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MIV Therapeutics Inc.

  • ISIN US55306V2051
  • Country Kanada

Company profile

MIV Therapeutics is developing a next-generation line of ultra thin, polymer-free passive and drug-eluting coatings for cardiovascular stents and a broad range of other implantable medical devices.


The Company’s proprietary ultra-thin, hydroxyapatite (HAp) based polymer-free coating has demonstrated excellent safety and biocompatibility in animal studies and human clinical trials for the Companies first hydroxyapatite based product the VESTAsyncTM Coronary Drug Eluting Stent System began in May 2007.


In August 2008, MIV reported continued excellent results of VESTAsyncTM, a polymer-free drug-eluting stent, at a twelve-month clinical follow up for all fifteen patients in its first-in- man (FIM) VESTASYNC I Trial. Patients remain free of any major adverse cardiac events or MACE. MIV also announced that it now has accumulated nine-month intravascular ultrasound (IVUS) and Quantitative Coronary Angiography (QCA) for all fifteen patients enrolled in the VESTASYNC I trial. This data showed no statistical difference from the safety and efficacy data reported at four months. Patients in the VESTASYNC I trial will be followed for two years and the company expects to continue to provide updates throughout the duration of the follow up period. Most importantly, patients in the VESTASYNC I study have not been taking anti-platelet medication (Plavix) for almost one year now and remain event free.


In addition to the ongoing VESTASYNC I trial, MIV continues to enroll patients in the VESTASYNC II trial. The VESTASYNC II trial is a 120 patient randomized controlled study designed to demonstrate the safety and efficacy of the VESTAsyncTM Stent in a larger group of patients. It is anticipated that the VESTASYNC II results will form the basis of a regulatory filing for marketing approval in Europe. Building on the positive outcomes of the VESTASYNC I study VESTASYNC II patients will be given antiplatelet medication (Plavix) for only three months. This is in stark contrast to the current anti-platelet standard, which is a minimum duration of one year and in many cases lifelong therapy.


In July of this year, MIV reported its ProteaTM ultra-thin cobalt-alloy bare metal stent has excelled in animal studies. Protea is the company’s next generation bare metal stent and is the bare-metal stent platform for the VESTAsync stents that are currently being implanted in the VESTASYNC II study. Animal results showed that the ultra-thin strut Protea with MIV’s proprietary surface finishing technology is statistically superior to one of the best and most deliverable cobalt-alloy bare metal stents on the market today.


In October 2006 the Company’s GenX Coronary Stent System received CE Mark and is currently being marketed in countries honoring the CE Mark through BioSync Scientific, the Company’s wholly owned subsidiary in Surat, India.


MIVT has a Collaborative Research Agreement (CRA) with The University of British Columbia and has received Government grant for its research program on the ‘Development of Novel Drug Eluting Composite Coatings for Cardiovascular Stents,’ under the National Research Council-Industrial Research Assistance Program (NRC-IRAP). In collaboration with the University of British Columbia, the Company has developed unique coating technologies that utilize HAp for application on medical devices and drug delivery systems. MIVT has licensed from the UBC worldwide rights to technologies for coating stents and other medical devices with HAp.


Hydroxyapatite is a naturally occurring porous material that makes up human bone mineral and the matrix of human teeth and is widely used today as a bone substitute material and for coatings on implantable fixation devices in orthopedic, dental and other applications.


Introduction of new biocompatible polymer-free coatings is expected to provide an attractive alternative to current polymer-based drug-eluting coatings especially in the drug eluting stent market, where it is widely believed that polymers are associated with an increase in undesirable side effects that may be fatal.