CartiHeal receives FDA approval of Agili-C implant for cartilage, osteochondral defects
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CartiHeal Ltd. has announced FDA premarket approval of the Agili-C implant for treatment of ICRS grade 3 or above knee-joint surface lesions, 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 Kellgren-Lawrence grade 0 to 3. The implant, which received FDA breakthrough device designation in October of 2020, outperformed microfracture and debridement for the treatment of knee joint surface lesions, as well as chondral and osteochondral defects, according to results of an investigational device exemption pivotal clinical trial.
“The 2-year study results, which demonstrated superiority of the Agili-C implant over the current surgical standard of care, offer an important potential benefit to millions of patients,” Nir Altschuler, founder and CEO of CartiHeal, 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. The FDA’s approval enables us to initiate commercialization and provide a superior solution for patients compared to the current standard of care options,” Altschuler added.
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