NeuroPace Expects FDA Submission for Expanded IGE Indication in 2H 2025

NeuroPace (NPCE) is on track to submit NAUTILUS data to the FDA for potential IGE indication expansion in 2H 2025. The company is focusing on elevating its investing strategy and unlocking powerful tools, advanced data, and expert analyst insights to invest with confidence. The submission is expected to expand the indication for its RNS system.

Mountain View, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) — NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today reported its financial results for the second quarter ended June 30, 2025, and provided an update on its strategic initiatives. The company achieved record quarterly revenue of $23.5 million, an increase of 22% year-over-year, driven by strong performance of its RNS System. Additionally, NeuroPace increased its full-year 2025 revenue guidance to between $94 million and $98 million and its gross margin guidance to between 75% and 76%.

The company's operational highlights included delivering compelling preliminary data from the NAUTILUS study evaluating RNS therapy in IGE, which demonstrated statistically significant safety and clinically meaningful improvements in seizure reduction. NeuroPace also reported that it is on track to submit NAUTILUS data to the FDA for potential IGE indication expansion in the second half of 2025.

Financial Results
- Total revenue in the second quarter of 2025 grew 22% to $23.5 million, compared to $19.3 million in the second quarter of 2024.
- RNS System revenue grew 21% in the first half of 2025 compared to the first half of 2024 and 16% in the second quarter of 2025 compared to the second quarter of 2024.
- Gross margin for the second quarter of 2025 was 77.1%, compared to 73.4% in the second quarter of 2024 and 77.0% in the first quarter of 2025.
- Total operating expenses in the second quarter of 2025 were $25.0 million, compared to $20.4 million in the same period of the prior year.
- Loss from operations was $6.8 million in the second quarter of 2025, compared to $6.2 million in the prior year period.
- Net loss was $8.7 million for the second quarter of 2025, compared to $7.5 million in the second quarter of 2024.

Updated Full Year 2025 Financial Guidance
- Increased total revenue guidance for full year 2025 to between $94 million and $98 million, representing growth of 18% – 23% versus $79.9 million in 2024.
- Increased gross margin guidance to between 75% and 76%.

Operational and Strategic Highlights
- NeuroPace announced compelling one-year preliminary data from the NAUTILUS study, demonstrating statistically significant safety and clinically meaningful improvements in seizure reduction.
- The company is on track to submit NAUTILUS data to the FDA for potential IGE indication expansion in the second half of 2025.
- NeuroPace achieved record highs in the number of both active accounts and prescribers.
- The company received a favorable outcome in CMS’s FY 2026 Inpatient Prospective Payment System (IPPS) final rule, with RNS procedures remaining in MS-DRG 023, preserving reimbursement stability for Medicare patients.

Joel Becker, Chief Executive Officer of NeuroPace, commented, "We are pleased with the continued momentum in our business through the second quarter of 2025, as we made significant progress across a number of key initiatives to position NeuroPace for sustained long-term growth. We are advancing our strategy, driving increased access to and adoption of RNS therapy and supporting operating leverage as we scale. We also made important clinical and regulatory and research and development progress in the quarter, including advancing our NAUTILUS and the pediatric PMA supplement programs and advancing our AI software development programs."

NeuroPace will host a conference call to discuss the second quarter 2025 financial results after market close on Tuesday, August 12, 2025, at 4:30 P.M. Eastern Time. Investors interested in listening to the conference call may do so by accessing a live and archived webcast of the event at [click here]. Individuals interested in participating in the call via telephone may access the call by dialing +1-877-407-3982 and referencing Conference ID 13754370. The webcast will be archived on the Company’s investor relations website at https://investors.neuropace.com/news-and-events/events and will be available for replay for at least 90 days after the event.

References:
[1] https://www.globenewswire.com/news-release/2025/08/12/3132117/0/en/NeuroPace-Reports-Second-Quarter-2025-Financial-Results-and-Increases-2025-Revenue-Guidance.html