RANCHO CORDOVA, Calif., Feb. 3, 2021 — ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, today announced that it has completed the development process, submitted a Letter to File and updated the device listing with the U.S. Food and Drug Administration (FDA) for the PXP™-LAVARE System. The PXP-LAVARE is a GMP compliant automated cell processing system and allows for fast, automated, and reliable washing and reformation of cell suspensions. The PXP-LAVARE system is an optional cell reformation accessory designed for use along with the PXP™-1000 System, a U.S. FDA-cleared 510(k) class II medical device that is used for downstream cGMP compliant clinical manufacturing of cell-based therapeutics, such as chimeric antigen receptor-T (CAR-T) cells.
“We continue to develop and improve upon our broad line of automated cell processing tools to address the rapid growth of the cell and gene therapy market,” said Chris Xu, PhD, Chief Executive Officer of ThermoGenesis. “This latest filing is a testament to our team’s commitment and leadership in the field.”
The PXP-LAVARE System is a complete, automated closed system that includes the PXP-LAVARE control module, docking station, disposable cartridge and DataTRAK software, which captures sample processing data to assist with quality assurance and compliance with current good manufacturing practices (cGMP).
About ThermoGenesis Holdings, Inc.
ThermoGenesis Holdings, Inc. develops, commercializes, and markets a range of automated technologies for CAR-T and other cell-based therapies. The Company currently markets a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology, including its semi-automated, functionally-closed CAR-TXpress™ platform, which streamlines the manufacturing process for the emerging CAR-T immunotherapy market. For more information about ThermoGenesis, please visit: www.thermogenesis.com.
Paula Schwartz, Rx Communications