NeuroPace, Inc. 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. 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. 40% 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. IGE is the second most common type of epilepsy, after focal onset epilepsy, where seizures originate from various parts of the brain at once.

It is typically diagnosed in childhood or adolescence and often results in life-long seizures. Patients with IGE often have seizures that may cause loss of consciousness and commonly experience injuries from seizure-related falls. Further consequences from uncontrolled seizures include poor cognitive outcomes, depression, decreased social interaction with peers, increased seizure frequency, and sudden unexplained death in epilepsy (SUDEP).

The NAUTILUS Study received an Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) and is a prospective, multicenter, single-blind randomized, sham stimulation controlled pivotal study designed to demonstrate that the RNS System is safe and effective as an adjunctive therapy for patients aged 12 and older with drug-resistant IGE. NeuroPace received FDA Breakthrough Device Designation status in 2021 for the potential use of its RNS System to treat IGE. The trial requires evaluation of a primary safety endpoint and an effectiveness evaluation 12-months post-implant.

If the study achieves its primary endpoints, NeuroPace plans to submit a PMA Supplement and also intends to publish findings in a peer-reviewed medical journal.