News | July 22, 2007

Derma Sciences Receives FDA Clearance for its Active Manuka Honey Absorbent Dressing

July 23, 2007 – Derma Sciences Inc., a manufacturer and marketer of advanced wound care products, today announced that it has received clearance from the FDA to market and sell its API-MED Active Manuka Honey Absorbent Dressing.

This represents the first FDA clearance of a honey-based product for the management of wounds and burns. Honey-based products have been available throughout Europe where they compete against silver-based dressings, and have in only two years captured approximately 10% of that market.

CEO Ed Quilty said, “This is great news for Derma Sciences. This clearance marks a significant milestone in Derma’s plan to use the cash flow from our base business to fund the development and promotion of novel advanced wound care products. Based on what we have seen in the European market, we are confident that honey, like silver, will become a rapidly growing category within advanced wound care dressings. With significant data and evidence being published about Active Manuka Honey, our dressing should do well in the $2.3 billion US advanced wound care segment”. Quilty also added,

VP of Marketing & Business Development Barry J. Wolfenson commented, “We hit our goal to be first in the US with a honey-based product. Through our partner Comvita’s dominance in the procurement of Manuka honey as well as their advanced processing systems and patents for the use of honey in wound dressings, our head start plus these other barriers to entry should ensure Derma a leadership position in what is expected to be a significant market.” Wolfenson added, “the evidence being published globally about Active Manuka Honey and other Leptospermum honeys and their role in managing chronic wounds and burns is steadily increasing, and the number of large scale randomized controlled trials is greater than that of silver dressings. We are confident that this non-toxic, effective, naturally-derived product with its large and growing evidence base will be readily adopted by clinicians who are calling for easy and effective products to use throughout all phases of wound healing.”

Professor Peter Molan, who heads the Honey Research Unit at the University of Waikato in New Zealand, said, "It has taken 25 years since we discovered the unique properties of Manuka Honey for it to be possible to market it in the USA for medical purposes. Derma Sciences are to be congratulated for satisfying the FDA that their strict requirements for medical products have been met. I am delighted that at last the USA public can benefit, like those in other countries have, from natural products that effectively manage persistent chronic wounds and burns.” Rose Cooper, BSc, PhD, PGCE, CBiol, MIBiol, FRSA, Microbiologist and Principal Lecturer at the Cardiff School of Health Sciences at the University of Wales Institute Cardiff, said “I am optimistic that clinicians and patients in the United States will discover the therapeutic benefits of Active Manuka Honey in the management of wounds and that it readily becomes an accepted treatment option.”

For more information: www.dermasciences.com

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