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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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November 20, 2014
06:09 EDTKOOLCesca Therapeutics files IDE application for no-option critical limb ischemia
Cesca Therapeutics has submitted an investigational device exemption application to the FDA for a pivotal multicenter study of the company's SurgWerks-CLI and VXP System for treating advanced stages of no-option lower limb critical limb ischemia. The IDE application is the result of two prior positive pilot and feasibility studies conducted in Italy and India, respectively, and collaborative pre-IDE feedback from the U.S. FDA. The primary endpoint is major amputation free survival at 12 months following enrollment.
November 13, 2014
16:02 EDTKOOLCesca Therapeutics reports Q1 EPS (8c), consensus (7c)
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