MIV Therapeutics Receives India Regulatory Approval For Two Bare Metal Stents

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 13 Nov 2007 - 4:00 PDT

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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, announces that the Drugs Controller General of India (DCGI), the governmental agency with regulatory authority over medical products, has approved two of the Company's bare metal stents for manufacture and sale in India.

The GenX™ Stainless Steel Coronary Stent & Stent System and the GenX™ CrCo Chromium Cobalt Coronary Stent & Stent System along with the company's additional angioplasty products will be officially launched into the Indian market at the Cardiological Society of India 59th Annual Meeting beginning December 5th to 9th in Hyderabad and will be available for sale in India through third party distributors.

Dr. Mark Landy, president of MIV Therapeutics, said, "This regulatory achievement permits MIV Therapeutics' entrée into one of the world's fastest growing stent markets with a highly competitive offering, and allows us to continue refining and increasing our manufacturing capability as we advance the clinical development of our unique drug-eluting stents using our advanced biocompatible coatings and drug delivery technology."

Coronary heart disease is a major health problem in India, one of the world's largest markets. According to a global study on cardiac diseases by the World Health Organization (WHO), India has the highest number of deaths from coronary heart disease in the world, exceeding 1.5 million in 2002. The WHO has predicted a cardiac epidemic for India by 2010.

"These two stents are designed to expand in a very controlled manner providing better vessel coverage. By expanding from the center outwards versus from the edges inwards they are designed to help reduce the injury caused during stent deployment and expansion. We believe they will help cardiovascular patients in India lead longer, healthier lives," concluded Dr. Landy.

The two stents are identical in design and performance with the main difference being strut thickness. The GenX™ Stainless Steel Coronary Stent has a strut thickness of 105 microns making it one of the thinnest-strut stainless steel stents available today. The GenX™ CrCo Chromium Cobalt Coronary Stent has a strut thickness of 65 micron, placing it amongst the thinnest-strut stents available today. Strut thinness has long been regarded as an important stent design feature as it reduces injury and aids re-endothelialization leading to lower restenosis and thrombosis rates.

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 http://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.

MIV Therapeutics