Derma Sciences Receives Second FDA 510K Clearance And Adds To Their MEDIHONEYTM Wound & Burn Dressings With Active Leptospermum Honey Line

Main Category: Dermatology
Article Date: 16 Nov 2007 - 12:00 PDT

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Derma Sciences (OTCBB: DSCI), a manufacturer and marketer of advanced wound care products, announced that the FDA has given 510K clearance to the company's second dressing in the MEDIHONEY line. This dressing is indicated for use on wounds with light to moderate exudate, and - based on its hydrocolloidal properties - forms a gel when it comes into contact with wound fluid to assist in promoting a moist environment conducive to healing. Hydrocolloids are the most commonly used advanced wound care dressings, as most chronic wounds fall into the category of light to moderate exudate. In 2007 it is estimated that over $150 million in hydrocolloids will be sold in the US alone. The first MEDIHONEY dressing from Derma Sciences, cleared for use by the FDA in July 2007, is in an alginate base and is indicated for wounds with moderate to heavy levels of exudate.

The new dressings, both in adhesive and non-adhesive versions, have been shown to lower the pH level of wounds. This is significant in that much recent attention has been focused on the effect of pH modulation in wounds, and the research suggests that lowering the pH of a wound helps to create a more optimal environment for wound healing. When wound pH is lowered, it has been shown that protease modulation and increased oxygen diffusion take place, both beneficial to hard-to-heal wounds.

Additionally, the dressings - due to their high levels of glucose and other sugars - have been shown to promote a strong osmotic effect. This osmotic effect, drawing fluid from surrounding tissues, helps to constantly bathe wounds in lymph fluid, which assists in the removal of necrotic tissue, slough, and debris from the wound bed.

Speaking of the recent 510K clearance, Derma Sciences' CEO Edward J. Quilty said, "This is another important milestone in the launch of our MEDIHONEY dressings. Ultimately, we intend to offer clinicians a complete line of dressings based on the patented honey-based wound dressing technologies we have licensed from our partner, Comvita New Zealand, Ltd. Since our recent launch only a month ago, initial sales and product trials have exceeded our expectations. The addition of these new dressings to the line will help to ramp up sales even more quickly. As previously stated, we are watching this closely and are prepared to increase our growing direct sales force as is necessary."

The dressings are expected to be launched in the first quarter of 2008.

About Derma Sciences

Derma Sciences is a manufacturer and marketer of advanced wound care products, with operations based in the US and Canada, and sales worldwide. The company sources Active Manuka (Leptospermum scoparium) Honey from Comvita New Zealand, Ltd. Comvita controls over 70% of the flow of manuka honey, and owns several patents around the use of honey in wound dressings. The Company has also obtained FDA clearance to market and sell its MOBILITY-1™ boot and compressor device for the treatment of venous ulcers, lymphedema, and other conditions that require compression therapy. For more information about Derma Sciences, Inc., visit its home page on the Internet at http://www.dermasciences.com.

Forward-looking Statements

Statements contained in this 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 which may be made in this release or which are otherwise made by or on behalf of the Company. Factors which 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 Securities and Exchange Commission.

Derma Sciences