FDA Issues Guidance for Derma Sciences' Exclusive Wound Dressing With pDADMAC
11/20/2009
PRINCETON, NJ--Derma Sciences, Inc. (OTC Bulletin Board: DSCI), a specialty medical device / pharmaceutical company specializing in advanced wound care, announced today that the Food and Drug Administration (FDA) has issued its Guidance Document to support the classification of the Company's BIOGUARD™ barrier gauze wound dressings as Class II medical devices. This novel wound dressing received its initial market clearance on February 25, 2009, via the FDA's De Novo review process, a special clearance program for medical devices that are found to be "not substantially equivalent" to any predicate device.
Commenting on the move by the FDA, Derma Sciences CEO Edward J. Quilty stated, "This guidance document is significant in that it will allow us to quickly expand the product offerings within the BIOGUARD line. Notably, the document covers only the use of the active compound in BIOGUARD - polyDADMAC. As a result, through our license with Quick-Med Technologies, Inc. (QMDT.OB), the patent and patents pending around the use of this antimicrobial will ensure that this milestone not only helps us broaden our line, but also gives us a strong competitive advantage against other companies seeking to develop similar cost-effective products." Quilty concluded, "The guidance document states that BIOGUARD could be used as part of an overall infection prevention program. This is significant for us, as we believe that - due to its unique properties - BIOGUARD represents the best product on the market for cost-effective broad spectrum infection protection, without the risk of creating antimicrobial resistant strains."
The newly issued guidance pertains to a wound dressing with permanently bound cationic biocide polyDADMAC, one of the molecular entities covered in nine Quick-Med U.S. patents/patents pending and in 24 foreign counterparts.
BIOGUARD dressings, which were introduced in June, are the first wound care products to feature the novel technology subject of the newly issued Guidance. The dressings serve as a barrier to infection, kill germs absorbed into the dressing, and provide an optimum wound healing environment. The active agent maintains effectiveness even in the presence of large amounts of wound fluid.
BIOGUARD is unique in that it is the only non-leaching antimicrobial wound dressing, which the company believes is an important distinction; other antimicrobial dressings rely on the release of chemicals to the wound bed, which can impede the wound healing process and can cause the formation of resistant bacterial strains. This makes BIOGUARD dressings ideal for use as prophylactic infection control dressings, especially in the hospital environment, where deaths related to hospital-acquired infections have risen to become the fourth leading cause of death in the U.S. after heart disease, automobile accidents and cancer. To date, widespread prophylactic usage of antimicrobial dressings has been mitigated by concerns about the creation of antimicrobial resistant pathogens.
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