NeuroPace has released preliminary one-year results from its Nautilus clinical trial, assessing its RNS System for idiopathic generalized epilepsy (IGE). While the study did not meet its primary effectiveness endpoint, it showed significant seizure reduction in a key patient subgroup.
The 100-patient, 23-center U.S. study met its primary safety goal, with a low rate of serious adverse events. The RNS System showed strong results in patients with lower baseline seizure frequency, representing the majority of participants. Secondary endpoints, including median seizure reduction and seizure-free days, also trended positively.
NeuroPace plans to seek FDA indication expansion and submit the full dataset for publication. The RNS System holds FDA breakthrough designation for IGE and is already approved for focal epilepsy.
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