Healthcare Industry News: thrombin
News Release - June 19, 2008
ThermoGenesis Announces Receipt of CE Mark for MarrowXpress (TM)Approval Allows Company to Begin Commercial Sales of Device in Europe
RANCHO CORDOA, Calif., June 19 (HSMN NewsFeed) -- ThermoGenesis Corp. (Nasdaq: KOOL ), a leading supplier of innovative products and services that process and store adult stem cells, today announced TUV has issued an EC Certificate to ThermoGenesis Corp. for the MarrowXpress (MXP(TM)) System, which allows the Company to affix the CE Mark and commence selling the product in the European Community. The MXP device is used to process bone marrow in a laboratory setting.
The MXP is a derivative of the Company's approved AutoXpress(TM) (AXP(TM)) Platform that is used to volume reduce and collect stem cells from umbilical cord blood. Earlier this month, ThermoGenesis announced it had submitted a 510(k) pre-market notification application to the FDA seeking regulatory clearance in the U.S.
"We have had very encouraging feedback from a number of European centers at which bone marrow clinical trials are either underway or planned. With this approval, we can now ramp up those discussions and initiate a formal launch for the MXP in Europe," noted Dr. William Osgood, Chief Executive Officer of ThermoGenesis.
"There are a number of clinical trials already underway, as well as the practice of medicine, evaluating the use of adult stems cells to treat indications such as critical limb ischemia, coronary artery disease and orthopedic conditions. We believe the collection of stem cells from bone marrow could ultimately represent a multi-billion dollar market opportunity for the Company," he added.
About ThermoGenesis Corp.
ThermoGenesis Corp. (http://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 products include:
-- The BioArchiveŽ System, an automated cryogenic device, is used by cord blood stem cell banks in more than 25 countries for cryopreserving and archiving cord blood stem cell units for transplant. GE Healthcare is the non-exclusive global distribution partner for the BioArchive System.
-- AXP(TM) AutoXpress Platform (AXP(TM)) is a proprietary family of automated devices that includes the AXP and the MarrowXpress(TM) and companion sterile blood processing disposable for harvesting stem cells in a closed system. The AXP device is used for the processing of cord blood. GE Healthcare is the exclusive global distribution partner for the AXP cord blood product. The MarrowXpress is used for isolating stem cells from bone marrow. ThermoGenesis sells the MarrowXpress directly to global customers.
-- The CryoSealŽ FS System, an automated device and companion sterile blood processing disposable, is used to prepare fibrin sealants from plasma in about an hour. We received FDA approval to market the CryoSeal FS System in liver resection surgeries in July 2007. The CryoSeal FS System has received the CE Mark. From a marketing perspective, the CE Mark is the European equivalent to an FDA approval, in that it allows sales of the product throughout the European Community. Asahi Medical is the exclusive distributor for the CryoSeal System in Japan and the Company markets through independent distributors in Europe and South America.
-- The thrombin Processing Device(TM) (TPD(TM)) is a sterile blood processing disposable that prepares activated thrombin from a small aliquot of plasma in less than 30 minutes. The CE-Marked TPD is currently being marketed in Europe by Biomet, Inc., subsidiary Biomet Biologics, Medtronic, Inc. and independent distributors.
This press release contains forward-looking statements, and such statements are made pursuant to the safe harbour provisions of the Private Securities Litigation Reform Act of 1995. 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 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 2008, 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 2008. 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.
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