Healthcare Industry News: thrombin
News Release - March 15, 2006
ThermoGenesis' AXP AutoXpress(TM) Platform is Launched by GE Healthcare as the First Automated Functionally Closed Sterile System for the Processing of Cord Blood Stem CellsRANCHO CORDOVA, Calif., March 15 (HSMN NewsFeed) -- ThermoGenesis Corp. (Nasdaq: KOOL ), a company that designs and develops enabling technologies for cell therapy and wound care, announced today that GE Healthcare has introduced the Company's AXP AutoXpress Platform (AXP Platform), the first automated, functionally closed, sterile system that harvests stem cells from cord blood with high yield and high throughput. The AXP Platform is designed to bring automation and precision to cord blood stem cell processing, which is today performed using manual methods.
In October 2005, GE Healthcare acquired the global exclusive distribution rights for the AXP Platform from the Company, as well as the non-exclusive distribution rights for the BioArchiveŽ System, a computer-controlled cryopreservation and storage system for cord blood. The Company estimates there are already about 200 cord blood banks operating in 44 countries collecting several hundred thousand cord blood units annually in this rapidly growing field.
According to Phil Coelho, Chairman and CEO, "A critical step in cord blood banking is the reduction of the collected volumes of cord blood (up to 170 ml/each) into a final volume of 20 ml with minimal loss of the mononuclear cell populations, which include all the stem cells. Reproducible volume reduction, without significant loss of stem cells, is critical in obtaining the precise freezing profile essential for post thaw stem cell viability. Since studies demonstrate that the AXP Platform can collect 97%(1) of the mononuclear cells (MNC) from cord blood, cord blood banks that implement the AXP Platform should benefit not only from consistent high recoveries of the MNC, but also from using an automated functionally closed system that eliminates the need to process cord blood in labor-intensive and expensive clean rooms."
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 29 countries for cryopreserving and archiving cord blood stem cell units for transplant.
-- The AutoXpress System, is a newly developed semi-automated device and companion sterile closed blood processing disposable, 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 blood 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 patient blood, or 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.
(1) Dobrila et al. "ThermoGenesis AXP AutoXpress Platform and BioArchive System for automated cord blood banking." Presented at BMT Tandem Meeting, February 2006.
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