NeuroPace has received FDA guidance regarding its epilepsy treatment expansion submission for the RNS® System. The company announced updates on the Premarket Approval (PMA) Supplement review process. This submission aims to broaden the labeling indication for the RNS System. The target population includes patients suffering from IGE who do not respond to antiseizure medications. Nonetheless, the FDA explained that the PMA Supplement is not approvable in its current status. After the above communication, the medical device company held a meeting with the representatives of the FDA. The meetings revolved around additional data necessary for approval considerations. In addition, the company intends to file an SIR.
“We received communication from FDA on the PMA-S target due date indicating that our submission was not approvable in its current form due to questions that remained under review. Having reviewed FDA’s written communications and having had subsequent discussions with the Agency, we believe there is a path for approval of the submission. Our interactions are now focused on providing the information needed to answer FDA’s remaining requests.
While we are disappointed with not receiving an initial approval, we were encouraged by our subsequent discussion with the Agency, and importantly, their interest in engaging interactively, their request for additional information to address certain questions, and their willingness to work collaboratively to bring the RNS indication expansion for drug-resistant IGE patients to market,” said Joel Becker, President and Chief Executive Officer of NeuroPace. “We are working closely with the FDA beginning the day following the receipt of their letter, this week with the review team and with a subsequent SIR meeting. We will provide additional updates as appropriate.”
The company will also keep collaborating with the FDA to solve outstanding issues. Additionally, NeuroPace plans to supply further data and background information, which includes findings from the clinical trial. The application for expansion of the indication of its epilepsy treatment is based on findings of the NAUTILUS study. It is the first randomized controlled study of neuromodulation for drug-resistant IGE.
NeuroPace Highlights Clinical Evidence Supporting RNS System Expansion
NAUTILUS Trial findings were published in Epilepsia in June 2026 after 18 months. It offered evidence of peer review about responsive thalamic stimulation. Within 18 months, individuals on the RNS System experienced a 77% reduction in their GTC seizures. In addition, 40% of the subjects attained GTC seizure freedom.
“Patients with drug-resistant idiopathic generalized epilepsy live with substantial life limitations, and risks of physical injury and death imposed by generalized seizures, especially generalized tonic clonic seizures,” said Martha Morrell, MD, Chief Medical Officer of NeuroPace. “In the NAUTILUS trial, the average patient had lived with uncontrolled generalized seizures for more than 18 years and was taking nearly 4 antiseizure medications a day. These patients are not candidates for epilepsy surgery, and there are no approved neuromodulation devices. Their only choice is to continue with the status quo. Patients with medically uncontrolled IGE are motivated to access better treatments, as demonstrated by the rapid rate of enrollment in the NAUTILUS study. We remain encouraged by the data gathered through 24 months and are working collaboratively with FDA to provide the information needed to support approval of this indication expansion.”
Improvements were observed not only in tonic-clonic but also in generalized seizure types. This includes absence and myoclonic seizures. In addition, more than 90% of patients had improvements measured using the PGIC scale. More than 80% of physicians also noted improvements among their patients. The FDA even asked for an additional 24 months of data from the NAUTILUS study.
For the participants evaluated after a 24-month follow-up who received stimulation for 23 months. The median percentage of reduction of GTC seizures from baseline was 100%. NeuroPace continues working with the FDA towards getting the treatment approved for the treatment of epilepsy. More information will be made available when necessary.
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News Source: Businesswire.com
