Derma Sciences Receives Health Canada Clearance for API-MEDTM Antimicrobial Dressings with Active Manuka Honey
Business Wire, 6/14/2007
PRINCETON, N.J.--(BUSINESS WIRE)--Derma Sciences, Inc. (OTCBB: DSCI), a manufacturer and full line supplier of advanced wound care products, today announced 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…
Barry Wolfenson, VP 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.”…
About Active Manuka Honey: Most varieties of honey will produce hydrogen peroxide upon dilution. This hydrogen peroxide, in low enough concentrations to not be cytotoxic to tissue, results in a strong antimicrobial activity. However, upon introduction to a wound, much of this hydrogen peroxide is converted to water and oxygen through a reaction with a common enzyme – catalase – found in wound fluid. Thus, typical honeys would require numerous daily dressing changes to be effective as topical antimicrobials. However, Active Manuka Honey is one of only a few identified species of honey that has a strong antimicrobial activity that continues on even in the presence of catalase, making it an effective and commercially viable topical antimicrobial. This attribute, along with the large supply of pure Active Manuka Honey harvested in New Zealand – a country known for its tightly controlled agricultural industry – are the reasons why Active Manuka Honey has been the most often studied honey for wounds and burns…
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