(RANCHO CORDOVA, CA), April 11, 2012—ThermoGenesis Corp. (NASDAQ: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, said today that China’s State Food and Drug Administration (SFDA) has approved the registration of the Company’s BioArchive® System (BioArchive), enabling its direct commercial sale by the Company into the People’s Republic of China.
“This is an essential step in our strategy to be the ‘first-mover’ in China for automated processing and storage solutions to address what we expect will be a high growth cord blood market. This approval demonstrates the leadership position of our state-of-the art storage technology,” said Matthew Plavan, Chief Executive Officer of ThermoGenesis.
The Company has established a strong presence in China with three leading Chinese stem cell banks as customers. These include Nanshan Memorial Medical Institute, which will be using the BioArchive to store stem cells at its two cord blood stem cell banks in China; BoyaLife, which is currently developing capacity to store more than one million stem cell units; and Beike Biotechnology Co., Ltd., which operates three stand-alone cord blood processing and storage facilities. Beike is also the first company in China to receive accreditation from the AABB (formerly the American Association of Blood Banks).
“With this major milestone now behind us, we look forward to facilitating regulatory approval for our AXP® AutoXpress® (AXP), which is currently in final technical review by the SFDA,” Plavan added. The AXP is used to concentrate stem cells from cord blood.
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/PRP (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
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.