NeuroPace Announces Early Completion of Patient Enrollment in NAUTILUS Pivotal Study

NAUTILUS is the first and only pivotal clinical study to evaluate neuromodulation therapy for treating drug refractory idiopathic generalized epilepsy

Neuromodulation therapy is not currently indicated for patients with drug refractory generalized epilepsy

If successful, NeuroPace’s RNS System would represent the first neuromodulation indication in idiopathic generalized epilepsy

MOUNTAIN VIEW, Calif., Dec. 21, 2023 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a commercial, growth-stage, medical technology company focused on transforming the lives of people living with epilepsy, today announced the completion of the patient enrollment goal in its NAUTILUS pivotal study for the treatment of idiopathic generalized epilepsy (IGE) more than one quarter ahead of schedule.

“We are extremely proud to have completed patient enrollment in our NAUTILUS pivotal study significantly ahead of schedule,” said Martha Morrell, M.D., NeuroPace’s Chief Medical Officer. “We would like to recognize and thank the clinical investigators and patients that have enrolled in this important and groundbreaking trial. We believe that the pace of enrollment in the trial highlights the significant unmet need that exists for patients with drug refractory idiopathic generalized epilepsy.”

NAUTILUS is the first and only pivotal clinical study to evaluate neuromodulation therapy in idiopathic generalized epilepsy, or IGE, and, if successful, RNS could secure the first device-based indication for generalized epilepsy. Forty percent of drug-refractory epilepsy patients are diagnosed with generalized epilepsy, and NeuroPace believes that this early patient enrollment milestone is reflective of the excitement amongst patients and clinicians in potentially addressing this significant unmet need with the RNS System. Patients with generalized epilepsy do not need Phase II invasive monitoring and would be able to proceed to RNS System therapy faster, through a noninvasive diagnostic process that could be performed both within and outside of the Comprehensive Epilepsy Center setting. These efforts are part of NeuroPace’s broader focus of expanding access to RNS System therapy to aid in addressing the treatment gap for the 1.2 million drug refractory epilepsy patients in the United States.