According to the company, this represents the first FDA clearance for Nimbus – a technology that is so unique and that it was put through FDA’s de novo process.
Anticipating FDA clearance, Quick-Med has already licensed Nimbus gauze for marketing in the US and Canada to Derma Sciences, a provider of advanced wound care products. Derma Sciences and the company expect the product to launch in spring, 2009.
The company is actively negotiating with other medical device manufacturers for application of nimbus to other substrates.