Knobias Clip Report (06-17-2008)
Submitted By Knobias ClipReport
MIVT: CEO Discusses Company’s Next Generation of Drug Eluting Stents
MIV Therapeutics Inc (MIVT) develops a 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.
MIV Therapeutics recently began enrollment in a registration trial for its VESTAsync(TM) polymer-free drug-eluting stent. Based on excellent nine-month human safety and efficacy data, the Company has accelerated its original timeline for the VESTASYNC II trial, which is designed to test the efficacy of the VESTAsync(TM) in a sufficient number of patients to form the basis of a regulatory filing for marketing approval in Europe. It is anticipated that these patient data will also be part of an eventual submission to the U.S. FDA.
Dr. Mark Landy, President and CEO of MIV Therapeutics, told Knobias on Tuesday, “The VESTAsync(TM) technology is a drug eluting stent with a drug delivery technology that, unlike its competitors, is made of substances that occurs naturally in the human body rendering it extremely biocompatible and a promoter of expedited healing. Based on its numerous attributes such as ultra thin struts, low coating thickness (0.6 microns making it over ten time thinner than the thinnest drug eluting stent coating available today), and low drug dose (60% less than Cypher) patients who receive VESTAsync should heal faster with 100% stent endothelial coverage and aquire significantly less dual antiplatelet therapy than those receiving polymer based drug eluting stents, which are the only one available today.”
“No other company has taken a polymer free DES through FIM. Two companies (Atrium and Biosensors) have started studies, but we will have to wait for results to see if they will be direct competitors in the polymer free DES market. Companies that are selling polymer based drug eluting stents include Johnson and Johnson, Abbott, Boston Scientific, Medtronic, Terumo, Biosensors, and a number of smaller companies with me too technology.”
VESTAsync was recently featured in Scientific American, an online science, health, and technology source. According to the article, “…such devices are just as good as bare metal stents at keeping arteries open and less likely than polymer-coated stents — which typically administer a drug to keep tissue growth at bay — to contribute to blood clotting, irritation and inflammation.”
“We have developed a drug delivery system that can be used on stents and other implantable medical devices that is polymer-free and can administer medication to the local tissue to keep an artery from re-closing,” the article quotes Dr. Landy. “Patients who receive drug-coated polymer stents are generally required to take Plavix or another anticoagulant for at least a year after an angioplasty, in addition to the medicine dispensed by the stents. MIV’s goal is to create a drug eluting stent with the safety profile and deliverability of a bare metal stent.”
Dr. Landy explained to Knobias, “VESTAsync is not another me too drug eluting stent and should not be tarnished with the same concerns that have plagued the first and second generation of drug eluting stents. VESTAsync is a new concept aimed at combining bare metal stent safety with drug eluting stent efficacy thereby eliminating all the drawbacks of current drug eluting stents and rejuvenating the drug eluting stent market.”
For the past seven years, the Company has funded operations in the public markets. The Company does not currently have any development partners other than The University of British Columbia who developed the original technology.
Dr. Landy added, “We are not making any public comments at this time regarding partnerships or potential partnerships. We have publicly announced six products in angioplasty available for sale, including CE approved bare metal stents. We are actively working on pipeline products but have not made these public.”
The Company announced on Monday that its board of directors approved a one-for-10 reverse stock split of the company’s approximately 116 million issued and outstanding common shares.
“We view the split as a positive move to benefit both the company and its shareholders. It is expected to result in an increase in attractiveness to institutional investors,” commented Dr. Landy. He added, “The split will also adjust the authorized and outstanding shares to a level better suited to a company of our size.”
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