ThermoGenesis Announces 510(k) Clearance for AutoXpress(TM) Cord Blood Process...( RANCHO CORDOVA Calif. Oct 9 /- Th...),Health

RANCHO CORDOVA, Calif., Oct 9 /PRNewswire-FirstCall/ -- ThermoGenesis Corp. (Nasdaq: KOOL), a leading supplier of innovative products and services that harvest, process, store, and administer therapeutic doses of adult stem cells for treatment of disease and injury, announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its proprietary AXP AutoXpress(TM) Platform (AXP), an automated system that isolates and captures stem cells from umbilical cord blood in a closed system. The product has been commercially available since March 2006.

"This is an important milestone for the Company as it provides us equal footing in the market from a regulatory standpoint and complements the superior performance of our product as demonstrated in the clinical setting. This includes studies at the New York Blood Center's (NYBC) National Cord Blood Program (NCBP), which demonstrated that the AXP harvests 98 percent of the mononuclear cell population from cord blood consistently and efficiently," noted William Osgood, Chief Executive Officer of ThermoGenesis.

"This clearance positions ThermoGenesis to be in full compliance with the imminent FDA regulatory requirements for cord blood processing," said Dr. John Chapman, Vice President of Research and Development and Scientific Affairs. "The AXP Platform is technically very strong and provides our customers with the state of the art cell processing of cord blood. This achievement reinforces our position as the leading provider of advanced technology solutions for use in cord blood stem cell processing for both domestic and international markets," he added.

This 510(k) clearance covers the complete AXP Platform, including the AXP
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