CardioTech International receives Ethical Committee approval in France.WOBURN, Mass.--(BW HealthWire)--April 21, 1997--CardioTech International, Inc. (AMEX: CTE) announced today that it has received "Ethical Committee" approval to commence clinical investigations of its VascuLink(TM) Vascular Access 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 the blood (hemodialysis) of patients in renal failure. The investigation will compare the patency pa·ten·cy (p t n-s )n. 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 state or quality of being open, expanded, or unblocked. 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, 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 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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