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Product / Company Performance

CartiHeal Reaches 100th Surgery in Agili-C IDE Study -

CartiHeal announced successful enrollment and surgery of the 100th patient in the pivotal study of the Agili-C™ implant. The device is a porous, biocompatible and resorbable bi-phasic scaffold made of interconnected natural inorganic calcium carbonate. The Investigational Device Exemption study commenced one year ago in the U.S., EU and Israel, and will support CartiHeal's pursuit of an FDA premarket approval application. Its objective is to demonstrate superiority of Agili-C vs. microfracture and debridement in osteoarthritic knees and knees without degenerative damage—mimicking the range observed by surgeons in clinics. (CartiHeal, 10/26/18)