CartiHeal started its investigational device exemption study for Agili-C, an implant for cartilage and osteochondral defects.
Here are five points:
1. Surgeons at three European centers implanted the device in the study's 16 patients.
2. The study will test the superiority of the Agili-C implant over microfracture and debridement for cartilage or osteochondral defect treatment in knees.
3. CartiHeal plan to enroll at least 250 patients in the study. It hopes to open additional trial sites in the U.S., Europe and Israel.
4. A cell-free, off-the-shelf implant, Agili-C possesses the CE mark.
5. The Agili-C implant is an investigational device in the U.S., only usable in this study, currently.