addition, because these animals appear not to suffer from schizophrenia or Alzheimer&rsquo;s, some scientists have suggested that these diseases might be a result of humans&rsquo; highly-evolved brains and extended lifespan.</span></p> <p><br /><span style="font-size: 10pt;">The study was the result of an international collaboration between the University of Oxford neuroscience imaging team, neuroscience researchers from the University of Oslo and research clinicians from the University Hospital Basel, Imperial College London and the University of Oxford&rsquo;s Department of Psychiatry.&nbsp;&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Douaud explains: &ldquo;Our results show that the same specific parts of the brain not only develop more slowly, but also degenerate faster than other parts. These complex regions, which combine information coming from various senses, seem to be more vulnerable than the rest of the brain to both schizophrenia and Alzheimer&rsquo;s. These results, which might seem surprising at first, are really exciting as they actually reconcile two historical hypotheses &ndash; until now presented completely separately in the scientific literature &ndash; that the brain damage observed in Alzheimer&rsquo;s and schizophrenia is related to these higher order regions of the brain.&rdquo;</span></p> <p><span style="font-size: 10pt;">Hugh Perry, chairman of the MRC&rsquo;s Neurosciences and Mental Health Board, which funded the work, says: &ldquo;Early doctors called schizophrenia &lsquo;premature dementia&rsquo; but until now we had no clear evidence that the same parts of the brain might be associated with two such different diseases. This large-scale and detailed study provides an important, and previously missing, link between development, ageing and disease processes in the brain.&rdquo;&nbsp;</span></p></div> Medtronic acquisition of Covidien receives US Federal Trade Commission and European Commission clearance 2014-11-27T09:50:00Z 2014-11-27T09:50:00Z <div id="ImageMain38" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction38" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The US Federal Trade Commission (FTC) and the European Commission have given clearance of Medtronic&rsquo;s proposed acquisition of Covidien.&nbsp;</strong></span></p> </div><div id="Text138" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The FTC&rsquo;s and European Commission&rsquo;s clearances follow Medtronic&rsquo;s and Covidien&rsquo;s agreement to a proposed consent order, which includes a commitment to divest certain assets related to Covidien&rsquo;s drug-coated balloon catheter product. A subsidiary of Covidien entered into an agreement to divest these assets to Spectranetics and the divestiture is expected to close shortly following completion of Medtronic&rsquo;s acquisition of Covidien.</span></p> <p><br /><span style="font-size: 10pt;">Medtronic and Covidien also entered into a parallel consent agreement regarding the divestiture of assets related to Covidien&rsquo;s drug-coated balloon catheter product with the Canadian Competition Bureau, which announced its clearance of the deal&nbsp;at the same time as the FTA.</span></p> <p><br /><span style="font-size: 10pt;">Medtronic&rsquo;s acquisition of Covidien is expected to close in early 2015 after receipt of certain additional regulatory clearances and approvals by both companies&rsquo; shareholders and sanction by the High Court of Ireland.&nbsp;</span></p> </div> Silk Road Medical unveils data from the ROADSTER trial 2014-11-26T11:10:00Z 2014-11-26T11:10:00Z <div id="ImageMain39" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction39" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Silk Road Medical&rsquo;s 30-day outcomes from the ROADSTER IDE study were presented at the Late Breaking Clinical Trials Session at the 2014 Vascular InterVentional Advances (VIVA) Meeting in&nbsp;Las Vegas, with additional data presented at the VEITHsymposium in&nbsp;New York. &nbsp;</strong></span></p> </div><div id="Text139" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The trial studied the Enroute transcarotid neuroprotection system (NPS), which is designed to provide direct access to the carotid artery and reduce the risk of stroke during carotid angioplasty and stenting (CAS) by diverting dangerous debris away from the brain with a surgically-inspired mechanism to temporarily reverse blood flow. The 1.4% 30-day stroke rate was the lowest seen to date of any contemporary prospective trial of CAS.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Celebrating its 60<sup>th</sup>&nbsp;anniversary in 2013, carotid endarterectomy (CEA) has been the gold standard in carotid artery revascularisation because of the low stroke and death rates in multiple prospective trials. Yet CEA is not free of the potential for certain local and systemic complications such as cranial nerve injury and myocardial infarction.</span></p> <p><br /><span style="font-size: 10pt;">Fifteen years ago transfemoral CAS was introduced with much initial excitement due to the minimally invasive, endovascular advantage, but fell out of favour for physicians and payers due to the excess risk of periprocedural stroke compared to CEA. In a standard surgical risk population, the CREST trial demonstrated that periprocedural strokes occur twice as often in transfemoral CAS patients.</span></p> <p><span style="font-size: 10pt;">ROADSTER was a prospective, multicentre, IDE study designed to evaluate the safety and effectiveness of the Enroute transcarotid NPS in a hybrid procedure combining the best elements of CEA and CAS. Richard Cambria and&nbsp;Christopher Kwolek, of Massachusetts General Hospital, served as the trial national co-principal investigators. Patients were enrolled at 15 vascular surgery sites, one neurosurgery site, and two multi-specialty sites. The primary endpoint was a composite of any stroke (S), death (D), or myocardial infarction (MI) through 30 days.</span></p> <p><br /><span style="font-size: 10pt;">Two-hundred and eight&nbsp;(67 lead-in, 141 pivotal) symptomatic and asymptomatic patients who were at high risk for complications from CEA were enrolled.&nbsp;Food and Drug Administration (FDA)-approved carotid stent systems were delivered through the direct carotid access point under high rate flow reversal afforded by the Enroute transcarotid NPS. Baseline pivotal population characteristics included 26% symptomatic, 35% female, and 47% age greater than or equal to 75.&nbsp;</span></p> <table> <tbody> <tr> <td> <p><span style="font-size: 10pt;">ROADSTER trial</span></p> <p><span style="font-size: 10pt;">results at 30 days</span></p> </td> <td> <p><span style="font-size: 10pt;">ITT population</span></p> <p><span style="font-size: 10pt;">n=141</span></p> </td> <td> <p><span style="font-size: 10pt;">Per protocol population</span></p> <p><span style="font-size: 10pt;">n=136</span></p> </td> </tr> <tr> <td> <p><span style="font-size: 10pt;">Stroke/death/MI</span></p> </td> <td> <p><span style="font-size: 10pt;">3.5%</span></p> </td> <td> <p><span style="font-size: 10pt;">2.9%</span></p> </td> </tr> <tr> <td> <p><span style="font-size: 10pt;">Stroke/death</span></p> </td> <td> <p><span style="font-size: 10pt;">2.8%</span></p> </td> <td> <p><span style="font-size: 10pt;">2.2%</span></p> </td> </tr> <tr> <td> <p><span style="font-size: 10pt;">All stroke</span></p> </td> <td> <p><span style="font-size: 10pt;">1.4%</span></p> </td> <td> <p><span style="font-size: 10pt;">0.7%</span></p> </td> </tr> </tbody> </table> <p><span style="font-size: 10pt;">There were no strokes in patient&rsquo;s age greater than or equal to 75 or in symptomatic patients. There was one (0.7%) CNI presenting as hoarseness which fully resolved.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These stroke rates in a high surgical risk population are the lowest to date for CAS and comparable to the periprocedural rates in the standard surgical risk CEA arm of CREST (2.3%). The Silk Road procedure is less of an operation for the patient than a traditional CEA and can be performed in under an hour with local anaesthesia,&rdquo; Cambria explains.</span><br /><br /></p> <p><span style="font-size: 10pt;">Erica Rogers, chief executive officer of Silk Road Medical, says: &ldquo;The ROADSTER data support our hypotheses that led to this device design and procedure.&nbsp;It is all about stroke.&nbsp;Doctors perform these procedures to reduce the risk of stroke, not to cause a stroke. The ENROUTE transcarotid platform finally delivers a less invasive alternative with the neuroprotection you would expect from a CEA procedure.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The Enroute NPS and Stent Systems are limited by&nbsp;United States&nbsp;law to investigational use; the Enroute transcarotid NPS has been submitted for 510(k) review and the ROADSTER trial also supports the pending Premarket Approval PMA for the Enroute transcarotid Stent System. The Enroute transcarotid NPS and the Enroute transcarotid Stent System have been granted CE mark.</span></p></div> New Alzheimer’s programme to focus on prevention, intervention, research and support 2014-11-25T17:00:00Z 2014-11-25T17:00:00Z <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>Cedars-Sinai&nbsp;has launched the Alzheimer&rsquo;s Prevention Program to help identify patients at risk of developing the neurological disorder and to reduce the impact on those diagnosed with the condition.</strong></span></p> </div><div id="Text140" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The programme represents a concerted effort by clinicians, researchers, patients, families, caregivers and community agencies to address an approaching &ldquo;tsunami&rdquo; of Alzheimer&rsquo;s care. Medical authorities expect the number of cases nationally to triple by 2050, costing more than US$1tn.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We know that we can have a major impact on this disease if we take bold action,&rdquo; says&nbsp;Dean Sherzai, director of the programme. &ldquo;If Alzheimer&rsquo;s is detected early enough, we can take steps to slow or even prevent its progression.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Sherzai said the first goal of the Alzheimer&rsquo;s Prevention Program will be to identify patients in the early stages of the disease when interventions and treatments can have the biggest impact. The second goal will be to provide patients and families with comprehensive, long-term care and education in a well-established centre that combines research and clinical services with a network of support in the community.</span><br /><br /></p> <p><span style="font-size: 10pt;">Cedars-Sinai&rsquo;s comprehensive approach eventually may serve as a model that can be implemented elsewhere, with interventions, treatments and care plans built around each patient&rsquo;s background and interests.</span><br /><br /><span style="font-size: 10pt;">&ldquo;If we tell patients they have Alzheimer&rsquo;s, prescribe the drugs that exist right now and send them out without providing any other resources, all we have done is create chaos in their lives,&rdquo; comments Sherzai, a faculty member in the department of neurology&nbsp;and the&nbsp;department of neurosurgery. &ldquo;We have to give them counselling and direction. We can help make the journey much less painful, becoming one in which families bceome&nbsp;closer rather than being torn apart by tensions and financial burdens.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The Alzheimer&rsquo;s Prevention Program will serve as the hub for a clinical trial site for experimental Alzheimer&rsquo;s drugs, including several studied at Cedars-Sinai. Over 50 drugs have worked in animal models of dementia and Alzheimer&rsquo;s disease but failed when applied to humans. Researchers believe the drugs did not work in patients because their disease was too advanced. Indeed, existing drugs treat symptoms without slowing the onset of the disease.</span><br /><br /></p> <p><span style="font-size: 10pt;">Although genetic and environmental factors influence the development of the disease, lifestyle changes, especially if made early, can alter its course. If applied early enough, nutrition, exercise and certain kinds of mental activity not only affect quality of life but its length as well. &ldquo;This is remarkable, because none of the drugs we have can do that,&rdquo; Sherzai notes.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The studies going on at Cedars-Sinai are very exciting, and we&rsquo;re looking forward to helping patients participate in clinical trials,&rdquo; he said.&nbsp;</span></p></div> Repetitive transcranial magnetic stimulation studied for stroke rehabilitation 2014-11-25T16:39:00Z 2014-11-25T16:39:00Z <div id="ImageMain41" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction41" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers at the Ohio State University Wexner Medical Center are attempting to improve arm movement in stroke patients by using a transcranial magnetic stimulator (TMS) device. By using TMS to reduce brain activity on the uninjured side of the brain, researchers hope that the injured side may have a better chance of recovering.</strong></span></p> </div><div id="Text141" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">When one side of the brain is damaged by a stroke, the healthy side tends to increase its activity to compensate. However, that may actually prevent the injured side from recovering, according to&nbsp;principal investigator Marcia Bockbrader, assistant professor of physical medicine and rehabilitation at Ohio State.</span><br /><br /></p> <p><span style="font-size: 10pt;">Ohio State is one of 12 rehabilitation sites nationwide participating in the multicentre clinical trial that will enrol up to 200 patients during the next two years. Nexstim has launched the double-blinded, randomised, and sham-controlled trial to determine the therapeutic effects of navigated repetitive transcranial magnetic stimulation (rTMS) for stroke rehabilitation. This stroke therapy combines occupational therapy with navigated repetitive transcranial magnetic stimulation (n-rTMS).</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Nexstim is a way to specifically stimulate a brain area of interest,&rdquo; says Bockbrader. &ldquo;In our study, we are stimulating the motor areas that are sometimes injured in a stroke. This device targets the overactive side, quieting it down enough, so that through therapies, the injured side can learn to express itself again.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">To qualify for the study, participants must have had a stroke 3-12 months before, and continue to experience&nbsp;weakness in the arm and hand on one side. All participants also receive six weeks of hand and arm therapy free of charge. An occupational therapist focuses on improving movement, flexibility, strength and use of the weak arm and hand. The study lasts for up to eight months and will involve up to 29 visits.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;In this particular study, we are looking at people who are 3-12 months after stroke who have not recovered all the way and are trying to use this technology to boost their recovery process to restore the brain balance,&rdquo; Bockbrader explains.</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers are using stereotactic MRI-guided rTMS to non-invasively modulate precise areas of the motor cortex. The system&rsquo;s targeting tool allows the therapist to accurately locate the patient&rsquo;s exact stimulation target using technology similar to mapping the globe with a GPS. The n-rTMS is used to stimulate the patient&acute;s non-injured brain hemisphere at a low frequency, said co-investigator Stephen Page, associate professor of health and rehabilitation sciences at Ohio State.</span><br /><br /></p> <p><span style="font-size: 10pt;">This results in down-regulation of the excitability of the healthy side and restoration of the balance between the lesioned and healthy sides, allowing the lesioned side to regain function. Adding navigation to TMS is the key to finding the exact location and orientation of the motor area that should be inhibited by stimulation. The stimulation is then accurately repeated in every session, assuring the dose is applied to the correct place, said co-investigator Lise Worthen-Chaudhari, assistant professor of physical medicine and rehabilitation at Ohio State.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;What we are doing is allowing the brain to be ready and more receptive for therapies,&rdquo; comments Bockbrader. &ldquo;It is not a technology limited to just motor recovery after stroke, it seems to be something that has a potential to affect many of the brain circuits that are injured in stroke.&rdquo; Other sites in the clinical trial are Mayo Clinic in Arizona; Ranchos Los Amigos National Rehabilitation Institute in California; Shepherd Center in Georgia; Rehabilitation Institute of Chicago; Indiana University; Spaulding Rehabilitation Hospital in Massachusetts; Columbia University; Burke Rehabilitation Center in New York; Duke University, University of Cincinnati; and TIRR Memorial Hermann Hospital in Texas.</span></p></div> InVivo Therapeutics announces OHSU as fifth clinical trial site for Neuro-Spinal Scaffold 2014-11-25T16:22:00Z 2014-11-25T16:22:00Z <div id="Introduction42" style="clear:both;"> <p><strong><span style="font-size: 11pt;">InVivo Therapeuticshas announced that the Oregon Health &amp; Science University (OHSU) in Portland, Oregon, USA, is the fifth clinical site in the company&rsquo;s ongoing IDE pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). Ahmed Raslan, an assistant professor of neurological surgery at OHSU, will be the study&rsquo;s principal investigator at that site.</span></strong></p> </div><div id="Text142" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;It is very exciting to be a part of this first-in-human trial for the Neuro-Spinal Scaffold,&rdquo; Raslan comments. &ldquo;This important contribution to science demonstrated promising results in pre-clinical studies and provides, for the first time, a categorically distinct form of potential repair after SCI.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">In October, InVivo announced enrolment of its first patient at Barrow Neurological Institute in Phoenix, Arizona, USA. Mark Perrin, InVivo chief executive officer, says: &ldquo;We are delighted to have Ahmed Raslan and OHSU join us. OHSU and the other centres will be able to enrol the next subject following the three-month observation period for first patient.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">This is the company&rsquo;s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The IDE pilot study has been approved by the US Food and Drug Administration (FDA) and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialisation under a humanitarian device exemption.</span></p></div> Portable electric device found to slow and reverse growth of glioblastoma 2014-11-21T10:35:00Z 2014-11-21T10:35:00Z <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>A non-invasive, portable electrical device tested at the Hermelin Brain Tumor Center at Henry Ford Hospital along with other major medical centres around the USA, has been found to lengthen the lives of some patients suffering from glioblastoma, the most common and deadliest form of brain cancer.</strong></span></p> </div><div id="Text143" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The device proved to be so successful in early testing that an independent monitoring committee recommended cutting short the latest phase of its clinical trials and allowing all test patients to be treated with it.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This is not a cure,&rdquo; says Tobias Walbert, a neuro-oncologist and researcher in the department of neurosurgery at Henry Ford Hospital. &ldquo;But these early results have been so impressive that we might be looking at a game-changer in the treatment of glioblastoma.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The electrical device, designed to be worn at least 20 hours a day to be effective, weighs about six pounds (2.72kg), is powered by rechargeable batteries and is carried by the patient in a small backpack. It received US Food and Drug Administration (FDA) approval in 2011 only to treat patients with recurring glioblastoma, not first-time cases.</span><br /><br /></p> <p><span style="font-size: 10pt;">The manufacturer, Novocure, is currently seeking FDA approval to use the device on all glioblastoma patients. Marketed under the brand name Optune, the equipment creates low-intensity alternating electric fields, referred to as tumour treating fields, and delivers them through wires attached to the patient&rsquo;s shaved scalp by four adhesive transducer pads that target the brain tumour. Individual placement of the transducers is determined by MRI scan. The clinical trials showed that the tumour treating fields reversed the tumour&rsquo;s growth and killed cancer cells by disrupting mitosis, the process by which cells divide and replicate.</span><br /><br /></p> <p><span style="font-size: 10pt;">Research results were presented by the study&rsquo;s leader Roger Stupp, chairman of the oncology department at Switzerland&rsquo;s University of Zurich, at the annual meeting of the Society for Neuro-Oncology in Miami, USA. Data collected from the first 315 of around 700 patients included in the international clinical trials showed:</span></p> <ul> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Patients treated with both tumour treating fields and temozolomide chemotherapy showed a &ldquo;significant increase&rdquo; in progression-free survival compared to those treated with chemotherapy alone - a median of 7.1 months compared to 4 months;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Those treated with both tumour treating fields and temozolomide also showed a &ldquo;significant increase&rdquo; in overall survival compared to temozolomide alone - a median 19.6 months compared the 16.6 months.</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 43% of patients treated with both tumour treating fields and temozolomide chemotherapy were still alive after 2 years compared to 29% treated with the chemotherapy alone.</span><br /><br /></li> </ul> <p><span style="font-size: 10pt;">The only side effect reported by the researchers was irritation of the scalp where the transducers were attached. &ldquo;These results are spectacular, a lot better and much more convincing than we ever would have dreamt of,&rdquo; says Stupp.</span></p></div> Barrow neurosurgeons implant the world’s first scaffold into a patient’s spinal cord 2014-11-21T10:19:00Z 2014-11-21T10:19:00Z <div id="Introduction44" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Neurosurgeons at Barrow Neurological Institute have implanted the world&rsquo;s first scaffolding device into the spinal cord of a patient.&nbsp;Performed last month, the surgery involves inserting a bioresorbable scaffolding implant to act as a bridge across the gap of the injured section of the cord in an attempt to help the spinal cord heal.</strong></span></p> </div><div id="Text144" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">This first case is part of a pilot study to measure the clinical safety of the implanted device developed by InVivo Therapeutics. &ldquo;This could be the first step in identifying a new treatment option to improve the overall recovery of individuals with acute spinal cord injury,&rdquo; says Nicholas Theodore, chief of spinal surgery at Barrow and principal investigator of the study.</span></p> <p><span style="font-size: 10pt;">Twenty-five-year-old Jordan Fallis, the first patient to have the scaffold implanted, will be closely monitored throughout his recovery to see if there are any changes or improvements to his spinal cord and mobility. A section of Fallis&rsquo; spinal cord was injured in a dirt biking accident and he was airlifted to Barrow which is located at Dignity Health St Joseph&rsquo;s Hospital and Medical Center, where he underwent emergency surgery that evening. Fallis spent a week in the ICU before being transferred to the hospital&rsquo;s Neuro Rehabilitation Center where he is currently undergoing intensive physical and occupational therapy.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;I&rsquo;m excited to be the first patient in this research study that may one day become the standard of spinal cord injury treatment,&rdquo; says Fallis.</span><br /><br /></p> <p><span style="font-size: 10pt;">To measure the safety of the device, the US Federal Drug Authority has approved five individuals in the USA&nbsp;to undergo the procedure. Fallis will be monitored for three months before InVivo reopens enrolment. In addition to Barrow, the University of North Carolina, the University of Arizona and the Washington University Medical Center are participants in the study.</span></p></div> FDA clears Ahead 100 device for adjunctive assessment of traumatic brain injury 2014-11-20T15:30:00Z 2014-11-20T15:30:00Z <div id="ImageMain45" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction45" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>BrainScope&nbsp;has announced that the United States Food and Drug Administration (FDA) has cleared the company&rsquo;s Ahead&nbsp;100 device through the&nbsp;<em>de novo</em>&nbsp;classification process. The Ahead&nbsp;100 uses a patient&rsquo;s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient&rsquo;s brain after head injury.</strong></span></p> </div><div id="Text145" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">It is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head computerised tomography (CT) scan, but should not be used as a substitute for a CT scan. It is to be used on patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury, and are between the ages of 18-80 years.</span></p> <p><br /><span style="font-size: 10pt;"> &ldquo;Each year there are approximately two million patients in the United States alone who sustain head injuries and go to Emergency Departments for evaluation,&rdquo; states J Stephen Huff, associate professor of Emergency Medicine and Neurology at the University of Virginia School of Medicine and the clinical principal investigator of the B-AHEAD II trial. &ldquo;Many of these patients present with very mild symptoms, yet may have life-threatening bleeds in the brain. An objective, accurate capability that can rapidly help identify and categorise patients with even the mildest forms of brain injury could help save lives, reduce radiation exposure, and decrease costs to the healthcare system. The performance and clinical utility of the Ahead&nbsp;100 is superior to that of standard of practice tools. Also, the possibility of reduction of use of neuroimaging in patients with head injury is consistent with the&nbsp;<em>Choosing Wisely</em>&nbsp;campaign sponsored by several professional organisations.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;"> &ldquo;This is a landmark event in the assessment of head injury,&rdquo; adds Daniel Hanley, the Jeffrey &amp; Harriet Legum professor of Acute Care Neurology at Johns Hopkins University, director of the Johns Hopkins Brain Injury Outcomes Services division, and Medical Advisory Board member to BrainScope. &ldquo;I am greatly impressed by the performance of the Ahead&nbsp;100 for discriminating clinically important mild traumatic brain injury and believe this device is a practical, safe and transformative adjunct to acute CT scan.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;"> The BrainScope Ahead&nbsp;100 has been developed over six years of technology development and clinical studies at hospital Emergency Rooms across the USA, creating an extensive database of head injured patients. &ldquo;Using sophisticated classification algorithm methods we sought neurophysiological profiles or signatures of changes in brain electrical activity associated with traumatic structural brain injury,&rdquo; explains Leslie Prichep, director of the Quantitative Neurophysiological Brain Research Laboratories at the NYU School of Medicine and consultant to BrainScope. &ldquo;One of the most important findings was the extremely high performance of the Ahead&nbsp;100 to identify the absence of structural brain injury after a patient has sustained a head injury. This provides important information to the clinician, contributing to a rule-out for one of the most prevalent concerns clinicians have with mildly presenting patients.&rdquo;</span></p></div> Specialised ambulance increases thrombolysis for stroke patients in ‘golden hour’ 2014-11-19T09:40:00Z 2014-11-19T09:40:00Z <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><span style="font-size: 11pt;"><strong>A specialised ambulance staffed with a neurologist and equipped with a computed tomographic scanner helped increase the percentage of patients with stroke who received thrombolysis to break down blood clots within the so-called &lsquo;golden hour,&rsquo; the 60 minutes from time of symptom onset to treatment when treatment may be most effective, according to a study published online by <a href="" target="_blank"><em>JAMA Neurology</em></a>.</strong></span></p> </div><div id="Text146" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The time to treatment with tissue plasminogen activator (tPA) to break down blood clots is crucial to how patients fare after acute ischaemic stroke. But when pre-hospital times are added to hospital delays the onset to treatment (OTT) within 60 minutes seems out of reach for most patients. An approach to shorten the OTT is pre-hospital thrombolysis in a specialised ambulance, according to background information in the study.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Martin Ebinger of the Charit&eacute;-Universit&auml;tsmedizin Berlin, Germany, and co-authors examined the achievable rate of golden hour thrombolysis in pre-hospital care and the effect it had on how patients fared. The authors used data from a study conducted in Berlin where weeks were randomised according to the availability of a stroke emergency mobile unit (STEMO) from May 2011 through January 2013.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Study results indicate there were 3,213 emergency calls for suspected stroke during weeks when STEMO was available and 2,969 calls during control weeks when STEMO was not available. Overall, 200 of 614 patients with stroke (32.6%) received thrombolysis when the STEMO was deployed and 330 of 1,497 patients (22%) received thrombolysis in conventional care. Median OTT was 24.5 minutes shorter after STEMO deployment compared with conventional care. In all ischaemic strokes, the rate of golden hour thrombolysis increased from 16 of 1,497 patients (1.1%) during conventional care to 62 of 614 (10.1%) after STEMO deployment. The median OTT was 50 minutes in golden hour thrombolysis vs. 105 minutes in all other thrombolysis. Patients with golden hour thrombolysis had no higher risks for seven- or 90-day mortality compared with patients with longer OTT and were more likely to be discharged home.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The use of STEMO increases the percentage of patients receiving thrombolysis within the golden hour. Golden hour thrombolysis entails no risk to the patients&rsquo; safety and is associated with better short-term outcomes,&rdquo; the study notes.</span></p> <p><span style="font-size: 10pt;"><strong>&nbsp;</strong></span></p> <p><span style="font-size: 10pt;"><br />In a related editorial, Steven Warach of the University of Texas Southwestern Medical Center, Austin, USA, writes: &ldquo;There is no doubt that, in Berlin, STEMO significantly shortened the time to thrombolytic treatment, which may translate to clinical benefits. Let there also be no doubt that the mobile stroke unit is here to stay and is starting to disseminate into pre-hospital stroke care. Many questions need to be answered in order to determine the appropriate niche where the benefit justifies the intensive use of resources that this approach requires. It is the duty of the early adopters to resist the temptation to uncritically embrace this approach as a certain good and to address these issues through rigorous clinical investigations.&rdquo;</span></p></div> MR CLEAN: expert opinion 2014-11-18T11:31:00Z 2014-11-18T11:31:00Z <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><span style="font-size: 11pt;"><strong>Since the first presentation of data at the World Stroke Congress, the MR CLEAN trial has sent a ripple across the entire neurointerventional arena, raising questions about the future of stroke treatment and the fate of similar trials, some of which have already been halted.</strong></span></p> </div><div id="Text147" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">At the Society of Vascular and Interventional Neurology meeting (SVIN) the as yet unpublished MR CLEAN (Multicentre randomised clinical trial of endovascular treatment for acute ischaemic stroke in the Netherlands) results were discussed by an expert panel. The panel, including Jeffrey Saver, Tudor Jovin, Osama Zaidat, Italo Linfante, Raul Nogueira, and Dileep Yavagal, focused on the effect of the trial results on other trials and where that leaves clinical practice going forward.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;"> MR CLEAN is a pragmatic phase III multicentre randomised clinical trial with blinded outcome assessment. Endovascular treatment (intra-arterial thrombolysis, mechanical treatment or both) was compared with no treatment, against a background of optimal medical management, with or without intravenous alteplase. With the enrolment of 500 patients complete, the results presented at World Stroke Congress were in favour of interventional treatment.</span></p> <p><br /><span style="font-size: 10pt;"> Jeffrey Saver, who was present at the World Stroke Congress, gave a brief summary of MR CLEAN: &ldquo;MR CLEAN had a very broad design. They could enrol patients who were getting t-PA or not getting t-PA as the background therapy up to six hours after onset. They had broad clinical criteria&mdash;NIHSS score of two or higher. Patients had to have an occlusion in the terminal ICA, in the M1 M2 or in the A1 A2. Even though they were broadly inclusive and started in the pre-stent retriever era, most of the patients (97%) were treated with retrievable stents, so MR CLEAN is basically a stent retriever trial. The average time from onset to t-PA was under 90 minutes, but the average time from onset to randomisation was 200 minutes. Because there was 110 minutes between t-PA start and randomisation, they ended up with t-PA failure patients. Onset to groin puncture was 60 minutes faster than some of the prior studies. Serious adverse events were not greatly different between the two groups. In terms of results, in the onset to randomisation, whether patients were randomised early or late, within the first two hours or beyond the first two hours, they benefited, so two hours is not a key cut point.&rdquo;</span></p> <p><strong><br /> <br /> </strong></p></div><div id="Text247" style="clear:both; text-align:left"><p><span style="font-size: 10pt;"><strong>Way forward</strong></span></p> <p><br /><span style="font-size: 10pt;"> The question was then raised: with MR CLEAN and similar trials such as ESCAPE and EXTEND IA declared positive, what is the next step? &ldquo;Are we done with our trials; can we just go into clinical practice and not have to worry about anything yet?&rdquo;</span></p> <p><br /><span style="font-size: 10pt;"> Saver responded that just looking at the results of MR CLEAN, the answer is no. He pointed to the fully able to return to work/non-disabled outcome which reportedly showed that 88% of patients in the intervention arm are still unable to return to work and 97% of patients still have symptoms from their stroke. &ldquo;So there is still a huge need for additional therapies. We have had a major step forward but we need to keep doing better, and so we need to move on to the next generation of trials.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;"> As for the process of making decisions for other trials based on data that are yet to be published, the expert panel maintained that care must be taken.</span></p> <p><br /><span style="font-size: 10pt;"> Tudor Jovin cautioned, &ldquo;We must remember that these results are in non-published form; we do not know how these results are going to look in their definitive form. The same applies to ESCAPE. Before ESCAPE we could have said that this could be an outlier, but to me, the fact that ESCAPE was stopped due to crossing pre-defined efficacy boundaries tells me that this probably is the kind of treatment effect that we are looking at. So I suspect the data are real and because of that I have no reason to believe that other ongoing trials are not going to go the same direction. The question to me is less &lsquo;should the trials be stopped&rsquo;, and more, &lsquo;should consenting be changed&rsquo;, because for all of these reasons you can make a good argument that trials should not be stopped. The question is &lsquo;how do we incorporate this kind of information into the consenting process&rsquo;.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;"> Following on from Jovin, Raul Nogueira stated, &ldquo;Equipoise is not what we [personally] think, it is about what the whole medical community thinks, and we do not know if things are going to change, and stopping before things change would be a mistake. We have duties to the patient in front of us and to the whole community of patients we will see for the rest of our lives. It is a complicated ethical dilemma, I think we need to measure the degree of equipoise in the whole community, and I think the trials should probably be put on hold as opposed to stopped.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;"> Up to time of publication, the ESCAPE trial has been permanently halted, the SWIFT-PRIME trial has been temporarily halted, and the REVASCAT trial continues to enrol, with a scheduled pre-planned analysis due in the near future.</span></p></div> Majority of UK neurosurgical units following published recommendations, but room for improvement remains 2014-11-18T11:00:00Z 2014-11-18T11:00:00Z <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><span style="font-size: 11pt;"><strong>It has been discovered via a national survey of current practice that six months post-publication of the National Confidential Enquiry into Patient Outcome and Death report, the majority of neurosurgical units across the United Kingdom and Ireland have been following most of the key recommendations for the management of aneurysmal subarachnoid haemorrhage.</strong></span></p> </div><div id="Text148" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Study authors Othman Al-Helli <em>et al</em> report in the <a href="" target="_blank"><em>Journal of Neurointerventional Surgery</em></a> however, that in the remainder of neurosurgical units they found variability in clinical practice.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to the authors, the management of aneurysmal subarachnoid haemorrhage has undergone extensive change in recent years with the publication of recommendations and guidelines by specialty bodies. The National Confidential Enquiry into Patient Outcome and Death report and recommendations were published in November 2013 as a follow-up to the 2012 recommendations for the management of aneurysmal subarachnoid haemorrhage published by the Royal College of Physicians and the American Heart Association/American Stroke Association. The aim of Al-Helli <em>et al&rsquo;s</em> study was to assess how many of these recommendations were being followed six months after the latest publication, and to compare current practice with the National Confidential Enquiry into Patient Outcome and Death data collected in 2011.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />To carry out their investigation, study authors formulated a survey composed of 19 questions regarding the management of aneurysmal subarachnoid haemorrhage, and conducted a telephone interview with the neurosurgical registrars on call. The 19 questions covered six areas: hospital policies and facilities for treatment of aneurysmal subarachnoid haemorrhage; medical measures to prevent rebleeding; surgical and endovascular methods of treatment; management of cerebral vasospasm and delayed cerebral ischaemia; management of hydrocephalus; and management of medical complications. Thirty neurosurgical units participated in the survey. The results were then compared against currently available published recommendations.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to the results, &ldquo;22 out of the 30 centres aimed to treat ruptured aneurysms by coiling or clipping within 48 hours of ictus, yet only 15 units offered regular weekend interventional neuroradiological treatment. In nine units, all aneurysmal subarachnoid haemorrhages were routinely discussed in a multidisciplinary meeting.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The authors note: &ldquo;In the vast majority of neurosurgical centres, the main recommendations from the Royal College of Physicians, the American Heart Association/American Stroke Association, and the National Confidential Enquiry into Patient Outcome and Death report were being followed. Given data from previous studies over the past 15 years suggesting a longer interval to securing a ruptured intracranial aneurysm compared with other developed countries such as the USA, this survey suggests that there has been improvement in the service in the UK.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />They conclude noting that while there appears to be recent considerable improvement in the management of aneurysmal subarachnoid haemorrhage in the UK, more work is required before care delivery is optimised. They further state their intention to repeat the survey in the future to assess the progress made.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Al-Helli told <em>NeuroNews</em>: &ldquo;The most concerning finding of the study is the fact that only half of the neuroscience centres provide weekend neurointerventional service despite the guidelines recommend very clearly that early treatment not later than 48 hours post-ictus is a key factor for better outcome. I believe that our findings imply that patients who their bleed on a Friday night will have worse outcome that those who have it on any other weekday.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Commenting on what might be done to improve outcomes, he added, &ldquo;Providing a six day service might help. I personally wish that neither myself or any friend or family or indeed anybody get their bleed on a Friday night. Otherwise they might have to wait more than 48 hours to secure aneurysm preventing the potentially disastrous complication of rebleeding!&rdquo;</span></p></div> CE mark for new Asahi Intecc neurovascular guide wires 2014-11-17T14:36:00Z 2014-11-17T14:36:00Z <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><span style="font-size: 11pt;"><strong>Asahi Intecc has received CE certification of neurovascular guide wires: Asahi Chikai 008, Asahi Chikai black, and Asahi Chikai black 18 and is initiating sales in Europe.</strong> </span></p> </div><div id="Text149" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to the company, the above wires join the currently marketed Asahi Chikai and Asahi Chikai 10 in incorporating Asahi Intecc&rsquo;s unique Actone technology, which provides improved torque performance, shape retention and support. One of the new wires, Asahi Chikai 008 is designed to deliver the flow directed microcatheters that are used for the arterial venous malformation treatment. Asahi Chikai black 18 is designed to deliver microcatheters for stent assist procedures, flow diverters, stroke devices and other devices that require large inner lumen diameter catheters. The third wire, Asahi Chikai black is a 0.014 inch workhorse wire for neuro endovascular procedures. Unlike the Asahi Chikai, the Chikai black has a polymer jacket over the spring coils to facilitate enhanced lubricity. </span><br /><span style="font-size: 10pt;"> <br />Masahiko Miyata, president and chief executive officer of Asahi Intecc comments, &ldquo;Developing and manufacturing various sizes and designs of the neurovascular wires in response to the neuro interventionalists&rsquo; needs will contribute to the expansion of neuro endovascular therapy and ultimately benefit patients.&rdquo;</span><br /><span style="font-size: 10pt;"> <br />Asahi Intecc started selling neurovascular guide wires in Japan from 2010 and has more than 60% market share in Japan today. In addition to the Asahi Chikai series Asahi Intecc will continue to improve guide wire and product design allowing for increased business expansion overseas.</span></p></div> Lazarus Effect Cover device receives CE mark 2014-11-06T16:17:00Z 2014-11-06T16:17:00Z <div id="Introduction50" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Lazarus Effect has announced that the Lazarus Cover accessory device has received CE mark. The Lazarus Cover is a nitinol-mesh cover that surrounds a retriever device and captures material during removal from a blood vessel.</strong></span></p> </div><div id="Text150" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The Lazarus Cover provides a unique solution to what has been a major limitation of current retrieval systems, and it does so without requiring physicians to switch from their favourite stent or other retriever device,&rdquo; says Martin Dieck, chairman and chief executive of Lazarus Effect. &ldquo;It is among a series of disruptive devices Lazarus Effect is developing to overcome longstanding challenges associated with current vascular interventional procedures.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Stent-based thrombectomy devices have demonstrated success in &lsquo;capturing&rsquo; clots within an affected blood vessel, but often lose thrombus as the device is extracted. Recent results from a 500-patient, multicentre, randomised European ischaemic stroke trial (<a href="">MR CLEAN</a>), presented at the 9th World Stroke Congress in Istanbul, Turkey, revealed that direct vascular intervention (97% used retrievable stents) generated better outcomes than standard stroke therapy alone. The study also demonstrated that, despite generating better outcomes for patients, there is still room for improvement in vascular intervention. Clot particles were lost during interventional procedures, resulting in an ischaemic stroke to a new region of the brain 5.6% of the time, vs. 0.4% of the time in the control (ie., standard therapy) group.</span></p> <p><br /><span style="font-size: 10pt;">Lazarus Effect plans to launch the Lazarus Cover, which can be used with a variety of available retriever devices, in Europe during Q1 2015.</span></p> <p><br /><span style="font-size: 10pt;">The US Patent and Trademark Office recently issued a new patent covering core technology behind the Lazarus Cover, as well as the Lazarus ReCover device. The Lazarus Cover is a generalised device and can be used with a number of retriever types, whereas the ReCover is designed specifically for the retrieval of thrombus during an ischaemic stroke.</span></p></div> American Shared Hospital Services announces 2015 CMS gamma knife and proton reimbursement rates 2014-11-04T16:46:00Z 2014-11-04T16:46:00Z <div id="Introduction51" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>American Shared Hospital Services has announced that the Centers for Medicare and Medicaid Services (CMS) has posted its final Medicare hospital outpatient prospective payment rates for calendar year 2015. The rates for gamma knife and proton therapy remained as proposed earlier this year.</strong></span></p> </div><div id="Text151" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Effective as of 1 January, 2015, the Centers for Medicare and Medicaid Services has established a comprehensive ambulatory payment classification for both gamma knife and LINAC one session cranial radiosurgery. The reimbursement rate of approximately US$9,768 will be inclusive of the delivery and ancillary codes but exclusive of co-insurance payments or other adjustments. The average current Centers for Medicare and Medicaid Services reimbursement rate for delivery and ancillary codes (exclusive of co-insurance and other adjustments) is approximately US$5,600. This represents an estimated increase of US$4,168 per Medicare gamma knife treatment (exclusive of co-insurance and other adjustments) effective as of 1 January, 2015.<br /><br /></span></p> <p><span style="font-size: 10pt;">Medicaid Services&rsquo; final 2015 proton therapy delivery code rates per daily session are US$515 (US$872 in 2014) for a simple treatment without compensation, US$1,056 (US$872 in 2014) for a simple treatment with compensation, and US$1,056 (US$1,205 in 2014) for an intermediate or complex treatment.</span></p></div> ALS Association triples research spending following ice bucket donations 2014-11-04T15:56:00Z 2014-11-04T15:56:00Z <div id="ImageMain52" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction52" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The ALS (amyotrophic lateral sclerosis) Association Board of Trustees has developed a long-term strategy for leveraging the Ice Bucket Challenge donations it has received to advance its integrated mission of leading the fight to treat and cure ALS through global research, care services and public policy. This will result in the Association tripling the amount of money it spends on ALS research to ensure the most promising research continues to be funded. It will also result in greater support to the Association&rsquo;s Certified Treatment Centers of Excellence, which provide evidence-based, multi-disciplinary ALS care and services in a supportive atmosphere with an emphasis on hope and quality of life.</strong></span></p> </div><div id="Text152" style="clear:both; text-align:left"><p>&ldquo;We are thrilled with the additional funding for research and care services that the Ice Bucket Challenge has provided, even more important is the chance the entire ALS community now has to leverage our good fortune to work together toward our common goal of defeating this horrific disease,&rdquo; says Bill Thoet, chairman of the Board of Trustees of the ALS Association. &ldquo;Together, we now have the unique opportunity to fundamentally change the nature of this fight.&rdquo;<br /><br /></p> <p>&ldquo;We now have tremendous momentum in the search for a cure. Our integrated mission, combined with increased collaboration, is accelerating our ability to move potential treatments through the drug development process and improve the support for people living with ALS at our care centres,&rdquo; says Barbara Newhouse, president and chief executive officer of the ALS Association. The Certified Treatment Centers of Excellence both extend and improve the quality of life for those living with ALS, and actively participate in ALS-related research.</p> <p>Earlier this month, the ALS Association announced it was supporting six different programmes and initiatives designed to expedite the search for treatments and a cure for ALS. Four of these projects involve global research cooperative alliances that would not have moved forward without the funding from the ALS Association and the matching donations it received.<br /><br /></p> <p>In addition, the Association launched a new collaborative initiative that will bring the ALS community together to establish an ALS drug development guidance document. No such document currently exists, which creates uncertainty and risk for what already is a difficult, lengthy and costly process. The Association hopes that this initiative will incentivise ALS drug development, reduce obstacles and provide new opportunities to accelerate research and bring new treatments forward.</p></div> NeuroSigma receives notice of allowance for subcutaneous trigeminal nerve stimulation patent 2014-11-04T15:51:00Z 2014-11-04T15:51:00Z <div id="ImageMain53" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction53" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroSigma has announced that the Mexican Institute of Industrial Property has issued a Notice of Allowance for Mexican Patent Application No. MX/a/2012/004051. The patent application is co-owned by NeuroSigma and the Regents of the University of California as a result of research conducted by physicians and scientists at NeuroSigma and the University of California, Los Angeles (UCLA). NeuroSigma is the exclusive licensee of the Regents&rsquo; rights to the patent application.</strong></span></p> </div><div id="Text153" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The patent application is related to the use of trigeminal nerve stimulation with minimally invasive, subcutaneously implanted electrodes and pulse generator for the treatment of a wide variety of medical disorders including neurological and neuropsychiatric disorders such as epilepsy, depression, post-traumatic stress disorder, attention deficient hyperactivity disorder, and traumatic brain injury.<br /><br /></span></p> <p><span style="font-size: 10pt;">&ldquo;NeuroSigma has previously received several US patents related to our external and subcutaneous trigeminal nerve stimulation systems. We are very pleased to be receiving our first non-US patent related to our minimally invasive, fully implantable subcutaneous trigeminal nerve stimulation system, which is currently under development. It is an important step in obtaining patent coverage in markets outside of the USA in support of our global commercialisation strategy,&rdquo; says David Hayes, chief administrative officer and general counsel of NeuroSigma.</span></p></div> Studies support the use of the CyberKnife system as a safe and effective treatment option 2014-11-04T15:03:00Z 2014-11-04T15:03:00Z <div id="ImageMain54" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction54" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Accuray Incorporated has announced that studies presented at the 15<sup>th</sup> European Congress of Neurosurgical Societies (EANS) in Prague, October 12 &ndash; 17, 2014 reinforce the benefits of the CyberKnife robotic radiosurgery system for the treatment of neurological diseases such as meningiomas, acoustic neuromas, trigeminal neuralgia, and spinal tumours.</strong></span></p> </div><div id="Text154" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Alfredo Conti, neurosurgeon at the University Hospital of Messina in Italy is using the CyberKnife system to treat perioptic meningiomas. The flexibility of the CyberKnife system enabled by its unique architecture allows tumour control while preserving vision. The results Conti presented in a plenary session included a series of 64 patients with perioptic meningiomas treated in 2-5 fractions with CyberKnife schemes from July 2007&ndash;May 2010.</span><br /><br /></p> <p><span style="font-size: 10pt;">The study included two cohorts of patients with different tumour volumes. In one cohort, 25 patients with a small tumour volume (less than 5cc) were followed for an average of 60 months (+12 months). In the second cohort, 39 patients with a larger tumour volume (7.5cc) were followed for an average of 17 months (+10 months). No visual deterioration was observed and tumour control was achieved in all cases.</span><br /><br /></p> <p><span style="font-size: 10pt;">These results support the clinical benefits of CyberKnife treatment for perioptic meningiomas, and were achieved thanks to the ability to fractionate depending on the tumour volume and its proximity to the optic nerve.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The CyberKnife robotic radiosurgery system is able to treat safely and efficiently tumours with large volumes, in particular meningiomas, as well as acoustic neuromas,&rdquo; says Alfredo Conti. &ldquo;This is a real breakthrough because treating large tumours with radiosurgery in a single fraction is very challenging, and often not possible. Furthermore, treating tumours close to the optic nerves or other critical brain structures is sometimes very challenging for neurosurgeons and the CyberKnife system represents a safer and effective treatment option.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">A second study done by Pantaleo Romanelli, CyberKnife Center, Centro Diagnostico Italiano, Milan, Italy, evaluated the clinical benefits of the CyberKnife system as a treatment for patients with trigeminal neuralgia. A cohort of 103 patients was treated with a 60 Gy dose delivered in a single fraction by the CyberKnife system.</span><br /><br /></p> <p><span style="font-size: 10pt;">Results indicate that use of the CyberKnife system provides a safe and effective treatment option for people with trigeminal neuralgia. After six months, more than 90% of patients showed significant improvement in their symptoms. The system also provided an opportunity to successfully retreat 24 patients who had relapsed within two years from their first treatment.</span><br /><br /></p> <p><span style="font-size: 10pt;">Finally, at the Accuray symposium held in Prague at the 15th EANS congress, Alexander Muacevic, director of the Europ&auml;isches CyberKnife Zentrum in Munich, Germany, presented the extension of indications, such as spinal tumours, treated with the CyberKnife system. &ldquo;The CyberKnife robotic radiosurgery system is safe and effective in the treatment of spinal lesions. It treats with a sub-millimetre accuracy, which is crucial for tumour treatments all along the spine,&rdquo; Muacevic comments.</span></p></div> Boston Scientific announces schedule for presentations at NANS meeting 2014-11-03T16:38:00Z 2014-11-03T16:38:00Z <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>Boston Scientific will present data on key clinical programs at the 18th <a href="">North American Neuromodulation Society (NANS) Meeting</a>, being held in <span class="xn-location">Las Vegas</span>, from the 11-14 December 2014.&nbsp;</strong></span><span style="font-size: 11pt;"><strong>The company&rsquo;s data will focus on long-term back pain relief using the Boston Scientific Precision Spectra spinal cord stimulator system and highlight research on stimulation waveforms.</strong></span></p> </div><div id="Text155" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;We are excited about the continuing success of our next-generation Precision Spectra spinal cord stimulator system in providing sustained and highly significant low back pain relief, and we look forward to releasing our &rsquo;real-world&rsquo; experience with 12-month clinical data,&rdquo; says Maulik Nanavaty, president, neuromodulation, Boston Scientific. &ldquo;In addition, we are committed to further advancing the science and understanding of pain relief with our comprehensive research program exploring both high rate therapy and novel waveforms.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">Boston Scientific data will be presented during oral sessions or as posters. All programmes will be held at the Mandalay Bay and Four Seasons Hotels in Las Vegas. The programmes are as follows:<br /><br /></span></p> <p><span style="font-size: 10pt;">Precision Spectra spinal cord stimulation system:</span></p> <ul> <li><span style="font-size: 10pt;">PRO study (low back pain) - One-year, multicentre consecutive case-series of patients with chronic low back pain treated with the Precision Spectra spinal cord stimulation system using a 32-contact multiple independent current control system.</span></li> </ul> <p><span style="font-size: 10pt;">Advanced Research Programs:</span></p> <ul> <li><span style="font-size: 10pt;">ACCELERATE &ndash;Prospective multicentre trial evaluating high-rate (10 kHz) spinal cord stimulation in management of chronic, intractable pain.</span></li> <li><span style="font-size: 10pt;">WHISPER &ndash; Prospective multicentre trial evaluating the use of sub-perception multiple independent current control spinal cord stimulation</span></li> <li><span style="font-size: 10pt;">Preclinical Research &ndash; Pre-clinical model for investigating the mechanism of spinal cord stimulation.</span></li> </ul> <p><span style="font-size: 10pt;">Additionally, results will be released from the investigator-sponsored exploratory research of the sub-perception multiple independent current control spinal cord stimulation.</span></p></div> Over US$30m in funding allocated to rare brain disease research 2014-10-31T11:43:00Z 2014-10-31T11:43:00Z <div id="ImageMain56" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction56" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers studying frontotemporal degeneration disease, a leading cause of early onset dementia, will receive more than US$30m over the next five years in grants from the National Institutes of Health (NIH). The funding will be used to further scientific collaboration and investigate new treatments in the quest to find a cure for frontotemporal degeneration.</strong></span></p> </div><div id="Text156" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Frontotemporal degeneration received a total of four grants, each independently peer reviewed, that will allow for building reliable clinical networks to diagnose and treat frontotemporal degeneration and related variants; recruiting frontotemporal degeneration -causing gene mutation carriers for study; and study of a specific genetic mutation that is the most common cause of both inherited frontotemporal degeneration and inherited amyotrophic lateral sclerosis.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The frontotemporal degeneration community is extremely gratified to be the recipient of this unprecedented level of funding that we believe is the result of the tremendous momentum underway in frontotemporal degeneration science,&rdquo; says Susan Dickinson, executive director of The Association for Frontotemporal Degeneration. &ldquo;What started with frontotemporal degeneration&rsquo;s recent inclusion in national research priorities to cure Alzheimer&rsquo;s disease and other dementias by 2025, has now catapulted into what promises to be significant progress in learning about this debilitating neurodegenerative disease.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Three of the grants, totalling US$5.9 million per year, are being funded by the NIH&rsquo;s National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA) and the National Center for Advancing Translational Sciences (NCATS). The three projects will enable scientists to collaborate on research approaches for frontotemporal degeneration, with the goal of diagnosing and treating patients more effectively.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The projects aim to advance our understanding of frontotemporal degeneration by improving diagnosis, identifying preventive strategies and providing new insights into the genetics underlying this complex disorder,&rdquo; says Margaret Sutherland, program director at NINDS.</span><br /><br /></p> <p><span style="font-size: 10pt;">A fourth grant is part of US$29m earmarked for the Rare Diseases Clinical Research Network, a network of 22 consortia dedicated to furthering translational research and investigating new treatments for patients with rare diseases. The major focus of this grant is to study amyotrophic lateral sclerosis, including the disease variant of amyotrophic lateral sclerosis with frontotemporal degeneration.</span></p></div> Researchers join Biogen Idec to advance drug discovery for neurodegenerative diseases 2014-10-31T11:26:00Z 2014-10-31T11:26:00Z <div id="Introduction57" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Two leading neuroscientists have joined Biogen Idec to advance its research in neurodegenerative diseases. Christopher Henderson joins as vice president, neurology. Richard Ransohoff joins as senior research fellow, neuroimmunology. The addition of these top researchers bolsters Biogen Idec&rsquo;s discovery engine.</strong></span></p> </div><div id="Text157" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Henderson joins Biogen Idec from Columbia University, where he was the Gurewitsch and Vidda Foundation professor of rehabilitation and regenerative medicine with joint appointments in the departments of Pathology and Cell Biology, Neurology and Neuroscience. Ransohoff joins Biogen Idec from the Cleveland Clinic, where he served as director of the Neuroinflammation Research Center in the Department of Neurosciences of the Lerner Research Institute; professor of Molecular Medicine at the Lerner College of Medicine at Case Western Reserve University; and staff neurologist at the Mellen Center for Multiple Sclerosis Treatment and Research.</span><br /><br /></p> <p><span style="font-size: 10pt;">Biogen Idec has extensive discovery efforts focused on neurodegenerative and neuroimmune diseases, including Alzheimer&rsquo;s disease, Parkinson&rsquo;s disease, amyotrophic lateral sclerosis and multiple sclerosis. Henderson and Ransohoff will work collaboratively within Biogen Idec&rsquo;s research and development organisation to identify and accelerate the development of new product candidates. Both will report directly to Spyros Artavanis-Tsakonas, senior vice president and chief scientific officer of Biogen Idec.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Transformative medicines result from transformative science,&rdquo; says Artavanis-Tsakonas. &ldquo;We are bringing together some of the brightest minds in research to create new ways of looking at devastating neurological diseases where there are few, if any, effective therapies. Chris and Richard will help accelerate our efforts to bring innovative new medicines to patients who desperately need them.&rdquo;</span></p></div> New test to help brain injury victims recover 2014-10-30T16:31:00Z 2014-10-30T16:31:00Z <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>A dynamic new assessment for helping victims of trauma to the brain, including those suffering from progressive conditions such as dementia, has been developed by a clinical neuropsychologist at the University of Leicester, UK.</strong></span></p> </div><div id="Text158" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Short Parallel Assessments of Neuropsychological Status (SPANS) is the brainchild of Gerald Burgess from the University of Leicester&rsquo;s School of Psychology and has been designed to engage with patients suffering from a variety of brain injuries in order to aid in their recovery. </span><br /> <br /><span style="font-size: 10pt;"> SPANS is unique in that it measures the cognitive skills of individuals with acquired brain injury and progressive neurological conditions in a user-friendly and concise way, taking patients an estimated 35 minutes to complete. </span><br /> <br /><span style="font-size: 10pt;"> The assessment is capable of measuring seven key cognitive skills: orientation, attention and concentration, language, memory and learning, visuo-motor performance, efficiency and conceptual flexibility.</span><br /> <br /><span style="font-size: 10pt;"> An alternate version is available, SPANS B, which complements SPANS A for reliable retesting of patients. </span><br /> <br /><span style="font-size: 10pt;"> Both versions were developed based upon real neurological syndromes, such as aphasia, and common referral questions informed by Burgess&rsquo;s experience as a clinical psychologist in brain injury wards. </span><br /> <br /><span style="font-size: 10pt;"> Burgess says: &ldquo;With SPANS clinicians now have a broader and more reliable assessment that is even more useful than most tests for tracking changes in cognitive skills over time. Patients are now more thoroughly assessed by&nbsp;a test&nbsp;that is less taxing on them than some other tests, so that their difficulties may be better understood.&rdquo;</span><br /> <br /><span style="font-size: 10pt;"> The test is suitable to be administered by a range of healthcare professionals, including clinical or research psychologists, occupational therapists, speech and language therapists, psychiatrists and neurologists. </span><br /> <br /><span style="font-size: 10pt;"> During the development of SPANS Burgess worked with Hogrefe, the publisher, who helped in collecting data and developing SPANS to a professional standard through production and marketing efforts.</span></p></div> Diets high in fruit, vegetables, whole grains and nuts lower first-time stroke risk 2014-10-30T09:49:00Z 2014-10-30T09:49:00Z <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><strong><span style="font-size: 11pt;">Eating Mediterranean or DASH (Dietary Approaches to Stop Hypertension)-style diets, regularly engaging in physical activity and keeping blood pressure under control can lower a person&rsquo;s risk of a first-time stroke, according to updated American Heart&nbsp;</span><span style="font-size: 15px;">Association</span><span style="font-size: 11pt;">/American&nbsp;Stroke Association guidelines published in the </span><a style="font-size: 11pt;" href="">American Heart Association&rsquo;s</a><span style="font-size: 11pt;"> journal </span><em style="font-size: 11pt;"><a href="">Stroke</a></em><span style="font-size: 11pt;">.</span></strong></p> </div><div id="Text159" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;We have a huge opportunity to improve how we prevent new strokes, because risk factors that can be changed or controlled &mdash; especially high blood pressure &mdash; account for 90% of strokes,&rdquo; says James Meschia, lead author of the study and professor and chairman of neurology at the Mayo Clinic in Jacksonville, Florida, USA.<br /><br /></span></p> <p><span style="font-size: 10pt;">The updated guidelines recommend the following tips to lower risk:</span></p> <ul> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Eat a Mediterranean or DASH-style diet, supplemented with nuts;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Monitor high blood pressure at home with a cuff device;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Keep pre-hypertension from becoming high blood pressure by making lifestyle changes such as getting more physical activity, eating a healthy diet and managing your weight;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Reduce the amount of sodium in your diet;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Visit your healthcare provider annually for blood pressure evaluation;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; If your medication to lower blood pressure does not work or has bad side effects, talk to your healthcare provider about finding a combination of drugs that work for you;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Do not smoke. Smoking and taking oral birth control pills can significantly increase your stroke risk. If you are a woman who experiences migraines with aura, smoking raises your risk of stroke even more than in the general population.</span></li> </ul> <p><span style="font-size: 10pt;">Mediterranean-style and DASH-style diets are similar in their emphasis on fruits, vegetables, whole grains, legumes, nuts, seeds, poultry and fish. Both are limited in red meat and foods containing saturated fats, which are mostly found in animal-based products such as meat, butter, cheese and full-fat dairy.<br /><br /></span></p> <p><span style="font-size: 10pt;">Mediterranean-style diets are generally low in dairy products and DASH-style diets emphasise low-fat dairy products. Avoiding second hand smoke also lowers stroke and heart attack risks, according to the guidelines.<br /><br /></span></p> <p><span style="font-size: 10pt;">The writing committee reviewed existing guidelines, randomised clinical trials and some observational studies. &ldquo;Talking about stroke prevention is worthwhile,&rdquo; Meschia says. &ldquo;In many instances, stroke is not fatal, but it leads to years of physical, emotional and mental impairment that could be avoided.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">Co-authors are Cheryl Bushnell, Bernadette Boden-Albala, Lynne Braun, Dawn Bravata, Seemant Chaturvedi, Mark Creager, Robert Eckel, Mitchell Elkind, Myriam Fornage, Larry Goldstein, Steven Greenberg, Susanna Horvath, Costantino Iadecola, Edward Jauch, Wesley Moore, and John Wilson.</span></p></div> Traumatic brain injury associated with increased dementia risk in older adults 2014-10-29T09:55:00Z 2014-10-29T09:55:00Z <div id="Introduction60" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>According to a study published online by <em><a href="">JAMA Neurology</a>,</em>&nbsp;traumatic brain injury appears to be associated with an increased risk of dementia in adults 55 years and older.</strong></span></p> </div><div id="Text160" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Controversy exists about whether there is a link between a single traumatic brain injury and the risk of developing dementia because of conflicting study results. The Centers for Disease Control and Prevention says that Americans 55 years and older account for more than 60% of all hospitalisations for traumatic brain injury, with the highest rates of traumatic brain injury-related emergency department visits, inpatient stays and deaths happening among those patients 75 years and older. Therefore, understanding the effects of a recent traumatic brain injury and the subsequent development of dementia among middle or older adults has important public health implications.</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers Raquel C Gardner, of the University of California, San Francisco, and colleagues examined the risk of dementia among adults 55 years and older with recent traumatic brain injury compared with adults with non- traumatic brain injury body trauma, which was defined as fractures but not of the head or neck. The study included 164,661 patients identified in a state-wide California administrative health database of emergency department and inpatient visits.</span><br /><br /></p> <p><span style="font-size: 10pt;">In the study, a total of 51,799 patients with trauma (31%) had traumatic brain injury. Of those, 4,361 patients (8.4%) developed dementia compared with 6,610 patients (5.9%) with non-traumatic brain injury body trauma. The average time from trauma to dementia diagnosis was 3.2 years and it was shorter in the traumatic brain injury group compared with the non- traumatic brain injury group (3.1 vs 3.3 years). Moderate to severe traumatic brain injury was associated with increased risk of dementia at 55 years or older, while mild traumatic brain injury at 65 years or older increased the dementia risk.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Whether a person with traumatic brain injury recovers cognitively or develops dementia, however, is likely dependent on multiple additional risk and protective factors, ranging from genetics and medical comorbidities to environmental exposures and specific characteristics of the traumatic brain injury itself,&rdquo; the authors note.</span><br /><br /></p> <p><span style="font-size: 10pt;">Steven T DeKosky, of the University of Pittsburgh School of Medicine, writes: &ldquo;Unfortunately, there was not a non-trauma control group included, which may have answered the question of whether non-traumatic brain injury body trauma raised the risk of dementia significantly above age-equivalent controls without non-brain trauma (perhaps from inflammation or other complications).&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Judicious use of data by skilled researchers who are familiar with the entire range of dementia research from pathobiology to healthcare needs will enable us to ask important questions, evolve new or more informed queries, and both lead and complement the translational questions that are before us. Dementia is both a global problem and a pathological conundrum; thus, the complementary use of big data and basic neuroscience analyses offers the most promise,&rdquo; DeKosky concludes.</span></p></div> Thymosin beta-4 crosses blood-brain barrier in animal stroke model 2014-10-29T09:32:00Z 2014-10-29T09:32:00Z <div id="Introduction61" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>At the <a href="">Fourth International Symposium on Thymosins in Health and Disease</a> in Rome, Italy, researchers from RegeneRx Biopharmaceuticals reported on study findings in which thymosin beta-4 crossed the blood-brain barrier in an animal stroke model.</strong></span></p> </div><div id="Text161" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;When thymosin beta 4 (TB4) linked with rhodamine was injected into the peritoneal cavity in a rodent model of stroke, it was visualised outside of blood vessels and throughout the brain parenchyma. The leakage of TB4 in this rat model of embolic stroke confirmed our hypothesis that TB4 crossed the blood brain barrier since previous experiments using MRI and gadolinium showed compromise of the blood brain barrier in this model of embolic stroke,&rdquo; reports Daniel Morris, senior staff physician, Department of Emergency Medicine, Henry Ford Health System, Detroit, MI, USA.</span><br /><br /></p> <p><span style="font-size: 10pt;">These experiments show the ability of TB4 to cross the blood-brain barrier, which is impermeable to most drugs. Thus, health care providers would potentially have a novel means to treat patients of neurological injury in which the blood brain barrier is compromised, such as stroke, by systemically administering TB4 to accelerate repair and regenerate damaged brain tissue.&nbsp;</span></p></div> The Roskamp Institute discovers new target for drugs to treat Alzheimer&apos;s disease 2014-10-27T17:12:00Z 2014-10-27T17:12:00Z <div id="ImageMain62" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction62" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Published in the online edition of the <em><a href="">Journal of Biological Chemistry</a></em>, the results of the extensive studies offer a new target for drug development in the quest for a cure for Alzheimer&rsquo;s, the most prevalent form of dementia in the elderly.&nbsp;</strong></span></p> </div><div id="Text162" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Roskamp researchers have identified a single enzyme which propagates the three key hallmarks of Alzheimer&rsquo;s disease &ndash; inflammation, accumulation of amyloid protein, and modulation of the &rsquo;tau&rsquo; protein, all of which are responsible for damage to the nerve cells of the brain.<br /><br /></span></p> <p><span style="font-size: 10pt;">&ldquo;These studies suggest there is a single drug target to inhibit all the three key pathologies of Alzheimer&rsquo;s disease,&rdquo; says neurobiologist Daniel Paris, lead researcher for the study.<br /><br /></span></p> <p><span style="font-size: 10pt;">Michael Mullan, senior author of the published study, adds, &ldquo;Our studies have revealed that the spleen tyrosine kinase (SYK) enzyme is at a crossroad from which all three of the brain abnormalities known to be associated with Alzheimer&rsquo;s disease diverge. Hopefully, academic or industry researchers can now develop new drugs to inhibit SYK which are suitable for clinical trials in Alzheimer&rsquo;s disease.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">In working out how an anti-hypertensive drug called Nilvadipine works to reduce amyloid protein accumulations, Roskamp researchers realized the drug also had positive effects on neuroinflammation and thetau protein. The scientists retraced the molecular steps leading to these three factors and discovered they all led back to the SYK protein.<br /><br /></span></p> <p><span style="font-size: 10pt;">Paris then went on to show that drugs blocking SYK activity in the brain could represent a new strategy for treating Alzheimer&rsquo;s. "The potential for developing a single "multi-modal" drug treatment that will control all three of these Alzheimer&rsquo;s characteristics has us very excited,&rdquo; Paris says. &ldquo;All of these pathologies are interrelated. In theory, by interrupting these three molecular pathways, we can develop more effective drugs to stop the disease. To date, all the drugs that have been tested only attack one Alzheimer&rsquo;s characteristic, at a time. What is needed is one drug to address all three.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">Having discovered and demonstrated the molecular pathway linking SYK with these traits, Roskamp scientists are looking forward to testing their hypothesis, either by developing new drugs themselves or partnering with academic and commercial groups.<br /><br /></span></p> <p><span style="font-size: 10pt;">&ldquo;We didn&rsquo;t know until now that SYK was a possible therapeutic target for Alzheimer&rsquo;s disease,&rdquo; says Fiona Crawford, chief executive officer of the Roskamp Institute. &ldquo;We&rsquo;d be delighted for anyone to come up with an &lsquo;anti-SYK&rsquo; treatment to stop Alzheimer&rsquo;s.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">&ldquo;These findings are really significant,&rdquo; states David H Cribbs, research professor at University of California Irvine, associate director of the Institute for Memory Impairment and Neurological Disorders, and co-leader of the University of California Irvine Alzheimer&rsquo;s Disease Research Center neuropathology core.<br /><br /></span></p> <p><span style="font-size: 10pt;">&ldquo;With all of the failures of the clinical trials of drugs for this dementia up to this point the finding of new therapeutics is wonderful. And Nilvadipine has a good safety profile,&rdquo; he adds. A phase III clinical trial of Nilvadipine for Alzheimer&rsquo;s disease is currently underway in Europe.<br /><br /></span></p> <p><span style="font-size: 10pt;">Five hundred Alzheimer&rsquo;s patients in 26 clinics across nine countries are participating in the double-blind, placebo-controlled study that began in 2013. Each participant will be followed for 18 months to see if the drug is effective at slowing or stopping the course of the disease.</span></p></div> Encouraging trial results for electroCore’s non-invasive vagus nerve stimulation treatment for headaches 2014-10-27T15:50:00Z 2014-10-27T15:50:00Z <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>Preliminary results of an open-label trial carried in the <em><a href="">Journal of Headache and Pain</a></em> reported that a single treatment with electroCore&rsquo;s handheld non-invasive vagus nerve stimulation device gammaCore, completely resolved 44.8% of migraines within 30 minutes, with an additional 11.4% experiencing moderate benefits (incomplete resolution of their headaches) by two hours.&nbsp;</strong></span><br /> <!--[endif]--></p> </div><div id="Text163" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">This result follows two presentations at the International Headache Meeting in Copenhagen in September showing that patients using 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. It also found that patients experienced a greater reduction in number of attacks the longer they stayed on treatment.<br /><br /></span></p> <p><span style="font-size: 10pt;">This open-label migraine study was carried out at the Headache Centre in the Neurological Institute in Milan. The study involved thirty patients, 18 &ndash; 65, who had migraine without aura and suffered from five to nine attacks per month. Patients treated between three and six migraine episodes with gammaCore. Ninety six migraine attacks were treated by a single dose. Forty three attacks were resolved completely within 30 minutes (44.8%); for 42 (43.7%) attacks the application did not show any benefit in the first two hours so patients recurred to rescue medication; in 11 (11.4%) attacks the result was uncertain: no resolution of attack, only a moderate relief of pain. No adverse events were recorded.<br /><br /></span></p> <p><span style="font-size: 10pt;">Licia Grazzi, lead author, comments: &ldquo;The results look very promising and patients found the therapy easy to apply and it was well tolerated.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">electroCore had previously reported, at the <em><a href="">American Headache Society</a></em> that a US prevention of chronic migraine study, with a sham control arm, met its primary endpoint of safety, and demonstrated a reduction in the number of headache days per month for patients using the active device. The study suggests that patients who remain on therapy for longer periods of time, enjoy progressively larger decreases in headache days.<br /><br /></span></p> <p><span style="font-size: 10pt;">electroCore, which is running the broadest headache trial programs in the world, will report shortly on two further sham-controlled clinical studies; a US trial on the acute treatment of episodic and chronic cluster, and a European trial on the acute treatment of episodic and chronic cluster headache.<br /><br /></span></p> <p><span style="font-size: 10pt;">electroCore chief executive officer and founder JP Errico says: &ldquo;As the results of our studies continue to demonstrate positive results, we are increasingly optimistic that the extensive investment we have made in both pre-clinical trials and clinical trials was a wise use of our capital and human resources. We believe that this therapy is unique in both its safety and efficacy profiles. With few adverse events reported, non-invasive vagus nerve stimulation appears to be the first therapeutic option that offers both acute and prophylactic benefits for patients who suffer frequent and severe headaches. As such, we believe that gammaCore will ultimately move to a first line treatment for these patients, and will continue to conduct the clinical research necessary to support that conclusion.&rdquo;</span></p></div> A new window of opportunity to prevent cardiovascular and cerebrovascular diseases 2014-10-24T16:46:00Z 2014-10-24T16:46:00Z <div id="Introduction64" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Future prevention and treatment strategies for vascular diseases may lie in the evaluation of early brain imaging tests long before heart attacks or strokes occur, according to a systematic review conducted by a team of cardiologists, neuroscientists, and psychiatrists from Icahn School of Medicine at Mount Sinai and published in <em><a href="">JACC Cardiovascular Imaging</a></em>.</strong></span></p> </div><div id="Text164" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Mount Sinai researchers examined all relevant brain imaging studies conducted over the last 33 years. They looked at studies that used every available brain imaging modality in patients with vascular disease risk factors but no symptoms that would lead to a diagnosis of diseased blood vessels in the heart or brain, or periphery.</span><br /><br /></p> <p><span style="font-size: 10pt;">The review demonstrates that patients with high blood pressure, diabetes, obesity, high cholesterol, smoking, or metabolic syndrome, but no symptoms, still had visible signs on their neuroimaging scans of structural and functional brain changes long before the development of any events related to vascular diseases of the heart or brain.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This is the first time we have been able to disentangle the brain effects of vascular disease risk factors from the brain effects of cardiovascular and cerebrovascular disease and/or events after they develop,&rdquo; says the article&rsquo;s lead author, Joseph I Friedman, associate professor in the Departments of Psychiatry and Neuroscience at Icahn School of Medicine at Mount Sinai. &ldquo;Moreover, subtle cognitive impairment is an important clinical manifestation of these vascular disease risk factor-related brain imaging changes in these otherwise healthy persons.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Friedman adds that, because diminished cognitive capacity adversely impacts a person&rsquo;s ability to benefit from treatment for these medical conditions, early identification of these brain changes may &ldquo;present a new window of opportunity&rdquo; for doctors to intervene early and improve prevention of advancement from vascular disease risk factors to established cardiovascular and cerebrovascular diseases. His team is currently testing these hypotheses in ongoing studies at Mount Sinai.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Patients need to start today to control their vascular risk factors, otherwise their brains may forever harbour physical changes leading to devastating heart and vascular conditions impacting their future overall health and even cognitive decline causing diseases like dementia or when it exists it can accelerate Alzheimer&rsquo;s,&rdquo; says study author, Valentin Fuster, director of Mount Sinai Heart, physician-in-chief of The Mount Sinai Hospital, and chief of the Division of Cardiology at Icahn School of Medicine at Mount Sinai. &ldquo;Our publication raises the possibility that these early brain changes are major warning signs of what the future may hold for these asymptomatic patients. These high risk patients, along with their doctors, hold the power to modify their daily vascular risk factors to help halt the future course of the manifestation of their potentially looming cardiovascular diseases.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We hope our publication serves as a primer for cardiologists and other doctors interpreting the early neuroimaging data of their patients who may be high risk for vascular disease,&rdquo; says senior article author Jagat Narula, director of cardiovascular imaging, professor of medicine and Philip J and Harriet L. Goodhart chair in cardiology at Icahn School of Medicine at Mount Sinai. &ldquo;These subtle brain changes are clues to us physicians that our patients need to start to lower their vascular risk factors always and way before symptoms or a cardiac or brain event happens. This simple step to lower vascular risk factors can have huge impacts on global prevention efforts of cardiovascular diseases.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers identified the following impact of key vascular risk factors on the structural and functional brain health of asymptomatic patients:</span></p> <ul> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Hypertension is associated with globally appreciable brain volume reductions;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Connecting brain fibre abnormalities, reduced brain blood flow and alterations in the normal pattern of synchronised brain activity between different regions;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Diabetes is associated with connecting brain fibre abnormalities, reduced brain blood flow, and alterations in the normal pattern of synchronised brain activity between different regions;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Obesity is associated with brain volume reductions, reduced brain blood flow and metabolism;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; High total cholesterol and low-density lipoprotein cholesterol are associated with brain volume reductions, and connecting brain fibre abnormalities. In addition, high triglycerides are associated with reduced brain blood flow, and high total cholesterol is associated with reduced brain metabolism.</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Smoking is associated with brain volume reductions, and alterations of the normal pattern of blood flow. In addition, it causes reduced Monoamine Oxidase B which metabolizes dopamine, the neurotransmitter chemical that controls the brain&rsquo;s reward and pleasure zones.</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Metabolic Syndrome is associated with a greater burden of silent brain infarcts, visible only on MRI, which represents subclinical cerebrovascular disease. In addition, it is associated with connecting brain fibre abnormalities, and alterations in the normal pattern of synchronised brain.</span></li> </ul></div> ALS Association and NEALS issue request for proposals for phase II clinical development of ALS treatments 2014-10-24T15:26:00Z 2014-10-24T15:26:00Z <div id="Introduction65" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>ALS Accelerated Therapeutics (ALS ACT), the ALS Association, and the Translational Research Advancing Therapy ALS (TREAT ALS) Northeast ALS Consortium (NEALS) clinical trials have announced a call for phase II clinical trial applications for novel, high-potential treatments in amyotrophic lateral sclerosis (ALS).</strong></span></p> </div><div id="Text165" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The call for clinical study proposals is directed toward academic-industry partnerships, including pharmaceutical, biotherapeutic/biotechnology companies, academic members of the NEALS Consortium, and ALS scientists throughout the world. Up to US$1,500,000 in direct costs in ALS ACT clinical research support is available.<br /><br /> </span></p> <p><span style="font-size: 10pt;">In the United States, ALS affects one in approximately 30,000 people, with 5,000 new diagnoses each year. There is currently one FDA-approved treatment for ALS &ndash; Riluzole (Rilutek). The goal of this request for proposals is to expedite the process of bringing new treatments forward for testing in people with ALS and to measure if that therapeutic agent is reaching its target.<br /><br /></span></p> <p><span style="font-size: 10pt;">For this request for proposals, potential phase II clinical trials should include therapeutic interventions that have the following attributes: A pharmacodynamics marker that can measure whether pathway of interest has been affected and a plan to collect samples for biomarker studies.<br /><br /></span></p> <p><span style="font-size: 10pt;">The ALS ACT steering committee will review the applications, which will be judged on scientific rationale, merit, novelty, and the value of the project and the availability of appropriate facilities and the technical ability to carry out the clinical study.<br /><br /> </span></p> <p><span style="font-size: 10pt;">Funds will be awarded in the form of infrastructure support provided by NEALS and funds for per subject fee, sample collection, pharmacodynamic marker testing and other trial-related costs as needed. Applicants may apply for a combination of any of the following clinical research support services available through NEALS: project management, grants and contracts management, data management, study monitoring, outcome measure development and training, biostatistical support, site selection, start-up, regulatory document review, and ongoing site management and site trainings, which encompass good clinical practice, regulatory compliance and site management.</span></p></div> New NICE guidance to tackle inequalities in multiple sclerosis care 2014-10-24T15:18:00Z 2014-10-24T15:18:00Z <div id="Introduction66" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>People with multiple sclerosis should be offered a rapid and accurate diagnosis of their condition and access to specialist advice and proven therapies, says the National Institute for Healthcare and Excellence (NICE).</strong></span></p> </div><div id="Text166" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Multiple sclerosis is the most common neurological condition in young adults in the UK, affecting around 100,000 people. Currently, many people with multiple sclerosis are diagnosed in an ad-hoc way and are often misdiagnosed. People with multiple sclerosis can be left for more than a year without having their condition and medication monitored.<br /><br /></span></p> <p><span style="font-size: 10pt;">An audit carried out by the Royal College of Physicians and the Multiple Sclerosis Trust in 2011 found that although some multiple sclerosis patients received excellent care from the NHS, this was not universal and there were variations in both the quality and the quantity of care provided in England and Wales.<br /><br /></span></p> <p><span style="font-size: 10pt;">In an update to the original 2003 guideline, NICE has set out how people with multiple sclerosis can receive better care. Paul Cooper, consultant neurologist at the Greater Manchester Neuroscience Centre, who chaired the NICE guideline group, says: &ldquo;The care someone receives should not depend on where they live. One of the central areas that we have tried to address in the guidance is identifying and recognising inequalities in services and in care throughout the NHS.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">Cooper continues: "In the past some people got access to prompt and appropriate treatment but many did not. Many people with multiple sclerosis were diagnosed perhaps in a rather ad-hoc way without access to specialist advice, or information and support at the time of diagnosis. Many were potentially being misdiagnosed. The other area that we have tried to address is improving access to therapies of proven benefit for this disabling and distressing condition.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">Mark Baker, director of clinical practice at NICE, comments: &ldquo;It&rsquo;s a paradigm-shifting guideline which reshapes much of our advice on multiple sclerosis and its management. It&rsquo;s a full update and it lays out a new framework for the diagnosis and management of people suspected of having multiple sclerosis.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">In the update, NICE recommends that people with suspected multiple sclerosis should be referred to a consultant neurologist. Multiple sclerosis should not be diagnosed on the basis of MRI findings alone and only a consultant neurologist should make the diagnosis of multiple sclerosis.<br /><br /></span></p> <p><span style="font-size: 10pt;">Every person with multiple sclerosis should have a comprehensive review of all aspects of their care at least once a year and that multidisciplinary teams - made up of multiple sclerosis nurses, GPs, psychologists, and therapists - should oversee the care they receive.<br /><br /></span></p> <p><span style="font-size: 10pt;">The guidance does not recommend the use of the cannabinoid drug Sativex or fampridine as they provide only a modest benefit at a significant cost to the NHS. Sativex costs &pound;50,000 per quality-adjusted life year (QALY), while fampridine costs in the region of &pound;160,000 per QALY. Both are well above NICE&rsquo;s threshold of &pound;30,000 per QALY.<br /><br /></span></p> <p><span style="font-size: 10pt;">Other key recommendations include offering people with multiple sclerosis an appropriate single point of contact to speak about their care, concerns and different treatment options, and encouraging people with multiple sclerosis to exercise. Supervised exercise programmes should be available for those who struggle with mobility and fatigue.</span></p></div> Costs to treat bleeding strokes increases 10 years later 2014-10-24T14:59:00Z 2014-10-24T14:59:00Z <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>Costs to treat strokes caused by bleeding in the brain may increase significantly 10 years later, according to a study in the <em><a href="">American Heart Association</a></em> journal <em><a href="">Stroke</a>. </em>The Australian study is the first to include 10 years of follow-up data on stroke cost estimates</strong>.</span></p> </div><div id="Text167" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Generally, expenses associated with a stroke peak within the first year and decline over time. Previous estimates of lifetime costs in Australia were based on a five-year average and may have underestimated costs, specifically for haemorrhagic strokes.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Prevention of stroke should be a focus, since the costs of providing care to people who suffer stroke are unlikely to diminish,&rdquo; says Dominique Cadilhac, study senior author and an associate professor and head of the Translational Public Health: Stroke and Ageing Research Centre at Monash University in Victoria, Australia. &ldquo;Much could be gained if we could work to prevent the majority of strokes that are due to modifiable risk factors, such as high blood pressure or diabetes.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers interviewed 243 ischemic stroke patients and 43 intracerebral haemorrhage patients who had survived for 10 years or more. The patients had participated in an earlier Australian regional study that estimated five-year costs.</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers found that:</span></p> <ul> <li><span style="font-size: 10pt;">Average annual direct costs for ischaemic stroke remained stable between five to 10 years at about US$5,207.</span></li> <li><span style="font-size: 10pt;">Average annual direct costs for intracerebral haemorrhage stroke increased 31%, from US$5,807 at five years to US$7,607 at 10 years and the overall average lifetime costs per case for intracerebral haemorrhage stroke increased 25%, from US$43,786 to US$54,956.</span></li> <li><span style="font-size: 10pt;">Medication, aged-care facilities and informal care expenses explained the majority of costs at 10 years. Rehabilitation expenses decreased for ischemic stroke.</span></li> </ul> <p><span style="font-size: 10pt;">&ldquo;We did not know that the cost differentials would be so great between ischaemic stroke and interecerebral haemorrhage and that short-term estimates (six-12 months after a first stroke) used to approximate lifetime annual resource use after the first year would not be a good predictor of future costs,&rdquo; says Cadilhac, who is also the head of public health and epidemiology within the Stroke Division of the Florey Institute of Neuroscience and Mental Health and Data Custodian for the Australian Stroke Clinical Registry.</span><br /><br /></p> <p><span style="font-size: 10pt;">The Australian healthcare system is funded through public and private health insurance. However, the way health care is delivered and priced may influence cost differences between the two health systems. For example, if patients in America stay in the hospital longer or are offered different rehabilitation choices to what is available in Australia, estimates may be too low or high.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We hope that our findings can be used to influence the need for more primary prevention and to also support assessment of the cost effectiveness of interventions to reduce disability from stroke,&rdquo; Cadilhac comments. &ldquo;In addition, ensuring that the best evidenced-based guideline treatment is provided in hospitals will assist in reducing disability associated with stroke and may, in turn, avoid unnecessary aged-care placements or an undue burden to caregivers.&rdquo;</span></p></div> Codman Neuro launches first disposable forceps with dual irrigation 2014-10-22T11:07:00Z 2014-10-22T11:07:00Z <div id="ImageMain68" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction68" 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="Text168" 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="ImageMain69" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction69" 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="Text169" 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="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>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="Text170" 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="ImageMain71" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction71" 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="Text171" 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="Introduction72" 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="Text172" 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="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>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="Text173" 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="Introduction74" 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="Text174" 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="ImageMain75" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction75" 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="Text175" 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="Introduction76" 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="Text176" 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="Introduction77" 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="Text177" 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="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>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="Text178" 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="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>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="Text179" 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="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>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="Text180" 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="Introduction81" 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="Text181" 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="ImageMain82" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction82" 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="Text182" 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="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>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="Text183" 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="Introduction84" 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="Text184" 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="Introduction85" 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="Text185" 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="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>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="Text186" 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="ImageMain87" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction87" 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="Text187" 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="Introduction88" 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="Text188" 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="ImageMain89" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction89" 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="Text189" 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="Introduction90" 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="Text190" 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="ImageMain91" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction91" 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="Text191" 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="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>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="Text192" 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="Introduction93" 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="Text193" 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="Introduction94" 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="Text194" 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="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>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="Text195" 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="Introduction96" 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="Text196" 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="Introduction97" 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="Text197" 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="ImageMain98" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction98" 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="Text198" 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="Introduction99" 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="Text199" 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="Introduction100" 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="Text1100" 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>