Regentis Biomaterials Ltd. has announced new long-term imaging data from a completed European clinical trial of its GelrinC® device for knee cartilage repair. The results, published in the peer-reviewed journal Cartilage, show that patients treated with GelrinC® demonstrated regenerated cartilage with internal structural organization closely resembling healthy, native hyaline cartilage after 24 months. The MRI analysis, conducted using validated methodologies accepted by both the U.S. FDA and the European EMA, indicated that the repaired tissue exhibited a layered architecture similar to native cartilage. GelrinC® is currently approved for commercialization in Europe with a CE Mark, and a Phase III U.S. FDA study is ongoing.
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