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 […]
FDA OKs Regentis Biomaterials trial for GelrinC knee cartilage treatment
Regentis Biomaterials said today it won an investigational device exemption from the FDA for a pivotal trial of its GelrinC hydrogel-based resorbable treatment for focal cartilage defects in the knee. The Phase III study aims to evaluate the safety and efficacy of GelrinC compared to microfracture treatment to support pre-market approval for focal defects, which normally occur […]
Biomaterial startup Regentis raises $15m
Israeli start-up Regentis Biomaterials said yesterday it raised $15 million in a Series D round of funding to support its GelrinC hydrogel-based resorbable cartilage replacement. Funds from the round will be used to support a pivotal clinical trial for GelrinC in the U.S., and to obtain marketing approval from the FDA. Regentis’ GelrinC is implanted […]
