RANCHO CORDOVA, Calif., Jan. 4, 2012 /PRNewswire/ -- ThermoGenesis Corp. (NASDAQ: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, said today that India's Ministry of Health has approved the AutoXpress® System (AXP), enabling the Company to initiate commercial sales of the product in India. The AXP is used for the processing of stem cells from cord blood.
"We are pleased to have achieved registration for the AXP in India and will be working closely with Fenwal, Inc., our AXP distributor in the market, to begin the commercial launch of the device," said J. Melville Engle, Chairman and Chief Executive Officer of ThermoGenesis.
"The AXP represents advanced stem cell technology and India is one of the largest and fastest-growing markets in the world," said Vikram Karnani, vice president, Therapeutics, for Fenwal. We look forward to working with ThermoGenesis to introduce this important technology to physicians in India."
Engle noted that the AXP approval in India comes as the Company awaits approval of the product in China. "As we announced in October, the submission has been accepted by the Chinese Food & Drug Administration (SFDA), which represents successful completion of product testing and the administrative acceptance of the submission. The final professional review is now in process and we are hopeful that the AXP will receive regulatory approval in China in early 2012."
About ThermoGenesis Corp.
ThermoGenesis Corp. (www.thermogenesis.com) is a leader in developing and manufacturing automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products. These include:
- The BioArchive® System, an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries for cryopreserving and archiving cord blood stem cell units for transplant.
- AXP® AutoXpress® Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP® MarrowXpress® and companion sterile blood processing disposables for harvesting stem cells in closed systems. The AXP device is used for the processing of cord blood. The MXP is used for the preparation of cell concentrates, including stem cells, from bone marrow aspirates in the laboratory setting.
- The Res-Q® 60 BMC (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates.
- The CryoSeal® FS System, an automated device and companion sterile blood processing disposable, used to prepare fibrin sealants from plasma in about an hour. The CryoSeal FS System is approved in the U.S. for liver resection surgeries. The CryoSeal FS System has received the CE-Mark which allows sales of the product throughout the European community.
This press release contains forward-looking statements. 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 and foreign regulatory 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 2012, 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 2012. 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 Corp.