Regentis Biomaterials is developing GelrinC, a cell-free hydrogel implant for focal knee cartilage defects, which the company said reflects a shift in orthopedics toward earlier structural repair rather than symptom management alone.
GelrinC is designed to erode as new cartilage tissue forms. The procedure takes roughly 10 minutes and does not require cell harvesting or a second procedure, according to a Sept. 28 news release.
In a phase 2 study of 56 patients, GelrinC produced roughly 100% greater improvement in overall knee injury and osteoarthritis outcome scores than microfracture at 24 months. Patients were followed for up to five years.
Regentis reported a mean magnetic resonance observation of cartilage repair tissue score of 88.8 out of 100 at 24 months on the nine-part MRI scoring system.
GelrinC has CE Mark approval in Europe. Regentis is conducting a pivotal FDA trial under an Investigational Device Exemption, targeting enrollment of 80 patients. More than half have been recruited and treated.
The company expects to complete enrollment by the end of 2026 and to begin its premarket approval submission at the end of 2027.
The company is developing GelrinP and an injectable formulation aimed at moderate osteoarthritis. Both remain preclinical.
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