Healthcare Industry News: CryoSeal
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.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 BioArchive® 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 CryoSeal® 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.
This press release, including statements regarding financial information for future periods, contain forward-looking statements, and such statements are made pursuant to the safe harbour provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking statements. Several factors, including timing of FDA approvals, changes in customer forecasts, our failure to meet customers' purchase order and quality requirements, supply shortages, production delays, changes in the markets for customers' products, introduction timing and acceptance of our new products scheduled for fiscal year 2006, and introduction of competitive products and other factors beyond our control, could result in a materially different revenue outcome and/or in our failure to achieve the revenue levels we expect for fiscal 2006. A more complete description of these and other risks that could cause actual events to differ from the outcomes predicted by our forward looking statements is set forth under the caption "Risk Factors" in our annual report on Form 10-K and other reports we file with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward looking statements.
Source: ThermoGenesis
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