CartiHeal's Implant for Cartilage, Osteochondral Defects Gets FDA Premarket Approval

CartiHeal has been granted the FDA’s premarket approval for its Agili-C implant for knee-joint cartilage surface lesions.

The implant is indicated to treat lesions if they are grade III on the scale of the International Cartilage Repair Society, have a total treatable area of 1-7 square centimeters and are not accompanied by severe osteoarthritis, according to the Israel-based company.

The FDA granted the implants premarket approval based on the results of a pivotal, two-year investigational device exemption study that demonstrated the superiority of the Agili-C implant over the current surgical standard of care — microfracture and debridement — for the treatment of knee-joint surface lesions, and chondral and osteochondral defects, the company said.