FDA grants 510(k) clearance for Derma Sciences MEDIHONEY Gel Wound and Burn Dressing

Feb 28 2011

Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company's patent-pending MEDIHONEY® Gel Wound and Burn Dressing. This latest MEDIHONEY line extension is dispensed from a tube and is comprised of Active Manuka (Leptospermum) honey blended with natural-based gelling agents. This is the fourth product in the expanding MEDIHONEY franchise, and will be launched into the market by the Company's 20-person U.S. sales force at the major annual wound conferences this spring.

Commenting on the clearance, Edward J. Quilty, Derma Sciences' President and Chief Executive Officer said, "This is an important addition to our MEDIHONEY product offering and we expect the marketplace to embrace this new product as we strengthen our category leadership. MEDIHONEY Gel will provide clinicians and patients with added versatility in their use of honey-based products for challenging wounds and burns. Because the product is blended with gelling agents, the honey is able to better maintain its physical integrity at the site of the wound, even in the presence of wound fluid and body heat. This will make for a more durable and lasting product, which is key in the management of chronic wounds. Importantly, its proprietary formulation utilizing natural gelling agents has a patent pending in the U.S., which if granted, will further increase our IP around the MEDIHONEY brand."

The new MEDIHONEY Gel will be manufactured by Derma Sciences in its facility in Toronto.