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MIVT's Proprietary Stent Coating Technology Completes Major Long-Term Animal Study with Excellent Results; Six-Month Study Demonstrates Unparalleled Biocompatibility and Safety of MIVT HAp Coatings for Drug-Eluting Stent Applications.


VANCOUVER, British Columbia -- MIV MIV Motorisierter Individualverkehr (German: Motorized Individual Traffic)
MIV Master Internet Volunteer (University of Minnesota Extension Service)
MIV Multimedia, Internet & Video
 Therapeutics, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:MIVT MIVT Mechanism, Injuries, Vital Signs, Treatment (trauma reporting) ) (FWB (Fixed Wireless Broadband) See fixed wireless. :MIV), a leading developer of new 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.  coatings and advanced drug delivery systems, announced today that a pivotal long-term animal study of its novel stent coating technology has been concluded, with results that were unequivocally successful in demonstrating the coating's excellent biocompatibility biocompatibility

the quality of not having toxic or injurious effects on biological systems.

biocompatibility 1. The extent to which a foreign, usually implanted, material elicits an immune or other response in a recipient 2.
 and safety.

The 6-month study, performed by Center for Research in Cardiovascular Interventions of the Methodist Hospital Research Institute, an independent research organization, indicated that MIVT's Hydroxyapatite-based coatings were excellent candidates for advanced drug-eluting stent coatings.

Dr. Greg L. Kaluza, MD, scientific director of the CRCI CRCI Chambre Régionale de Commerce et d'Industrie (France)
CRCI Columbia River Correctional Institution
 at the Methodist Hospital Research Institute, was the lead investigator for the study. Dr. Fred J. Clubb, Jr. of Texas Heart Institute served as a study pathologist.

"The study's results are particularly encouraging for several reasons," said Dr. Kaluza. "The polymeric stent coatings that are now widely used are increasingly criticized as a suboptimal solution, because many of them may elicit prolonged foreign body response and foster platelet deposition which may in turn trigger in-stent thrombosis," he said. "In contrast, the 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.  coating we studied is built entirely of a mineral native to the human body and as such may have a long-term biocompatibility advantage."

The results of this recently completed study indicate this coating may be safely used as a drug-eluting platform since it may be expected from the present study that the Hydroxyapatite (HAp) coating will remain inert in the arterial wall even long after the drug is completely eluted. The well-known long-term neutral effects and natural absorption of HAp coatings from orthopedic and dental implants strongly reinforce this belief. The HAp coating with microporous structure is expected to enable effective drug elution elution /elu·tion/ (e-loo´shun) in chemistry, separation of material by washing; the process of pulverizing substances and mixing them with water in order to separate the heavier constituents, which settle out in solution, from the  without ever involving any polymer, a design concept that is currently viewed as superior and the most attractive for drug-eluting stents."

"We now have a comprehensive set of data demonstrating that the ultra-thin Hydroxyapatite coating with a potential for use in non-polymeric and composite drug-eluting systems selected for this study has excellent biocompatibility at all three studied time points, up to as long as six months of observation," said Dr. Kaluza. "The safety profile of the studied coating is exemplary and appears at least on par with stainless steel stent surface, which remains a benchmark whose biocompatibility has not been surpassed by any coating to date."

Stents are devices implanted in the arteries to prop open the blood vessels and maintain healthy blood flow to the heart and throughout the body. MIVT has developed a next-generation line of coatings based on a substance called Hydroxyapatite (HAp), to create both passive and drug-eluting coatings designed to eliminate many of the serious problems that are associated with current generations of stent coatings.

"The study provided critical long-term data that reinforced our preliminary research that has indicated the exceptional safety and biocompatibility of our proprietary coating technologies," said Alan Lindsay, 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 MIVT. "The uncompromised biocompatibility stands behind the potential of MIVT's HAp coating technologies and their expected therapeutic advantages over the existing coatings and stent technologies currently available to the biomedical industry."

The successful results of the animal study will enable MIVT to plan future clinical trials to continue to advance its research and product development programs for the multi-billion-dollar global stent marketplace.

The study was conducted in a standard model of porcine coronary arteries and utilized angiography, intravascular ultrasound and histology to evaluate tissue response to HAp-coated stents in comparison to identical stainless steel stents. The study was performed in compliance with GLP See gateway location protocol.  (Good Laboratory Practice) guidelines, CE-Mark and 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.
 requirements.

MIV Therapeutics is developing a diverse suite of HAp coating formulas to enable the surface of stents and other implanted devices to virtually mimic the natural state of structurally-sound 100% biocompatible and bio-active tissue. Hydroxyapatite, unlike polymer coatings, is naturally derived and found in such hard tissues and bioceramic materials as human bone and teeth. Research has indicated that MIVT's HAp coatings do not trigger the various adverse and inflammatory reactions that are often associated with implantation of polymer-coated stents and other foreign substances. HAp coatings are also expected to reduce the risk of thrombogenic throm·bo·gen·ic
adj.
Causing or resulting in thrombosis or coagulation of the blood.
 (blood clotting) events attributable in some instances to polymer-coated stents. Some of the most recent information presented at the TCT TCT The Capital Times (Madison, WI newspaper)
TCT Transcatheter Cardiovascular Therapeutics
TCT The Coroner's Toolkit
TCT Trans Canada Trail
TCT Tcl Core Team
TCT Tsukuba College of Technology (Japan) 
 2005 conference estimated that thrombogenicity Thrombogenicity refers to the tendency of a material in contact with the blood to produce a thrombus, or clot. It not only refers to fixed thrombi but also to emboli, thrombi which have become detached and travel through the bloodstream.  was identified in 20,000 cases of implanted drug-eluting stents to-date, resulting in approximately 8,000 premature deaths.

About The Methodist Hospital Research Institute

The Methodist Hospital Research Institute in Houston, TX, is a cornerstone of The Methodist Hospital's strategic vision for its future as a top-ranked academic medical center. The Research Institute is committed to moving the latest discoveries in the laboratory to the bedside in order to provide a new standard of care for our patients in Houston and in other parts of the country. For more information on The Methodist Hospital and the Methodist Hospital Research Institute, see http://www.methodisthealth.com/.

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 for application on broad range of 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 (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 technologies based on Hydroxyapatite provide an attractive 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. MIVT is traded on the Frankfurt, Germany, stock exchange under the symbol MIV.

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.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
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Publication:Business Wire
Geographic Code:1CANA
Date:Nov 15, 2005
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