ThermoGenesis Provides Update on Res-Q® Clinical Evaluations at Leading Stem Cell Therapy Conference
INITIAL DATA SHOW POSITIVE OUTCOMES IN TREATING CRITICAL LIMB ISCHEMIA AND LONG BONE FRACTURES
RANCHO CORDOVA, Calif., Feb. 1, 2012 /PRNewswire/ -- ThermoGenesis Corp. (NASDAQ: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, today provided updates on two clinical evaluations involving its Res-Q® 60 BMC (Res-Q) system, a point-of-care platform designed for the preparation of cell concentrates from bone marrow.
Speaking at the Seventh International Conference on Cell Therapy for Cardiovascular Disease, Vijay Kumar, Ph.D., the Company's principal scientist and Manager of Research, said the initial data are encouraging for patients being treated in clinical evaluations for Critical Limb Ischemia (CLI) and long bone fractures with concentrates prepared by the Res-Q.
The studies covered in Kumar's presentation included:
- A clinical evaluation in India co-sponsored by ThermoGenesis and Totipotent SC, the Company's distributor for the Res-Q in India. Ten of 15 planned patients with advanced CLI have been enrolled to date with the primary endpoints of safety and rate of limb salvage at one year. Kumar reported a statistically significant improvement in ankle brachial index, six-minute walk test, and rest pain though further data remain to be collected. The lead investigator for this study is Dr. Suhail Bukhari of Fortis Escorts Heart Institute and Research Center in New Delhi.
- A clinical evaluation that has enrolled sixteen of 20 planned patients with a non-union or delayed union fracture of a long bone who have undergone composite grafting with autologous bone marrow cell concentrate to evaluate the procedure's safety and effect on fracture healing. To date, there have been no intra-operative complications, and one non-device related adverse event. Of the nine patients who are at three-to-six months post-treatment, four have fractures that have united and four have experienced partial unions of the bone fracture. The lead investigator of this study which was sponsored by SpineSmith, LLC is Dr. Mark Lee of University of California, Davis, Medical Center.
"These outcomes demonstrate encouraging preliminary results with stem cell concentrates collected with our Res-Q System. CLI is a severe form of peripheral artery disease, with as many as 200,000 patients in the U.S. undergoing a limb amputation annually. Currently, there are more than 30 studies underway exploring stem cell therapy as an alternative treatment regimen for CLI patients. In addition, we are hopeful that stem cells will provide a new avenue for promoting the healing of serious bone fractures," said Matthew Plavan, Chief Executive Officer.
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 include:
- The BioArchive® System, an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries for cryopreserving and archiving cord blood stem cell units for transplant.
- AXP® AutoXpress® Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP® MarrowXpress® and companion sterile blood processing disposables for harvesting stem cells in closed systems. The AXP device is used for the processing of cord blood. The MXP is used for the preparation of cell concentrates, including stem cells, from bone marrow aspirates in the laboratory setting.
- The Res-Q® 60 BMC/PRP (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
- The CryoSeal® FS System, an automated device and companion sterile blood processing disposable, used to prepare fibrin sealants from plasma in about an hour. The CryoSeal FS System is approved in the U.S. for liver resection surgeries. The CryoSeal FS System has received the CE-Mark which allows sales of the product throughout the European community.
| This press release contains forward-looking statements. 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 and foreign regulatory 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 2012, 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 2012. 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. |
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SOURCE ThermoGenesis Corp.
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