Regentis Biomaterials Ltd. (NYSE American: RGNT) Moves GelrinC Along Parallel US Clinical and European Commercial Tracks
Regentis has passed 50% enrollment in the pivotal Phase III SAGE study of GelrinC, with recruitment completion targeted for the third quarter of 2026 and a PMA process expected to begin by the end of 2027. FDA approved a single-arm protocol using a historical microfracture control data package the company owns, and Regentis reports that the first 40 patients closely match that control group. In Europe, where GelrinC already holds CE Mark approval, surgeon training began in the third quarter of 2026 at Humanitas Research Hospital in Milan, supported by an expanded clinical site network and a newly approved manufacturing…