US FDA has agreed to Regentis Biomaterials Ltd.'s plan to use an historical control, instead of a randomized control, in its pivotal trial of the GelrinC biodegradable hydrogel for the treatment of focal cartilage defects in the knee, the Israeli company announced Sept. 26.
GelrinC, which emerged out of technology developed at Technion University in Haifa, Israel, is a mixture of denatured polyethylene glycol and human fibrinogen polymerized into a solution that forms a...