09:15 AM EDT, 05/27/2025 (MT Newswires) -- NeuroPace ( NPCE ) said Tuesday that initial one-year results from its study evaluating the RNS system in idiopathic generalized epilepsy met the primary safety target but failed to achieve statistical significance for its primary effectiveness target in the full trial population.

The company said safety outcomes were consistent with earlier findings. However, the trial did not demonstrate a statistically significant improvement in the time to a second generalized tonic-clonic seizure across all participants, NeuroPace ( NPCE ) said.

A subgroup of patients with fewer seizures at the start of the study, representing the "majority of participants," indicated a statistically significant response, according to the company.

NeuroPace ( NPCE ) said it plans to submit the data to the US Food and Drug Administration and may seek approval for a narrower indication based on the subgroup findings.

The company reaffirmed its 2025 financial guidance. NeuroPace ( NPCE ) expects 2025 total revenue of $93 million to $97 million, the company said in its Q1 results earlier this month. Analysts polled by FactSet expect $94.8 million.

Shares of NeuroPace ( NPCE ) were down more than 15% in recent Tuesday premarket activity.