RANCHO CORDOVA, Calif., March 12 /PRNewswire-FirstCall/ -- ThermoGenesis Corp. , a leader in developing and marketing enabling technologies for cord blood stem cell therapy and surgical wound care, announced today that the U.S. Patent and Trademark Office has granted the Company notice of allowance of claims for the first two patents for the AutoXpress(TM) System and has granted an additional patent that extends coverage on the CryoSeal System.
AutoXpress Platform
The two patents, both entitled “Blood Component Separation Method and Apparatus” protect the key device claims that enable this novel semi-automated method of isolating and capturing clinically important cell populations from cord blood, peripheral blood and bone marrow in a sterile, functionally closed system during centrifugation. The Company believes this technology provides higher recoveries of stem and progenitor cells than other means and it has been adopted by the New York Blood Center’s pioneering National Cord Blood Program, the first and world’s largest public cord blood bank and Cord Blood Registry, the world’s largest private family cord blood bank. Additional patent applications intended to further broaden protection of the AutoXpress technology are pending.
“Protection of our proprietary technology is a critical element of our growth strategy and essential to our competitive strength,” said Dan Segal, Vice President of Sales and Marketing, Cell Therapy. “These newly issued patents represent the achievement of a significant milestone for ThermoGenesis, erecting a formidable barrier to entry for competitive technologies at a time when our distributor, GE Healthcare, is embarking on a global roll-out of the AXP platform.”
CryoSeal Platform
The patent, entitled “Biological Adhesive Loading Station and Method”, protects the method of sterile production of up to four surgical fibrin sealant kits from a single unit of blood plasma by the CryoSeal(R) Fibrin Sealant (“FS”) System, an automated device and disposable system used to prepare autologous fibrin sealants from plasma.
Regulatory Status
ThermoGenesis Corp. has been granted the right to affix the CE Mark to the CryoSeal FS System by our European Notified Body. The product is being used in a number of field clinical trials. In Japan, the pivotal clinical trial was completed and a pre-market application (“PMA”) equivalent was filed with the MHLW in March 2005. A response from the MHLW is expected later in calendar 2007; however, the process, timing and results of any regulatory submissions will be determined solely by the MHLW. In the United States, the Company filed a February 6, 2007 response to FDA questions on the PMA which followed completion of the U.S. pivotal clinical trial in December 2005. The Company expects a response from the FDA by summer 2007; however, the process, timing and results of any regulatory submissions will be determined solely by the FDA.
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. GE Healthcare is the non-exclusive global distribution partner for the BioArchive System. * The AutoXpress(TM) System (AXP(TM)) is a proprietary, semi-automated device and companion sterile blood processing disposable for harvesting stem cells from cord blood in a functionally closed system. GE Healthcare is the exclusive global distribution partner for the AXP AutoXpress System. * 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. Enrollment in a 150-patient U.S. pivotal clinical trial has been completed and a PMA is being reviewed by the FDA. 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, including statements regarding financial information for future periods, contain 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 2007, 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 2007. 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: Fern Lazar of Lazar Partners +1-212-867-1762
ThermoGenesis Corp.
CONTACT: Fern Lazar of Lazar Partners, +1-212-867-1762, for ThermoGenesisCorp.
Web site: http://www.thermogenesis.com//
