FDA News

FDA Panel Recommends Approval of SyntheMed's REPEL-CV Adhesion Barrier for Pediatric Patients

(Sept 20, 2007)-- SyntheMed, 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 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."

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