ThermoGenesis Receives Health Canada Approval of its Next-Generation AXP® II System for Cord Blood Processing
Wednesday, June 19, 2019
ThermoGenesis Corp., a wholly owned subsidiary of Cesca Therapeutics (Nasdaq: KOOL), and a market leader in automated cellular processing, today announced that it has received Health Canada approval of its next-generation AXP®II 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%."
More About the AXP® II System
The AXP® II is a proprietary, automated system for the separation, processing and storage of hematopoietic stem cell concentrates from cord blood. Its functionality:
- automates the volume reduction process,
- provides consistent buffy coat concentration volumes,
- ensures high recoveries of mononuclear cells in a targeted volume, and
- allows for simultaneously processing of multiple cord blood units in one centrifuge.
The AXP® II System includes the AXP II Device, AXP II Docking Station, AXP Processing Bag Set, XpressTRAK® software and accessories.
