Regentis Biomaterials said today it won an investigational device exemption from the FDA for a pivotal trial of its GelrinC hydrogel-based resorbable treatment for focal cartilage defects in the knee.
The Phase III study aims to evaluate the safety and efficacy of GelrinC compared to microfracture treatment to support pre-market approval for focal defects, which normally occur as a result of trauma.
“Gaining 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. 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.,” president & CEO Alastair Clemow said in a press release.
GelrinC is administered as a liquid to fill varying sizes and shapes of defects, Regentis said, and converts to a solid implant after exposure to ultra-violet light. The GelrinC implant is designed to naturally degrade within 6 to 12 months as it’s replaced by cartilage.
“GelrinC is a potential game-changer in the cartilage repair space, and can be an attractive and viable option for patients. GelrinC has promising clinical outcomes to date and the pre-clinical work is very supportive,” Dr. Brian Cole, of Chicago’s Rush University Medical Center, said in prepared remarks.
In February, Regentis said it raised $15 million in a Series D round for the GelrinC cartilage replacement. Funds from the round went to support the pivotal clinical trial for GelrinC.
The round was led by Chinese pharma company Haisco Pharmaceutical group, and joined by existing investors Medica Partners, SCP Vitalife Partners, Generali Financial Holdings and both the Technion R&D Foundaint and Technion Innovation Opportunities Fund.
As part of the funding round, Haisco will serve as the exclusive distributor of GelrinC in China, Regentis Biomaterials said at the time.