RANCHO CORDOVA, Calif.,
Feb. 3, 2021 /PRNewswire/ --
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)
"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.
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
Paula Schwartz, Rx
SOURCE ThermoGenesis Holdings, Inc.