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# CartiHeal Gets Breakthrough Status for Agili-C Implant
- URL: https://www.fdaweb.com/cartiheal-gets-breakthrough-status-for-agili-c-implant/
- Published: 2020-10-12T12:00:00.000Z
- Updated: 2026-09-14T16:32:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147847

FDA has granted CartiHeal a breakthrough device designation for the Agili-C implant and its use in treating cartilage lesions in arthritic and non-arthritic joints. CartiHeal is currently conducting a pivotal clinical study to evaluate the implant’s superiority over the current surgical standard of care – microfracture and debridement. The company says 251 subjects were enrolled at 26 sites in the U.S., Europe and Israel and it includes those with mild to moderate osteoarthritis and focal defects. Final study results are expected next year.