ThermoGenesis Announces FDA (JOBS) Authorization to Market MarrowXpress(TM)
RANCHO CORDOVA, Calif., July 14 /PRNewswire-FirstCall/ -- ThermoGenesis Corp. , a leading supplier of innovative products and services that process and store adult stem cells, today said it has received authorization from the FDA to begin marketing its MarrowXpress (MXP) device for use in a clinical laboratory setting or intraoperatively for preparation of a cell concentrate from bone marrow.
Last month, the Company announced it had submitted a 510(k) pre-market notification application to the FDA. Upon its review, the FDA determined that the device was exempt from the agency's pre-market notification requirements and will instead be regulated as laboratory equipment labeled for a specific medical use. The device is a derivative of the Company's AutoXpress(TM) (AXP(TM)) Platform that is used to volume reduce and collect stem cells from umbilical cord blood.
"This notification that we can immediately begin marketing our MXP device is a major regulatory milestone for the Company and particularly exciting since we received this notification just several weeks after filing our submission, and since it follows by less than a month from having received the CE-Mark enabling us to market the device in the European Community," noted Dr. William Osgood, Chief Executive Officer.
Bone marrow derived stem cells are the dominant source of stem cells studied in regenerative medicine clinical trials for treating several large patient population diseases and injuries including blood disorders, ischemic heart diseases, peripheral artery diseases, and diabetes. According to the latest statistics, there are 24 million people in the U.S. Centers for Disease Control and Prevention with heart disease, 16.2 million with peripheral artery disease, and 15.8 million with diabetes. Worldwide statistics would be more than twice these amounts.
In addition, bone marrow stem cells are currently processed in a number of orthopedic and vascular surgeries inside and outside the U.S. Outside the U.S., stem cell treatments for ischemic heart disease are practiced and reimbursed by insurance companies.
"In anticipation of this authorization, we have initiated discussions with an orthopedic surgery group, vascular surgeons, and leading academic medical centers not only in the U.S. but also in Europe and Asia, and look forward to begin placing this device in the clinical setting in the near future. We believe this positions ThermoGenesis to significantly participate in what will ultimately represent a multi-billion dollar market opportunity in regenerative medicine," Osgood added.
"We are confident that the users of this technology will value the unique capability of this device to achieve significantly improved recovery of the stem cells from bone marrow meaning that less marrow will need to be collected from their patients to obtain the same number of stem cells," said Dr. John Chapman, Vice President of Research and Development and Scientific Affairs. "While the initial marketing application for the MXP will be for bone marrow processing, both at point-of-care and in a laboratory, we will continue our exploration of the use of this technology platform for other sources of adult stem cells including mobilized peripheral blood and adipose tissue stem cell processing," Chapman added.
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 manufacture, preservation and delivery of cell and tissue therapy products. These products include:
-- The BioArchive(R) 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.
-- 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 except for Central and South America, China and Russia/CIS, where ThermoGenesis markets through independent distributors. 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 sterile blood processing disposable, is used to prepare fibrin sealants from plasma in about an hour. The CryoSeal FS System is approved in the U.S. for liver resection surgeries. The CryoSeal FS System has received the CE-Mark which 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 harbor 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 2009, 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 2009. 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: Investor Relations, ThermoGenesis Corp., +1-916-858-5107,
ir@thermogenesis.com
Web site: http://www.thermogenesis.com/