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Regentis receives IDE approval for trial of novel treatment for cartilage defects in the knee
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Regentis Biomaterials announced it has received an FDA investigational device exemption approval to begin a phase 3 clinical study of GelrinC, a treatment for focal cartilage defects in the knee.
According to the release, the clinical study will support a premarket approval application, which would give Regentis the opportunity to market GelrinC in the United States (U.S.).
“Gaining [investigational device exemption] IDE approval is a significant step forward for Regentis and brings us that much closer to helping U.S. patients recover from damaged articular knee cartilage,” Alastair Clemow, Regentis president and chief executive officer, said in the release. “GelrinC has been shown to effectively regenerate high-quality cartilage, a key challenge in treating these kinds of knee injuries. GelrinC has already demonstrated excellent clinical outcomes in our European study, and we look forward to substantiating these results in the U.S.”
The FDA trial will reportedly evaluate the safety and efficacy of GelrinC and compare the results with the raw level data of a historical microfracture control arm.
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