Healthcare Industry News: drug-eluting stent
News Release - March 31, 2008
MIV Preliminary Nine-Month Human Data Affirms Excellent Safety and Efficacy of VESTAsync(TM) Polymer-Free Drug-Eluting StentPreliminary Results Presented at the Annual Meeting of the American College of Cardiology Conference Call to be Held Wednesday April 2nd, 2008 at 11:00 a.m. ET
ATLANTA--(HSMN NewsFeed)--MIV Therapeutics, Inc. (OTCBB:MIVT ) (Frankfurt:MIV ), a leading developer of next-generation coatings and advanced drug-delivery systems for cardiovascular stents and other implantable medical devices, announced that nine month results from the first-in-man (FIM) MIVT Pilot Trial of its VESTAsync™ drug-eluting stent suggest that the stent has the potential for superior safety and equivalent efficacy when compared to currently available drug-eluting stents. Jose Costa, M.D. of Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil discussed the preliminary data in a moderated poster presentation yesterday at the 57th Annual Scientific Sessions of the American College of Cardiology in Chicago. The presentation titled, “Preliminary Results of the Hydroxyapatite Non-Polymer-Based Sirolimus-Eluting Stent for the Treatment of Single de novo Coronary Lesions: A First-in-Human Analysis of a Third-Generation drug-eluting stent System” concluded that the VESTAsyncTM polymer-free nanoscale microporous hydroxyapatite stent demonstrates excellent efficacy and safety.
Dr. Costa presented nine month follow up intravascular ultrasound (IVUS) data for 11 patients who demonstrated a volumetric obstruction of 3.8% (+/- 2.3%) versus 2.8% (+/- 2.2%) at four months. Quantitative coronary angiography (QCA) of 12 patients at nine months found a late-lumen loss of 0.37mm (+/- 0.24) versus 0.31mm (+/- 0.26) at four months. The study concluded that there was no significant difference between the four and nine month results and that the observed degradation was uniform across all patients with no outliers. No late acquired incomplete stent apposition, stent thrombosis or major adverse coronary events were reported.
Dr. Costa commented, “The preliminary nine month data of the MIVT Pilot Trial are very encouraging, and reaffirm our positive findings at four months. The data compare favorably with FIM data of drug-eluting stents available in the United States and abroad, but what is more remarkable is these results were obtained with 60% less drug delivered from an ultra-thin 0.6 micron coating that is entirely polymer-free.”
Dr. Mark Landy, MIVT President and Chief Executive Officer remarked, “We are very excited with the data generated from the MIVT Pilot Trial. Not only do the data demonstrate that our VESTAsyncTM polymer-free drug-eluting stent is safe and effective, but we believe that it suggests the potential to rejuvenate the worldwide drug-eluting stent market and increase stent usage. We are looking forward to conducting a larger trial in the coming months to further support our belief that the VESTAsyncTM has the potential to deliver drug-eluting stent efficacy with bare metal stent safety, and short-term anticoagulant therapy. We expect to begin this trial in the second quarter of this year and look forward to providing updates as we move ahead.”
Conference Call and Webcast Information
MIV will hold a conference call and webcast on Wednesday, April 2, at 11:00 a.m. Eastern time to discuss this announcement and to answer questions. The speaker on the call will be Dr. Mark Landy, MIV’s president and chief executive officer. The webcast will be accessible through the Investor Relations section of MIV's website at www.mivtherapeutics.com, and will be archived on the website for future on-demand replay.
Alternatively, the live call can be accessed by dialing (866) 844 - 2998 from the U.S. and Canada or (706) 634-9275 for international callers. A telephone replay will be available from noon Eastern time on April 2, 2008 through 11:59 p.m. Eastern Time on April 9, 2008 by dialing (800) 642-1687 (domestic) or (706) 645-9291 (international) and entering conference ID number 41676644.
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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