Today, Quick-Med Technologies, Inc. announced that the FDA has issued guidance to support the company’s NIMBUS® barrier gauze wound dressings as Class II medical devices. The innovative wound dressing received its initial market clearance in February 2009 following the FDA’s “De Novo” review process, a special clearance program for medical devices that are “not substantially equivalent” to any predicate device.
Ladd Greeno, Quick-Med CEO, stated, “This guidance is important because it now lets us pursue other planned medical device applications using our own bandage product as a predicate device. And since we have significant patent protection using this molecule, we believe that other companies cannot make similar use of this guidance.”
The guidance pertains to a wound dressing with permanently bound cationic biocide pDADMAC, a key component of the NIMBUS technology. It is also found in one of the molecular entities covered in nine Quick-Med U.S. patents and patents pending in 24 foreign counterparts. Dressings with other cationic biocides are not within the scope of this guidance.
As the only non-leaching antimicrobial wound dressing, NIMBUS technology holds an important distinction; NIMBUS forms a sterile bacterial barrier that prohibits the transfer of microorganisms into the wound. Other antimicrobial dressings rely on the release of chemicals to the wound bed that can actually impede the healing process. NIMBUS is non-toxic, long-lasting and not blocked by organics such as blood, exudates, urine and perspiration. 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/GuidanceDocuments/ucm186571.htm.