NeuroPace (Nasdaq:NPCE) announced that the first patient received their implant in the Nautilus clinical study of its RNS system.
The company’s Nautilus study evaluates the safety and efficacy of its RNS system. It aims to treat individuals aged 12 and older with drug-resistant idiopathic generalized epilepsy (IGE). This is also known as primary generalized epilepsy.
NeuroPace designed its FDA-approved RNS system as a brain-responsive neuromodulation system. It features closed-loop technology that delivers personalized, data-driven treatment targeted to the seizure source. It does so by continuously monitoring brain activity and recognizing unique seizure patterns. As a result, the system can respond in real time with stimulation to prevent a seizure.
Co-investigators Dr. Angela Crudele and Dr. Dario Englot performed the first procedure at Vanderbilt Health in Nashville, Tennessee.
“Today, we have limited treatment options for patients who have drug-resistant, idiopathic generalized epilepsy,” said Crudele. “This condition can be very difficult to treat and has a significant impact on a patient’s and family’s quality of life. I am excited about the possibility of having an FDA-approved treatment for this population, such as brain-responsive neuromodulation, and giving these patients a better future.”
“A groundbreaking study”
NeuroPace said its RNS system represents the only FDA-approved brain-responsive neuromodulation system that delivers personalized, targeted treatment at the seizure source. In addition, its closed-loop technology differentiates it from competitors. The real-time therapy delivery typically comes in before clinical symptoms occur.
The company designed the prospective, multicenter, randomized, controlled pivotal Nautilus study to demonstrate the system’s safety and efficacy for RNS. The system received FDA breakthrough device designation in 2021 for the potential use of treating IGE.
“This is a groundbreaking study that could allow individuals who have drug-resistant generalized epilepsy to be treated with the RNS System. Brain-responsive neuromodulation is a proven therapy for drug-resistant focal epilepsy, with long-term studies demonstrating significant seizure reduction and quality of life improvements for patients,” said Dr. Martha Morrell, CMO of NeuroPace. “I look forward to investigating whether this therapy could provide similar benefits to patients suffering from primary generalized epilepsy, helping to fill a large unmet need in this population.”