Cesca Therapeutics Inc. , an autologous cell-based regenerative medicine company developing proprietary devices and methods for cardiovascular, orthopedic and hematological/oncological procedures, today announced it has submitted an investigational device exemption application to the U.S. Food and Drug Administration 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.
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