DEVICE DESIGNED TO PROVIDE POINT-OF-CARE BONE MARROW PROCESSING
RANCHO CORDOVA, Calif., June 4 /PRNewswire-FirstCall/ -- ThermoGenesis Corp. (Nasdaq: KOOL - News), a leading supplier of innovative products and services that process and store adult stem cells, today announced that it has submitted a 510(k) pre-market notification application to the FDA requesting regulatory clearance for its MarrowXpress(TM) (MXP(TM)), a device designed for the processing of bone marrow in a laboratory setting. The device 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.
“This is an important milestone in the Company’s product diversification and growth strategy. We are hopeful that the regulatory process will be facilitated because the MXP is based on a currently approved device,” said Dr. William Osgood, Chief Executive Officer.
Osgood said the Company expects to receive a CE Mark for the MXP this month, which would enable the Company to begin commercial marketing of the device in Europe.
“The use of adult stem cells to treat a variety of diseases and injuries is very promising. There are a number of clinical trials already underway, and in several countries it is a practice of medicine for indications such as critical limb ischemia, coronary artery disease and orthopedic conditions. We have had very encouraging discussions with leading research centers in both the U.S. and Europe regarding the potential use of the MXP in ongoing clinical trials and look forward to getting this device into the clinical setting. We believe this 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 BioArchive® 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 CryoSeal® 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.
ThermoGenesis Corp. Web site: http://www.thermogenesis.com Contact: Investor Relations +1-916-858-5107, or ir@thermogenesis.com
Source: ThermoGenesis Corp.
