Derma Sciences Receives Health Canada Clearance for API-MEDTM Antimicrobial Dressings with Active Manuka Honey

PRINCETON, N.J. -- Derma Sciences, Inc., a manufacturer and supplier of advanced wound-care products, announces that it has obtained clearance from Health Canada to market and sell as Class II devices its line of API-MED Antimicrobial Dressings with Active Manuka Honey. This represents the first honey-based products to be cleared for medical use in North America. Active Manuka Honey based products have been available throughout Europe, Australia, and New Zealand for the past two years.

Ed Quilty, president and CEO said, This clearance represents a major milestone for Derma Sciences as we move forward to implement our plan of using the strong cash flow from our base business to fund the development and promotion of novel advanced wound care products. Adoption of honey-based products, and notably Active Manuka Honey products, has been very encouraging in the markets where these products have been available. Additionally, Derma Sciences enjoys a leading position in wound care in Canada through the Dumex line we purchased in 2001, with contracts in about 50 percent of Canadian hospitals. As such, we hope to be able to add this novel product to many of our existing contracts, and compete within the rapidly growing topical antimicrobial market. Initially, we will be targeting the market for silver based dressings, which is the current standard for advanced wound care. The U.S. market for silver based dressings is approximately $100 million and normally the Canadian wound care market is about 10 percent of the U.S. market. With our strong presence in Canada, we expect to make significant inroads into the advanced wound care market there.

Barry Wolfenson, vice president of marketing and business development, added, The World Health Organization (WHO) cites that, since 1970, the development of new classes of antimicrobials has slowed to a virtual standstill. This, along with the growing number of resistant microbes, has led the WHO to call for greater investment in R&D in this area as well as for faster approval times to allow novel products to get to market more quickly. With its well documented activity against MRSA and other resistant strains, we are confident that clinicians will readily adopt Active Manuka Honey products. We are currently awaiting the results of a standard in vitro study which quantifies the possibility of resistant organisms to a given antimicrobial. Although antimicrobials such as silver have been shown to create resistant organisms, to date Active Manuka Honey has not. We expect this to hold true in the study. Added to this the lack of toxicity a common issue with other topical antimicrobials including silver and the growing base of evidence for Active Manuka Honey as having powerful benefits conducive for wound healing, the API-MED line of products should provide clinicians in Canada a powerful new tool for chronic wounds and burns.

Results from the most recent randomized controlled study using Active Manuka Honey were presented last month at the European Wound Management Association Conference. The 108 patient leg ulcer study compared the effectiveness of Active Manuka Honey against a common advanced wound care hydrogel, both under standard compression wraps. The honey arm demonstrated improved healing and infection control rates, along with effective debridement of necrotic tissue. These results will be published in a major medical journal later this year.

Source: Derma Sciences, Inc.