First U.S. Patients Receive Agili-C Implants

By Julie A. Vetalice

CartiHeal announced successful enrollment of the first two U.S. patients in the Agili-C™ Investigational Device Exemption pivotal study.

The study received FDA approval at the end of 2016. To date, in Europe and Israel, 80 patients have been enrolled and treated. The trial's objective is to demonstrate superiority of the Agili-C implant vs. microfracture and debridement for the treatment of cartilage or osteochondral defects, in both arthritic knees and knees without degenerative changes.

Sources: CartiHeal; ORTHOWORLD Inc.

Product Labels: Orthobiologic Soft Tissue Repair

Tags: Regulatory, Trial/Study