NeuroPace NAUTILUS trial met primary 12-week post-implant safety endpoint

NeuroPace (NPCE) announced the preliminary primary endpoint one-year results of the two-year NAUTILUS study evaluating safety and effectiveness of the RNS System for treatment of individuals with drug-resistant idiopathic generalized epilepsy. The study successfully met its primary 12-week post-implant safety endpoint, demonstrating a low rate of serious adverse events related to the device and implant procedure, consistent with the established safety profile of the RNS System. The study did not reach statistical significance for the primary effectiveness endpoint in the overall study population, which was to show a longer time to a second generalized tonic-clonic seizure in the active stimulation group compared to the sham stimulation group. Importantly, however, the data did show a clinically meaningful and highly statistically significant response in the primary effectiveness endpoint within a subgroup of patients with lower baseline frequency of generalized tonic-clonic seizures which represented the majority of trial participants. While the study is not powered to show effectiveness in subgroups, this analysis suggests that there is a therapeutic and clinically meaningful benefit of the RNS System in a substantial subpopulation.