NeuroPace Announces Data From a Long-Term Post-Approval Study of the RNS System in Focal Epilepsy at the 2025 AAN Annual Meeting
NeuroPace (NPCE) has announced significant three-year effectiveness data from their Post-Approval Study (PAS) of the RNS® System at the 2025 AAN Annual Meeting. The study, involving 324 patients across 32 centers, represents the largest FDA-reviewed prospective neuromodulation trial for drug-resistant focal epilepsy.
Key findings include:
- 82% median seizure reduction at 3 years
- 62% median seizure reduction at 6 months
- 42% of patients remained seizure-free for 6+ months
- 1 in 3 patients did not require intracranial EEG monitoring
The RNS System, the only FDA-approved epilepsy device providing brain-responsive neurostimulation, addresses drug-resistant epilepsy (DRE), which affects approximately 1.2 million people in the U.S. The three-year safety and effectiveness data were submitted to the FDA in November 2024, with the study continuing to five years.
NeuroPace (NPCE) ha annunciato dati significativi sull'efficacia a tre anni dal loro Studio Post-Approvazione (PAS) del Sistema RNS® durante il Meeting Annuale AAN 2025. Lo studio, che ha coinvolto 324 pazienti in 32 centri, rappresenta il più grande trial prospettico di neuromodulazione esaminato dalla FDA per l'epilessia focale resistente ai farmaci.
I risultati chiave includono:
- riduzione mediana delle crisi del 82% a 3 anni
- riduzione mediana delle crisi del 62% a 6 mesi
- il 42% dei pazienti è rimasto senza crisi per oltre 6 mesi
- 1 paziente su 3 non ha richiesto monitoraggio EEG intracranico
Il Sistema RNS, l'unico dispositivo per l'epilessia approvato dalla FDA che fornisce neurostimolazione reattiva al cervello, affronta l'epilessia resistente ai farmaci (DRE), che colpisce circa 1,2 milioni di persone negli Stati Uniti. I dati di sicurezza ed efficacia a tre anni sono stati inviati alla FDA nel novembre 2024, con lo studio che continua fino a cinque anni.
NeuroPace (NPCE) ha anunciado datos significativos de efectividad a tres años de su Estudio Post-Aprobación (PAS) del Sistema RNS® en la Reunión Anual de la AAN 2025. El estudio, que involucró a 324 pacientes en 32 centros, representa el mayor ensayo prospectivo de neuromodulación revisado por la FDA para la epilepsia focal resistente a medicamentos.
Los hallazgos clave incluyen:
- reducción mediana de convulsiones del 82% a los 3 años
- reducción mediana de convulsiones del 62% a los 6 meses
- el 42% de los pacientes permanecieron libres de convulsiones durante más de 6 meses
- 1 de cada 3 pacientes no requirió monitoreo de EEG intracraneal
El Sistema RNS, el único dispositivo para la epilepsia aprobado por la FDA que proporciona neuroestimulación responsiva al cerebro, aborda la epilepsia resistente a medicamentos (DRE), que afecta aproximadamente a 1,2 millones de personas en EE. UU. Los datos de seguridad y efectividad a tres años fueron presentados a la FDA en noviembre de 2024, con el estudio continuando hasta cinco años.
NeuroPace (NPCE)는 2025 AAN 연례 회의에서 RNS® 시스템의 승인 후 연구(PAS)에서 3년간의 중요한 효과 데이터를 발표했습니다. 이 연구는 32개 센터에서 324명의 환자를 포함하며, 약물 저항성 국소 간질에 대한 FDA 검토를 받은 가장 큰 전향적 신경조절 시험을 나타냅니다.
주요 발견 사항은 다음과 같습니다:
- 3년 동안 중간 발작 감소율 82%
- 6개월 동안 중간 발작 감소율 62%
- 환자의 42%가 6개월 이상 발작이 없었습니다
- 3명 중 1명은 두개내 EEG 모니터링이 필요하지 않았습니다
RNS 시스템은 뇌 반응형 신경 자극을 제공하는 FDA 승인 유일의 간질 장치로, 약물 저항성 간질(DRE)을 다루며, 이는 미국에서 약 120만 명에게 영향을 미칩니다. 3년간의 안전성과 효과 데이터는 2024년 11월 FDA에 제출되었으며, 연구는 5년까지 계속됩니다.
NeuroPace (NPCE) a annoncé des données d'efficacité significatives sur trois ans provenant de son Étude Post-Approbation (PAS) du Système RNS® lors de la Réunion Annuelle de l'AAN 2025. L'étude, impliquant 324 patients dans 32 centres, représente l'essai de neuromodulation prospectif le plus important examiné par la FDA pour l'épilepsie focale résistante aux médicaments.
Les résultats clés incluent:
- réduction médiane des crises de 82% à 3 ans
- réduction médiane des crises de 62% à 6 mois
- 42% des patients sont restés sans crise pendant plus de 6 mois
- 1 patient sur 3 n'a pas eu besoin de surveillance EEG intracrânienne
Le Système RNS, le seul dispositif d'épilepsie approuvé par la FDA fournissant une neurostimulation réactive au cerveau, s'attaque à l'épilepsie résistante aux médicaments (DRE), qui touche environ 1,2 million de personnes aux États-Unis. Les données de sécurité et d'efficacité sur trois ans ont été soumises à la FDA en novembre 2024, l'étude se poursuivant jusqu'à cinq ans.
NeuroPace (NPCE) hat auf dem AAN-Jahrestreffen 2025 bedeutende Wirksamkeitsdaten über einen Zeitraum von drei Jahren aus ihrer Post-Approval-Studie (PAS) des RNS®-Systems bekannt gegeben. Die Studie, an der 324 Patienten in 32 Zentren beteiligt waren, stellt die größte von der FDA geprüfte prospektive Neuromodulationsstudie für medikamentenresistente fokale Epilepsie dar.
Wichtige Ergebnisse umfassen:
- 82% mediale Anfallsreduktion nach 3 Jahren
- 62% mediale Anfallsreduktion nach 6 Monaten
- 42% der Patienten blieben 6 Monate oder länger anfallsfrei
- 1 von 3 Patienten benötigte keine intrakranielle EEG-Überwachung
Das RNS-System, das einzige von der FDA zugelassene Epilepsiegerät, das hirnreaktive Neurostimulation bietet, behandelt medikamentenresistente Epilepsie (DRE), die etwa 1,2 Millionen Menschen in den USA betrifft. Die Sicherheits- und Wirksamkeitsdaten über drei Jahre wurden im November 2024 bei der FDA eingereicht, wobei die Studie bis zu fünf Jahre fortgesetzt wird.
- Strong clinical efficacy with 82% median seizure reduction at 3 years
- High seizure freedom rate with 42% of patients seizure-free for 6+ months
- Rapid effectiveness showing 62% median reduction within 6 months
- Reduced need for invasive monitoring in 33% of patients
- Largest FDA-reviewed prospective trial in the field strengthens evidence base
- Study still ongoing and requires completion of full 5-year follow-up
- Treatment to focal epilepsy subset of patients
Insights
NeuroPace's latest RNS System data represents a significant clinical validation for their brain-responsive neurostimulation technology. The three-year results from this 324-patient study - the largest FDA-reviewed prospective neuromodulation trial for drug-resistant focal epilepsy - demonstrate
What's particularly compelling is the rapid efficacy (
The finding that one-third of patients didn't require intracranial EEG monitoring has significant clinical workflow implications, potentially reducing procedural complexity and improving the risk-benefit profile. This technology's ability to deliver personalized, real-time treatment based on brain activity monitoring represents a fundamental advance over static stimulation approaches.
With this data submitted to the FDA in November 2024 and study continuation through the five-year mark, NeuroPace is building a compelling evidence foundation that should drive wider clinical adoption. The presentation of these results at the prestigious AAN Annual Meeting further enhances visibility among the neurology community who influence device selection for epilepsy patients.
These RNS System results represent exceptional outcomes for drug-resistant focal epilepsy (DRE) patients. The
The
NeuroPace's brain-responsive approach distinguishes itself by delivering stimulation only when abnormal brain activity is detected, rather than continuous stimulation used in other neurostimulation devices. This targeted approach likely contributes to the superior efficacy while potentially improving battery longevity.
The simplified pathway for appropriate patients (avoiding intracranial EEG in one-third of cases) represents a significant clinical workflow improvement. Intracranial monitoring typically requires separate surgical procedures, adding risk and delaying treatment. This streamlined approach could accelerate time-to-treatment for suitable candidates.
As the only FDA-approved responsive neurostimulation system for epilepsy, these compelling results should strengthen NeuroPace's position as a leading option for DRE patients who have failed multiple medications and are seeking non-pharmacological alternatives.
- Three-year data from the largest FDA-reviewed prospective neuromodulation study of safety and effectiveness in drug-resistant focal epilepsy1
- Long-term seizure reduction with a median reduction of
82% at 3 years. - Seizure freedom with
42% of patients remaining seizure free for 6+ months.i
MOUNTAIN VIEW, Calif., April 08, 2025 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced three-year effectiveness data from the Post-Approval Study (PAS) of the RNS® System, which showed an
“Drug-resistant epilepsy is a significant unmet medical need, accounting for up to 30
The PAS enrolled 324 patients from 32 centers making it the largest-ever, FDA-reviewed, prospectively enrolled trial in the field of neuromodulation for drug-resistant focal epilepsy.1,2,3 ii Data from the prespecified three-year effectiveness analysis presented at the AAN Annual Meeting showed continued evidence of substantial seizure reductions with the RNS System for all types of DRE focal epilepsy. Most notably, the data showed1:
- Long-term seizure reduction with a median reduction of
82% at 3 years. - Rapid seizure reduction with a median reduction of
62% at 6 months. - Seizure freedom with
42% of patients remaining seizure free for 6+ months. - 1 in 3 patients did not require intracranial EEG monitoring.
Focal epilepsy is the most common form of DRE and often results in a lifetime of debilitating seizures from the time of childhood or adolescence and, if uncontrolled, 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 therapies1,4 ,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,” said Joel Becker, NeuroPace’s Chief Executive Officer. “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, and the study will continue to five years as part of its initial FDA approval.
Abstract program number S20.009 was presented at the AAN 2025 Annual Meeting on Monday, April 7, 2025.
About NeuroPace, Inc.
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 is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source. This platform can drive a better standard of care for patients living with drug-resistant epilepsy and has the potential to offer a more personalized solution and improved outcomes to the large population of patients suffering from other brain disorders.
Forward Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: NeuroPace’s assessments about the value of the PAS data, including, but not limited to, the value of the data to physicians and their ability to effectively utilize the RNS System to treat patients with DRE focus epilepsy; the potential of the RNS System to continue to offer safe and effective treatment for larger segments of the total addressable market of DRE focal patients; current expectations, forecasts and beliefs; future financial performance, including management’s outlook for fiscal year 2025; the Company’s commitment to effectively managing its operating expenses; ability to capitalize on increased market opportunities by expanding access to treatments; and clinical trial results and indication expansion. NeuroPace may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties related to market acceptance and adoption of NeuroPace’s RNS System; risks related to the pricing of the RNS System and availability of adequate reimbursement for the procedures to implant the RNS System and for clinicians to provide ongoing care for patients treated with the RNS System; the risk that NeuroPace may not realize the intended benefits of its partnership with DIXI Medical; risks related to regulatory compliance and expectations for regulatory approvals to expand the market for NeuroPace’s RNS System; NeuroPace’s reliance on contractors and other third parties, including single-source suppliers and vendors; and other important factors. These and other risks and uncertainties include those described more fully in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in NeuroPace’s public filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 5, 2025, as well as any other reports that it may file with the SEC in the future. Forward-looking statements contained in this announcement are based on information available to NeuroPace as of the date hereof. NeuroPace undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing NeuroPace’s views as of any date subsequent to the date of this press release and should not be relied upon as a prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of NeuroPace.
Contact:
Katie Keller
Vice President of Marketing, NeuroPace
kkeller@neuropace.com
Investor Contact:
Jeremy Feffer
Managing Director
LifeSci Advisors
jfeffer@lifesciadvisors.com
_____________________
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.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0efca94f-0de9-47da-878c-e860f36f2574
FAQ
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