Regentis announced that the first three cases have been performed in their IDE study for GelrinC, a novel hydrogel that is applied after standard microfracture for the treatment of focal knee cartilage defects. The liquid formulation becomes solid after exposure to UV light, conforming to the size and shape of the lesion. The company says the implant acts as a scaffold for the growth of new cartilage and that it completely degrades within 6-12 months.
The first three patients were treated at two U.S. sites (Peninsula Orthopaedic Clinic in Salisbury, Maryland and Mansfield Orthopaedics at Copley Hospital in Morrisville, Vermont) and one Danish site (Aarhus University Hospital in Aarhus). The study’s ClinicalTrials.gov page reports that 181 subjects will be enrolled overall. Safety and efficacy endpoints for patients who receive the GelrinC treatment will be compared to a historical microfracture control arm. The company says this study design will enable faster enrollment and thus faster approval.
GelrinC has CE mark approval and is sold in Europe; in the U.S., the ongoing clinical trial will support a PMA in the U.S.