FDA clears Derma Sciences' MEDIHONEY Hydrogel Wound and Burn Dressing

Aug 2 2011

Derma Sciences, Inc. ("Derma Sciences" or "the Company") (Nasdaq: DSCI), 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® 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."

Mr. Quilty continued, "Aside from the prescription burn market in the U.S., we are hopeful that this dressing allows us to capitalize on two additional opportunities. First is that we designed this dressing with an eye towards the OTC market, and we will be discussing it with our OTC partners through our First Aid products division. Most burns in the U.S. are first degree and occur in the home. We believe our MEDIHONEY Hydrogel dressings can be ideally suited for the management of these burns. Second, while the burn market in the U.S. is significant, 90% of all burns occur outside the U.S. We believe this product could provide meaningful upside in our international sales. Towards that end, we have already begun the process of gaining CE Mark status from the EU for the product, and will be discussing it with our other international distributors that rely on FDA clearance for product registration in their markets."

Source: Derma Sciences, Inc.