Regentis Biomaterials commenced first surgeries in its Phase III pivotal clinical trial of GelrinC biodegradable hydrogel for the treatment of focal knee cartilage defects. Three procedures occurred in the U.S. and Denmark.
The FDA-approved Investigational Device Exemption study is comparing GelrinC to microfracture, the standard of care, and results will support a U.S. Premarket Approval Application. IDE approval for this trial was secured in 3Q16.
The trial is evaluating safety and efficacy of GelrinC compared to raw level data derived from a historical microfracture control arm. This design, which may overcome limitations of randomized control studies in this field, may generate faster patient enrollment and significantly reduce the time for product approval.
Source: Regentis Biomaterials