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.”