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Home » CartiHeal wins FDA breakthrough designation for Agili-C implant

CartiHeal wins FDA breakthrough designation for Agili-C implant

October 13, 2020 By Sean Whooley

CartiHealCartiHeal 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.”

Filed Under: Food & Drug Administration (FDA), Implants, Orthopedics, Regulatory/Compliance Tagged With: CartiHeal Ltd., FDA

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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