Healthcare Industry News: drug-eluting stent
News Release - April 5, 2007
MIV Therapeutics Announces Pivotal Test Results Further Validating Company Stent Coatings Meet Critical FDA Fatigue GuidelinesBench Test Merged Biosync Stent Platform with Company's Biocompatible Coating, Validating Milestone Acquisition of India-Based Subsidiary
ATLANTA--(HSMN NewsFeed)--MIV Therapeutics Inc. (OTCBB:MIVT ; FWB:MIV), a leading developer of next-generation biocompatible coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices, today announced that a recent Company sponsored bench test confirmed that merging Biosync Scientific's certified bare metal stent platform, which MIVT recently acquired, with the Company's polymer-free drug delivery system met critical "FDA Draft Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices" requirements for in vitro mechanical fatigue testing.
The milestone bench test further validates the recent acquisition of India-based Biosync Scientific. The acquisition is expected to accelerate the commercialization of MIVT's proprietary next generation stent technology that targets an estimated $8 billion marketplace.
"We want to establish a high bench mark against which similar coating will have to be compared," said Mark Landy, President of MIV Therapeutics. "This test was a major validation of both our next generation drug eluting technology as well as our strategic move to acquire Biosync Scientific. It also reflects our mission to do everything possible in our commitment to bring to the market a safe, effective product, even if it means going beyond FDA mandates."
The rigorous bench test combined Biosync's GenX Cr-Co, a highly competitive bare metal stent platform that has already received CE Mark certification, with MIVT's HAp technology, a novel polymer-free drug-eluting stent coating. The test results proved that MIVT's microporous ceramic coating demonstrated exceptional durability with no failures, exceeding critical FDA longevity requirements.
The bench test successfully demonstrated the integrity of MIV's HAp and bare metal stents under mechanical fatigue failures for a minimum of 10 years post-implantation. There were no failures of stent structure detected at Medical Device Testing Services during 30x endoscopic inspection of either the GenX Cr-Co Hydroxyapapatite coated stents, or the GenX Cr-Co bare metal stents.
The Biosync Scientific acquisition was the latest step in MIVT's strategic plan to become a world leader in the multibillion billion dollar interventional cardiology market. MIVT also recently signed an agreement to acquire Vascore Medical, a China-based manufacturer and distributor of advanced interventional cardiology devices.
About MIV Therapeutics Inc.
MIV Therapeutics is developing a next-generation line of advanced biocompatible coatings for passive and drug-eluting applications on cardiovascular stents and 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. The Company's unique ultra-thin coating platform is derived from an organic material called hydroxyapatite (HAp) which has demonstrated excellent safety and biocompatibility in vivo animal studies. 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 Hydroxyapatite could also provide an attractive alternative to current polymer-based drug eluting coatings on the stent market, which have been associated with undesirable medical 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. 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). Under this sponsorship, the Company is expected to complete its drug-eluting research and development program and to reach product commercialization stage.
For more information, please visit http://www.trilogy-capital.com/tcp/mivt/website.html. To read or download MIV Therapeutics' Investor Fact Sheet, visit http://www.trilogy-capital.com/tcp/mivt/factsheet.html. To obtain daily and historical Company stock quote data, and recent Company news releases, visit http://www.trilogy-capital.com/tcp/html/mivt.htm. MIVT is traded on the Frankfurt, Germany, stock exchange under the symbol MIV.
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 potential for the unsuccessful closing by the Company of its Vascore acquisition, together with the raising of funding sufficient to continue with its operations and those contemplated by the Company as a consequence thereof, and 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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