ThermoGenesis Corp., a wholly owned subsidiary of Cesca Therapeutics and a market leader in automated cellular processing, today announced that it has received Health Canada approval of its next-generation AXPII system for cord blood processing.
The AXP II, together with the company’s companion, single-use, cell separation set, provides automated, rapid and reproducible harvesting of stem and progenitor cells from collected units of umbilical cord blood in a “functionally-closed” sterile system. The system, which received 510(k) market clearance from the U.S. Food & Drug Administration (FDA) in November 2018, is used by premier public and private cord blood banks, worldwide. It provides customers with upgraded functionality, user interface and compatibility with newer operating systems and features an improved docking station, and XpressTRAK software to maintain compliance with Current Good Manufacturing Practice (cGMP) and Current Good Tissue Practice (cGTP) regulations.
Haihong Zhu, President of ThermoGenesis, stated, “Health Canada’s approval of the AXP II — following its approval of the PXP System earlier this year — marks the achievement of yet another key milestone and should allow us to meaningfully expand our footprint with a best-in-class system that, today, continues to hold a market-leading position. That said, we look forward to building on our customer base by offering Cord Blood Banks throughout Canada with the ability to undertake cord blood processing with a system that generates mononuclear cell (MNC) recoveries of >90% and CD34+ stem and progenitor cell recoveries of > 95%.”