CardioTech International receives Ethical Committee approval in France.WOBURN, Mass.--(BW HealthWire)--April 21, 1997--CardioTech International, Inc. (AMEX AMEX See: American Stock Exchange : CTE (Coefficient of Thermal Expansion) The difference between the way two materials expand when heat is applied. This is very critical when chips are mounted to printed circuit boards, because the silicon chip expands at a different rate than the plastic board. ) announced today that it has received "Ethical Committee" approval to commence clinical investigations of its VascuLink(TM) Vascular Access vascular access Clinical medicine The ability to enter the vascular system; the ease with which the vascular system can be entered for administering therapy or obtaining blood for testing Graft at three institutions in France, starting in early summer. In the clinical investigation, involving up to forty patients, the VascuLink Vascular Access Graft will be used as part of a tri-weekly procedure to cleanse cleanse tr.v. cleansed, cleans·ing, cleans·es To free from dirt, defilement, or guilt; purge or clean. [Middle English clensen, from Old English the blood (hemodialysis hemodialysis /he·mo·di·al·y·sis/ (-di-al´i-sis) removal of certain elements from the blood by virtue of the difference in rates of their diffusion through a semipermeable membrane while being circulated outside the body; the process ) of patients in renal failure renal failure n. Acute or chronic malfunction of the kidneys resulting from any of a number of causes, including infection, trauma, toxins, hemodynamic abnormalities, and autoimmune disease, and often resulting in systemic symptoms, especially edema, . The investigation will compare the patency pa·ten·cy n. The state or quality of being open, expanded, or unblocked. patency the condition of being open. and complication rates of the VascuLink Vascular Access Graft with grafts marketed by third parties. As the Company has previously announced, it began a similar clinical investigation in Holland in November 1996. The clinical investigation in France will be coordinated by Professor Xavier Martin at Hospital Edouard Herriot, in Lyon, with participation from Dr. P. Bourquelot at Hospital St. Joseph, in Paris and Dr. B. Barrou at Groupe Hospitalier Pitie Salpetriere, in Paris. The study will be managed on behalf of CardioTech, by the Clinical Research Organization of Biomatech S.A., in Lyon, France, and will be under the direction of Mr. Patrice Becker. Biomatech has extensive experience with the management and monitoring of clinical studies. Alan Edwards Alan Edwards (1925—January 14, 2003) was an accomplished actor and founding Artistic Director of the Queensland Theatre Company in Brisbane, Queensland, Australia. [1] , Executive Vice President of CardioTech commented: "Based on our pre-clinical trials, we expect our VascuLink Vascular Access Graft to demonstrate that it is substantially self-sealing, compared to existing ePTFE grafts. We believe that this feature will minimize blood loss after dialysis treatment, resulting in shorter procedure time per patient, thus having a humanitarian and an economic benefit in the process." Dr. Michael Szycher, Chairman 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 CardioTech, commented: "France has the second largest hemodialysis patient population in Europe. We believe that commencing clinical investigations in France could lead to quicker acceptance of our product in Europe, if the clinical investigations are successful." Dr. Szycher further stated "We are honored by the participation of three leading French surgeons with extensive experience in the field of vascular access surgery." -0- The company believes that this release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include the expected results of the clinical investigations and the European market acceptance of the Company's product. Such statements are based on management's current expectations and are subject to a number of factors that could cause actual results to differ materially from the forward-looking statements. The Company cautions investors that there can be no assurance that the actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements, as a result of various factors, including but not limited to the following: the timely development of products by the Company, the Company's ability to obtain financing to support its working capital needs, intense competition related to the development of synthetic grafts and difficulties inherent in developing synthetic grafts. As a result, the Company's further development involves a high degree of risk. CONTACT: John E. Mattern CardioTech International, Inc. (617) 933-4772 |
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