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NeuroPace trims 2026 sales outlook by about $9m as RNS growth stalls in Q3

The epilepsy device maker lowered its full-year revenue forecast after a third quarter in which sales of its RNS System barely grew, even as regulatory work continued.

12 Nov 2026 · NeuroPace Inc NPCE · Company news

NeuroPace now expects 2026 revenue of $91 million to $92 million, down from a prior range of $99.5 million to $101.5 million. On the midpoints, that is a cut of roughly $9 million, or about 9%. The company announced the change on 12 November alongside third-quarter results.

Revenue for the quarter came to $23.1 million. Sales of the RNS System, the company's implanted neurostimulation device for epilepsy, rose only 1.4%. NeuroPace blamed the revised outlook on problems at individual customer accounts and on changes to how its field team is organised. The information available does not say which accounts were affected, what the field changes involve, or how much they are expected to weigh on future sales.

On the regulatory front, NeuroPace has filed a premarket approval (PMA) supplement with the US Food and Drug Administration for Remote Care, a feature that would let clinicians programme the RNS System over telehealth. The filing is now in a 180-day review. By way of context, a PMA supplement is how a manufacturer asks the agency to approve a modification to a Class III device that is already cleared for sale.

A separate PMA supplement, covering idiopathic generalised epilepsy (IGE), is also in play. NeuroPace met the FDA in October under the agency's Submission Issue Request process and plans to file an amendment to that supplement around the end of the year. The company has also started enrolling patients in AURORA, a real-world study in adolescents with focal epilepsy.

Why it matters

  • A guidance cut of about 9% at the midpoint, paired with 1.4% RNS growth, puts commercial execution in focus; the stated causes are limited to account problems and field changes.
  • Remote Care is under FDA review, so a decision on telehealth programming is a regulatory milestone for the company and its stakeholders to track.
  • The planned IGE supplement amendment around year end shows that regulatory work on that indication is continuing after the October FDA meeting.
  • AURORA adds a real-world data stream in adolescents with focal epilepsy, relevant to anyone following paediatric device evidence.

Company's press release (SEC filing): NeuroPace Inc ↗

Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.

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