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ThermoGenesis (KOOL) acceptance of AXP® Submission by Regulatory Body in China

KOOL’s submission for approval of the AXP® AutoXpress® (NYSE:AXP) which is used to concentrate stem cells from cord blood, has been accepted by the State Food & Drug Administration(SFDA) in China.

 

The Bottom Line: KOOL has established a strong footprint for its cord blood products in China through several major customer and distribution agreements. This submission represents the successful completion of product testing and the administrative acceptance.  Final technical review is now in process prior to in-country registration approval and commercial sales of the system. This is an important step in the regulatory process and KOOL should receive regulatory approval for the AXP in China by early calendar 2012.