CE Mark For GelrinC Hydrogel Cartilage Implant

In short

Tissue regeneration specialist company Regentis Biomaterials Ltd., 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. Regentis says 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 has the potential to be cost-effective and allow patients’ knees to be pain-free and function normally.

Background

Hydrogels in cartilage replacement are not entirely a new concept, having been theorised about for well over a decade now. And yet few, if any have made an impact in clinical practice. Indeed back in January we covered some US research on the very subject, here, which will resonate when you read the Regentis/GelrinC story.

Regentis’ offering, GelrinC is designed to serve as the foundation for future clinical applications including those for nerve and bone regeneration as well as cardiac repair.  It’s hydrogel basis combines the stability and versatility of a synthetic material with the bio-functionality of a natural substance for a range of clinical applications.

GelrinC is CE marked for use in 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. It says the results were extremely positive with patients’ knees effectively returning to normal, pain-free function. The company doesn’t say whether this was a controlled comparative study or over what time period the results were collected. They will continue to develop additional clinical data and initiate the marketing of GelrinC in select European countries.

Company comments

“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 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.”

Regulatory status

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.

Source: Regentis Biomaterials Ltd., PR Newswire