Here are three things to know:
1. NYU Langone is one of 15 U.S. sites in the new FDA investigational device exemption study of the implant, which is designed for joint surface lesion treatment.
2. With more than 100 enrolled patients, the IDE study is currently ongoing in the U.S. European Union and Israel. CartiHeal aims for an FDA premarket approval application.
3. CartiHeal’s cell-free, off-the-shelf implant is CE-marked for use in cartilage and osteochondral defects. Agili-C has been implanted in over 400 patients with cartilage lesions in the knee, ankle and big toe in European and Israeli trials.
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