Cesca Therapeutics Inc., has announced that its device subsidiary, ThermoGenesis® Corp., has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its proprietary AXP® II AutoXpress® Platform (AXP II) for clinical blood banking.
Cesca Therapeutics Inc., founded in 1986, headquartered in Rancho Cordova, California, USA, develops, commercializes and markets a range of automated technologies for CAR-T and other cell-based therapies.
The device division subsidiary, ThermoGenesis Corp., provides a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology. The Company is developing an automated, functionally-closed CAR-TXpress™ platform to streamline the manufacturing process for the emerging CAR-T immunotherapy market.
The AXP II, in combination with the Company’s companion, single-use, cell separation set provides automated, rapid and reliable harvest of stem and progenitor cells from collected units of umbilical cord blood in a “functionally-closed” sterile system.
The AXP II is the next-generation of the original AXP system, which received market clearance in 2007 and is currently used by premier public and private cord blood banks, worldwide. The AXP II upgrades functionality, user interface and compatibility with newer operating systems and features improved docking station, and XpressTRAK® software to maintain compliance with Current Good Manufacturing Practice (cGMP) and Current Good Tissue Practice (cGTP) regulations.
“Receipt of 510(k) clearance from the FDA for the AXP II is an important step for the Company and may expand market adoption as it provides cord blood bank customers with an automated system that achieves mononuclear cell (MNC) recoveries >90% and CD34+ stem and progenitor cell recoveries > 95%. The Company intends to build on this momentum as we continue to support clinical development in the significant market of cell-based therapeutics, particularly in the immuno-oncology field, where we already have begun to play an important role.” – Philip Coelho, ThermoGenesis’ chief technology officer