Marks Second Product Approval from Health Canada This Year
RANCHO CORDOVA, Calif., June 18, 2019 /PRNewswire/ -- ThermoGenesis Corp., a wholly owned subsidiary of Cesca Therapeutics (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.
ThermoGenesis develops, commercializes and markets a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology. The Company has developed an automated, functionally closed CAR-TXpress™ Platform to streamline the manufacturing process for the emerging CAR-T immunotherapy market. For additional information, please visit: www.thermogenesis.com.
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. is a market leader in cell processing technologies and autologous cell therapies for regenerative medicine. For more information, visit: www.cescatherapeutics.com.
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics' forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics' Annual Report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.
Paula Schwartz, Rx Communications