Study: NeuroPace’s Technology Can Help Reduce Epileptic Seizures

Three-year effectiveness data from a Post-Approval Study (PAS) of NeuroPace Inc.’s RNS System shows an 82% median reduction in seizures in adults with drug-resistant focal epilepsy (DRE).¹

“Drug-resistant epilepsy is a significant unmet medical need, accounting for up to 30% to 40% of all epilepsy diagnoses and affecting approximately 1.2 million people in the U.S.,” NeuroPace Chief Medical Officer Martha Morrell, M.D., said. “Our ongoing clinical programs aim to expand on the long-term clinical evidence of the safety and effectiveness of the RNS System, which is the only FDA-approved epilepsy device that provides brain-responsive neurostimulation. These results add to the growing body of evidence that demonstrates consistency in the power of combining neurostimulation with long-term direct brain data to provide seizure control for people who live with DRE.”

The PAS enrolled 324 patients from 32 centers, making it the largest-ever, U.S. Food and Drug Administration (FDA)-reviewed, prospectively enrolled trial in neuromodulation for drug-resistant focal epilepsy.^1,2,3 ii Data from the prespecified three-year effectiveness analysis indicate continued evidence of substantial seizure reductions with the RNS System for all types of DRE focal epilepsy. Most notably, the data showed:¹

• Long-term seizure reduction with an 82% median reduction at three years.
• Rapid seizure reduction with a 62% median reduction at six months.
• Seizure freedom with 42% of patients remaining seizure free for more than six months.ⁱ
• One in three patients did not require intracranial EEG monitoring.

Focal epilepsy is the most common form of DRE and often results in debilitating seizures from the time of childhood or adolescence; if uncontrolled, it can result in poor cognitive outcomes, depression, decreased social interaction, increased seizure frequency, and sudden unexplained death in epilepsy (SUDEP). The RNS System delivers greater seizure reduction than other neuromodulation therapies^1,4 ,5 ,ii and is the first and only neuromodulation platform that delivers personalized, real-time seizure treatment.

“We are committed to helping people with drug-resistant epilepsy attain seizure freedom and a better standard of care,” NeuroPace CEO Joel Becker stated. “The substantial seizure reduction data reported in this study thus far—the largest FDA-reviewed prospective study in neuromodulation history for focal DRE—furthers our goal of getting physicians the data they need to confidently select and provide ongoing treatment for their patients.”

The three-year safety and effectiveness data of the RNS System in adults with drug-resistant focal epilepsy from the PAS were submitted to the FDA in November 2024. The the study will continue to five years as part of its initial approval.

Based in Mountain View, Calif., NeuroPace is a commercial-stage medical device company focused on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differentiated RNS System can potentially offer a more personalized solution and improved outcomes to patients suffering from other brain disorders.

References
¹ RNS System Post-approval Study Oral Presentation, American Academy of Neurology, April 2025, all outcomes are ITT, median seizure reduction is observed case data, seizure freedom at last follow-up is LOCF
² SANTE Trial: Salanova et al., 20151
³ DeGiorgio et al, Epilepsia, 2000
⁴ Morris et al, Neurology, 1999
⁵ Kaufmann et al., Epilepsia, 2024
ⁱ At some point during the study.
ⁱⁱ Therapies were studied using different study designs. Caution must be exercised when comparing results.