Derma Sciences, a provider of advanced wound care medical devices, has submitted a 510(k) application to the FDA for Medihoney Gel wound and burn dressing, and reported the achievement of regulatory and commercial milestones.
Derma Sciences said that the 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.
Derma Sciences has also achieved its staffing goal of 20 direct sales representatives in the US by the end of the second quarter, a doubling from 10 representatives at the close of 2009.
Edward Quilty, chairman and CEO of Derma Sciences, said: “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 US market upon receipt of FDA clearance.
“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.”
Derma Sciences 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 US.