RANCHO CORDOVA, Calif., Jan. 26 /PRNewswire-FirstCall/ -- ThermoGenesis Corp. announced today that Dr. Erhan Basad (orthopedic surgeon) and Dr. Detlef Kuhn (anesthesiologist) studied the use of CryoSeal autologous fibrin sealant in TKA at the University Hospital in Giessen, Germany. The results of the study were published in the December, 2004 issue of the German orthopedic journal “Orthopadische Praxis.”
According to Dr. Basad, “The 21-patient pilot study (study group 10, control group 11) measured blood loss, cardiovascular stability, pain score, range of motion and wound healing. The total blood loss in TKA was reduced by 50% when using CryoSeal fibrin sealant (control group blood loss was 1033 ml, versus 526 ml for study group). The CryoSeal patients also had better cardiovascular stability, a higher range of motion, less pain and better wound healing than the control group.” Dr. Basad noted that he is planning to perform a larger study to confirm the very positive results of the pilot study.
“We are very pleased with Dr. Basad’s and Dr. Kuhn’s findings,” said Philip Coelho, Chairman & CEO of ThermoGenesis Corp. “There are annually more than 1.3 million total knee arthroplasties worldwide (339,400 in U.S., 809,700 in Europe and 224,800 in Asia) according to the Frost & Sullivan 2004 report on orthopedic surgeries. These are surgeries that result in substantial bleeding and most patients pre-donate blood -- which makes them ideal for the CryoSeal System which can prepare as much as 16 ml of fibrin sealant from a unit of the patient’s own blood. We look forward to the expanded trial and its results,” concluded Mr. Coelho.
Regulatory Status
The CryoSeal FS System has received CE Mark approval from the European Union Competent Authorities and is being tested in European clinical trials. Additional field trials are underway in Canada and Brazil. In Japan the pivotal clinical trial has been completed by Asahi Medical, the Japanese distributor who expects to file the PMA in the near future. The CryoSeal FS System is not available for sale in the United States and is currently being tested to control bleeding in a Phase III liver resection trial at eight (8) clinical sites.
About ThermoGenesis Corp.
ThermoGenesis Corp. is a leader in enabling technologies for cell therapeutics. The Company’s technology platforms lead the world in their ability to produce biological products from single units of blood. Umbilical cord blood banks are utilizing the Company’s BioArchive(R) System as a critical enabling technology for cryogenic archiving of stem cells for transplant, while its CryoSeal FS System is used to prepare hemostatic and adhesive surgical sealants from patient blood in about an hour. ThermoGenesis Corp. has been a leading supplier of state-of-the-art Ultra-Rapid Blood Plasma Freezers and Thawers to hospitals and blood banks since 1992.
The statements contained in this release which are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements, including, but not limited to, certain delays beyond the Company’s control with respect to market acceptance of new technologies and products, delays in testing and evaluation of products, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission.
ThermoGenesis Corporation
CONTACT: Kevin Simpson of ThermoGenesis Corp., +1-916-858-5100
Web site: http://www.thermogenesis.com/