RANCHO CORDOVA, Calif., Feb. 11, 2019 /PRNewswire/ -- ThermoGenesis Corp, a private corporation owned by Cesca Therapeutics (Nasdaq: KOOL), and a market leader in automated cellular processing and autologous cell therapies for regenerative medicine, today announced that TÜV Rheinland has cleared the company's X-Series Control Module and Docking Station devices to be labeled with the cTUVus mark, indicating that they are NRTL (Nationally Recognized Testing Laboratory)-approved. Shipping of the newly marked X-Series Control Modules and Docking Stations will begin later this month.
The cTUVus mark signifies that ThermoGenesis' products have been tested and comply with international standards for electrical safety, specifically ANSI/AAMI ES60601-1:2005+A2 (R2012) +A1 and IEC60601-1-6:2010 +A1. These include the CAR-TXpress™ platform's X-LAB® System, for harvesting purified mononuclear cells from blood and blood products; the X-WASH® System, for washing and volume reducing cell suspensions or frozen cell preparations; and the PXP® System, for "Point-of-Care" automated preparation of bone marrow concentrate.
Haihong Zhu, ThermoGenesis' President, stated, "The recent transfer of the assembly of our X-Series cell processing disposables to our GMP compliant facility, has immediately allowed us to maintain better control over our supply chain and to provide higher quality products to the market. Qualification for cTUVus labelling is a direct result of this strategy. Specifically, the mark provides hospital, clinical and GMP laboratory customers and prospective customers with an easy visual indication of each product's electrical safety status, as certified by a nationally recognized testing lab – an important factor in the decision-making process."
About ThermoGenesis Corp.
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.
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
SOURCE Cesca Therapeutics Inc.