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CartiHeal Announces Positive Interim Results of Agili-C IDE Study -

CartiHeal announced that per results of interim analysis of the Agili-C™ Investigational Device Exemption study, trial enrollment will stop at 250 subjects. Agili-C is a proprietary biocompatible implant for the treatment of cartilage lesions in arthritic and non-arthritic joints. The clinical study is designed to evaluate Agili-C vs. microfracture and debridement for the treatment of joint surface lesions. An independent committee performed the first interim analysis following enrollment of the 250th patient (up from 200 as reported in June), and recommended to stop accrual for anticipated success. Based on pre-specified criteria, this early completion of enrollment was advised since the predictive probability of trial success with the current sample size is >0.95. Enrolled patients will continue follow-up according to the study's investigational plan. In total 251 patients were enrolled over two years at 26 sites in the US, Europe and Israel. Of these, 167 subjects were enrolled into the Agili-C study arm and 84 into control. The study includes both mild to moderate osteoarthritis (OA) and focal defects without arthritic changes; approximately half of the enrolled subjects have OA. The study hypothesis is that Agili-C will be superior to debridement or microfracture, the current surgical standard of care.