CartiHeal enrolled the first patient in the Investigational Device Exemption (IDE) pivotal study of Agili-C™ on the East Coast. NYU Langone Health's Sports Medicine Center, one of 15 U.S. sites in the trial, will enroll 20 patients with major knee cartilage injuries.
To date, over 100 of the minimum 250 patients are enrolled in the trial, which seeks to show superiority of Agili-C vs. microfracture and debridement in the treatment of cartilage/osteochondral defects in osteoarthritic knees and in knees without degenerative changes. The study is ongoing in the U.S., EU and Israel.
Cartiheal is a porous, biocompatible and resorbable bi-phasic scaffold made of interconnected natural inorganic calcium carbonate, CE marked to treat cartilage and osteochondral defects.