Healthcare Industry News: ThermoGenesis
News Release - October 9, 2007
ThermoGenesis Announces 510(k) Clearance for AutoXpress(TM) Cord Blood Processing SystemRANCHO CORDOVA, Calif., Oct 9 (HSMN NewsFeed) -- ThermoGenesis Corp. (Nasdaq: KOOL ), a leading supplier of innovative products and services that harvest, process, store, and administer therapeutic doses of adult stem cells for treatment of disease and injury, announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its proprietary AXP AutoXpress(TM) Platform (AXP), an automated system that isolates and captures stem cells from umbilical cord blood in a closed system. The product has been commercially available since March 2006.
"This is an important milestone for the Company as it provides us equal footing in the market from a regulatory standpoint and complements the superior performance of our product as demonstrated in the clinical setting. This includes studies at the New York Blood Center's (NYBC) National Cord Blood Program (NCBP), which demonstrated that the AXP harvests 98 percent of the mononuclear cell population from cord blood consistently and efficiently," noted William Osgood, Chief Executive Officer of ThermoGenesis.
"This clearance positions ThermoGenesis to be in full compliance with the imminent FDA regulatory requirements for cord blood processing," said Dr. John Chapman, Vice President of Research and Development and Scientific Affairs. "The AXP Platform is technically very strong and provides our customers with the state of the art cell processing of cord blood. This achievement reinforces our position as the leading provider of advanced technology solutions for use in cord blood stem cell processing for both domestic and international markets," he added.
This 510(k) clearance covers the complete AXP Platform, including the AXP hardware device, docking station, disposable bag processing set, overwrap bag and XpressTRAK(TM) software that assists with quality assurance and compliance with current good manufacturing practices (cGMP) and current good tissue practices (cGTP). The AXP is a proprietary and patented automated device and companion sterile closed blood processing disposable used to harvest stem cells from cord blood.
According to Pablo Rubinstein, MD, Director of the NCBP at NYBC, the 510(k) clearance for the AXP is important to the modern development of cord blood processing technology. He said, "NCBP decided one year ago to adopt the AXP Platform to process the large number of stem cell-containing cord blood units we store and provide for patients in need of bone marrow reconstitution. A high recovery of viable stem and progenitor cells from cord blood is essential for good transplantation results and the AXP consistently yields clinical grade units that provide transplant recipients with a superior chance of engraftment and survival. In addition, the AXP Platform software records the processing data for each stem cell unit and automatically documents the system's performance into the records we will make available to transplant physicians."
"Cord Blood Registry (CBR) has a solid history of investing in resources that provide the best value to our clients," said Tom Moore, Chief Executive Officer of CBR. "FDA clearance validates what published data already shows, that AXP enables us to yield the highest quality sample every time, regardless of the volume. This ensures that our clients, and physicians, have the best stem cell sample available to them should it be needed for medical therapy," he added.
About Cord Blood Stem Cells
Cord blood stem cells have been transplanted more than 11,000 times to treat patients with life threatening diseases, including leukemia, lymphoma and more than 60 different genetic disorders. Further, recent peer-reviewed scientific articles indicate stem cells residing in cord blood can also differentiate into other tissues of the body, including the brain, gone cartilage and muscle, indicating potential broader application of cord blood stem cells in future clinical use.
With approximately four million births per year in the Untied States alone, cord blood represents a large, natural resource for use in the treatment of malignant and genetic diseases in which sourcing does not involve donor risk. Cord blood is saved when a baby is born, processed and cryogenically stored for future use. Following the first successful cord blood transplant performed in 1988, awareness of the potential therapeutic value of cord blood stem cells has increased and collection and storage has grown rapidly.
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, automated device and companion sterile blood processing disposable for harvesting stem cells from cord blood in a closed system. GE Healthcare is the exclusive global distribution partner for the AXP AutoXpress Platform.
-- 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, 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 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.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.