BioMedNewsBreaks — Regentis Biomaterials Ltd. (NYSE American: RGNT) Expands GelrinC Clinical and Commercial Pathways

Regentis Biomaterials (NYSE American: RGNT) is advancing its GelrinC cell-free cartilage repair implant along parallel U.S. clinical and European commercial tracks, with more than half of the 80-patient pivotal Phase III SAGE study enrolled and recruitment targeted for completion in the third quarter of 2026. The FDA-approved single-arm study uses a historical microfracture control dataset owned by Regentis, and the company reports that the first 40 enrolled patients closely match the historical control group in baseline characteristics. In Europe, where GelrinC already has CE Mark approval, Regentis is preparing for broader commercialization through surgeon training, an expanding network of Centers of Excellence and distributor development. The company also received approval for a next-generation solvent-free manufacturing process that it says increases production yield by approximately 400%, potentially supporting commercial-scale supply while reducing costs and improving safety.

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About Regentis Biomaterials Ltd.

Regentis Biomaterials is a regenerative medicine company dedicated to developing innovative tissue repair solutions that restore health and enhance quality of life. With an initial focus on orthopedic treatments, Regentis’ Gelrin platform technology, based on synchronized, degradable hydrogel implants, regenerates damaged or diseased tissue including inflamed cartilage and bone. Regentis’ lead product GelrinC(R) is a cell-free, off-the-shelf hydrogel that is eroded and resorbed in the knee, allowing the surrounding cells to regenerate the cartilage in a controlled and synchronous process. GelrinC(R) aims to address a market of approximately 470,000 cases for cartilage knee repair annually in the U.S. where no off-the-shelf treatment is available.

This content has been disseminated on behalf of Regentis Biomaterials Ltd. (NASDAQ: RGNT) as part of a paid investor awareness and marketing engagement.

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