Healthcare Industry News: surgical sealant
News Release - February 14, 2006
ThermoGenesis Receives Health Canada Regulatory License to Market the AutoXpress System (AXP(TM))RANCHO CORDOVA, Calif., Feb. 14 (HSMN NewsFeed) -- ThermoGenesis Corp. (Nasdaq: KOOL ) announced today that the Medical Devices Bureau of Health Canada has issued ThermoGenesis a license to market the AXP System in accordance with Health Canada's Medical Device Regulations which allows GE Healthcare, the exclusive AXP System distributor, the right to begin its sales and marketing efforts to cord blood banks and hospitals in Canada.
Kevin Simpson, President and COO of ThermoGenesis noted that, "The AXP System is a newly-developed automated system that allows stem cells from cord blood to be harvested in a functionally-closed processing set without the requirement of expensive clean rooms and labor intensive processes. The AXP System automates what was typically an 18-step manual process while improving the recovery rates of the stem cells. Further, research facilities may choose to adopt this system to enable more precise selection and concentration of stem cells for investigation of intra-operative cell therapy applications."
About ThermoGenesis Corp.
ThermoGenesis Corp. is a leader in developing and manufacturing automated blood processing systems and disposables that enable the manufacture, preservation and delivery of cell and tissue therapy products.
-- The BioArchiveŽ System, an automated cryogenic device, is used by cord blood stem cell banks in 26 countries for cryopreserving and archiving cord blood stem cell units for transplant.
-- The AutoXpress System, is a newly developed automated device to harvest stem cells from cord blood.
-- The CryoSealŽ FS System, an automated device and companion sterile blood processing disposable, is used to prepare hemostatic and adhesive surgical sealants from the patient's plasma in about an hour. Enrollment in a 150 patient U.S. pivotal clinical trial has been completed and a PMA is being reviewed by the FDA.
-- The Thrombin Processing Device(TM) (TPD(TM)) is a sterile blood processing disposable that prepares activated thrombin from a small aliquot of blood plasma in less than 30 minutes. The TPD market launch is underway in Europe.
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