Regentis Biomaterials is a clinical-stage medical device company based in Israel developing GelrinC, a hydrogel implant for repairing damaged knee cartilage. GelrinC is delivered as a liquid directly into a cartilage lesion during a single procedure, where it is cured in place with UV light and gradually erodes over six to nine months while the patient's own cells regenerate new cartilage. The target patient suffers from a focal cartilage injury in the knee — often from sports or repetitive use — that can progress to osteoarthritis or require total knee replacement if untreated. GelrinC holds CE mark approval in Europe and is currently in an FDA pivotal trial, with 47 of 80 required patients enrolled and PMA submission targeted by end of 2027. Regentis has no commercial revenue today. After FDA approval, Regentis plans to commercialize through U.S. and European strategic partners rather than building its own sales force, earning revenue through product sales or royalty arrangements. Manufacturing is fully outsourced to CMOs, keeping capital requirements low. Beyond GelrinC, Regentis is developing two pipeline products on the same platform: GelrinP, a paste-form version for smaller joints, and GelrinV, an injectable gel targeting moderate osteoarthritis.
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