FDA News

FDA Accepts Synthemed's Pre-Market Approval (PMA) Application for REPEL-CV

(March 28, 2007)--SyntheMed, a biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery products, today announced that the US Food and Drug Administration (FDA) has accepted for review the Company's Pre-market Approval (PMA) application for REPEL-CV(R) Adhesion Barrier. REPEL-CV is a bioresorbable film designed to be placed over the surface of the heart at the conclusion of an open heart surgical procedure to reduce the formation of post-operative adhesions (scar tissue).

"Adhesions pose serious health risks to patients who have cardiac reoperations as well as result in higher costs for the hospitals where these procedures are performed," stated Robert P. Hickey, President and Chief Executive Officer, SyntheMed, Inc. "Our clinical trial results have demonstrated that REPEL-CV has the potential to reduce OR time, patient exposure to anesthesia and other complications associated with cardiac adhesions. The FDA acceptance of our PMA filing marks another important step toward our goal of making REPEL-CV available to patients in the US who may require secondary open heart surgery."

In September 2006, SyntheMed announced positive efficacy results from the Company's multi-center, randomized, masked pivotal clinical trial of REPEL-CV in neonatal patients who underwent staged, open-heart surgical procedures. The trial was conducted at 15 pediatric cardiac surgery centers throughout the United States, and enrolled 144 neonatal patients. In the trial, surgeons used a four-point grading system to determine the extent and severity of adhesions in the patients. Over 70% of the REPEL-CV treated patients were completely free of clinically-significant adhesions, the most severe grade of adhesions measured, as compared to less than 30% in the control patients, with a p value < 0.0001. In the primary clinical endpoint assessment, the mean extent of clinically-significant adhesions in the control patients was 2.5 times greater than in the REPEL-CV patients, with a p value = 0.0005.

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