NeuroPace filed a Premarket Approval Supplement with the FDA to broaden the labeling of its Responsive Neuro‑Stimulator (RNS) System to include patients with antiseizure‑medication‑resistant idiopathic generalized epilepsy (IGE) who experience generalized tonic‑clonic seizures. The filing follows the company’s NAUTILUS study, which reported a 77% median reduction in generalized tonic‑clonic seizures at 18 months of therapy.
The RNS System is currently approved for adults with drug‑resistant focal epilepsy. By adding an IGE indication, NeuroPace would open a market that represents roughly 27% of drug‑resistant epilepsy patients, a group that currently has no approved neuromodulation or surgical options. The company’s CEO, Joel Becker, said the filing is a “key milestone” that could significantly expand the device’s addressable patient population.
The NAUTILUS trial, the first randomized controlled study of neuromodulation in IGE, began enrolling in 2022. While the one‑year data presented in May 2025 did not reach statistical significance for the primary effectiveness endpoint, the 18‑month results presented on December 8, 2025, showed a 77% median reduction in generalized tonic‑clonic seizures, providing the clinical evidence the FDA requires for the supplement.
NeuroPace’s recent financial results reinforce the strategic value of the filing. In Q3 2025, the company generated record revenue of $27.4 million, up 30% year‑over‑year, driven by a 31% increase in RNS System sales. Gross margin rose to 77.4% from 73.2% in Q3 2024, reflecting a higher mix of high‑margin RNS revenue and manufacturing efficiencies. The company raised its full‑year 2025 revenue guidance to $97–$98 million and its gross‑margin guidance to 76%–77%.
Management highlighted that the expanded indication would accelerate adoption beyond the focal‑epilepsy niche and could become a significant revenue driver once FDA approval is obtained. The company also noted that the Breakthrough Device Designation for the IGE indication supports a streamlined review, with the FDA typically reviewing PMA supplements within approximately 180 days.
Analysts have noted that the filing aligns with NeuroPace’s broader strategy to grow its market share in the neuromodulation space. While the company’s stock has not been discussed here, the regulatory move is expected to reinforce investor confidence in the company’s growth trajectory.
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