RANCHO CORDOVA, Calif., Feb. 6 /PRNewswire-FirstCall/ -- ThermoGenesis Corp. announced today that the Company has responded to the U.S. Food and Drug Administration’s (FDA) questions on ThermoGenesis’ pre-market approval (PMA) application for its CryoSeal Fibrin Sealant (FS) System as an adjunct to hemostasis in liver resection surgeries. The CryoSeal FS System is an automated device and companion sterile blood processing disposable used to prepare surgical fibrin sealants from a patient’s own plasma in about an hour.
“We have worked diligently and methodically to answer inquiries from the FDA’s latest set of questions,” stated Kevin Simpson, President and General Manager of Surgical Wound Care for ThermoGenesis. “We look forward to continuing our communications with the agency and remain enthusiastically committed to commercializing CryoSeal in the United States upon receipt of approval from the FDA.”
If approved, CryoSeal would be the only system in the U.S. market that can produce fibrin sealant from the patient’s own blood (autologous). 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 newly developed 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 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 PMA application 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. 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//
