Regentis Biomaterials wins extended CE Mark for GelrinC

Regentis Biomaterials said today it won expanded CE Mark approval in the European Union for its GelrinC hydrogel-based resorbable treatment for focal cartilage defects in the knee, covering GelrinC products manufactured using denatured human fibrinogen.

The approval expands on previous approvals clearing versions of the device manufactured using denatured bovine-sourced fibrinogen, the Israel-based company said.

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.

“Since a CE mark is recognized internationally, this key approval opens the door to making the product available in many other territories. The data from our European clinical study indicates that GelrinC provides surgeons with an effective 1-step treatment. GelrinC is an off-the-shelf product that can be used at any time during surgery when a lesion is identified without the need for pre-planning or additional surgeries. This makes GelrinC an attractive treatment option that is as simple to perform as microfracture with superior clinical outcomes. With a potential yearly market of more than 150,000 procedures in the U.S. alone, the opportunities for GelrinC as the primary treatment for articular knee cartilage repair are very exciting,” CEO Alastair Clemow said in a press release.

A long-term clinical study of the product showed sustained relief from symptoms with most patients reporting pain-free knees, Regentis Biomaterials said. Magnetic resonance imaging of GelrinC showed it “had properties that were comparable to natural cartilage,” the company said.

Last September, Regentis said it won an investigational device exemption from the FDA for a pivotal trial of its GelrinC

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