The pivotal 150-patient, multi-center trial was designed to evaluate the safety and efficacy of the fibrin sealant prepared by ThermoGenesis’s CryoSeal FS System as an adjunct to hemostasis for cancer patients undergoing liver resection surgery. The study compared the ThermoGenesis treatment against Instat, a collagen absorbable hemostat.
The study reached its primary end point, which was to demonstrate the equivalency of the ThermoGenesis product to Instat. Not only did the data show statistical significance for “non-inferiority”, patients treated with CryoSeal FS actually showed “superiority”, demonstrating statistically significant quicker time to hemostasis (cessation of bleeding) compared to the control group.
These data will be included in a Pre-Market Approval submission that ThermoGenesis expects to file in December 2005. FDA approval would enable ThermoGenesis to address the $125 million US fibrin sealant market as well as other international markets that allow FDA-cleared products to be sold within their borders. According to ThermoGenesis, the worldwide market for fibrin sealant exceeds $450 million per year.
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 surgery.
In contrast, conventional fibrin sealants are sourced from large pools of 10,000 or more units of purchased plasma, and thus remain vulnerable to contamination by infectious pathogens residing in any of these 10,000 units of blood plasma.