MIV Therapeutics (MIVT) has continued its expansion with two acquisitions, strengthening its portfolio in embolic protection systems and drug eluting stents. In addition, the company has received a US Government grant to research drug eluting composites for cardiovascular stents.
MITV has completed its acquisition of SagaX Medical Technologies, Inc., a company developing a range of proprietary solutions that decrease likelihood of strokes and other frequently-occurring. SagaX is developing a proprietary Aortic Embolic Protection Device (AEPD) and other related devices at its research and development center in Herzliya, Israel. The AEPD filters the blood in the aorta capturing embolic particles which originate in the heart and are released during heart surgery and other invasive cardiology procedures. This filtration prevents the embolic particles from traveling upstream in the direction of the patient's brain.
MIVT believes the SagaX embolic protection device will be particularly useful during invasive heart procedures such as electrophysiology, valve dilatations and valve repair through angioplasty. In addition, the technology may also find broad preventative application during minimally invasive alternatives to open surgery. The market for AEPD is estimated to exceed $1.5 to $1.8 billion by 2009.
The SagaX AEPD employs patented stent based filter-deflector technology that can be used during trans-catheter cardiology procedures, as well as during heart surgery, to minimise the risk of stroke. Cardioembolic Stroke, a grave post-procedural complication, is most frequently experienced by patients with a number of risk factors. AEPD is one of the latest innovations in the field of filter-based embolic protection devices, and is the only filter developed for use in the aorta. Preliminary evaluation of prototype devices confirmed superior effectiveness of AEPD in comparison to other competitive devices in an in-vitro model.
Renowned cardiac surgeon Dr Dov Shimon, founder of SagaX, will continue to direct the AEPD research and development programme. Shimon, who is also Chief Medical Officer and Director of MIVT, said the company remains confident that based on the prior experience with implantable vascular mechanical filters, this is an effective solution minimising the chronic high risk of cardioembolic stroke and other potential post-procedural complications frequently associated with open heart surgery and some less invasive cardiovascular procedures.
In addition, MIVT has agreed to purchase Sahajanand Medical Technologies (SMT), one of the world's largest manufacturers of advanced coronary stents. SMT based in Surat, India, is the largest privately-held producer of coronary drug eluting stents outside of North America, with its stents sold in more than 33 countries and over 25,000 implants. The companies believe they will enter into a definitive agreement by April 2005, pending the successful completion of routine required auditing procedures. MIVT expects SMT to generate approximately $20 million in revenues in the next year. The company estimates that the market for its advanced stents will grow to approximately $100 million in the next three years.
MIVT is developing a next generation line of proprietary advanced biocompatible coatings for passive and drug-eluting application on cardiovascular stents and other implantable medical devices. MIVT's proprietary ultra-thin coating has been derived from a unique biocompatible material called Hydroxyapatite (HAp) that has been shown to significantly inhibit the body's inflammatory response, and other serious complications.
"This acquisition creates powerful synergies that will immediately make MIVT a world-class stent company, uniting our pipeline of proprietary future science with SMT's advanced manufacturing and distribution capabilities," said lan Lindsay, MIVT's President and CEO. "Access to SMT's facilities and personnel will also enable MIVT to accelerate our business and scientific strategies in the commercialisation of our unique Hap-based coating technology for biocompatible and drug-eluting stents. The union of our companies will truly make MIVT a major industry player."
Among the SMT's products are drug-eluting stents called the Infinnium Stent, and the Supralimus Stent, as well as bare metal Matrix Stent. SMT originally developed the advanced laser-based production technique to cut diamonds; because of that innovation 80% of the world's diamonds are now cut in India.
Since adapting that technology to the production of coronary stents, large clinical registry studies have shown the SMT stents provide performance on par with the best products, involving more than 2,000 post-operative patients.
SMT expects to cross the benchmark of 50,000 implanted stents in the current year. SMT's laser cutting methods also enable the company to produce state-of-the-art stents at significantly lower prices than competitors.
Since 1998, SMT-India has been focused on drug eluting stents. In 2002, Infinnium Revolutionary Paclitaxel Eluting Stent was commercially launched in the Indian market and has been an overwhelming domestic success. Subsequently the Supralimus stent was launched in 2004. SMT products are supplied in over 140 Cathlabs across India with exports made in 17 countries worldwide and locally registered products in five countries. The prospective study called "Simple II" was completed recently and will be presented at Euro-PCR in Paris in May, 2005.
In addition, MIVT's wholly-owned subsidiary, MIVI, a developer of multilayer coating technologies with drug eluting capability for cardiovascular stents and other implantable devices, has received a US Government grant for the research programme entitled "Development of Novel Drug Eluting Composite Coatings for Cardiovascular Stents".
The National Research Council has approved MIVI's application following an in-depth familiarisation with the advanced concept of novel technologies proposed by MIVI, and a review of the company's organisational and fiscal capability to carry on with the proposed $1 million R&D programme.
Dr Tom Troczynski, Professor of Ceramics at The University of British Columbia and MIVT Vice President of Coatings said, "The programme will develop a new generation of multilayer drug eluting coatings combining the superb biocompatibility already achieved by our proprietary HAp coatings with expanded applications and enhanced properties offered by the composites."
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