ThermoGenesis Corp announced that its Brazilian distributor, CEI, based in Rio de Janeiro, has successfully completed registration of the CryoSeal FS System with the Brazilian Ministry of Health. This will now permit the import of the system into Brazil and allow sales efforts to commence.

Kevin Simpson, President and COO of ThermoGenesis Corp. commented, "We're pleased that CEI has obtained the required regulatory approval. CEI is a well-respected sales and marketing organization of medical devices and blood processing disposables, with strong ties to both the blood bank and surgical end user customers for the CryoSeal FS System in Brazil. This registration will allow CEI to begin the clinical evaluations at leading surgery hospitals required for a successful product launch."

Ana Pacheco, Vice President for CEI commented, "We are pleased to be able to market the first total human fibrin sealant into the Brazilian market. Now that we have completed the registration process, we can begin placing systems at selected locations to begin the evaluations that are needed for launching the product. While we expect it to take some time to develop the concept of Autologous and single donor Homologous fibrin sealant, our pre-marketing activities have shown us that there is a demand for this product and we will work closely with our partner ThermoGenesis to assure a successful market entry."

The CryoSeal FS System prepares both components (cryoprecipitate and thrombin) of CryoSeal Fibrin Sealant from a single unit of autologous human plasma in about an hour. Once prepared, the CryoSeal Fibrin Sealant may be frozen or used immediately as a hemostatic agent for patients undergoing liver resection.

Conventional fibrin sealants, which are sourced from pooled plasma of 10,000 or more units, remain vulnerable to new and re-emerging pathogens. Newly discovered hepatitis viruses, such as parvovirus B-19, and other agents of transmissible spongiform encephalopathies have been known to compromise the safety of homologous plasma provided in the form of fresh frozen plasma to surgical patients.

In contrast to commercially available fibrin sealants, CryoSeal Fibrin Sealant is free of animal proteins such as bovine thrombin or bovine aprotinin. Animal proteins are a potential source of viral and prion contamination to blood products, the latter of which are resistant to all forms of viral inactivation technology available to fractionators at this time.