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Palo Alto, CA, United States, 2008/03/13 - Frost & Sullivan recognizes MIV Therapeutics, Inc. (OTC/BB: MIVT) (Frankfurt: MIV), a leading developer of next-generation coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices.
Based on its recent analysis of the interventional cardiology markets, Frost & Sullivan recognizes MIV Therapeutics, Inc. (OTC/BB: MIVT) (Frankfurt: MIV), a leading developer of next-generation coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices,. with the 2008 North American Frost & Sullivan Award for Technology Innovation.
This Award recognizes MIV Therapeutics’ development of next generation coatings and drug delivery systems based on hydroxyapatite (HAp) for cardiac stents and other implantable medical devices.
“MIV Therapeutics’ HAp-based drug delivery systems are completely polymer-free and made from naturally occurring materials making them unique in addressing the limitations of commonly used polymeric coatings and polymeric drug delivery systems,” says Frost & Sullivan Research Analyst Pramodh Ishwarakrishnan. “Animals and human studies performed thus far indicate that HAp-based coatings are safe, effective in delivering drug, and do not induce thrombogenic, allergic or inflammatory reactions seen with polymers, making them strong candidates for future medical device applications.”
In collaboration with The University of British Columbia (UBC), MIV Therapeutics has developed two HAp coatings that range in thickness from 100 to 500 nanometers.
The first is non-porous and can be used as a biocompatible surface coating to protect the surrounding tissue from potential side effects caused by metals used in implantable medical devices.
The second is porous and can be used as a biocompatible surface coating capable of delivering drug to local tissue. The company's lead product incorporating this novel technology is a drug eluting stent (DES) aimed at addressing the drawbacks of the currently available DES and is in early human testing.
“DES safety is drawing much scrutiny as the events of restenosis, late stage thrombosis (the formation of blood clots) and death are now exceeding those seen with bare-metal stents (BMS) – despite the original evidence as demonstrated in clinical trials that DES are as safe as their BMS counterparts,” notes Ishwarakrishnan. “Correspondingly, the global use of DES has plummeted and in many countries the use of BMS exceeds the use of DES.”
One other serious limitation of current DES is the need for patients to comply with a long-term antiplatelet regimen to prevent the formation of blood clots and late stage thrombosis. Antiplatelet therapy severely hampers the ability to provide future medical and dental treatment to patients who are taking them as they reduce the patient’s ability to clot and increase the risk of severe bleeding.
To address these limitations, MIV Therapeutics has developed a new DES, the VESTAsync™, which has demonstrated excellent safety and efficacy profiles in trials. The VESTAsync is polymer-free, combining nanothin microporous HAp with low dose sirolimus in a proprietary formulation.
VESTAsync has an ultra thin drug coating which, at 600 nanometers, is over 10 times thinner than any drug coating currently found on today’s drug eluting stent‘s. When compared to the competition, VESTAsync shows superior healing, lower inflammation, 75 percent less fibrinoid deposition (a marker of delayed healing) and early efficacy results that are comparable to currently FDA approved DES. These results are strong reinforcement’s of MIV Therapeutics’ strategy to bring to market a DES with the safety profile of a BMS, requiring BMS-like antiplatelet therapy.
“The company holds an exclusive license to the intellectual property (IP) that was originally developed at UBC, which covers the HAp surface modification available on the stent and also some of the formulations that are used to load the drug” adds Ishwarakrishnan.
In summary, the surface modifications and drug delivery systems based on HAp show excellent biocompatibility, flexibility, deliverability and optimal drug delivery compared to the first and second generation polymer-based DES.
For developing a completely polymer-free approach to tackling the present day limitations of the first and second generation stents, Frost & Sullivan is proud to present MIV Therapeutics with the 2008 North American Technology Innovation Award in the field of interventional cardiology.
Each year Frost & Sullivan presents this Award to the company that has carried out new research, which has resulted in innovation(s) that have or are expected to bring significant contributions to the industry in terms of adoption, change, and competitive posture. The Award recognizes the quality and depth of a company’s research and development program as well as the vision and risk-taking that enabled it to undertake such an endeavor.
Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.
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