Oxygen Biotherapeutics files request for designation of new wound care product

The RFD submission is part of a process with the FDA for determining which agency component will have primary jurisdiction for a drug, device or biological product.

The product is Oxycyte gel in a single-dose packaging delivered as an ointment onto wounds and is protected by a standard bandage. Oxycyte is the company’s perfluorocarbon therapeutic oxygen carrier. The gel has a substantially higher oxygen permeability than most wound ointments currently on the market, the company said.

Chris Stern, chairman and CEO of Oxygen Biotherapeutics, said: “Biomedical companies should not just depend on one product area. This is part of our plan to apply Oxycyte broadly to multiple products for a range of indications.”