ThermoGenesis Corp. Submits 510(k) Application To FDA For AutoXpress(TM) Cord Blood Processing System

Main Category: Stem Cell Research
Also Included In: Blood / Hematology;  Medical Devices / Diagnostics;  Transplants / Organ Donations
Article Date: 09 Feb 2007 - 0:00 PDT

email to a friend   printer friendly   opinions  

ThermoGenesis Corp. (Nasdaq: KOOL) announced today that the Company has submitted a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory clearance for its AutoXpress System (AXP(TM)). The AXP automates the isolation and capture of stem cells from umbilical cord blood in a functionally closed system. GE Healthcare, the exclusive global distribution partner for the AXP, began selling the product commercially in March 2006.

"ThermoGenesis initiated an FDA Device Master File for the AXP in October 2005 and began preparing the 510(k) application upon receipt of the October 24, 2006 notification from the FDA of their intention to start regulating 'cord blood processing systems and containers,'" said Philip H. Coelho, ThermoGenesis' Chairman and Chief Executive Officer. "FDA regulation of cord blood processing devices and disposables, which prepare stem cell units for transplant, is a pivotal event in transplant medicine as it clearly signals that patient safety will be protected as the number of transplants worldwide continues to increase."

"As we work with the FDA through this regulatory process, our partner, GE Healthcare, continues to market the AXP System to cord blood banks worldwide," Coelho continued. "We're pleased that, New York Blood Center and Cord Blood Registry, respectively the world's largest public and private family cord blood banks, have already adopted the AXP System due to its ability to automate the harvesting of nearly all the stem cells from the cord blood samples consistently and efficiently."

This 510(k) submission requests market clearance for the AXP System for processing cord blood stem cells and claims substantial equivalence to other devices used for this purpose. The 510(k) submission covers the complete AXP System including the AXP hardware device, docking station, disposable bag processing set, and XpressTRAK(TM) software that assists with quality assurance and compliance with current good manufacturing practices (cGMP) and current good tissue practices (cGTP). This submission is supported by studies at the New York Blood Center's National Cord blood Program, which showed that the AXP can harvest 98% of the mononuclear cell (MNC) population (which contain all the stem cells) from cord blood consistently and efficiently.

The process, timing and results of any such submissions will be determined solely by the FDA. ThermoGenesis also plans to meet with the FDA in the near future to discuss preparing a 510(k) pre-market notification application for its BioArchive(R) System based on data from the BioArchive Device Master File. Cord blood banks use the BioArchive to freeze in a controlled manner then store cord blood stem cell units in liquid nitrogen for later transplant.

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, bone, 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 United 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, then available 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 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.

-- The AutoXpress System (AXP) is a newly developed proprietary and patented semi-automated device and companion sterile closed blood processing disposable, to harvest stem cells from cord blood. 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. A 150-patient U.S. pivotal clinical trial has been completed and a pre-market approval application (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.

-- 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.
http://www.thermogenesis.com

• Additional
• References
• Citations