Winston-Salem, NC, June 2, 2017 – KeraNetics, LLC, the global leader in purified keratin medical products, announced today that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for KeraStat® Gel. KeraStat® Gel is a hydrogel wound dressing that maintains a moist environment to support wound healing. The prescription indications approved for use include the management of: partial thickness burns; severe sunburns; superficial injuries, cuts, abrasions, and incisions/surgical wounds; ulcers of a variety of etiologies; donor sites; and grafts.
KeraStat® Gel development was funded, in part, by the Department of Defense and Biomedical Advanced Research Development Authority. Luke Burnett, Chief Science Officer, said “The FDA approval of KeraStat® Gel means that this treatment is now available for the catastrophic battlefield wounds our Soldiers get in combat. This has been a multiyear effort and would not have been possible without the generous funding we have received from governmental partners at the Department of Defense and BARDA.”