Surface Modification and Drug Delivery
At the present time the Company is aggressively pursuing the commercialization of three unique leading edge proprietary technologies:
1) NanoFilm Hydroxyapatite surface modification or coating
2) MicroPorous Hydroxyapatitesurface modification or coating
3) Polymer-free lipid-based drug eluting and encapsulation formulations
HAp is naturally found in bone and tooth enamel. Numerous results from clinical tests and surgical practice have shown that in addition to its demonstrated biocompatibility, this new generation of advanced biocompatible coatings is non-toxic and does not trigger adverse reactions of the human immune system. Extensive animal studies performed by MIVT also confirmed that Hydroxyapatite, when applied to vascular applications, does not induce thrombogenicity, allergic or inflammatory reactions commonly associated with polymeric coatings, therefore making it a solid candidate as a potential coating for coronary and peripheral stents, and other implantable medical devices.
MIVT’s HAp coating technology has demonstrated that it can meet the stringent technical requirements set by the regulatory agencies for coatings of cardiovascular stents. MIVT coating technologies completed successfully a comprehensive range of demanding animal and mechanical trials required for CE Mark and FDA approvals in both Europe and the US. These include thrombogenicity (blood clotting), cytotoxicity, and 400-million-cycle fatigue life testing. The results of these extensive tests confirmed exceptional biocompatibility and safety of these coatings and paved the way for human trials.
On May 31, 2007, MIVT announced the first ever human implantation of a hydroxyapatite coated stent and the launch of the MIVT Pilot Trial which will evaluate the safety and efficacy of the VESTAsync™, MIVT’s polymer-free nanoscale microporous hydroxyapatite drug-eluting stent for the treatment of single de novo lesions in native coronary arteries.
The first procedure was conducted by Dr. Alexandre Abizaid of Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil.
In parallel with hydroxyapatite-based surface modifications and coatings, MIVT’s team of scientists have also developed a new generation of polymer-free lipid-based technologies and formulations which encapsulate drug and target its delivery. These formulations are designed to work in conjunction with hydroxyapatite or as standalone drug delivery systems.
