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CartiHeal Announces FDA IDE Approval of Its Agili-C Implant for the Treatment of Joint Surface Lesions

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CartiHeal Announces FDA IDE Approval of Its Agili-C Implant for the Treatment of Joint Surface Lesions

21/12/2016

KFAR SABA, Israel, Dec. 20, 2016 /PRNewswire/ — CartiHeal (2009) Ltd., developer of a cell-free, off-the-shelf implant for use in cartilage and osteochondral defects, announced today the FDA approval of the Investigational Device Exemption (IDE) application submitted by CartiHeal for their Agili-C™ implant, towards a PMA application.

The 2 year-long pivotal study will involve a minimum of 250 patients in US and OUS centers. The study is aimed to show superiority of the Agili-C™ implant over surgical standard of care, i.e. microfracture and debridement, in the treatment of cartilage/osteochondral defects in both osteoarthritic knees and in knees without degenerative changes, making it the first approved study of such broad indications using a single implant.