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ThermoGenesis Announces 510(k) Clearance for AutoXpress(TM) Cord Blood Processing System
Date:10/9/2007

hardware device, docking station, disposable bag processing set, overwrap bag and XpressTRAK(TM) software that assists with quality assurance and compliance with current good manufacturing practices (cGMP) and current good tissue practices (cGTP). The AXP is a proprietary and patented automated device and companion sterile closed blood processing disposable used to harvest stem cells from cord blood.

According to Pablo Rubinstein, MD, Director of the NCBP at NYBC, the 510(k) clearance for the AXP is important to the modern development of cord blood processing technology. He said, "NCBP decided one year ago to adopt the AXP Platform to process the large number of stem cell-containing cord blood units we store and provide for patients in need of bone marrow reconstitution. A high recovery of viable stem and progenitor cells from cord blood is essential for good transplantation results and the AXP consistently yields clinical grade units that provide transplant recipients with a superior chance of engraftment and survival. In addition, the AXP Platform software records the processing data for each stem cell unit and automatically documents the system's performance into the records we will make available to transplant physicians."

"Cord Blood Registry (CBR) has a solid history of investing in resources that provide the best value to our clients," said Tom Moore, Chief Executive Officer of CBR. "FDA clearance validates what published data already shows, that AXP enables us to yield the highest quality sample every time, regardless of the volume. This ensures that our clients, and physicians, have the best stem cell sample available to them should it be needed for medical therapy," he added.

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
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SOURCE ThermoGenesis Corp.
Copyright©2007 PR Newswire.
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