Cesca Therapeutics Submits Device Master File (MAF) with the FDA for the X-LAB® Automated Cell Processing Devices
CESCA THERAPEUTICS INC COMMON (KOOL)
Last cesca therapeutics inc common earnings: 8/13 04:05 pm
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Source: PR Newswire
RANCHO CORDOVA, Calif., Nov. 13, 2018 /PRNewswire/ -- Cesca Therapeutics Inc. (NASDAQ: KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced that its device subsidiary, ThermoGenesis® Corp., has filed a Device Master File (MAF) with the U.S. Food and Drug Administration (FDA) for its X-LAB® automated cell processing device.The X-LAB device isolates and purifies target cell fractions from blood, bone marrow or leukapheresis in a "closed system," with precision and high efficiency. It also serves as an efficient and ficoll-free platform to isolate human T cells for chimeric antigen receptor-T (CAR-T) cell therapeutics. This MAF contains all the relevant information that the FDA will need to allow principal investigators to include Cesca's systems in their investigational new drug applications, or INDs, while also protecting Cesca's intellectual property.Philip Coelho, ThermoGenesis's Chief Technology Officer, explained, "
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