CartiHeal enrolled 16 patients in its investigational device exemption study of Agili-C™ implants in the treatment of joint surface lesions.
The study will include a minimum 250 patients in U.S. and ex-U.S. centers in support of a premarket approval submission. Its objective is to demonstrate superiority of Agili-C vs. microfracture and debridement in osteoarthritic knees and knees without degenerative damage—mimicking the range observed by surgeons in clinics. This study was approved by FDA at the end of 2016 and represents the first approved study of broad indications using a single implant.
Sources: CartiHeal; ORTHOWORLD Inc.