PRINCETON, N.J.--()--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.”
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.
About Derma Sciences, Inc.
Derma Sciences is a medical technology company focused on three segments of the wound care marketplace, traditional dressings, advanced wound care dressings, and pharmaceutical wound care products. Its MEDIHONEY® product is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown to be effective in a variety of indications, and was the focus of a positive large-scale, randomized controlled trial involving 108 subjects with leg ulcers. Other novel products introduced into the $14 billion global wound care market include XTRASORB® for better management of wound exudate, and BIOGUARD® for infection prevention. Derma Sciences has successfully completed a Phase 2 clinical trial in diabetic foot ulcer healing with DSC127, a novel pharmaceutical drug under development for accelerated wound healing and scar reduction. For more information please visit www.dermasciences.com.
Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release or that are otherwise made by or on behalf of the Company. Factors that may affect the Company's results include, but are not limited to, product demand, market acceptance, impact of competitive products and prices, product development, completion of an acquisition, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements include but are not limited to, those discussed in the Company's filings with the U.S. Securities and Exchange Commission.