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Neuropace Inc

NeuroPace, Inc. is a medical device company based in the United States. It develops the RNS System, a brain-responsive neuromodulation system that delivers personalized, real-time treatment at the seizure source for drug-resistant focal epilepsy. The RNS System includes an RNS neurostimulator, cortical strip and depth leads, a Patient Remote Monitor, and other implantable and non-implantable accessories. The company also offers a physician tablet for prescribing and programming implanted devices and managing patient care, a patient data management system that collects data recorded by the RNS System, and the nSight Platform, which provides clinicians with personalized patient reports and programming suggestions. It sells its products to hospital facilities for initial RNS System implant procedures and replacement procedures. NeuroPace, Inc. was incorporated in 1997 and is headquartered in Mountain View, California.

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Brain-Computer Interface▲

NeuroPace Beats Q2 Estimates, Raises 2026 Revenue Guidance to $99.5-$101.5 Million

NeuroPace reported a second-quarter 2026 loss per share of 18 cents, beating the Zacks Consensus Estimate by 5.3% and improving from a loss of 30 cents a year earlier. Revenue rose 17.1% year over year to $22.8 million, led by the RNS System, whose revenues totaled $22.5 million, up 21.3%, while service revenues fell to $302,000 from $937,000 a year ago following the DIXI Medical wind-down. Adjusted gross margin contracted 60 basis points to 83.4%, and the adjusted operating loss narrowed to $2.8 million from $5 million. Management raised full-year 2026 revenue guidance to $99.5-$101.5 million from $99-$101 million, reflecting expected service revenues of about $1 million, up from roughly $500,000 previously, while the RNS revenue growth outlook remains 21%-23%. The company also lifted its adjusted gross margin outlook to 82%-83% and narrowed its expected adjusted EBITDA loss to $7.5 million-$8.5 million, though consensus estimates have trended downward over the past month.
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NeuroPace Faces FDA Delay on IGE Expansion

NeuroPace has hit a regulatory delay in its bid to expand the RNS System into idiopathic generalized epilepsy, or IGE, after the FDA said its premarket approval supplement was not approvable in its current form. The agency requested more information on clinical benefit across patient subgroups, including by baseline generalized tonic-clonic seizure frequency, and on the clinical meaningfulness of reducing those seizures. Management said the response was not a disapproval and that discussions remained interactive, with questions unrelated to safety. NeuroPace is pursuing the FDA's Submission Issue Request process before amending the filing, and the planned response may include additional subgroup analyses, patient- and physician-reported outcomes, published and real-world evidence, and longer-term NAUTILUS data showing a 100% median reduction in GTC seizures at 24 months. Second-quarter RNS System revenues rose 21.3% year over year to $22.5 million, with record active prescribers, active accounts, and patient pipeline, while the company's 2026 revenue guidance excludes any IGE contribution.
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NeuroPace Q2 Loss Narrows, Raises 2026 Revenue Outlook

NeuroPace reported a narrower second-quarter 2026 loss and raised its full-year revenue guidance. The company posted a loss per share of 18 cents, beating the Zacks Consensus Estimate by 5.3%, while revenues rose 17.1% year over year to $22.8 million, led by 21.3% growth in RNS System revenues to $22.5 million. Management lifted 2026 revenue guidance to $99.5-$101.5 million from $99-$101 million, reflecting higher expected service revenues, and improved its adjusted EBITDA loss outlook to $7.5-$8.5 million from $8.5-$9.5 million. NeuroPace also launched ECoG Assistant, the first in its planned suite of AI-based clinical decision-support tools, and reported 18-month NAUTILUS data showing a 77% median reduction in generalized tonic-clonic seizures.
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NeuroPace Receives FDA Approval for AI-Driven ECoG Assistant

NeuroPace received U.S. Food and Drug Administration approval for ECoG Assistant, the first AI-driven clinician-enabled feature designed to aid epilepsy care using long-term intracranial EEG data. Built on 124,450 epileptologist-labeled records, the tool identifies ECoGs of Interest and allows physicians to review trends and timing patterns across months through integrated reports and charts, improving efficiency in data review and treatment decisions. Chief Medical Officer Martha Morrell said the feature represents an important advancement, with faster access to insights for more informed care. CEO Joel Becker added that the approval shows how the firm's data advantage is moving toward practical tools for clinicians. The company debuted the technology at the ASSFN Annual Meeting on May 30 and has submitted its next-generation patient data platform for FDA review, targeting approval in the second quarter of 2026.
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