FDA Issues Guidance For Quick-Med Technologies' Exclusive Wound Dressing With PDADMAC

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 26 Oct 2009 - 5:00 PDT

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Quick-Med Technologies, Inc. (OTCBB: QMDT) announced that the Food and Drug Administration has issued Guidance to support the classification of the Company's NIMBUS® barrier gauze wound dressings as Class II medical devices. This novel wound dressing received its initial market clearance on February 25, 2009 via 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.

"This guidance is important because it now lets us pursue other planned medical device applications using our own bandage product as a predicate device" stated Ladd Greeno, CEO of Quick-Med Technologies, Inc. "And since we have significant patent protection using this molecule, we believe that other companies cannot make similar use of this guidance," Mr. Greeno added.

The newly issued guidance pertains to a wound dressing with permanently bound cationic biocide pDADMAC, a key component of the NIMBUS technology and one of the molecular entities covered in nine Quick-Med U.S. patents and patents pending and in 24 foreign counterparts. The guidance document specifies only the cationic biocide polyDADMAC; dressings with other cationic biocides are not within the scope of this guidance.

BIOGUARD™ dressings, which were introduced in June by Quick-Med licensee Derma Sciences, Inc. (OTCBB: DSCI), are the first wound care products to feature the novel, FDA-cleared NIMBUS technology and subject of the Guidance. The dressings serve as a barrier to infection, kill germs absorbed into the dressing, and provide an optimum wound healing environment. The NIMBUS active agent maintains effectiveness even in the presence of large amounts of proteinaceous exudates.

NIMBUS 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 that can impede the wound healing process. NIMBUS forms a sterile bacterial barrier that prohibits the transfer of microorganisms into the wound because the microbicidal agent is bound to the dressing. NIMBUS is non-toxic, long-lasting and not blocked by organics such as blood, exudates, urine and perspiration. By its design, NIMBUS poses minimal risk of bacteria developing resistance.

Copies of the Guidance, which was announced in the Federal Register on October 16, are available on the FDA website FDA website.

Source
Quick-Med Technologies, Inc.