Quick-Med Technologies out of Gainesville, Florida got its NIMBUS barrier gauze wound dressing classified as a novel Class II medical device by the FDA:
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., 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.
Press release: FDA Issues Guidance for Quick-Med Technologies’ Exclusive Wound Dressing with pDADMAC …
