NeuroPace (NPCE) FDA announcement summary

Details of approval or decision

• FDA communicated that the PMA supplement for RNS System expansion to drug-resistant idiopathic generalized epilepsy (IGE) is not approvable in its current form, requesting additional clinical evidence and analyses, particularly from the NAUTILUS trial and supporting literature, but did not issue a denial or disapproval letter.

• FDA encouraged submission of a Submission Issue Request (SIR) to clarify requirements and align on supplemental data before resubmission; continued dialogue is ongoing.

• The agency expressed willingness to work collaboratively and interactively to address outstanding questions and move toward potential approval.

Impact on industry and stakeholders

• Patients with drug-resistant IGE currently lack approved neuromodulation or surgical options, representing a significant unmet need.

• Approval would provide the first device-based treatment for this population, potentially improving safety and quality of life and setting a new standard of care.

• No changes to financial guidance for 2026, as expanded IGE indication was not included; updates will be provided as the process advances.

Scientific data and evidence

• The PMA supplement is supported by the NAUTILUS study, the first randomized controlled trial of neuromodulation in drug-resistant IGE.

• At 18 months, RNS System showed a 77% median reduction in GTC seizures and 40% seizure freedom; at 24 months, evaluable patients achieved a 100% median reduction.

• Over 90% of patients and 80% of physicians reported improvement; reductions in seizure-related injuries and rescue medication use were observed.

• FDA requested more detailed subpopulation analyses, patient-reported outcomes, and literature supporting clinical meaningfulness.