Wednesday, August 03, 2011

Derma Sciences Receives FDA Clearance for MEDIHONEY Hydrogel

PRINCETON, N.J., Aug 01, 2011 (BUSINESS WIRE) -- Derma Sciences, Inc. , a medical device and pharmaceutical company focused on advanced wound care, today announced it has received U.S. Food and Drug Administration 510(k) clearance for its patented MEDIHONEY(R) Hydrogel Wound and Burn Dressing with Leptospermum (Manuka) honey. This product will be available in both prescription and over-the-counter (OTC) formulations for the treatment of first- and second-degree burns, in addition to various chronic and acute wounds. The product will be sold in several sizes and configurations including dressings with and without an adhesive border and is expected to be available in early 2012, with a full commercial launch in the spring of 2012.

Commenting on the clearance, Edward J. Quilty, president and chief executive officer of Derma Sciences, said, "This proprietary dressing, our fifth line extension in our rapidly growing MEDIHONEY franchise, combines the proven healing properties of Manuka honey with hydrogels that provide and maintain a moist wound environment to help clean and debride necrotic tissue. Importantly, this dressing does not adhere to the wound bed and, as such, will not disturb the wound bed during dressing changes. MEDIHONEY Hydrogel dressing will be the first in the line that is directed to the treatment of burns, an enormous therapeutic area, expanding our advanced wound care addressable market."…
According to the American Burn Association National Burn Repository (2010 report) there were 450,000 burn injuries that received medical attention in the United States last year. The majority are first-degree (damage only the outer layer of skin) and second degree (damage the outer layer and the layer underneath). The leading cause of burns is direct flame, with scalding the second leading cause of burns.

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