CartiHeal announced initial cases in Europe with the next-gen version of the Agili-C™ unicondylar implant, designed to treat large cartilage lesions.
Agili-C has been used successfully ~250 patients throughout Europe in knee, ankle and great toe clinical trials. Preclinical results indicate that the implant regenerates hyaline articular cartilage and underlying subchondral bone simultaneously.
At the end of 2016, CartiHeal received FDA approval of its Investigational Device Exemption application submitted for Agili-C implant, towards a Premarket Approval application.
Sources: CartiHeal Ltd.; ORTHOWORLD Inc.