ThermoGenesis Corp. announced has that the Company has submitted a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory clearance for its AutoXpress System (AXP™).
The AXP automates the isolation and capture of stem cells from umbilical cord blood in a functionally closed system. GE Healthcare, the exclusive global distribution partner for the AXP, began selling the product commercially in March 2006.
"ThermoGenesis initiated an FDA Device Master File for the AXP in October 2005 and began preparing the 510(k) application upon receipt of the October 24, 2006 notification from the FDA of their intention to start regulating 'cord blood processing systems and containers,'" said Philip H. Coelho, ThermoGenesis' Chairman and Chief Executive Officer.
"FDA regulation of cord blood processing devices and disposables, which prepare stem cell units for transplant, is a pivotal event in transplant medicine as it clearly signals that patient safety will be protected as the number of transplants worldwide continues to increase."
"As we work with the FDA through this regulatory process, our partner, GE Healthcare, continues to market the AXP System to cord blood banks worldwide," Coelho continued.
"We're pleased that, New York Blood Center and Cord Blood Registry, respectively the world's largest public and private family cord blood banks, have already adopted the AXP System due to its ability to automate the harvesting of nearly all the stem cells from the cord blood samples consistently and efficiently."
This 510(k) submission requests market clearance for the AXP System for processing cord blood stem cells and claims substantial equivalence to other devices used for this purpose.
The 510(k) submission covers the complete AXP System including the AXP hardware device, docking station, disposable bag processing set, and XpressTRAK™ software that assists with quality assurance and compliance with current good manufacturing practices (cGMP) and current good tissue practices (cGTP).
This submission is supported by studies at the New York Blood Center's National Cord blood Program, which showed that the AXP can harvest 98% of the mononuclear cell (MNC) population (which contain all the stem cells) from cord blood consistently and efficiently.
The process, timing and results of any such submissions will be determined solely by the FDA.