NeuroPace is a commercial-stage medical device company focused on transforming the lives of people living with epilepsy. The company's flagship product is the RNS System, a brain-responsive neuromodulation system designed to treat drug-resistant focal epilepsy. The RNS System is the only FDA-approved brain-responsive neuromodulation system that delivers personalized, targeted treatment at the seizure source. It works by continuously monitoring brain activity, recognizing a patient's unique seizure pattern, and responding in real-time with imperceptible stimulation to prevent seizures before clinical symptoms occur.
The RNS System consists of a small, implantable neurostimulator connected to leads that are placed in up to two seizure onset areas. It is currently approved in the US as an adjunctive therapy for patients 18 years of age and older with drug-resistant focal epilepsy. Long-term clinical studies have demonstrated that the RNS System provides significant reduction in seizure frequency and enduring improvements in quality of life and cognition with no stimulation-related side effects.
In 2023, NeuroPace reported total revenue of USD 65.4 million, representing a 44% increase compared to 2022. The company's growth strategy includes expanding market usage of the RNS System, increasing adoption across clinicians, and expanding therapy utilization by current prescribers. NeuroPace is also working on expanding access to RNS therapy through its Project CARE program, which aims to provide treatment to patients outside of Level 4 comprehensive epilepsy centers.
NeuroPace is currently conducting the NAUTILUS pivotal study to evaluate the safety and effectiveness of the RNS System in individuals aged 12 and older with drug-resistant idiopathic generalized epilepsy (IGE). This study could potentially expand the approved indications for the RNS System to include generalized epilepsy, for which there are currently no neuromodulation products indicated in the US.
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