RANCHO CORDOVA, Calif., June 19 /PRNewswire-FirstCall/ -- ThermoGenesis Corp. and the Stem Cell Program at the University of California, Davis (SCP) today announced a collaborative research agreement to develop stem cell therapies based upon ThermoGenesis' AutoXpress(TM) (AXP), BioArchive(R) and CryoSeal(R) Fibrin Sealant (FS) blood processing systems.
"Through this collaboration, we and our research collaborators at SCP will be investigating the cell populations and fibrin gel carriers isolated from bone marrow and cord blood using our blood processing systems. The focus will be on stem cell treatments for peripheral artery disease, myocardial infarction and dermal wounds. Our systems are well positioned to competitively provide the stem cells that the physicians need to treat these large patient population diseases. It is exciting to be working with Dr. Jan Nolta and Gerhard Bauer who are internationally recognized stem cell experts. Our geographic proximity to SCP will facilitate our collaborative efforts." said Philip Coelho, ThermoGenesis' Chairman and Chief Executive Officer.
Under the terms of the agreement, ThermoGenesis will supply SCP with an AXP Platform, one BioArchive and one CryoSeal FS System for use in their translational cell therapy research, which will focus on sourcing the stem cells from the patient's own bone marrow or umbilical cord blood. ThermoGenesis will have first option to negotiate a license to the resulting intellectual property.
"UC Davis is committed to playing a leading role in unlocking the potential of non-controversial adult stem cells and advancing these cell therapies into clinical practice as treatments for numerous life-threatening diseases," said Dr. Jan A. Nolta, Stem Cell Program director at UC Davis School of Medicine. "We look forward to researching the stem cells isolated by ThermoGenesis AXP technology. Their technologies for stem cell isolation and stem cell storage may be important for scaling up stem cell therapies to meet the demands for wide acceptance and success in clinical practice."
About Bone Marrow Stem Cells
Bone marrow is the body's reservoir for hematopoietic and mesenchymal stem cells of remarkable capacity and therapeutic potential. For instance the hematopoietic stem cells (hHSCs) in the bone marrow of an adult must produce about 3 million red cells and 120,000 white cells every second to maintain normal health. Human mesenchymal stem cells (hMSCs) can be differentiated into chondrogenic, osteogenic, adipogenic and myogenic lineages and can be readily expanded in vitro. Endothelial progenitor cells can also be harvested from bone marrow and represent another population with the potential to treat vascular disorders. Most strategies for tissue/organ regeneration are based upon hematopoietic or mesenchymal stem cells derived from the patient's own bone marrow but stem cells from umbilical cord may prove a promising additional source.
About Cord Blood Stem Cells
Cord blood stem cells have been transplanted more than 10,000 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 UC Davis Stem Cell Research
UC Davis has more than 50 scientists working on a variety of stem cell investigations in both Davis and Sacramento. The university is currently constructing a 100,000 square foot stem cell research facility on its campus in Sacramento, where researchers will have access to state-of-the-art laboratories and cell manufacturing and testing rooms. That project, along with the newly-funded Translational Human Embryonic Stem Cell Shared Research Facility in Davis, will complement the university's Clinical and Translational Science Center, which is supported by the National Institutes of Health (NIH). In 2005, the NIH awarded $6 million to fund a Center of Excellence in Translational Human Stem Cell Research on the Davis campus. One of only two such centers in the nation, it is focused on exploring stem and progenitor cell therapies for the treatment of childhood diseases. The California Institute for Regenerative medicine (CIRM) has awarded over $11 million to researchers at UC Davis, to develop stem cell cures. The programs are designed to expedite the translation and integration of scientific research into discoveries and treatments that benefit society.
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. -- AXP(TM) AutoXpress Platform (AXP(TM)) is a newly developed semi-automated device and companion sterile closed blood processing disposable, to harvest stem cells from cord blood and bone marrow. 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. -- The Thrombin Processing DeviceTM (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: Matthew T. Plavan +1-916-858-5100, or Ryan Rauch +1-917-733-8700
ThermoGenesis Corp.CONTACT: Matthew T. Plavan, +1-916-858-5100, or Ryan Rauch,+1-917-733-8700, both of ThermoGenesis
Web site: http://www.thermogenesis.com/
