Protein Polymer Technologies submits 510(k) application for Surgica's embolization products

By Lisa Kerner

Erie, Pa., May 10 - Protein Polymer Technologies, Inc. said it has filed a 510(k) application with the Food and Drug Administration for clearance to expand the labeled indications of Surgica's embolization products to include treatment of hypervascular tumors including uterine fibroids, liver and renal tumors.

Surgica's proprietary foam embolization products are cleared for use in the treatment of neurovascular arteriovenous malformations and neoplastic lesions.

In December, Protein Polymer acquired the exclusive rights to develop and commercialize Surgica's embolization products.

Protein Polymer said the annual market potential for uterine fibroid embolization could exceed $200 million in the United States and $300 million to $500 million worldwide.

Protein Polymer is a San Diego-based biotechnology company that develops technology and products for use in soft tissue augmentation, tissue adhesives and sealants, wound healing support and drug delivery devices.

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