Regentis to Launch CE Marked GelrinC® in Europe 2026 with Italy, Eastern Europe Sites
Regentis Biomaterials received CE Mark approval for its GelrinC® knee cartilage implant and will launch commercially in Europe in 2026 with an expanded clinical site network across Italy and Eastern Europe. These sites will engage leading orthopedic surgeons and bolster its pivotal U.S. Phase III study enrollment above 50%.
1. European Clinical Network Expansion
Regentis added new clinical sites in Italy (Humanitas in Milan; Fondazione I.R.C.C.S. in Pavia), Germany’s University of Regensburg and Eastern Europe (Clinical Center of Vojvodina in Serbia; University of Ljubljana; Timiş County in Romania) to deepen engagement with orthopedic centers of excellence.
2. CE Mark Approval and Commercial Strategy
GelrinC® received CE Mark approval for knee cartilage repair and is slated for a 2026 commercial launch across Europe. The expanded network is designed to attract commercial partners and facilitate broad clinical adoption through streamlined engagement with high-volume surgical centers.
3. Pivotal U.S. Phase III Study Progress
Regentis’ pivotal U.S. Phase III trial of GelrinC® has surpassed 50% enrollment, with the European sites expected to support trial execution and data collection. This integrated clinical approach aims to accelerate product validation and global regulatory milestones.