Resources for Food and Drug Administration (FDA)

FDA approves ThermoGenesis' cord blood processing system

www.bizjournals.com

ThermoGenesis Corp.'s AXP AutoXpress Platform has been approved by the U.S. Food and Drug Administration, a critical step in the Rancho Cordova company's effort to process, store and administer adult stem cells for the treatment of injuries and diseases.The company announced the approval Tuesday, sending its stock soaring 6.6 percent.

AXP is an automated device that isolates and captures stem cells from a umbilical cord blood. The product has been commercially available since early 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," ThermoGenesis chief executive officer William Osgood said in a news release. The FDA clearance covers the complete AXP Platform, including the hardware device, docking station and software.

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