NeuroPace Announces Data From a Long-Term Post-Approval Study of the RNS System in Focal Epilepsy at the 2025 AAN Annual Meeting
- 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 82% median reduction in seizures in adults treated with brain-responsive stimulation for drug-resistant focal epilepsy (DRE).1 The data were presented in an oral presentation at the American Academy of Neurology (AAN) Annual Meeting, taking place in San Diego from April 5-9, 2025.
"Drug-resistant epilepsy is a significant unmet medical need, accounting for up to 30-40% of all epilepsy diagnoses and affecting approximately 1.2 million people in the U.S.," said Martha Morrell, M.D., NeuroPace's Chief Medical Officer. "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 presented at AAN 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, 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
[email protected]
Investor Contact:
Jeremy Feffer
Managing Director
LifeSci Advisors
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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.
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