DSCI files 510(K) for Medihoney Gel - Analyst Blog

Recently, Derma Sciences Inc. (DSCI) filed a 510(K) application to the U.S. Food and Drug Administration (FDA) for Medihoney Gel, indicated for wound and burn dressing. The FDA is expected to give a response to the application within 90 days from the submission date.

Medihoney gel consists of Active Manuka Honey mixed with some gelling agents. Its extended usage is ideal for the management of chronic and acute wounds and burns including chronic ulcers, burns and post-operative wounds. The dressing keeps the honey intact at the wound area for a long time, even in the presence of body fluids or heat.

Furthermore, Derma Sciences also achieved its second quarter 2010 goal of recruiting 20 sales representatives in the U.S., thereby doubling the sales force strength, to meet the increasing demands for the wound care products. The company expects to achieve its productivity goals faster through these new sales professionals by creating more awareness of its wide range of wound care products, including Medihoney.

Derma Sciences’ three operating segments include wound care, wound closure and specialty securement devices as well as skin care three or four segments. The wound care segment, consisting of basic and advanced dressings, adhesive strips, ointments and sprays, accounted for 95% of total revenues in fiscal 2009. In the first quarter 2010, the segment’s sales increased 25% year-over-year to $12.25 million.

Derma Sciences expects continued enhancement of its wound care product portfolio in response to the expanded sales and marketing efforts. We believe that the launch of Medihoney will further add to the company’s future sales growth.
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