IndustryCompany release

NeuroPace slashes 2026 revenue guidance after weak third quarter, files Remote Care PMA supplement

🇺🇸 NeuroPace Inc (NPCE) · Thu 12 Nov 2026

The RNS System maker cut its full-year revenue outlook to $91–92 million while advancing Remote Care, an idiopathic generalised epilepsy amendment and a new adolescent study.

NeuroPace reported third-quarter 2026 revenue of $23.1 million on 12 November, with revenue from its RNS System rising just 1.4%. The company lowered its full-year revenue guidance to $91–92 million, down from a previous range of $99.5–101.5 million.

NeuroPace attributed the reduction to account-level issues and changes to its field organisation. The summary of the announcement does not give further detail on the nature of those issues or on how the changes are expected to affect sales going forward.

On the regulatory side, the company has submitted a premarket approval (PMA) supplement to the US Food and Drug Administration for Remote Care, which would allow telehealth programming of the RNS System. The submission follows a 180-day review cycle. As context, a PMA supplement is the route by which manufacturers seek FDA approval for changes to an already approved Class III device.

NeuroPace also held a Submission Issue Request meeting with the FDA in October on its separate PMA supplement for idiopathic generalised epilepsy (IGE). Following that meeting, it plans to file an amendment to the IGE supplement around the end of the year.

In addition, the company has begun enrolling patients in AURORA, a real-world study in adolescents with focal epilepsy.

What it means for your team

  • Remote Care is now under FDA review on a 180-day cycle, so a decision on telehealth programming of the RNS System is a regulatory milestone to track.
  • The IGE PMA supplement will be amended around year end after the October Submission Issue Request meeting, signalling that the FDA's feedback required further submission work.
  • AURORA enrolment adds real-world evidence collection in adolescents with focal epilepsy, relevant for teams following paediatric and adolescent device data.
  • The sharply lowered revenue guidance is relevant to market-access teams assessing commercial execution at the company, though the stated causes are limited to account-level issues and field changes.

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

Article written by VigiEye from the official source (NeuroPace Inc). Claims are the company's own. AI-assisted; check the source before acting.

More Industry All →