FDA Clears First Quick-Med Product
Innovative NIMBUS® Gauze Receives Special “De Novo” Clearance
Brings Highly Effective, Non-Leaching, and Affordable Barrier Protection
to the $14 Billion Global Wound Care Market
Gainesville, Florida – February 26, 2009 – Quick-Med Technologies, Inc. announced
today that it has received clearance from the U.S. Food and Drug Administration to
market and distribute its patented NIMBUS® barrier gauze wound care dressings. This
represents the first FDA clearance for NIMBUS – an innovative technology that is so
unique and cutting edge that it was put through FDA’s De Novo process, a special
clearance program for medical devices that are found to be “not substantially equivalent”
to any predicate device.
What makes NIMBUS-treated gauze different from other antimicrobial dressings are its
permanent bond and its ability to be effective even in the presence of large amounts of
serum and exudate. The active agent is permanently bonded to the gauze, keeping the
biocide from depletion, while killing microbes (such as MRSA, VRE, and many others)
that are drawn into the absorbent dressing. NIMBUS permits the control of microbes
without leaching any material into the wound bed, thus eliminating the associated
interference with the wound-healing process. Being bound in the dressing keeps the
antimicrobial at full strength; test results show that even in 90% serum, NIMBUS gauze
continues to kill microbes outperforming other antimicrobials.
Anticipating FDA clearance, Quick-Med has already licensed NIMBUS gauze for
marketing in the United States and Canada to Derma Sciences, Inc., a leading provider of
advanced wound care products. Derma Sciences’ CEO, Ed Quilty, recently characterized
NIMBUS as representing “the first real fusion of traditional and advanced wound care
technologies.” Derma Sciences and the Company expect the product to launch in spring,
2009.
NIMBUS will bring safe, affordable, highly effective barrier protection to the $14 billion
global wound care market which is projected to continue rapid growth for the next
several years primarily due to the aging population. The Company is actively negotiating
with other medical device manufacturers for application of NIMBUS to other substrates.
About NIMBUS®
NIMBUS is non-toxic, long-lasting and not blocked by organics such as blood, urine and
perspiration. Product labeling has been allowed that indicates various organisms such as
MRSA, VRE, Pseudomonas aeruginosa and Escherichia coli are killed at levels
exceeding 99.999%.
NIMBUS is a next-generation wound care technology. According to Gregory Schultz,
Professor, Institute for Wound Research at the University of Florida and Past President of
the Wound Healing Society, “NIMBUS poses no danger of bacteria developing
resistance, or of releasing toxic material into the wound and impeding the wound healing
process. It is a novel technology: bonded and effective even in high concentrations of
body fluids.” We believe health care practitioners will have more comfort about
providing NIMBUS dressings to acute wounds or chronic, difficult to heal, wounds.
Unlike silver dressings, NIMBUS technology causes no discoloration and no cell
damage.
Roy Carr, Quick-Med’s Director of Business Development, noted “NIMBUS has several
advantages over silver, the current market-leading antimicrobial for medical devices,
summed up by: better performance at less than a tenth of the cost. It is also less likely to
interfere with or retard wound healing because it is bound and held at the required level
of cell inactivation.”
“This clearance is an important milestone for Quick-Med and will be a predicate for other
medical device filings incorporating the NIMBUS technology,” according to J. Ladd
Greeno, Quick-Med’s CEO. NIMBUS technology is versatile, and with FDA market
clearance, can be made available in several other wound dressing formats including
adhesives, foams, hydrogels, films, and hydrocolloids.
The De Novo clearance validates NIMBUS technology as satisfying all FDA
requirements, above and beyond the normal 510(k) process. The Company believes this
clearance through the De Novo process may provide potential market advantages as we
understand that the FDA may be taking a new posture with antimicrobials that could
considerably raise the barrier to entry.
About Derma Sciences, Inc.
Derma Sciences is a global manufacturer and marketer of advanced wound-care products.
For more information, see: www.dermasciences.com.
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