FDA OKs BioTime Wound Management Hydrogel

The FDA has granted 510(k) clearance to BioTime’s Premvia HyStem hydrogel for the management of a wide range of wounds, including diabetic ulcers, second-degree burns and draining wounds.

Premvia mimics the body’s natural extracellular matrix by cross linking collagen and hyaluronic acid, making it compatible with cells and tissues, said Gregory Keller, co-director of the UCLA facial plastic surgery fellowship.

The FDA clearance — the company’s first — lays the foundation for more bioactive and cell-matrix combination products in the HyStem hydrogel line, BioTime said.

The company estimates the global market for aesthetic and reconstructive surgery at more than $6 billion annually. Premvia is expected to serve a subset of the overall market. — Kellen Owings

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