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January 21, 2014
09:13 EDTKOOLThermogenesis, TotipotentRX report significant Phase Ib trial results
ThermoGenesis and TotipotentRX announce their co-sponsored Phase Ib clinical trial safety and efficacy results treating no-option patients suffering from critical limb ischemia with Totipotent's Critical Limb Ischemia Rapid Stem cell Therapy, or CLIRST, treatment. The trial achieved both its primary safety and secondary efficacy endpoints at 12 months, achieving statistical significance in five key areas including, major amputation free survival rates, both resting and walking pain reduction, improved walking distance, open wound healing and vasculogenesis in the treated leg. Furthermore, there were no serious adverse events determined to be related to the therapy.
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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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