Regentis Biomaterials expanded the SAGE clinical trial of GelrinC™ to 11 U.S. sites, comparing the device to microfracture in the treatment of damaged articular knee cartilage.
SAGE is an FDA Investigational Device Exemption multi-center Phase III pivotal study that will enroll 120 patients. GelrinC contains synthetic polyethylene glycol material and a structurally modified form of human fibrinogen protein. The device is implanted as a liquid to completely fill a defect, and is cured into a gel upon which the body’s own stem cells settle. Over time, GelrinC is resorbed and replaced by new cartilage tissue.
Source: Regentis Biomaterials