Regentis Biomaterials Gets Expanded CE Mark for GelrinC
Regentis Biomaterials received an expanded CE Mark 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.
GelrinC is administered as a liquid to fill varying sizes and shapes of defects, 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.