Healthcare Industry News: drug-eluting stent
News Release - November 8, 2007
New Data Show MIV Therapeutic's Vestasync Drug Eluting Stent Produces Less Fibrinoid and Equivalent Efficacy When Compared to Other StentsPre-Clinical Data Presented at AHA Meeting
ATLANTA, GA--(Healthcare Sales & Marketing Network)--Nov 8, 2007 -- MIV Therapeutics, Inc. (OTC BB:MIVT.OB ) (Frankfurt:MIV.F ) ("the Company"), a leading developer of next-generation coatings and advanced drug-delivery systems for cardiovascular stents and other implantable medical devices, announces that new data from a previously presented animal study comparing the safety and efficacy of the Company's Vestasync hydroxyapatite (HAp) coronary stent coating with low-dose Sirolimus to the Cypher® Stent showed less fibrinoid, a marker for delayed healing and equivalent efficacy. The data were presented at the American Heart Association's Scientific Sessions 2007 in Orlando, Fla. yesterday.
Lead researcher Helena M. van Beusekom of Erasmus MC in Rotterdam, The Netherlands, made an oral presentation entitled, "Hydroxy apatite coating eluting low dose sirolimus shows less delayed healing but equal efficacy to Cypher in Porcine Coronary Arteries." The data presented showed a statistically significant difference between an increase in Sirolimus and an increase in fibrinoid material, which is a strong indicator of delayed healing. In the presentation, the researchers concluded that "Hydroxyapatite is a safe coating and effectively releases Sirolimus. All dosages were equivalent to Cypher at 28 days, even at a four-fold lower dose and shows significantly less fibrinoid." The data are derived from an earlier study in porcine coronary arteries presented last year that concluded that HAp is a safe coating and effective in releasing Sirolimus.
Dr. Mark Landy, president of MIV Therapeutics, said, "Our VESTASYNC stent utilizes significantly less Sirolimus than the Cypher and we believe that our 55 µg dosage form is by far the lowest dose Sirolimus stent either available or in development. All three doses of Sirolimus tested in this animal study, produced significantly less fibrinoid material than Cypher. In our recent First-In-Man trial, we went one step further and demonstrated both safety and efficacy of the VESTASYNC in humans at four months, and look forward to starting a larger study shortly."
"Applying the findings from this study could help patients experience faster healing. This is another benefit of inert non-polymeric coatings such as HAp, compared with conventional drug-eluting stents that use polymers to attach the drug to the stent. It is our goal to develop a drug-eluting stent that does not produce the same response as the current generation of stents. These data are another confirmatory point in our endeavor to develop the safest possible drug eluting stent and clearly support the further development of our technology," concluded Dr. Landy.
Delayed healing is a well documented problem of the current generation of approved drug-eluting stents and could lead to an increase in thrombosis rate or an increased need for revascularization. In the study, there was a clear correlation between the amount of Sirolimus eluted and fibrinoid material.
Cypher is a registered trademark of Cordis Corporation.
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. 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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