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Muralidhar Rejeti
MIV Therapeutics VESTAsync(TM) Drug-Eluting Stent Trials Progress
In August, MIV reported continued excellent results of VESTAsync(TM), 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 VESTAsync(TM) 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 anti-platelet 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 life-long therapy.
In July of this year, MIV reported its Protea(TM) 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.
"We are pleased with the continued progress of our international trials and are confident MIV will reach approval for VESTAsync," said Dr. Mark Landy, Chief Executive Officer of MIV Therapeutics. "MIV remains focused on our objective to provide a safer drug-eluting stent requiring short-term anti-platelet therapy to cardiovascular patients in need."
Dr. Landy concluded, "MIV is committed to seeing VESTAsync and our product pipeline through clinical trials and look forward to communicating further progress with our shareholders and the investment community as we continue to pursue our shared goals."
About MIV Therapeutics
MIV Therapeutics is developing a next-generation line of advanced biocompatible coatings for passive and drug-eluting applications on cardiovascular stents, as well as for a broad range of other implantable medical devices. The Company's ultra-thin coating formulation is designed to protect surrounding tissue from potentially harmful interactions with bare metallic stents. This coating platform is derived from hydroxyapatite (HAp), an organic material that has demonstrated excellent in vivo safety and biocompatibility. Hydroxyapatite is a porous material that makes up the bone mineral and matrix of teeth, and is widely used today as a bone substitute material and for coatings on implantable fixation devices in orthopedic, dental and other applications. The Company's novel polymer-free drug-eluting technologies based on HAp could also provide an attractive alternative to current polymer-based drug-eluting coatings on the stent market, which have been associated with undesirable effects. The Company's drug-eluting coatings are additionally designed to suit a broad range of implantable medical devices that could benefit from highly customizable drug release profiles. MIV Therapeutics has a Collaborative Research Agreement with the University of British Columbia and has received a 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. Under this sponsorship, the Company is expected to complete its drug-eluting research and development program and to reach product commercialization. MIV's intellectual property portfolio includes patents held by the University of British Columbia and exclusively licensed to MIV. Key patent applications filed simultaneously in various countries around the world further protect the commercial exclusivity of MIV's inventions in the global marketplace. For more information, please visit www.mivtherapeutics.com.
For Investor Inquiries: MIV Therapeutics, Inc. Anthony L. Huston, 604-301-9545, x14 Vice President, Business Development & Investor Relations ahu...@mivtherapeutics.com inve...@mivtherapeutics.com or The Investor Relations Group Investor Relations: Rachel Colgate, 212-825-3210 rcol...@investorrelationsgroup.com or Media Relations: Laura Colontrelle, 212-825-3210 lcolon...@investorrelationsgroup.com