Regentis Biomaterials Receives CE Mark Approval for GelrinC Implant

By Julie A. Vetalice

Regentis Biomaterials received CE Mark approval for its GelrinC® biodegradable implant, made with denatured human fibrinogen, for the treatment of articular knee cartilage defects. This expands upon the existing CE Mark that is based upon denatured bovine-sourced fibrinogen.

Regentis is conducting an FDA-approved Phase III pivotal multi-site clinical trial on GelrinC in the U.S. and Europe to support a premarket approval application.

Sources: Regentis Biomaterials Ltd.; ORTHOWORLD Inc.

Product Labels: Orthobiologic Soft Tissue Repair, PRP/Cell-Based/Osteoinductive Materials

Tags: CE Mark, Regulatory