Healthcare Industry News: VESTASYNC
News Release - September 15, 2008
MIV Therapeutics VESTAsync(TM) Drug-Eluting Stent Trials ProgressExcellent Safety and Efficacy Data
ATLANTA--(HSMN NewsFeed)--MIV Therapeutics, Inc. (OTCBB: MIVI, www.mivtherapeutics.com), a leading developer of next-generation coatings and advanced drug-delivery systems for cardiovascular stents and other implantable medical devices, provides corporate update.
In August, MIV reported continued excellent results of VESTASYNC™, 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™ 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™ 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.
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements. All statements that discuss expectations and projections with respect to future matters including, without limitation, statements relating to the safety and efficacy of the Company’s product and the ability of the Company’s product to rejuvenate the stent market are forward-looking statements. Such statements are indicated by words or phrases such as “proposed,” “expected,” “believe,” “will,” “breakthrough,” “significant,” “indicated,” “feel,” “revolutionary,” “should,” “ideal,” “extremely” and “excited.” These statements are made under “Safe Harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those described in forward-looking statements and are subject to risks and uncertainties including, without limitation, market acceptance of the Company’s product, the ability of the Company to raise sufficient funding and to continue to develop its various business interests as presently contemplated, and other factors identified in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's annual report on Form 10-K for the year ended May 31, 2007 and Forms 10-Q. The Company expressly disclaims any obligation to update publicly or otherwise revise these statements, whether as a result of new information, future events or otherwise, except to the extent required by law.
Source: MIV Therapeutics
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