NeuroPace, Inc. (Nasdaq: NPCE) has announced the submission of three-year safety and effectiveness data from its Post-Approval Study (PAS) of the RNS System to the U.S. Food and Drug Administration (FDA). This submission marks a significant step in gathering long-term clinical evidence for the treatment of adults with drug-resistant focal epilepsy. The study, involving over three hundred patients from more than thirty leading Level 4 Comprehensive Epilepsy Centers in the United States, is the largest prospectively enrolled trial in the field of neuromodulation for drug-resistant focal epilepsy.
RNS System Post-Approval Study Details
The RNS System PAS is a five-year prospective, multicenter study designed to gather additional data on the safety and effectiveness of the RNS System as an adjunctive therapy for adult patients with drug-resistant focal epilepsy. The pre-specified primary effectiveness endpoint is at three years of treatment. The study aims to evaluate the RNS System in the adult focal population, which represents the largest patient segment of drug-resistant epilepsy.
Significance of the RNS System
The RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source. This technology differentiates itself by providing stimulation and monitoring the patient's response over time. The data from the Post-approval Study is expected to further support physicians in optimizing care for patients with drug-resistant focal epilepsy.
Management Commentary
"We are excited to have completed the prospective three-year follow up of patients enrolled in this important study and to have submitted the data to the FDA," said Joel Becker, NeuroPace’s Chief Executive Officer. "As the leader in the field of responsive neurostimulation to treat drug-resistant epilepsy, we are committed to studying the impact of RNS System treatment over time in order to continue generating high-quality clinical evidence."
Dr. Martha Morrell, NeuroPace’s Chief Medical Officer, added, "We are excited to reach this important follow up milestone and look forward to FDA review, as well as future peer reviewed publication and presentation of this rigorously collected clinical data. Information from the Post-approval Study will further support physicians as they seek to optimize care for drug-resistant focal epilepsy patients."
Focal Epilepsy and Unmet Needs
Focal epilepsy, where seizures originate from specific areas of the brain, is the most common form of drug-resistant epilepsy. It is often diagnosed in childhood or adolescence and can result in a lifetime of seizures. Uncontrolled seizures can lead to poor cognitive outcomes, depression, decreased social interaction, increased seizure frequency, and sudden unexplained death in epilepsy (SUDEP). The RNS System aims to address these unmet needs by reducing or eliminating the occurrence of debilitating seizures.
