ThermoGenesis Announces Receipt of CE Mark for MarrowXpress(TM)
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 umbilicalcord blood. Earlier this month, ThermoGenesis announced it had submitted a510(k) pre-market notification application to the FDA seeking regulatoryclearance in the U.S.
"We have had very encouraging feedback from a number of European centersat which bone marrow clinical trials are either underway or planned. With thisapproval, we can now ramp up those discussions and initiate a formal launchfor the MXP in Europe," noted Dr. William Osgood, Chief Executive Officer ofThermoGenesis.
"There are a number of clinical trials already underway, as well as thepractice of medicine, evaluating the use of adult stems cells to treatindications such as critical limb ischemia, coronary artery disease andorthopedic conditions. We believe the collection of stem cells from bonemarrow could ultimately represent a multi-billion dollar market opportunityfor the Company," he added.
About ThermoGenesis Corp.
ThermoGenesis Corp. (http://www.thermogenesis.com) is a leader indeveloping and manufacturing automated blood processing systems and disposableproducts that enable the manufacture, preservation and delivery of cell andtissue therapy products. These products include:
-- The BioArchive(R) System, an automated cryogenic device, is used bycord blood stem cell banks in more than 25 countries for cryopreserving andarchiving cord blood stem cell units for transplant. GE Healthcare is thenon-exclusive global distribution partner for the BioArchive System.
-- AXP(TM) AutoXpress Platform (AXP(TM)) is a proprietary family ofautomated devices that includes the AXP and the MarrowXpress(TM) and companionsterile blood processing disposable for harvesting stem cells in a closedsystem. The AXP device is used for the processing of cord blood. GE Healthcareis 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 CryoSeal(R) FS System, an automated device and companion sterileblood processing disposable, is used to prepare fibrin sealants from plasma inabout an hour. We received FDA approval to market the CryoSeal FS System inliver resection surgeries in July 2007. The CryoSeal FS System has receivedthe CE Mark. From a marketing perspective, the CE Mark is the Europeanequivalent to an FDA approval, in that it allows sales of the productthroughout the European Community. Asahi Medical is the exclusive distributorfor the CryoSeal System in Japan and the Company markets through independentdistributors in Europe and South America.
-- The Thrombin Processing Device(TM) (TPD(TM)) is a sterile bloodprocessing disposable that prepares activated thrombin from a small aliquot ofplasma in less than 30 minutes. The CE-Marked TPD is currently being marketedin Europe by Biomet, Inc., subsidiary Biomet Biologics, Medtronic, Inc. andindependent distributors.
This press release contains forward-looking statements, and suchstatements are made pursuant to the safe harbour provisions of the PrivateSecurities Litigation Reform Act of 1995. These statements involve risks anduncertainties that could cause actual outcomes to differ materially from thosecontemplated by the forward-looking statements. S
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