FDA Issues Guidance for Quick-Med Technologies’
Exclusive Wound Dressing with pDADMAC
Quick-Med To Pursue Additional Medical Device Applications
Based on Patented NIMBUS® Technology
Gainesville, Florida - October 23, 2009 - Quick-Med Technologies, Inc. (OTCBB:
QMDT) announced today 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 at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument
s/ucm186571.htm
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