CartiHeal announced that it received FDA breakthrough device designation for its Agili-C implant for treating cartilage lesions.
Kfar Saba, Israel.-based CartiHeal’s Agili-C implant is a proprietary implant for treating cartilage lesions in arthritic and non-arthritic joints, according to a news release.
The implant is currently being observed in a pivotal investigational device exemption study comparing it to the current surgical standard of care that is microfracture and debridement.
Across 26 sites in the U.S., Europe and Israel, CartiHeal enrolled 251 subjects with both mild to moderate osteoarthritis and focal defects without arthritic changes. The company expects final results to come next year.
“We are extremely pleased that FDA granted the Agili-C implant breakthrough device designation,” CartiHeal founder & CEO Nir Altschuler said in the release. “We look forward to working closely with FDA to expedite Agili-C’s review process, once the final IDE study results will be available, in order to provide a promising treatment for millions of patients who suffer from cartilage defects and currently lack good treatment options.”