Derma Sciences Submits 510(k) Application for MEDIHONEY Gel, Reaches Goal of 20-Person U.S. Field Sales Force
ney Firm Submits Application for Approval of Wound Gel
PRINCETON, N.J., Jul 09, 2010 (BUSINESS WIRE) -- Derma Sciences, Inc., 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(R) 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…