RANCHO CORDOVA, Calif., May 8, 2013 (GLOBE NEWSWIRE) -- ThermoGenesis Corp. (Nasdaq:KOOL), a leading supplier of enabling technologies for the processing and storage of stem cells and other biological tissues, today said it has received registration approval for its AXP® AutoXpress® (AXP) product from China's State Food & Drug Administration (SFDA). The product is used to concentrate stem cells from cord blood and, with this approval, the Company will immediately initiate commercial distribution of the product in China, one of the world's fastest growing cord blood markets.
"This is a major milestone for the Company as a first mover in China for the automation of cord blood processing and presents a significant catalyst for the growth of our cord blood business. We have established a strong footprint in China with leaders in the regenerative medicine market through our major customer agreements. Offering customers both the AXP System and our BioArchive® System—which is used for cryopreserving cord blood stem cell units and already has registration approval in China—provides us important competitive advantages in the form of efficient and integrated workflows," noted Matthew Plavan, Chief Executive Officer.
In August, ThermoGenesis announced a product purchase and distribution agreement for the AXP with Golden Meditech Holdings Limited, which is a leading developer of blood-related medical devices and affiliated with China Cord Blood Corporation, the first and largest umbilical cord blood bank operator in China. Under this five-year agreement, Golden Meditech has exclusive distribution rights for the AXP System in China (excluding Hong Kong and Taiwan) and in Singapore, Indonesia, India and the Philippines once relevant approval has been obtained in each respective region.
"The Golden Meditech agreement calls for annual minimum AXP bagset purchases, beginning with 60,000 bagsets. We believe distribution into Asia could generate up to $30 million in revenues over the initial five-year period, assuming Golden Meditech achieves its sales objectives and additional country regulatory approvals, as needed. In advance of their efforts to convert new customers to our automated processes and products, Golden Meditech placed their first AXP bagset order for China Cord Blood Corporation in December as part of their initial process qualification for conversion to automation of their own operations," Plavan noted.
In addition to the Golden Meditech agreement, ThermoGenesis has agreements with other major cord blood bank customers in China, including Beike Biotechnology Co., Ltd., and BoyaLife.
"We are excited to be one of the leaders in the China cord blood and regenerative medicine markets. We can use our registration approval in China as a launching pad for addressing other growth markets in Asia. We have previously established distribution agreements in a number of other Asian markets where we are working with our partners to achieve any remaining regulatory approval for the AXP in those countries. We expect to begin receiving these additional country approvals during the balance of calendar 2013, as we realize the strategy we began several quarters ago," Plavan noted.
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 processing and preservation of cell and tissue concentrates. These include:
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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.
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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-QTM 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 2013, 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 2013. 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.