Global Precision Medical Inc.: Update on Corporate Developments.Business Editors VANCOUVER, British Columbia--(BUSINESS WIRE)--Sept. 11, 2003 GLOBAL PRECISION MEDICAL INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :GBPMF) (the "Company") is pleased to provide an update on corporate developments pertaining to its stent technologies and, specifically, the commercialization of its first application, the Uro-Stent, as well as the further enhancement of the material characteristics of its proprietary 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. Nickel /Titanium (Nitinol) wire that forms the basis of its stents including the Uro-Stent. The Company is also reporting on a key strategic alliance which it has just entered into. The Uro-Stent The Uro-Stent, developed by leading Russian scientists and medical experts is used for the prevention of lumen restriction associated with benign prostate hyperplasia Benign prostate hyperplasia (BPH) Enlargement of the prostate gland. Mentioned in: Paruresis - (BPH BPH abbr. benign prostatic hyperplasia BPH Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men. is a non-cancerous enlargement of the prostate, which compresses the urethra urethra (y rē`thrə), canal in most mammals that carries urine from the bladder to the outside of the body; in the male it also serves as a genital duct. as it grows thereby restricting the flow of urine - a primary cause of urinary voiding dysfunction in men.) The patented Uro-stent is woven from a single nitinol wire with the appropriate radial rigidity and a unique longitudinal bending capability. The Uro-stent has non-traumatic butt-ends allowing for an exceptional engineering design highly suitable for insertion into the human body as a minimally invasive medical device. In order to move towards global commercialization of the Uro-Stent, the Company, as a first step in the process, has made an application to the Russian Ministry of Health for the approval for its use and sale in Russia, along with its related delivery system (catheter). The Company has devoted the past few months to performing additional required tests of the Uro-Stent to meet new regulations imposed by the Russian Federation to match the general criteria imposed by North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. and European regulatory requirements. These new procedures called for additional sterilization, toxicology and 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. testing. We are pleased to announce that the Company has now successfully completed and documented all of the requisite tests. Consequently, the application for approval has been re-submitted to the Russian Ministry of Health, and its decision is expected in the fourth quarter 2003. We are optimistic that a positive decision will be issued by the Russian Ministry of Health. In particular, the toxicology tests have shown no trace of Nickel ions, or any other ions. They have additionally shown a high compatibility of the Uro-Stent with human tissue. This is a direct consequence of the material structure and the thermo-chemical treatment used to strengthen the binding of the Nickel and Titanium ions, thus inhibiting any migration of these entities inside and outside of the metal. The electro-chemical treatment of the wire surface - passivation passivation the final stage in instrument manufacture, passing the finished instruments through a bath of nitric acid which removes foreign particles and promotes the formation of a protective coating of chromium oxide. process - creates a protective film on the surface of the stent, providing for a reinforced shielding. Cardiac, Oncology and Hepatology Stents Positive clinical results have formed the basis for the use of the same proprietary wire material in preliminary trials involving cardio-vascular, oncology and hepatology surgeries. Results received to date have been encouraging; the surgeons involved having reported good results from the use in clinical trials of the stent in cardiac and oncology applications, particularly with regard to overcoming issues of blood clotting blood clotting, process by which the blood coagulates to form solid masses, or clots. In minor injuries, small oval bodies called platelets, or thrombocytes, tend to collect and form plugs in blood vessel openings. which is thought to relate to the unique properties of the nitinol wire. This is considered a positive development. Representatives of the Company will visit Moscow in October to meet with the scientific and medical teams who conducted these trials with the view to incorporating these new developments into the expanded go-forward programs of the Company consistent with its goal to develop and market leading-edge minimally-invasive technologies in the medical device field. Strategic Alliance In order to strengthen and diversify its platform, the Company has entered into a "Consortium Letter of Understanding", executed with Global Medical Sciences Limited (Barbados), MDMI MDMI Monodisperse Dried Microparticulate Injector MDMI Matthew David Miller Investments (Milton, MA) Technologies Inc. (Vancouver, Canada) and Minimal Invasive Technology Ltd (Moscow, Russia). The Consortium brings together four groups with complementary expertise and resources. -- Global Precision Medical Inc. ("GPM GPM - General Purpose Macro-generator "): GPM will coordinate and finance the activities of the Consortium, provide the publicly traded vehicle through which investors can participate, and serve as the sales and marketing platform for stents and future medical devices introduced to it by other Consortium members; -- Global Medical Sciences Limited ("GMS GMS Greater Mekong Subregion GMS Global Mobile (Communications) System GMS Guild Management System GMS General Medical Services GMS Global Management System (Sonicwall) GMS GroupWise Mobile Server "): GMS is the owner and licensor of the wire material and the stent technology. It has a team of expert materials scientists. The scientists work in conjunction with IMET IMET international military education and training (US DoD) IMET Incident Meteorologist (NOAA) IMET Integrated Market Enforcement Team (Royal Canadian Mounted Police) (World-renowned Institute of Metallurgy and Material Sciences in Moscow, with the largest contribution in its field in the Sputnik program, the Russian Military and the current Space Station); -- MDMI Technologies ("MDMI"): - MDMI, a B.C. based private company, brings an established and ongoing level of operational success at the highest international level, which combines industry experience in device design, manufacturing, distribution and operational systems to navigate through the global regulatory processes including the 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. . MDMI will evaluate the technology presented to GPM, advise and assist in engineering feedback to the GMS scientists in Russia, and will formulate the pathway to regulatory approval and assist GPM executives in the, commercialization and marketing; -- Minimal Invasive Technology Ltd ("MIT MIT - Massachusetts Institute of Technology ") - MIT is a Russian manufacturer of various medical devices and holds proprietary rights to the catheter (delivery system), used during the clinical trials for the insertion of the Uro-stent. MIT holds numerous patents to medical devices being sold in Russia and surrounding countries. The purpose and activities of the Consortium will include the following: -- As set out in a Letter of Intent with MIT, the Company wishes to acquire rights in the delivery system (catheter) used for the Uro-Stent as well as the opportunity to evaluate MIT's extensive portfolio of medical technologies with the view to their suitability for commercialization in other markets including North America, the EEC EEC: see European Economic Community. and Asia. MIT is, at present, in the process of undergoing international certification of its products in compliance with ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9001; -- Relying on the established experience and strength of its members, the Consortium will develop, commercialize, produce and market the Company's stents and future medical devices on a global scale; -- Initially, the Consortium will work together to implement the commercialization and revenue-generating strategy of the URO-Stent in Russia and its associated markets where the Russian medical approval is accepted. MIT's extensive experience in Russia and Central and Eastern Europe The term "Central and Eastern Europe" came into wide spread use, replacing "Eastern bloc", to describe former Communist countries in Europe, after the collapse of the Iron Curtain in 1989/90. will allow the Company to take the Uro-Stent to revenue-generating mode from a solid base with the required network. To this end, MIT will provide manufacturing, sales and distribution support for the URO-Stent; -- The Consortium will then pursue regulatory approval procedures to enter other medical markets, which will be coordinated by the Company and MDMI; -- In keeping with the Consortium's work in connection with the Uro-Stent, the Consortium will explore the development, manufacture and sales of other stents and medical devices. The unique properties of the Company's Nitinol wire are driving the development of other minimally invasive medical devices. Emerging materials developments and medical devices based on the unique properties of NiTi will be presented by GMS to the Company on a most favoured basis for technical and market evaluation. -- In conducting its work, the Consortium will rely heavily on the advice of the Company's Scientific Board chaired by Dr. Dimitri Pushkar to ensure that the Company's product receive medical acceptance. Professor Pushkar is the Russian senior member of the European Urology Association. TSX Venture Exchange TSX Venture Exchange Originally called the Canadian Venture Exchange (CDNX), this was a result of the merger of the Vancouver and Alberta stock exchanges. The goal of TSX Venture Exchange is to provide venture companies with effective access to capital while protecting investors. Plans are underway to make application to list the Company's shares on the TSX Venture Exchange in Toronto while maintaining the Company's listing as is on the OTCBB. Such a listing would increase the exposure, transparency and liquidity of the shares in the investor market place. This action has become necessary following the abrupt cancellation of the startup of the BBX BBX Business Basic Extended BBX Business Barter Exchange BBX Blue Bell, Pennsylvania (Airport Code) BBX Blockbuster Express (UK video store) by NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on which had been promoted as a more transparent and liquid trading market to replace the OTCBB. The Company was relying on this enhanced exchange to broaden its potential investor base and indeed planned to become a Charter Member of the BBX. American Medical Review At the invitation of the American Medical Review for the PBS PBS in full Public Broadcasting Service Private, nonprofit U.S. corporation of public television stations. PBS provides its member stations, which are supported by public funds and private contributions rather than by commercials, with educational, cultural, network, the Company participated in a video documentary hosted by Morley Saefer showcasing the Company's URO-Stent technology as an example of emerging minimally invasive technologies towards a higher quality of life. The segment features interviews with Dmitri Pushkar M.D., Ph. D. Professor and Chairman of the Department of Urology at Moscow State Medical University (and Chairman of the Company's Advisory Board) and James Elliott, B.Sc., B.A.Sc., M.A.Sc, Chief Technology Officer for the Company. The segment is scheduled to be uplinked to the PBS network on September 29, and will be shown at times to be determined by each local PBS network. On behalf of the Board of Directors GLOBAL PRECISION MEDICAL INC. Lindsay B. Semple, 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. and Director SAFE HARBOR STATEMENT THIS NEWS RELEASE MAY INCLUDE FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF SECTION 27A OF THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED, AND SECTION 21E OF THE UNITED STATES SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED, WITH RESPECT TO ACHIEVING CORPORATE OBJECTIVES, DEVELOPING ADDITIONAL PROJECT INTERESTS, THE COMPANY'S ANALYSIS OF OPPORTUNITIES IN THE ACQUISITION AND DEVELOPMENT OF VARIOUS PROJECT INTERESTS AND CERTAIN OTHER MATTERS. THESE STATEMENTS ARE MADE UNDER THE "SAFE HARBOR" PROVISIONS OF THE UNITED STATES 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 AND INVOLVE RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE IN THE FORWARD-LOOKING STATEMENTS CONTAINED HEREIN. |
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