RANCHO CORDOVA, Calif., Oct. 19 /PRNewswire-FirstCall/ -- ThermoGenesis Corp. , a company that designs and develops enabling technologies for cell therapy and surgical wound care, announced today that it has scaled-up its production to begin volume shipments of its AutoXpress (AXP(TM)) cord blood stem cell processing disposables to fulfill orders to its exclusive global distribution partner GE Healthcare (GEHC). While ThermoGenesis began shipments earlier this year, ramping up to high volume shipments was predicated upon meeting ThermoGenesis’ own rigorous internal quality standards.
Earlier this year, GEHC announced agreements with the largest private and public cord blood banks in the world to supply each with ThermoGenesis’ AXP System, the first automated, functionally-closed, sterile system for harvesting stem cells from cord blood. Prior to ramping up shipments, ThermoGenesis completed internal quality assurance validation testing on AXP disposable bag sets.
“We designed the AXP System to bring automation and precision to cord blood stem cell processing, which is usually performed in a labor intensive manual process that often requires an expensive ‘clean room’, while at the same time maintaining our commitment to high quality standards,” said Philip Coelho, ThermoGenesis’ Chairman and Chief Executive Officer. “We have completed our rigorous quality testing program for AXP disposable bag sets and are pleased to fulfill the orders from GEHC. This announcement confirms ThermoGenesis’ progress in its transition to a market-driven commercial business.”
The AXP System harvests stem cells from cord blood with high yield and high throughput, providing cord blood banks an efficient and reliable method for processing cord blood with maximum recovery and viability of hematopoietic stem and progenitor cells. These cells can then be effectively used for patients who require stem cell reconstitution in the treatment of diseases like acute leukemia, lymphoma and numerous genetic diseases.
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(R) System, an automated cryogenic device, is used by cord blood stem cell banks in more than 25 countries for cryopreserving and archiving cord blood stem cell units for transplant. GE Healthcare is the non-exclusive global distribution partner for the BioArchive System. -- The AutoXpress System, is a newly developed semi-automated device and companion sterile closed blood processing disposable, to harvest stem cells from cord blood. GE Healthcare is the exclusive global distribution partner for the AXP AutoXpress System. -- The CryoSeal(R) FS System, an automated device and companion sterile blood processing disposable, is used to prepare fibrin sealants from 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 CryoSeal FS System has received the CE-Mark. From a marketing perspective, the CE Mark is the European equivalent to an FDA approval, in that it allows sales of the product throughout the European community. -- The Thrombin Processing Device(TM) (TPD(TM)) is a sterile blood processing disposable that prepares activated thrombin from a small aliquot of plasma in less than 30 minutes. The CE-Marked TPD is currently being marketed in Europe by Biomet, Inc. subsidiary Biomet Biologicals, Medtronic, Inc. and independent distributors.
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 2007, 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 2007. 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.
For More Information, Contact: ThermoGenesis Corp. Or Fern Lazar of Lazar Partners (212) 867-1762 or visit the web site at www.thermogenesis.com
ThermoGenesis Corp.
CONTACT: Fern Lazar of Lazar Partners, +1-212-867-1762, for ThermoGenesisCorp.
Web site: http://www.thermogenesis.com//
