PRINCETON, N.J., Oct. 28 /PRNewswire-FirstCall/ -- 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 has issued its Guidance Document to support the classification of the Company's BIOGUARD(TM) 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.
Copies of the Guidance, which was announced in the Federal Register on October 16, are available on the FDA website at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm186571.htm.
About Derma Sciences, Inc.
Derma Sciences is a global manufacturer and marketer of advanced wound care products. Its key product, MEDIHONEY(R), is sold throughout the world by Derma Sciences and Comvita New Zealand -- the licensor of the patented honey-based technology -- and is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown to be effective in a variety of wounds and burns, and was the focus of a positive large-scale randomized controlled trial on leg ulcers. Derma's recently FDA cleared BIOGUARD(TM) Barrier Dressing is the Company's latest new product entrant into the $14 billion global wound care market. The barrier technology was licensed from Quick-Med Technologies, Inc. in Q1 of 2007. Derma also has in development DSC127, a novel angiotensin analog for accelerated wound healing and scar reduction. DSC127 was licensed from the University of Southern California in Q4 of 2007. Patient enrollment for a Phase II study began in Q4 of 2008. Results from this study are expected to be submitted to the FDA in Q2 of 2010.
For more information about Derma Sciences, Inc., visit http://www.dermasciences.com
Statements contained in this release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements which may be made in this release or which are otherwise made by or on behalf of the Company. Factors which may affect the Company's results include, but are not limited to, product demand, market acceptance, impact of competitive products and prices, product development, completion of an acquisition, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements include but are not limited to, those discussed in the Company's fillings with the Securities and Exchange Commission.
Contact: Derma Sciences, Inc. Edward J. Quilty Chairman and CEO firstname.lastname@example.org (609) 514- 4744 The Investor Relations Group 212-825-3210 Investor Relations: Jason Strominger or Media Relations: Susan Morgenbesser
SOURCE Derma Sciences, Inc.
|SOURCE Derma Sciences, Inc.|
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