FDA Panel Recommends Approval of SyntheMed's REPEL-CV(R) Adhesion Barrier for Pediatri...( ISELIN N.J. Sept. 20 /- SyntheMed...),Health

ISELIN, N.J., Sept. 20 /PRNewswire-FirstCall/ -- SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery products, announced today that the Circulatory System Devices Advisory Panel of the US Food and Drug Administration (FDA) recommended approval of REPEL-CV(R) Adhesion Barrier for use in pediatric patients (21 and younger) who are likely to need secondary open heart surgery. The panel also recommended the development of additional safety data as a basis for expanding the indicated use to include adult patients. Dr. Eli Pines, the Company's Vice President of Research stated, "We are pleased with the panel's recommendation to approve REPEL-CV and we look forward to discussions with the FDA on securing approval to market REPEL-CV for the initial indication. We will also immediately seek FDA approval to initiate the adult clinical study."

About Adhesions

Adhesions, or scar tissue, occur after virtually all open-heart surgical procedures, often resulting in the heart becoming attached to the sternum and other surround tissue surfaces. The presence of adhesions represents a prevalent and serious complication in secondary surgical procedures, increasing the length, cost and risk of the surgical procedure. There are approximately 500,000 open heart surgeries performed annually in the United States, and another 350,000 procedures estimated throughout the European Union. In both markets, approximately 15-20 percent of these surgeries are secondary procedures.

About REPEL-CV

REPEL-CV is a bioresorbable adhesion barrier film designed to be placed over the surface of the heart at the conclusion of an open-heart surgical procedure to reduce the extent and severity of adhesions (scar tissue) that form between the surface of the heart and opposing tissue surfaces following the surgical procedure. REPEL-CV is designed to provide the therapeutic benefit and
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