30 Day Trial

FDA Approves Investigational Device Exemption for Agili-C Implant

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CartiHeal received FDA approval of its Investigational Device Exemption application submitted for the Agili-C™ implant, towards a Premarket Approval application.  

The 2-year U.S./ex-U.S. pivotal study will involve a minimum of 250 patients, and seeks to show superiority of Agili-C vs. microfracture and debridement in the treatment of cartilage/osteochondral defects in osteoarthritic knees and in knees without degenerative changes. This marks the first approved study of broad indications using a single implant.

In early 1Q16, the company completed a US $15MM financing round to support manufacturing scale-up, EU product commercialization in 2017 and clinical studies in new therapeutic areas for Agili-C.

The investment was led by Johnson & Johnson Innovation and existing investors Elron, Accelmed, Access Medical Ventures and Peregrine Ventures.

Sources: CartiHeal, Ltd.; ORTHOWORLD Inc.