SyntheMed: European study for adhesion barrier Repel-CV yields positive results

By E. Janene Geiss

Philadelphia, June 21 - SyntheMed, Inc. announced Wednesday positive results from the open-label clinical study of Repel-CV Bioresorbable Adhesion Barrier conducted at several European cardiac surgery centers.

The primary endpoint of the study was the extent to which Repel-CV reduced clinically significant adhesions in patients who have had previous open heart surgical procedures, according to a company news release.

The results indicated that 13 of the 15 patients treated with Repel-CV were completely free of severe adhesions at the point of the second surgical procedure, the company said.

SyntheMed said it has applied for CE Mark certification for the marketing of Repel-CV outside of the United States.

A network of independent distributors is being established in preparation for the impending product launch.

Repel-CV also is being evaluated in a multi-center, controlled pivotal clinical trial involving 15 cardiac surgical centers in the United States. The company said it anticipates completion of the U.S. trial soon. The results will be submitted to the Food and Drug Administration as a basis for gaining approval to commercialize Repel-CV in the United States.

The company said Repel-CV could become the first adhesion barrier approved by the FDA and European Union regulatory authorities for use in cardiac surgery, which represents a $300 million annual worldwide market opportunity, officials said.

SyntheMed is an Iselin, N.J., biomaterials company that discovers anti-adhesion and drug delivery products.

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