CartiHeal Nabs FDA Breakthrough Device Designation for Cartilage Lesion Implant

The FDA has granted a Breakthrough Device designation for CartiHeal’s Agili-C implant, a device used to treat cartilage lesions in joints.

The implant is used to treat cartilage lesions in both arthritic and nonarthritic joints. Cartilage lesions can be caused by a number of different injuries, including falling and athletic incidents, and are characterized by aching pain, swelling, impaired function and pain during activities.

The company is currently conducting a pivotal investigational device exemption (IDE) trial evaluating the implant’s superiority over current surgical standard of care, microfracture and debridement; 251 participants have been enrolled.