First Patients Enrolled In MIV Therapeutics VESTASYNC II Study |
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First Patients Enrolled In MIV Therapeutics VESTASYNC II StudyMIV 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 first patients have been enrolled in registration trial of its VESTAsync™ polymer-free drug-eluting stent. Based on excellent nine-month human safety and efficacy data reported in March at American College of Cardiology meeting, Company has accelerated its original timeline for VESTASYNC II trial, which is designed to test efficacy of VESTAsync™ in a sufficient number of patients to form the basis of a regulatory filing for marketing approval in Europe. It's anticipated that these patient data will also be part of an eventual submission to U. S. Food and Drug Administration. Alexandre Abizaid, M. D. , Ph. D. , Chief of Coronary Intervention of Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil, is a principal investigator in this 120-patient, multi-center, randomized, controlled study. In this study 90 patients will receive VESTAsync™ nano-porous hydroxyapatite ( HAp ) coated drug-eluting stent, while 30 patients will receive the Company's VESTAcor™ stent, company's nano-porous HAp coated stent, which contains no drug. The primary endpoint is late lumen loss as measured by Quantitative Coronary Angiography ( QCA ) at nine months. Secondary endpoints will include major adverse cardiac events and volumetric obstruction. Intravascular Ultrasound ( IVUS ) , Optical Coherent Tomography ( OCT ) and physiological sub studies are also expected to be performed. " We are accelerating this registration trial due to the results obtained with VESTAsync™ in our pilot study after nine-month patient follow up, and potential to address safety issues in currently marketed drug-eluting stents using polymers to deliver drug, " commented Doctor Mark Landy, president and chief executive officer of MIV Therapeutics. " Our stent is a polymer-free, nanoscale, microporous hydroxyapatite stent that has ability to deliver a much smaller effective dose of drug, in fact 60 percent less, with safety of bare-metal stents, and probably requires only short-term anticoagulant therapy. Currently available drug-eluting stents require patients to take anticoagulants, such as Plavix, for as long as one year. We intend for the data obtained from this study to support an application for CE mark of the VESTAsync™ by the end of 2009 and are looking forward eventually to offering patients and physicians a superior alternative to currently available products, " Doctor Landy added. 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, 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 University of British Columbia and exclusively licensed to MIV. Key patent applications filed simultaneously in various countries around the world further protect commercial exclusivity of MIV's inventions in global marketplace. For more information, please visit http: //www. mivtherapeutics. com. Forward-Looking Statements Except for the historical information contained herein, matters discussed in this press release are forward-looking statements. All statements that discuss expectations and projections with respect to future matters including, without limitation, statements relating to safety and efficacy of Company's product and ability of Company's product to rejuvenate stent market 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 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, market acceptance of Company's product, ability of the Company to raise sufficient funding and to continue to develop its various business interests as presently contemplated, and other factors identified in Company's filings with Securities and Exchange Commission including, without limitation, Company's annual report on Form 10-K for the year ended May 31, 2007 and Forms 10-Q. The Company expressly disclaims any obligation to update publicly or otherwise revise these statements, whether as a result of new information, future events or otherwise, except to extent required by law. MIV Therapeutics Compare prices from trusted online pharmacies and buy medicine cheapest |
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First Patients Enrolled In MIV Therapeutics VESTASYNC II Study The medicine we use: Allopurinol. Allopurinol with worldwide shipping OTC Cough and Cold Products: Not For Infants and Children Under 2 Years of Age, Questions and Answers for Consumers. FDA strongly recommends that over-the-counter (OTC) cough and cold products should not be used in infants and children under 2 years of age. Compare prices from trusted online pharmacies and buy medicine cheapest |
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