Healthcare Industry News: drug-eluting stent
News Release - November 29, 2006
MIV Therapeutics Announces Company's Biocompatible Stents Matches or Outperforms World's Leading Drug-Eluting Stent in Key CategoriesExcellent Results from Preclinical Study of Biocompatible Polymer-Free Drug Eluting Stent Coating Technologies Paves the Way Towards Human Trials
ATLANTA--(HSMN NewsFeed)--MIV Therapeutics Inc. (OTCBB:MIVT ; FWB:MIV), a leading developer of next-generation biocompatible polymer-free drug-eluting stents and advanced drug delivery systems, announced today that a comparative animal study of two of its novel polymer-free drug-eluting stent coating technologies has concluded with positive results.
This study compared stents coated with MIVT's polymer-free drug-eluting technologies to the J&J Cypher(TM) stent, one of the world's best selling drug-eluting stents. The Study successfully demonstrated that both of MIVT's proprietary, polymer-free, Sirolimus eluting coatings are at least as good as Johnson & Johnson's Cypher(TM) Stent. The study also demonstrated MIVT's coatings' potential and efficacy when compared to Cypher(TM).
The independently conducted four-week porcine study, performed by the Department of Cardiology, Thoraxcenter, Erasmus University Medical Center in the Netherlands, indicated that three variations of MIV's polymer-free Drug-Eluting coatings were at least as effective as -- and in some cases, better -- than Johnson & Johnson's Cypher, one of the world's leading drug-eluting cardiovascular stents.
Dr Willem J. van der Giessen, MD, PhD, Interventional Cardiologist and Dr. Heleen M.M van Beusekom, PhD, Experimental Cardiology, from the Thoraxcenter at the Erasmus University Medical Center were the study directors. The objectives of the study were to evaluate the safety of MIVT's Hydroxyapatite coating and to assess the efficacy of MIVT Sirolimus coated stents in a porcine coronary model.
The results from the first part of the study, conducted with no drug added to the coatings, showed that HAp coated stents and bare metal stents did best and performed equally well.
The results from the second part of the study, with drugs added to the coatings, showed that all of the MIVT drug-eluting technologies performed at least as well, and in some cases better than the industry's benchmark, the J&J Cypher(TM) stent.
The study concluded that MIV's HAp coating, with or without drugs, demonstrated highly promising performance. Based on these results the company will begin preparations for human implantation.
"The results of this study indicate that our drug-eluting polymer-free technologies are at least on par with the best in the world. We believe we have very strong candidates for a superior product as we move into the next phase of our regulatory program," said Dr. Mark Landy, President of MIV Therapeutics.
The study was conducted in a standard model of porcine coronary arteries and utilized angiography and histology to evaluate tissue response to stents coated with MIVT's proprietary polymer-free coatings in comparison to identical bare metal stents and also stents coated with MIVT's proprietary Sirolimus eluting technology to J&J's Cypher(TM) (Sirolimus) stent.
MIV Therapeutics is developing a diverse suite of Polymer-Free HAp coating formulas to improve the biocompatibility of stents and other implantable medical devices. Hydroxyapatite (HAp) occurs naturally in human bones and teeth. It rapidly integrates into the human body and has been shown to have excellent stability and biocompatibility. HAp is non-toxic, non-thrombogenic, non-inflammatory and has been shown to promote angiogenesis.
HAp coatings are also expected to reduce the increased risk of deadly blood clots currently associated with today's polymeric drug-eluting stents. Recent information presented at leading cardiology conferences estimated that blood clots have been identified in at least 20,000 cases of implanted drug-eluting stents to-date, resulting in approximately 8,000 premature deaths.
MIVT recently announced that it intends to begin the first human implants of a HAp Nano Film Coated stent early in 2007. Human implantation represents a significant milestone in MIVT's strategic plan to develop a new class of polymer-free drug-eluting stents that could provide patients with superior outcomes.
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 bioactive 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 "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. 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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