ThermoGenesis Announces Registration Approval of AXP in China
Product Launch and Distribution to Start Immediately
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
*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^TM 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.
CONTACT: ThermoGenesis Corp.
Web site: http://www.thermogenesis.com
Contact: Investor Relations
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