Healthcare Industry News: sirolimus-eluting
News Release - October 22, 2007
MIV Therapeutics Announces Positive Results From First Human Study With Its VESTASYNC Stent
Good Efficacy Observed With No Major Adverse Coronary EventsATLANTA, GA--(Healthcare Sales & Marketing Network)--Oct 22, 2007 -- MIV Therapeutics, Inc. (OTC BB:MIVT.OB ) (Frankfurt:MIV.F ), a leading developer of next-generation coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices, announced positive results from the four-month follow up of its First-In-Man study with its VESTASYNC stent. In a presentation titled "The MIV Polymer-Free Hydroxyapatite-Coated sirolimus-eluting Stent: First-in-Man Angiographic and IVUS Follow-Up Results," Principal Investigator Alexandre Abizaid, M.D., Ph.D., Chief of Coronary Intervention of Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil, noted excellent safety data with no Major Adverse Coronary Events (MACE), and good efficacy data.
At the Transcatheter Cardiovascular Therapeutics (TCT) 2007 conference being held this week at the Washington Convention Center in Washington, D.C., Dr. Abizaid presented four-month follow-up efficacy data on 13 patients in the 15-patient study, which by angiography showed average late-lumen loss of 0.27 mm (+/-0.27) in-stent and 0.18 mm (+/-0.31) in-lesion, and zero percent restenosis. IVUS analysis showed volumetric obstruction of only 2.8% (+/-2.4). All patients were thrombosis-free.
"These are excellent data, and they compare very favorably with FIM data generated by the currently available drug eluting stents both in the U.S. and abroad," commented Dr. Abizaid. "We are looking forward to completing our patient follow up and to further reporting on angiographic and IVUS data at nine months."
Dr. Mark Landy, president of MIV Therapeutics, said, "Based on this pilot trial, our VESTASYNC polymer-free HAp sirolimus-eluting stent system is sufficiently safe and effective to warrant testing in a larger human study. We are very pleased to be developing our protocol for further testing in the first half of 2008."
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.
Forward-Looking Statements
Except for the historical information contained herein, the matters discussed in this press release 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, the ability of the Company to raise sufficient funding and to continue to develop its various business interests as presently contemplated. See the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's recent Form 10-K and Form 10-Qs, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
Source: MIV Therapeutics
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