MIV Therapeutics Successfully Completes Animal Feasibility Studies of Stroke-Prevention Devices.VANCOUVER, British Columbia -- This replaces the release of earlier today, providing greater clarity on the applications of the technology discussed. The corrected release reads: MIV MIV Motorisierter Individualverkehr (German: Motorized Individual Traffic) MIV Master Internet Volunteer (University of Minnesota Extension Service) MIV Multimedia, Internet & Video THERAPEUTICS SUCCESSFULLY COMPLETES ANIMAL FEASIBILITY STUDIES OF STROKE-PREVENTION DEVICES POSITIVE EXPERIMENTAL RESULTS SPEED MIVT'S SAGAX SUBSIDIARY TOWARD HUMAN TRIALS OF NOVEL AORTIC aortic pertaining to or emanating from the aorta. See also aortic arch. aortic aneurysm occurs most often in dogs, where it is caused by Spirocerca lupi larvae, turkeys and primates, causing dyspnea, cyanosis and coughing. EMBOLIC embolic /em·bol·ic/ (em-bol´ik) pertaining to an embolus or to embolism. em·bol·ic adj. 1. Relating to, or caused by an embolus or embolism. 2. Relating to emboly. PROTECTION DEVICE MIV Therapeutics, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :MIVT MIVT Mechanism, Injuries, Vital Signs, Treatment (trauma reporting) ), a developer of next-generation biocompatible biocompatible /bio·com·pat·i·ble/ (-kom-pat´i-b'l) being harmonious with life; not having toxic or injurious effects on biological function. stent coatings and drug delivery technologies, has successfully completed Phase I animal feasibility studies in sheep of two models of a novel implantable arterial filtration technology device designed to prevent strokes by diverting embolic particles flowing through the bloodstream. These two models of MIVT's unique Aortic Embolic Protection Device (AEPD) are being designed to prevent both major types of embolic strokes -- those triggered by heart surgery and catheterization catheterization Threading of a flexible tube (catheter) through a channel in the body to inject drugs or a contrast medium, measure and record flow and pressures, inspect structures, take samples, diagnose disorders, or clear blockages. , and those that occur naturally, not in connection with such procedures. This successful first phase of the animal studies pave the way for further animal studies, and then for human clinical trials - the last major testing milestones as the Company prepares the stroke-preventing technology for FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval and potential commercialization. The AEPD filtration devices are being developed by wholly-owned MIVT subsidiary SagaX Medical Technologies Inc. Both SagaX AEPD filter prototypes employ proprietary stent-based filter-deflector technology. The AEPD I prototype model is designed to be implanted temporarily in the aorta, the body's main artery, during heart surgery and heart catheterization to divert particles that might otherwise reach the brain, where they could trigger embolic strokes. The AEPD II prototype is designed to be implanted permanently to prevent the embolic strokes that occur from natural causes, such as aging. "We fully expect that this new technology, once ready for the market, will have the capacity to save countless cardiac patients from the devastating dev·as·tate tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates 1. To lay waste; destroy. 2. To overwhelm; confound; stun: was devastated by the rude remark. effects of embolic stroke," said Dr. Dov Shimon, founder and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of SagaX, and Chief Medical Officer and Director of MIVT. "We look forward to proceeding to the next phases of animal studies, which are the next milestones in readying this technology for human trials." Embolic particles that reach the brain are among the chief causes of strokes, which are the third-leading cause of death and the leading cause of disability in the world. AEPD is one of the latest innovations in the field of filter-based embolic protection devices and is the only filter being developed for use in the aorta. MIVT estimates that the global market for AEPD devices could exceed $1.5 billion by 2009. The Company believes AEPD-1 will be particularly useful during invasive heart procedures such as electrophysiology, valve dilatations and valve repair through angioplasty, as well as heart operations. The permanently implanted AEPD-II is designed to find broad preventive applications. MIV Therapeutics' CEO Alan Lindsay said he was greatly encouraged with the results. "The feasibility studies confirm earlier observations in the laboratory showing excellent efficacy and function of AEPD," he said. "This continued progress in our development of both prototypes of the AEPD is essential in our realization of the devices' full business potential in multi-billion-dollar neurovascular marketplace segments." AEPD is one of the latest innovations in the field of filter-based embolic protection devices, and is the only filter developed for use in the aorta. Preliminary evaluation of prototype devices confirmed effectiveness of AEPD in an in-vitro model. The AEPD I version is a self-expanding stent-based filter in the aorta, and designed for temporary application. The AEPD II prototype is a braided self-expanding stent deployed in the innominate artery, extending downwards into the aorta. This version can be implanted permanently to prevent cardioembolic stroke. Both AEPD I and AEPD II were inserted through a small catheter in the sheep's femoral artery and were passed retrogradely under fluoroscopy fluoroscopy /flu·o·ros·co·py/ (fldbobr-ros´kah-pe) examination by means of the fluoroscope. fluo·ros·co·py n. Examination by means of a fluoroscope. Also called radioscopy. to the aortic arch. "The study demonstrated excellent hemodynamics hemodynamics /he·mo·dy·nam·ics/ (-di-nam´iks) the study of the movements of blood and of the forces concerned.hemodynam´ic he·mo·dy·nam·ics n. , ample X-ray visibility and easy drivability through 6 French (2.3mm)-diameter catheter," said Dr. Shimon. "Direct echocardiography Echocardiography Definition Echocardiography is a diagnostic test that uses ultrasound waves to create an image of the heart muscle. Ultrasound waves that rebound or echo off the heart can show the size, shape, and movement of the heart's valves and demonstrated ample location and no significant flow disturbances. In addition, AEPD I is deployed, recaptured, relocated and removed using a proprietary delivery system designed to make it an ideal solution for embolic protection for heart surgery and invasive trans-catheter procedures in the heart." The studies are being conducted at the world-renowned Hadassah University Hospital Cardiology Research Institute in Jerusalem, Israel, under the stewardship of cardiac specialists, Dr. Chaim Danenberg and Dr. Ronen Beeri. Cardioembolism occurs spontaneously without procedures in 30% of all stroke victims. The risk factors for cardioembolic stroke include previous strokes; rhythm irregularities such as atrial fibrillation (present in 1-2% of the adult population and 7-10% of the people above 70); congenital malformations of the heart, such as patent foramen ovale patent foramen ovale PFO Cardiology An opening between the left and right atria which allows blood to bypass the lungs in utero; the FO normally closes shortly after birth, but remains open in up to 20%; a PFO is, in absence of other cardiac defects, is of no consequence (PFO PFO Patent Foramen Ovale (defect of the heart) PFO Paphos, Cyprus - International (Airport Code) PFO Principal Federal Official (US Departement of Homeland Security) ); heart valve disease, and previous heart valve surgery. About SagaX Medical Technologies, Inc. SagaX develops a range of proprietary solutions, primarily endovascular interventional products, which decrease the likelihood of strokes and other serious complications that may result from cardiac procedures, as well as from naturally occurring Cardioembolic strokes. The Company's R&D center is located in Herzlya Israel, directed by Dr. Dov V. Shimon, M.D., a heart surgeon, the founder and CEO of SagaX Inc., and MIV Therapeutics director and Chief medical Officer. In March 2005, MIVT completed its acquisition of SagaX. One of the flagship technologies from SagaX is its Aortic Embolic Protection Device (AEPD), which employs proprietary stent based filter-deflector technology that can be used during Trans-Catheter Cardiology procedures, as well as during heart surgery, to minimize the risk of stroke. About MIV Therapeutics, Inc. MIV Therapeutics Inc. is developing a next generation line of advanced biocompatible coatings for passive and drug-eluting application on cardiovascular stents and other implantable medical devices. The Company's ultra-thin coating formulation is designed primarily to protect surrounding tissue from the chemical interaction with metal stents. The Company's unique ultra-thin coating has been derived from a biocompatible material called hydroxyapatite hydroxyapatite /hy·droxy·ap·a·tite/ (-ap´ah-tit) an inorganic calcium-containing constituent of bone matrix and teeth, imparting rigidity to these structures. (HAp) that during in-vivo animal trials demonstrated excellent safety and superior healing properties pursued by the science in the field of advanced implantable drug delivery systems. Hydroxyapatite is a bioactive porous material that makes up the bone mineral and matrix of teeth. It is widely used as a bone substitute material and for coating implantable fixation devices in orthopedic, dental and other applications. The Company's novel drug eluting technology provides an alternative solution to polymer-based drug eluting coatings currently in the stent market. The Company's drug eluting coating is designed to suit a broad range of implantable medical devices which may benefit from a highly customizable drug release profile. MIVT reached a Collaborative Research Agreement (CRA See Community Reinvestment Act. ) with the University of British Columbia Locations Vancouver The Vancouver campus is located at Point Grey, a twenty-minute drive from downtown Vancouver. It is near several beaches and has views of the North Shore mountains. The 7. and supported a research and development grant from the Natural Sciences and Engineering Research Council The Natural Sciences and Engineering Research Council (NSERC) is a Canadian government division that provides grants for research in the natural sciences and in engineering. In 2004-2005, it will invest CAD $850 million in university-based research and training. of Canada (NSERC NSERC Natural Sciences and Engineering Research Council (Canada) NSERC Naval Systems Engineering Resource Center ) in 2002 for the development of Hydroxyapatite as a drug eluting coating. In December 2004 MIVT received a Government grant for the research program titled "Development of Novel Drug Eluting Composite Coatings for Cardiovascular Stents" under the National Research Council -- Industrial Research Assistance Program (NRC-IRAP NRC-IRAP National Research Council - Industrial Research Assistance Program ). Under this sponsorship the Company will progress to the development stage, which is expected to finalize the drug-eluting research and development Program. For more information, please visit http://www.trilogy-capital.com/tcp/mivt/website.html. To read or download MIV Therapeutics' Investor Fact Sheet, visit http://www.trilogy-capital.com/tcp/mivt/factsheet.html. To obtain daily and historical Company stock quote data, and recent Company news releases, visit http://www.trilogy-capital.com/tcp/html/mivt.htm. Forward-Looking Statements 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 "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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Actual results may differ materially from those described in forward-looking statements and are subject to risks and uncertainties. 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. Copyright (C) 2005 MIV Therapeutics Inc. All rights reserved. |
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