RANCHO CORDOVA, Calif., Oct. 11, 2011 /PRNewswire/ -- ThermoGenesis Corp. (NASDAQ: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, said today that its submission for approval of the AXP® AutoXpress® (AXP) which is used to concentrate stem cells from cord blood, has been accepted by the State Food & Drug Administration (SFDA) in China. This represents the successful completion of product testing and the administrative acceptance of the submission. Final technical review is now in process and is the final step requiring completion prior to in-country registration approval and commercial sales of the system.
"This is an important step in the regulatory process and we are hopeful that we will receive regulatory approval for the AXP in China by early calendar 2012, if not before," said J. Melville Engle, Chairman and Chief Executive Officer of ThermoGenesis.
"We have established a strong footprint for our cord blood products in China through several major customer and distribution agreements with leaders in the country's regenerative medicine sector. We believe the China cord blood market could equal or surpass that of the U.S. and reach $200 million by the middle of the decade," he noted.
"Our cord blood relationships in China include our distributor Fenwal, Inc., a global medical technology company that has formed a joint venture with Golden Meditech in China to focus on blood collection and transfusion products, which we believe gives Fenwal a distinct 'in-country' competitive advantage. In addition," he continued, "our initial efforts in China have yielded three cord blood bank customers, including Beike Biotechnology Co., Ltd., Nanshan Memorial Medical Institute, and BoyaLife, our largest operating cord blood banking customer in China. Adoption of the AXP processing system enables these banks to substantially scale their processing operations in a closed, sterile system to meet growing customer demand and to achieve important quality accreditations such as from the AABB," he said.
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.