FDA: Special clearance for UF-developed antimicrobial wound dressing

March 2, 2009

GAINESVILLE, Fla. — The Food and Drug Administration has given its clearance to an innovative wound dressing primarily developed by University of Florida scientists and engineers and being marketed by a Florida company.

The FDA late last week gave permission for Quick-Med Technologies Inc. to begin selling its “NIMBUS” barrier gauze wound care dressings after reviewing the dressing in a rare clearance process used only for medical devices for which there is no equivalent FDA-cleared wound dressing.

The dressing is unique in its ability to retain its antimicrobial properties without allowing any bacteria to migrate back into the wound, where they interfere with healing and can worsen infection, said Chris Batich, a professor of materials science and engineering and one of three UF inventors of the technology.

The fact that the antimicrobial agents remain permanently bonded to the gauze means that the technology is effective for longer periods, allowing longer intervals between changing the dressing, which speeds up the healing process. Neither blood, urine nor sweat dull its capacity to kill microbes — including such well-known pathogens as MRSA, VRE and Escherichia coli — drawn from the wound into the absorbent dressing or arriving from the air in the room. Not only that, but the dressing is less costly than similar treatments, and can cope with wounds that leak larger amounts of pus and other fluids, Batich said.

“You could potentially leave it on a longer period of time,” Batich said. “And even if it’s on a shorter period of time, all this toxic material from the bacteria doesn’t get back into the wound where it can worsen the infection. It makes a very effective barrier.”

The FDA cleared the NIMBUS gauze in its De Novo process, designed for medical devices that are unlike any currently on the market. It is one of about three dozen medical devices cleared as part of the accelerated process in the last decade. By comparison, the traditional process, for devices “substantially equivalent to existing devices,” is used about 3,000 times per year.

The other inventors of the technology are Greg Schultz, director of the UF Institute for Wound Research, and Bruce Mast, a plastic surgeon formerly at UF now in private practice in Gainesville.

Quick-Med Technologies is a small, publicly traded company in Gainesville that develops technologies and licenses them to partner companies for commercialization. It has licensed the NIMBUS barrier gauze to Derma Sciences, which plans to market it starting this June under its trade name, BIOGUARD.

The FDA clearance “is an important milestone for Quick-Med and will be a predicate for other medical devices incorporating the NIMBUS technology,” said J. Ladd Greeno, chief executive officer of Quick-Med, in a Quick-Med press release.