gel-e Inc., announces expansion of its’ consumer products label to include antibacterial barrier capabilities while allowing for non-sterile manufacture of products with greater shelf- and use-life from the U.S. Food and Drug Administration (FDA).
The Company is developing a line of advanced hemostatic and wound treatment products that address unmet needs from the battlefield to the backyard. Following the FDA’s recent designation of our LifeFoam™ military product as a “Breakthrough” device and building on previous clearances for topical use of its platform technology (see http://www.gel-e.co/news.html), the Company is now expanding its’ Over-The-Counter (OTC) consumer products label.
The Company’s cleared consumer product’s label has been strategically developed starting with hemostatic and wound treatment claims (K172010 & K180152), now expanded to include the creation of antibacterial environments, non-sterile manufacture, longer and more durable shelf- & use-life, all provided in “non-irritating, convenient, and easy to apply” products (K182811 & K192667). These regulatory clearances, provide a foundation for bandage and gel-based products that can be used to manage acute bleeding, and although these products are not intended to treat active infections, they can deliver an effective antimicrobial barrier designed to prevent bacterial infection in a moist, clean healing environment.
“Our two recent FDA clearances are important milestones toward our goal of transforming the effective treatment and rapid management of bleeding for people of all ages” said Edward J. Quilty, Senior Strategic Advisor to the Company and former Chairman and CEO of Derma Sciences, Inc. “Our team, under Larry Tiffany our CEO, has successfully collaborated with the FDA building on in vitro, pre-clinical and clinical results that support expanded labels and, in the future, use of our platform to manage more severe internal military and surgical applications. Our product portfolio will include both prescription and OTC treatments for bleeding wounds and clinical incisions including antibacterial barriers and improved healing environments,” said Mr. Quilty.
Source: Company Press Release
