ThermoGenesis Holdings Updates 510(K) Listing with the FDA to Include its Next Generation PXP®-1000 System for Advanced Cellular Processing

RANCHO CORDOVA, Calif., Dec. 10, 2019 — 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 and submitted a Letter to the Design History File and updated the device listing with the U.S. Food and Drug Administration (FDA) for the PXP®-1000 System. The PXP-1000 is the next generation of ThermoGenesis’ automated systems and allows fast, automated and reproducible separation of cellular components from blood in a closed and sterile GMP compliant environment.

“We continue to develop automated 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-1000 System is a complete, automated closed system that includes the PXP-1000 control module, docking station, disposable cartridge and DataTRAK software, which captures sample processing data to assist with quality assurance and compliance with current good tissue practices (cGTP) and good manufacturing practices (cGMP).

 

About ThermoGenesis Holdings, Inc.
ThermoGenesis Holdings, Inc., formerly known as Cesca Therapeutics 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.

Company Contact:
Wendy Samford
916-858-5191
ir@ThermoGenesis.com

Investor Contact:
Paula Schwartz, Rx Communications
917-322-2216
pschwartz@rxir.com

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