CartiHeal Receives FDA Approval for Agili-C Implant for Cartilage and Osteochondral Defects

March 30, 2022

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CartiHeal Ltd. announced FDA premarket approval of the Agili-C implant for the treatment of superficial knee joint injuries of ICRS grade 3 or higher, according to a press release.

It is indicated for lesions with a total treatable area of ​​1 to 7 cm2 in patients without severe osteoarthritis, defined as a Kellgren-Lawrence grade of 0 to 3. The implant, which received FDA Breakthrough Device Designation in October 2020, outperformed microfracture and debridement for the treatment of lesions of the knee joint surface, as well as chondral and osteochondral defects, according to the results of a pivotal investigational device exemption clinical trial.

“The results of the 2-year study, which demonstrated the superiority of the Agili-C implant over the current surgical standard of care, offer significant potential benefit to millions of patients,” Nir Altschuler, founder and CEO of CartiHeal, said in the statement. “This milestone achievement was made possible through the support of our regulatory advisors, Hogan Lovells, our statistical consultants, Biomedical Statistical Consulting, and the many dedicated researchers and patients who participated in our studies. We are grateful for all their help. FDA approval allows us to begin commercialization and provide a superior solution to patients over current standard care options,” added Altschuler.

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