Cesca Therapeutics Management Provides Regulatory Update On Its Proposed U.S. Pivotal Critical Limb Ischemia Clinical Trial
7/8/2014 5:54:30 AM
RANCHO CORDOVA, Calif., July 8, 2014 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, announced today that it recently participated in a pre-submission IDE (Investigational Device Exemption) teleconference with the Food and Drug Administration's ("FDA") Center for Biologics Evaluation and Research to discuss the Company's proposed pivotal clinical trial design for the treatment of Critical Limb Ischemia ("CLI") using its CLIRST (Critical Limb Ischemia Rapid Stem cell Therapy) treatment protocol delivered via the Company's proprietary SURGWERKS-CLI kit.
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