Knee Implant GelrinC Receives European CE Mark Approval
Regentis Biomaterials Ltd., a privately held company focused on developing proprietary hydrogels for tissue regeneration, announced this week it has received European CE Mark approval for its GelrinC™ biodegradable implant.
GelrinC is the first synthetic implant to be CE-approved that provides a customized solution by completely filling cartilage lesions with acellular material. GelrinC allows high quality cartilage to regenerate in the knee in the exact shape of the defect. It is an off-the-shelf product that is cost-effective and allows patients' knees to be pain-free and function normally.
"This approval represents a major milestone in the development of cartilage repair technologies since it enhances growth of high-quality cartilage that fits tightly with the surrounding cartilage and underlying bone," said Regentis Biomaterials president and CEO Alastair Clemow, Ph.D. "With CE Mark approval, we look forward to making GelrinC available to European patients to help them return to an active lifestyle."
GelrinC is suitable for patients with traumatic knee injuries. It is inserted as a liquid to fill any shape of cartilage defect and it is then converted into a solid through exposure to ultra-violet light. GelrinC's matrix of synthetic polyethylene glycol diacrylate and denatured fibrinogen creates an environment conducive to cartilage tissue regeneration. After GelrinC is implanted, it starts to bio-degrade as it is replaced with new hyaline-like cartilage.
Regentis conducted a clinical trial treating 23 patients with damaged articular cartilage. The results were extremely positive with patients' knees effectively returning to normal, pain-free function. Regentis will continue to develop additional clinical data and initiate the marketing of GelrinC in select European countries. The CE Mark also opens the door to other international marketing efforts.
"GelrinC provides patients a customized solution with minimized costs because it is available off-the-shelf and applied in a single procedure," said Clemow. "This makes the implant an ideal treatment option that surgeons can now offer patients with traumatic knee cartilage damage."
GelrinC is based on a hydrogel platform that serves as the foundation for future clinical applications including those for nerve and bone regeneration as well as cardiac repair. GelrinC is an investigational device and not available for sale in the U.S. and Israel. The company is conducting a clinical trial in Europe with its investigational version of GelrinC.