CryoSeal asks for FDA approvalT hermoGenesis Corporation has applied to the U.S. Food and Drug Administration (FDA) for market clearance for the CryoSeal System. The system is designed to facilitate rapid automated preparation of cryoprecipitated AHF (Cryo), which is a blood component licensed by the FDA for the treatment of clotting in protein deficient patients. Current annual U.S. production of Cryo is approximately 1.2 million units per year.
Current blood bank Cryo production protocols typically require two to three days and the use of four separate machines, according to ThermoGenesis. "In contrast, the CryoSeal automated system will accomplish the production of Cryo by itself in less than 11 hours with comparable or greater yields of clotting proteins than result from current methods," said Philip Coelho, president and chief executive officer.
"We also anticipate that CryoSeal will be useful for the intraoperative preparation of autologous Cryo to enable a surgeon to utilize a patient’s own blood as a source for clotting and adhesive proteins, a biological tissue adhesive and a hemostatic agent," Coelho said. t