NeuroPace Announces FDA Submission of Three-Year Data from Post-Approval Study of the RNS System in Focal Epilepsy
NeuroPace has submitted three-year safety and effectiveness data from its Post-Approval Study (PAS) of the RNS System to the FDA. The study, involving over 300 patients from more than 30 Level 4 Comprehensive Epilepsy Centers in the US, is the largest prospective trial in neuromodulation for drug-resistant focal epilepsy. The RNS System is the only neuromodulation device that provides stimulation and monitors patient response over time. The study will continue to a five-year follow-up endpoint as part of the system's initial FDA approval.
NeuroPace ha presentato dati di sicurezza e efficacia triennali dal suo Studio Post-Approvazione (PAS) del RNS System alla FDA. Lo studio, che coinvolge oltre 300 pazienti provenienti da più di 30 Centri di Epilessia di Livello 4 negli Stati Uniti, è il più grande trial prospettico nel campo della neuromodulazione per l'epilessia focale resistente ai farmaci. Il RNS System è l'unico dispositivo di neuromodulazione che fornisce stimolazione e monitora la risposta del paziente nel tempo. Lo studio continuerà con un follow-up di cinque anni come parte dell'approvazione iniziale da parte della FDA del sistema.
NeuroPace ha presentado datos de seguridad y efectividad de tres años de su Estudio Post-Aprobación (PAS) del RNS System a la FDA. El estudio, que involucra a más de 300 pacientes de más de 30 Centros de Epilepsia de Nivel 4 en los EE. UU., es el ensayo prospectivo más grande en neuromodulación para la epilepsia focal resistente a medicamentos. El RNS System es el único dispositivo de neuromodulación que proporciona estimulación y monitorea la respuesta del paciente a lo largo del tiempo. El estudio continuará con un seguimiento de cinco años como parte de la aprobación inicial del sistema por la FDA.
NeuroPace는 RNS System의 사후 승인 연구(PAS)에서의 3년 안전성 및 효과성 데이터를 FDA에 제출했습니다. 이 연구는 미국의 30개 이상의 4단계 포괄적 간질 센터에서 300명 이상의 환자를 포함하여 약물 저항성 국소 간질에 대한 최상의 전향적 시험입니다. RNS System은 자극을 제공하고 시간이 지남에 따라 환자의 반응을 모니터링하는 유일한 신경 조절 장치입니다. 이 연구는 시스템의 초기 FDA 승인 일환으로 5년 후속 조사가 계속될 것입니다.
NeuroPace a soumis à la FDA des données de sécurité et d'efficacité sur trois ans tirées de son étude post-approbation (PAS) du RNS System. L'étude, impliquant plus de 300 patients provenant de plus de 30 centres d'épilepsie complets de niveau 4 aux États-Unis, est l'essai prospectif le plus vaste en neuromodulation pour l'épilepsie focale résistante aux médicaments. Le RNS System est le seul appareil de neuromodulation qui fournit une stimulation et surveille la réponse du patient au fil du temps. L'étude se poursuivra avec un suivi de cinq ans dans le cadre de l'approbation initiale de la FDA pour le système.
NeuroPace hat der FDA Daten zur Sicherheit und Wirksamkeit über einen Zeitraum von drei Jahren aus seiner Nachgenehmigungsstudie (PAS) des RNS Systems vorgelegt. Die Studie, an der über 300 Patienten aus mehr als 30 Level-4-Überweisungseinrichtungen in den USA beteiligt sind, ist die größte prospektive Studie zur Neuromodulation bei medikamentenresistenter fokaler Epilepsie. Das RNS System ist das einzige Neuromodulationsgerät, das Stimulationen bietet und die Patientenreaktion über die Zeit überwacht. Die Studie wird fortgesetzt und endet nach fünf Jahren, als Teil der ursprünglichen FDA-Zulassung des Systems.
- Largest prospective trial in neuromodulation for drug-resistant focal epilepsy
- Unique product feature: only device providing both stimulation and response monitoring
- Extensive study scope with 300+ patients across 30+ leading epilepsy centers
- Study results and effectiveness data not yet disclosed
- Five more years of study required for complete FDA approval
- Targeting market of drug-resistant focal epilepsy patients
Insights
The submission of three-year data from NeuroPace's RNS System post-approval study represents a significant milestone in epilepsy treatment validation. The study's scale - with over 300 patients across 30+ Level 4 Comprehensive Epilepsy Centers - provides robust evidence for the device's real-world performance.
The clinical significance lies in addressing focal epilepsy, the most prevalent form of drug-resistant epilepsy. The RNS System's unique capability to both stimulate and monitor patient response sets it apart in the neuromodulation space. This comprehensive data collection will likely influence treatment protocols and insurance coverage decisions.
While this FDA submission is a regulatory requirement, the extensive dataset from multiple centers strengthens the clinical evidence base. The continuation to five-year follow-up will provide valuable long-term effectiveness data, particularly important for a chronic condition like epilepsy.
The RNS System Post-Approval Study (PAS) is the largest prospective post-approval study in neuromodulation for patients with drug-resistant focal epilepsy
The RNS System PAS evaluates safety and effectiveness of the RNS System in the adult focal population – the largest patient segment of drug-resistant epilepsy
MOUNTAIN VIEW, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced Food and Drug Administration (FDA) submission of three-year safety and effectiveness data from its prospective Post-Approval Study (PAS) of the RNS System in adults with drug-resistant focal epilepsy. The study enrolled more than three hundred patients from more than thirty leading Level 4 Comprehensive Epilepsy Centers in the United States, making it the largest prospectively enrolled trial in the field of neuromodulation for drug-resistant focal epilepsy.
“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. This study is a key part of our ongoing commitment to provide physicians the information they need to confidently select and treat their patients with the RNS System.”
Focal epilepsy, in which seizures originate from specific areas of the brain, is the most common form of drug-resistant epilepsy. It is typically diagnosed in childhood or adolescence and often results in a lifetime of seizures. 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).
This RNS System PAS study is a five-year prospective, multicenter study required by FDA 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.
“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,” said Martha Morrell, M.D., NeuroPace’s Chief Medical Officer. “The RNS System is the only neuromodulation device that provides stimulation and monitors their response over time. The power of this approach was demonstrated in the randomized controlled and long-term treatment trials. Information from the Post-approval Study will further support physicians as they seek to optimize care for drug-resistant focal epilepsy patients,” added Dr. Morrell.
The RNS PAS study is planned to continue to a five-year follow-up endpoint as part of the RNS System’s initial FDA approval.
About NeuroPace, Inc.
Based in Mountain View, Calif., NeuroPace is a 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 current expectations, forecasts and beliefs; future financial performance, including management’s outlook for fiscal year 2024; 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 13, 2024, 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.
Investor Contact:
NeuroPace:
Jeremy Feffer
Managing Director
LifeSci Advisors
jfeffer@lifesciadvisors.com
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