Kfar Saba, Israel-based CartiHeal designed its Agili-C implant as a proprietary implant for treating cartilage lesions in arthritic and non-arthritic joints. Its PMA indication covers the treatment of an International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).
According to a news release, PMA approval arrived on the back of results from a two-year investigational device exemption (IDE) pivotal clinical study confirming the superiority of Agili-C compared to microfracture and debridement, the current standard of care.
“The 2-year study results, which demonstrated superiority of the Agili-C™ implant over the current surgical standard of care, offers an important potential benefit to millions of patients,” CartiHeal founder and CEO Nir Altschuler said in the release. “This milestone achievement was made possible due to the support of our regulatory advisors, Hogan Lovells, our statistical consultants, Biomedical Statistical Consulting, and the many dedicated investigators and patients who participated in our studies. We are grateful for all their help. FDA’s approval enables us to initiate commercialization and provide a superior solution for patients compared to the current standard of care options.”