Healthcare Industry News: CryoSeal FS
News Release - May 8, 2006
New Performance Data Presented at ISCT Demonstrates ThermoGenesis' AutoXpress(TM) System (AXP) Efficiently Separates Stem Cells From Cord Blood
ThermoGenesis' AXP and BioArchive(R) Systems Attain High Quality Standard for Processing Stem Cells from Cord BloodRANCHO CORDOVA, Calif., May 8 (HSMN NewsFeed) -- ThermoGenesis Corp. (Nasdaq: KOOL ) today announced that new performance data related to the Company's AXP, the first automated, functionally-closed, sterile system that harvests stem cells from cord blood with high yield and high throughput was presented at the International Society for Cellular Therapy (ISCT) Annual Meeting which took place from May 4 to 7 in Berlin, Germany. The results, compiled at the New York Blood Center's National Cord blood Program, showed that the AXP can harvest 97% of the mononuclear cell (MNC) population (which contain all the stem cells) from cord blood consistently and efficiently. When these cell populations are frozen and archived in the BioArchive System, the cell viabilities exceed 94% after thawing.
"Cord blood processing labs must use efficient and reliable methods for processing, cryopreserving, freezing and storing cord blood to maximize recovery and viability of hematopoietic stem and progenitor cells for bone marrow transplantation. These cells are critical to patients who require stem cell reconstitution in the treatment of diseases like acute leukemia, lymphoma and numerous genetic diseases" according to the presenting investigator of the study, John Chapman, Ph.D. Vice President of Scientific Affairs of ThermoGenesis Corp.
The AXP is designed to bring automation and precision to cord blood stem cell processing, which is usually performed in a labor intensive manual process that often requires an expensive "clean room". Cord blood is collected from umbilical cords in volumes of up to 170ml and essentially all the mononuclear cells should be concentrated into a consistent 20 ml volume prior to addition of the cryoprotectant.
In October 2005, GE Healthcare acquired the exclusive global distribution rights for the AXP from ThermoGenesis, as well as non-excusive distribution rights for the BioArchive System. The company estimates that approximately 200 cord blood banks are operating in 44 countries and processing several hundred thousand cord blood units annually.
About ThermoGenesis Corp.
ThermoGenesis Corp. 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(TM) System, 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(TM) 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. 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.
-- 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 of
Biomet Biologicals, Medtronic, Inc. and independent distributors.
This press release, including statements regarding financial information for future periods, contains 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 2006, 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 2006. 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: Fern Lazar of Lazar Partners, +1-212-867-1762, for ThermoGenesis Corp.
Source: ThermoGenesis
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