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March 26, 2014
09:15 EDTKOOLCesca Therapeutics submits pre-IDE information package to FDA for SurgWerks
Cesca Therapeutics announced it has submitted a pre-IDE, or Investigational Device Exemption, information package to the FDA for the use of the SurgWerks CLI Therapy designed to treat no option patients with late stage critical limb ischemia, or CLI. The pre-IDE documentation has been submitted to the FDA in order to obtain the agency's guidance on several key criteria regarding the regulatory pathway; the proper approach to refine the clinical and statistical plan considering the no-option status of the prospective subjects; the consideration of the combination of several devices into a single kit to ensure proper dosing and quality, and to ensure Cesca Therapeutics is working closely and cooperatively with the FDA review team. The basis for pre-IDE submission is data from an analysis of the 17 patient dataset collected in Cesca's feasibility/Phase Ib trial announced this past January.
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