STERIVET WILL BEGIN U.S. TESTING OF SYNACID SURGICAL IMPLANT
STERIVET WILL BEGIN U.S. TESTING OF SYNACID SURGICAL IMPLANT for joint lubrication in humans in late 1988 or early 1989. Sterivet is planning to apply for FDA approval to market Synacid, a biological polymer, as a device for humans. It is currently used as an injectable drug to treat horses suffering from osteoarthritis. Synacid can be implanted following arthroscopic procedures or it can be injected directly into the joint. The product lubricates the joint and nourishes the synovial membrane which keeps joints intact. Sterivet began human testing of the drug version of Synacid early this summer in Canada. Scandinavian clinical studies are scheduled to begin this month, the company said. Sterivet will use the data obtained from testing in Canada and Scandinavia to support the safety of Synacid in humans. After additional testing in the U.S. as an implant, the firm will have the necessary data to file for FDA clearance of Synacid as a device, a company spokesperson projected. Schering-Plough distributes Synacid for veterinary use in the U.S. and Canada; Sterivet has not yet selected a marketing partner for distribution of Synacid for human applications. Located in Toronto, Sterivet is a public company listed on NASDAQ and the Toronto Stock Exchange. The company was formed in 1968 and brought its first products -- equine pharmaceuticals -- to market a year ago. Sales for fiscal 1988 were $ 4.5 mil.
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