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BIO-VASCULAR DISCONTINUES CLINICAL TRIALS OF BIOFLOW GRAFT

 ST. PAUL, MINN., May 4 -- Bio-Vascular, Inc., (NASDAQ: BVAS) announced today that it has discontinued human clinical trials of its Bioflow(R) Small Diameter Graft product in coronary artery bypass procedures. The company said the U.S. Food and Drug Administration (FDA) had requested that the clinical investigation be temporarily suspended and, after reviewing the situation, the company elected to terminate the trial.
 The company reported in December that two overseas clinical investigators evaluating performance of the product had found that only about one in seven grafts remained functional 12 months or more after implantation. The company immediately informed the FDA and its U.S. clinical investigators of this information. Subsequently, the company received additional data from other overseas investigators that corroborated the original finding.
 The Bioflow graft is a biosynthetic blood conduit using bovine arteries that have been treated with special chemical agents. Under protocols for the clinical investigation, the Bioflow graft was used only when the patient had no suitable native vessels. Twelve grafts were implanted in the U.S. clinical trials. The company has received no reports of patient deaths resulting from the Bioflow implant.
 The Bioflow graft represented approximately 5 percent of the company's sales in fiscal 1992. James F. Lyons, chairman of the board, said ending the clinical trials is not expected to have a significant effect on the company's sales for fiscal 1993.
 Bio-Vascular, Inc., based in St. Paul, is a manufacturer and marketer of proprietary consumable medical products for cardiac and vascular surgery.
 -0- 5/4/93
 /CONTACT: Curt Swenson of Swenson Falker Eilertsen Inc., 612-371-0000 or M. Karen Gilles of Bio-Vascular, 612-631-3529/
 (BVAS)


CO: Bio-Vascular, Inc. ST: Minnesota IN: MTC SU:

KH -- MN019 -- 4537 05/04/93 16:53 EDT
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Publication:PR Newswire
Date:May 4, 1993
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