NeuroPace Files PMA Supplement to Expand RNS System Indication for IGE Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 17 2025
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Should l Buy NPCE?
Source: Newsfilter
- Clinical Trial Results: The NAUTILUS trial demonstrated a 77% median reduction in GTC seizures with the RNS System in patients with drug-resistant idiopathic generalized epilepsy, indicating the therapy's effectiveness and safety in a challenging patient population.
- FDA Application Progress: NeuroPace has filed a PMA supplement with the FDA to expand the RNS System indication to include patients with ASM-resistant idiopathic generalized epilepsy, with a review expected to take approximately 180 days, potentially accelerating market access for this new therapy.
- Breakthrough Device Designation: The RNS System has received Breakthrough Device Designation from the FDA, highlighting its potential to meet significant clinical needs and offer new hope to patients currently lacking effective treatment options.
- Strategic Objective: NeuroPace's CEO stated that this application represents a critical milestone in the company's strategy to provide responsive neuromodulation therapy to more patients in need, aiming to elevate the standard of care in epilepsy treatment.
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Analyst Views on NPCE
Wall Street analysts forecast NPCE stock price to rise
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 14.150
Low
16.00
Averages
19.17
High
22.00
Current: 14.150
Low
16.00
Averages
19.17
High
22.00
About NPCE
NeuroPace, Inc. is a medical device company. The Company is 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 a brain-responsive platform that delivers personalized, real-time treatment at the seizure source. The Company has developed its RNS System to address the individualized nature of drug-resistant epilepsy and deliver a safe therapy for focal onset seizures anywhere in the brain. The RNS System is a device that records brain activity data and allows clinicians to monitor patients not only in person, but also remotely. The RNS System monitors and analyzes the brain’s electrical activity, recognizes patient-specific abnormal patterns, and delivers treatment at the seizure source. The Company’s RNS System is also engaged in treating other brain disorders, including depression, impulse control disorders, memory disorders, and post-traumatic stress disorders.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
NeuroPace Reports Strong Q4 2025 Earnings with 24% Revenue Growth
- Strong Revenue Growth: NeuroPace achieved $26.6 million in revenue for Q4 2025, reflecting a 24% year-over-year increase, with RNS System revenue reaching $22.4 million, up 26%, indicating deepening market penetration and customer base in adult focal epilepsy.
- Improved Profitability: The gross margin exceeded 77% in Q4, up approximately 200 basis points year-over-year, showcasing the company's ongoing focus on financial discipline and operational leverage, despite an operational loss of $1.8 million, which is a significant improvement from the $3.7 million loss in the prior year.
- Ongoing Strategic Investments: The company continues to invest in its commercial organization, including adding sales representatives and nurse navigator resources to support the rollout of RNS therapy, with full-year revenue guidance for 2026 set at $98 million to $100 million, assuming a core RNS growth rate of 20% to 22%.
- Launch of Innovative Tool: NeuroPace introduced the AI-enabled Seizure ID tool designed to rapidly analyze patients' iEEG records and identify seizure trends, enhancing the relevance of clinical data and treatment outcomes, marking a strategic advancement in the company's technological innovation.
See More
NeuroPace Q4 Earnings Exceed Expectations
- Earnings Highlights: NeuroPace reported a Q4 GAAP EPS of -$0.08, beating expectations by $0.08, indicating an improvement in profitability despite remaining in the red.
- Revenue Growth: The company achieved revenue of $26.6 million, a 23.9% year-over-year increase, surpassing expectations by $1.81 million, reflecting sustained demand for its products and driving overall performance.
- Future Outlook: NeuroPace projects full-year 2026 revenue between $98 million and $100 million, representing a growth potential of 20% to 22%, demonstrating the company's confidence in future market opportunities.
- Cost Management: Non-GAAP gross margin is expected to range from 81.5% to 82.5%, and while GAAP gross margin is slightly lower when including stock-based compensation, effective control of operating expenses will aid in improving financial health.
See More
NeuroPace to Report Q4 2025 Financial Results on March 3, 2026
- Earnings Release Schedule: NeuroPace will report its financial results for Q4 2025 after market close on March 3, 2026, demonstrating the company's commitment to transparency and aiming to bolster investor confidence.
- Conference Call Timing: Management will host a webcast conference call at 1:30 PM Pacific Time (4:30 PM Eastern Time) to provide detailed insights into the financial performance, aiding investors in understanding the company's operational status.
- Participation Method: Investors can join the call by dialing +1 (800) 715-9871 and referencing Conference ID 8467256, ensuring broad dissemination of information and enhancing investor engagement.
- Webcast Archiving: The webcast will be archived on the company's investor relations website for at least 90 days, reflecting the company's commitment to ongoing communication with investors.
See More
NeuroPace to Present at 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026
- Conference Participation: NeuroPace will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, in San Francisco, showcasing its innovative technologies in epilepsy treatment, which is expected to attract investor interest and enhance the company's visibility.
- Investor Meetings: The management team will host investor meetings during the conference, aiming to establish connections with potential investors, boost market confidence, and drive future financing opportunities.
- Live Webcast: The presentation will be accessible via live webcast, allowing global investors to participate in real-time, enhancing transparency and demonstrating the company's commitment to investor relations.
- Technological Background: NeuroPace's RNS System is the first commercially available brain-responsive platform designed to provide personalized, real-time treatment for drug-resistant epilepsy patients, with the potential to improve patient quality of life, further solidifying the company's position in the medical device industry.
See More
NeuroPace to Present Innovative Treatment Solutions at 2026 J.P. Morgan Healthcare Conference
- Conference Presentation: NeuroPace will present at the J.P. Morgan Healthcare Conference on January 14, 2026, in San Francisco, which is expected to attract significant investor interest in its innovative medical devices for epilepsy.
- Investor Meetings: The management team will host investor meetings during the conference, aiming to strengthen engagement with potential investors and enhance the company's market visibility in the medical device sector.
- Live Webcast: The presentation will be accessible via live webcast, allowing global investors to participate in real-time, with a 30-day replay available afterward to further extend the reach of the information shared.
- Technological Background: NeuroPace's RNS System is the first commercially available brain-responsive platform designed to provide personalized, real-time treatment for drug-resistant epilepsy patients, showcasing significant market potential and societal value.
See More
NeuroPace Files PMA Supplement to Expand RNS System Indication for IGE Patients
- Clinical Trial Results: The NAUTILUS trial demonstrated a 77% median reduction in GTC seizures with the RNS System in patients with drug-resistant idiopathic generalized epilepsy, indicating the therapy's effectiveness and safety in a challenging patient population.
- FDA Application Progress: NeuroPace has filed a PMA supplement with the FDA to expand the RNS System indication to include patients with ASM-resistant idiopathic generalized epilepsy, with a review expected to take approximately 180 days, potentially accelerating market access for this new therapy.
- Breakthrough Device Designation: The RNS System has received Breakthrough Device Designation from the FDA, highlighting its potential to meet significant clinical needs and offer new hope to patients currently lacking effective treatment options.
- Strategic Objective: NeuroPace's CEO stated that this application represents a critical milestone in the company's strategy to provide responsive neuromodulation therapy to more patients in need, aiming to elevate the standard of care in epilepsy treatment.
See More
NeuroPace Reports Strong Q4 2025 Earnings with 24% Revenue Growth
- Strong Revenue Growth: NeuroPace achieved $26.6 million in revenue for Q4 2025, reflecting a 24% year-over-year increase, with RNS System revenue reaching $22.4 million, up 26%, indicating deepening market penetration and customer base in adult focal epilepsy.
- Improved Profitability: The gross margin exceeded 77% in Q4, up approximately 200 basis points year-over-year, showcasing the company's ongoing focus on financial discipline and operational leverage, despite an operational loss of $1.8 million, which is a significant improvement from the $3.7 million loss in the prior year.
- Ongoing Strategic Investments: The company continues to invest in its commercial organization, including adding sales representatives and nurse navigator resources to support the rollout of RNS therapy, with full-year revenue guidance for 2026 set at $98 million to $100 million, assuming a core RNS growth rate of 20% to 22%.
- Launch of Innovative Tool: NeuroPace introduced the AI-enabled Seizure ID tool designed to rapidly analyze patients' iEEG records and identify seizure trends, enhancing the relevance of clinical data and treatment outcomes, marking a strategic advancement in the company's technological innovation.
See More
NeuroPace Q4 Earnings Exceed Expectations
- Earnings Highlights: NeuroPace reported a Q4 GAAP EPS of -$0.08, beating expectations by $0.08, indicating an improvement in profitability despite remaining in the red.
- Revenue Growth: The company achieved revenue of $26.6 million, a 23.9% year-over-year increase, surpassing expectations by $1.81 million, reflecting sustained demand for its products and driving overall performance.
- Future Outlook: NeuroPace projects full-year 2026 revenue between $98 million and $100 million, representing a growth potential of 20% to 22%, demonstrating the company's confidence in future market opportunities.
- Cost Management: Non-GAAP gross margin is expected to range from 81.5% to 82.5%, and while GAAP gross margin is slightly lower when including stock-based compensation, effective control of operating expenses will aid in improving financial health.
See More
NeuroPace to Report Q4 2025 Financial Results on March 3, 2026
- Earnings Release Schedule: NeuroPace will report its financial results for Q4 2025 after market close on March 3, 2026, demonstrating the company's commitment to transparency and aiming to bolster investor confidence.
- Conference Call Timing: Management will host a webcast conference call at 1:30 PM Pacific Time (4:30 PM Eastern Time) to provide detailed insights into the financial performance, aiding investors in understanding the company's operational status.
- Participation Method: Investors can join the call by dialing +1 (800) 715-9871 and referencing Conference ID 8467256, ensuring broad dissemination of information and enhancing investor engagement.
- Webcast Archiving: The webcast will be archived on the company's investor relations website for at least 90 days, reflecting the company's commitment to ongoing communication with investors.
See More
NeuroPace to Present at 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026
- Conference Participation: NeuroPace will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, in San Francisco, showcasing its innovative technologies in epilepsy treatment, which is expected to attract investor interest and enhance the company's visibility.
- Investor Meetings: The management team will host investor meetings during the conference, aiming to establish connections with potential investors, boost market confidence, and drive future financing opportunities.
- Live Webcast: The presentation will be accessible via live webcast, allowing global investors to participate in real-time, enhancing transparency and demonstrating the company's commitment to investor relations.
- Technological Background: NeuroPace's RNS System is the first commercially available brain-responsive platform designed to provide personalized, real-time treatment for drug-resistant epilepsy patients, with the potential to improve patient quality of life, further solidifying the company's position in the medical device industry.
See More
NeuroPace to Present Innovative Treatment Solutions at 2026 J.P. Morgan Healthcare Conference
- Conference Presentation: NeuroPace will present at the J.P. Morgan Healthcare Conference on January 14, 2026, in San Francisco, which is expected to attract significant investor interest in its innovative medical devices for epilepsy.
- Investor Meetings: The management team will host investor meetings during the conference, aiming to strengthen engagement with potential investors and enhance the company's market visibility in the medical device sector.
- Live Webcast: The presentation will be accessible via live webcast, allowing global investors to participate in real-time, with a 30-day replay available afterward to further extend the reach of the information shared.
- Technological Background: NeuroPace's RNS System is the first commercially available brain-responsive platform designed to provide personalized, real-time treatment for drug-resistant epilepsy patients, showcasing significant market potential and societal value.
See More
NeuroPace Files PMA Supplement to Expand RNS System Indication for IGE Patients
- Clinical Trial Results: The NAUTILUS trial demonstrated a 77% median reduction in GTC seizures with the RNS System in patients with drug-resistant idiopathic generalized epilepsy, indicating the therapy's effectiveness and safety in a challenging patient population.
- FDA Application Progress: NeuroPace has filed a PMA supplement with the FDA to expand the RNS System indication to include patients with ASM-resistant idiopathic generalized epilepsy, with a review expected to take approximately 180 days, potentially accelerating market access for this new therapy.
- Breakthrough Device Designation: The RNS System has received Breakthrough Device Designation from the FDA, highlighting its potential to meet significant clinical needs and offer new hope to patients currently lacking effective treatment options.
- Strategic Objective: NeuroPace's CEO stated that this application represents a critical milestone in the company's strategy to provide responsive neuromodulation therapy to more patients in need, aiming to elevate the standard of care in epilepsy treatment.
See More
