Healthcare Industry News: BIOGUARD
News Release - July 9, 2010
Derma Sciences Submits 510(k) Application for MEDIHONEY Gel, Reaches Goal of 20-Person U.S. Field Sales ForcePRINCETON, N.J.--(HSMN NewsFeed)--Derma Sciences, Inc. (NASDAQ: DSCI ), a medical device and pharmaceutical company focused on advanced wound care, announces the achievement of regulatory and commercial milestones.
Late last week the Company submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for MEDIHONEY® Gel Wound & Burn Dressing. This latest MEDIHONEY line extension is dispensed from a tube and is comprised of Active Manuka (Leptospermum) Honey blended with gelling agents. It is intended for use in hard-to-dress areas and wounds. The Company expects an initial response by the FDA within 90 days of the date of submission. MEDIHONEY Gel is patented in the EU and is the subject of a patent application in the U.S.
“We have been systematically building our portfolio of novel proprietary, higher-margin, advanced wound-care products, and look forward to introducing MEDIHONEY Gel into the U.S. market upon receipt of FDA clearance,” said Edward J. Quilty, chairman and chief executive officer of Derma Sciences. “It is challenging to keep medical honey at the site of a wound for an extended period of time because when it comes into contact with body fluids or heat, it turns into a thin, runny liquid. Most of the patents covering our unique line of MEDIHONEY dressings are based on this challenge, helping to keep the honey within certain dressings and formulations so it can remain at the wound site for extended periods of time – even in the presence of wound fluid. Our patented MEDIHONEY Gel achieves this goal and will provide clinicians with another alternative dressing type to help expand usage.”
The Company also achieved its staffing goal of 20 direct sales representatives in the U.S. by the end of the second quarter, a doubling from 10 representatives at the close of 2009.
“I am particularly delighted with the quality of sales representatives who are attracted to the growth opportunity that Derma Sciences represents,” commented Mr. Quilty. “With the successful introduction of five innovative advanced wound care product lines over the past three years, we are building our sales presence to support growing demand. We believe these new sales professionals will reach productivity goals faster than our earlier hires because of the established awareness of MEDIHONEY and our other new brands, as well as the large and growing body of published clinical data that supports their efficacy.”
About Derma Sciences, Inc.
Derma Sciences is a global medical device and pharmaceutical company focused on wound care. 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 leg ulcer patients. Other novel products introduced into the $14 billion global wound care market include XTRASORB® for better management of wound exudates, and BIOGUARD™ for infection prevention. Derma Sciences also expects to complete preclinical studies with DSC127, a novel pharmaceutical for accelerated wound healing and scar reduction, by the end of 2010. 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.
Source: Derma Sciences
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