NeuroPace Completes Enrollment in Feasibility Study of RNS System for Lennox-Gastaut Syndrome
NeuroPace announced completion of enrollment and implant procedures in its feasibility IDE study of the RNS System for treating Lennox-Gastaut Syndrome (LGS), a severe childhood-onset epilepsy. The study, funded by a $9.3 million NIH grant, enrolled 20 patients aged 12 and older across six sites to evaluate the safety and effectiveness of brain-responsive stimulation for LGS treatment.
The study includes a one-year open label period followed by an 18-month long-term follow-up. LGS affects patients severely, with 85% continuing to have seizures into adulthood, 98% suffering from intellectual disability, and affected individuals being 12 times more likely to die prematurely than their peers.
NeuroPace ha annunciato il completamento dell'arruolamento e delle procedure di impianto nel suo studio di fattibilità IDE per il RNS System nel trattamento della Sindrome di Lennox-Gastaut (LGS), un'epilessia grave che inizia nell'infanzia. Lo studio, finanziato da un grant del NIH di 9,3 milioni di dollari, ha arruolato 20 pazienti di età pari o superiore ai 12 anni in sei centri per valutare la sicurezza e l'efficacia della stimolazione cerebrale reattiva per il trattamento della LGS.
Lo studio prevede un anno di periodo aperto, seguito da un follow-up a lungo termine di 18 mesi. La LGS colpisce i pazienti in modo severo, con l'85% che continua ad avere crisi anche in età adulta, il 98% che soffre di disabilità intellettuale e gli individui affetti che hanno 12 volte più probabilità di morire prematuramente rispetto ai loro coetanei.
NeuroPace anunció la finalización del reclutamiento y los procedimientos de implante en su estudio de viabilidad IDE del Sistema RNS para el tratamiento del Síndrome de Lennox-Gastaut (LGS), una epilepsia severa que comienza en la infancia. El estudio, financiado por una subvención de 9.3 millones de dólares del NIH, reclutó a 20 pacientes de 12 años o más en seis sitios para evaluar la seguridad y efectividad de la estimulación cerebral responsiva para el tratamiento de LGS.
El estudio incluye un período abierto de un año seguido de un seguimiento a largo plazo de 18 meses. La LGS afecta gravemente a los pacientes, con un 85% que continúa teniendo convulsiones en la adultez, un 98% que sufre de discapacidad intelectual, y los individuos afectados tienen 12 veces más probabilidades de morir prematuramente en comparación con sus compañeros.
NeuroPace는 렌녹스-가스타우 증후군(LGS), 어린 시절에 발병하는 심각한 간질 치료를 위한 RNS 시스템의 타당성 IDE 연구에서 enrollment과 이식 절차 완료를 발표했습니다. 이 연구는 930만 달러의 NIH 보조금으로 자금을 지원받아 12세 이상의 환자 20명을 6개 사이트에서 등록하여 LGS 치료를 위한 뇌 반응성 자극의 안전성과 유효성을 평가했습니다.
이 연구는 1년의 공개 라벨 기간과 그 뒤에 18개월의 장기 추적 조사로 구성되어 있습니다. LGS는 환자에게 심각한 영향을 미치며, 85%가 성인이 되어도 계속 발작을 경험하고, 98%가 지적 장애로 고통받으며, 영향을 받는 개인은 동료에 비해 조기 사망할 확률이 12배 높습니다.
NeuroPace a annoncé l'achèvement de l'inscription et des procédures d'implantation dans son étude de faisabilité IDE concernant le Système RNS pour le traitement du Syndrome de Lennox-Gastaut (LGS), une épilepsie sévère débutant dans l'enfance. L'étude, financée par une subvention de 9,3 millions de dollars du NIH, a recruté 20 patients âgés de 12 ans et plus sur six sites afin d'évaluer la sécurité et l'efficacité de la stimulation cérébrale réactive pour le traitement de la LGS.
L'étude comprend une période d'ouverture d'un an suivie d'un suivi à long terme de 18 mois. Le LGS a un impact sévère sur les patients, avec 85 % continuant à avoir des crises à l'âge adulte, 98 % souffrant d'un handicap intellectuel, et les personnes touchées ayant 12 fois plus de chances de mourir prématurément que leurs pairs.
NeuroPace hat den Abschluss der Rekrutierung und der Implantationsverfahren in seiner Machbarkeitsstudie IDE des RNS-Systems zur Behandlung des Lennox-Gastaut-Syndroms (LGS), einer schweren kindlichen Epilepsie, bekannt gegeben. Die Studie, die durch einen NIH-Zuschuss in Höhe von 9,3 Millionen Dollar finanziert wird, hat 20 Patienten im Alter von 12 Jahren und älter an sechs Standorten rekrutiert, um die Sicherheit und Wirksamkeit der hirnresponsive Stimulation zur Behandlung von LGS zu bewerten.
Die Studie umfasst einen einjährigen offenen Zeitraum, gefolgt von einer 18-monatigen Langzeitfolgenbeobachtung. LGS beeinträchtigt die Patienten erheblich, wobei 85 % auch im Erwachsenenalter weiterhin Anfälle haben, 98 % an intellektueller Behinderung leiden und betroffene Personen 12-mal höher das Risiko haben, vorzeitig zu sterben als ihre Altersgenossen.
- Secured $9.3 million NIH grant funding for the study
- Successfully completed enrollment of 20 patients for LGS treatment study
- Potential expansion of RNS System application to new patient population
- None.
Insights
The completion of enrollment in NeuroPace's LGS feasibility study marks a significant milestone in exploring new treatment options for a severe form of epilepsy. The study, backed by a
Key aspects of this development include:
- The study targets Lennox-Gastaut Syndrome, which affects
85% of patients into adulthood despite treatment - The RNS System's potential application in patients as young as 12 years old could open a new market segment
- The 30-month study structure (12-month open-label + 18-month follow-up) will provide comprehensive safety and efficacy data
This development could significantly impact NeuroPace's market position in the neuromodulation space, especially considering LGS's current treatment options and high unmet medical need. The successful completion of enrollment sets the stage for potential market expansion pending positive study results.
Enrollment and implant procedures completed in NIH funded feasibility study of LGS, a severe and disabling childhood-onset epilepsy
MOUNTAIN VIEW, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of people living with epilepsy, today announced completion of enrollment and implant procedures in its feasibility investigational device exemption (IDE) study of the RNS® System for the treatment of Lennox-Gastaut Syndrome (LGS), a devastating form of childhood-onset epilepsy characterized by cognitive dysfunction and frequent generalized onset seizures that often lead to injury.
The IDE study uses the RNS System, which has demonstrated safety and effectiveness of brain-responsive stimulation for treating medically intractable focal onset seizures in people 18 and older, to evaluate whether brain-responsive neurostimulation can also be used to treat LGS.
NeuroPace received a
“We are pleased to announce the advancement of our LGS IDE study and look forward to the data and learnings it provides. The results from this study could support further research of RNS therapy to improve the treatment of people with LGS. We appreciate the dedicated efforts of the investigators, research teams, participants and their families,” said Martha Morrell, MD, Chief Medical Officer of NeuroPace. “After completing the one-year open label period, participants will transition to the long-term follow-up period, which will continue over the next 18 months.”
"LGS is a devastating, childhood-onset seizure disorder that leads to lifelong disability.
Disclaimer: Research reported in this press release was supported by the National Institutes of Health’s Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative under award number UH3NS109557. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About the RNS® System
The RNS® System, a paradigm-shifting treatment for drug-resistant focal epilepsy, is the only brain-responsive neuromodulation system approved by the FDA. The closed-loop technology delivers personalized, data-driven treatment targeted to the seizure source by continuously monitoring brain activity, recognizing a patient’s unique seizure pattern, and responding in real-time with imperceptible stimulation to prevent seizures. By recording ongoing EEG data, the RNS System provides physicians with a unique “window to the brain,” enabling them to remotely monitor their patients, gain insights based on brain activity, and use that information to optimize patient care. Long-term clinical studies demonstrate that the RNS System provides significant reduction in seizure frequency and enduring improvements in quality of life and cognition with no stimulation-related side effects. The RNS System is available at most comprehensive epilepsy centers in the United States and is widely covered by insurance. It is currently approved in the United States as an adjunctive therapy for patients 18 years of age and older with drug-resistant focal epilepsy. See full indication for use and important safety information at www.neuropace.com/safety/.
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 suffering from 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. 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: risks related to regulatory compliance and expectations for regulatory approvals to expand the market for NeuroPace’s RNS System 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 September 30, 2024, filed with the SEC on November 12, 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:
Jeremy Feffer
Managing Director
LifeSci Advisors
jfeffer@lifesciadvisors.com
FAQ
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