Regentis Biomaterials has treated 43 of 80 patients in its pivotal U.S. trial evaluating GelrinC, a hydrogel implant for focal articular knee cartilage injuries.
The company now expects to complete full enrollment on or around the end of 2026, compared with its previous expectation of the third quarter. Regentis attributed the timeline to the pace of site activation and patient recruitment in the U.S. and Europe, according to a Sept. 11 news release.
Regentis also received regulatory approval in July from the European Notified Body for a new manufacturing process that increases GelrinC production yield by 400%. GelrinC has CE Mark approval in the European Union.
The company is also expanding its European clinical network and preparing for commercialization through physician engagement and surgeon training.
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