NeuroSigma Inc. has completed its pilot commercialization program for the first-generation Monarch eTNS System and launched a new website to prepare for the commercialization of its second-generation device. The pilot program validated strong market demand, with more than 1,000 Monarch eTNS Systems and 100,000 disposable patches dispensed since introducing the product in the United States.

“NeuroSigma is proud to report the successful completion of our pilot commercial program. Our results confirmed a robust reception and strong satisfaction for the therapy from both patients and caregivers, as reflected by a significant number of repeat prescribers,” NeuroSigma President/CEO Colin Kealey, M.D., stated. “We are also excited by the early results from launch of the new website. It is already proving to be an effective online gateway for all parties interested in the Monarch eTNS System.”

NeuroSigma’s new website provides Monarch eTNS System product information and allows physicians, parents, and caregivers to join an advance reservation list for the upcoming launch. 

The first-generation Monarch eTNS System was the first wearable medical device to receive U.S. Food and Drug Administration (FDA) clearance as a drug-free treatment for pediatric attention-deficit/hyperactivity disorder (ADHD). The second-generation device treats pediatric ADHD with the same therapeutic trigeminal nerve stimulation as the first-generation product, but with an efficient, more modern design and a simplified user interface. The new device is scheduled to debut in the U.S. market in Q1 2026.

The Monarch eTNS System is the only eTNS-based neurostimulation device with peer-reviewed data from double-blinded, placebo-controlled studies. These studies were conducted at universities and institutions, using the FDA-cleared Monarch eTNS System, with results published in reputable academic journals.  

“The results of our pilot commercial program, including substantial recurring revenue through the sale of daily disposable patches, demonstrated strong demand for this product and validation for NeuroSigma’s business model,” NeuroSigma Director and Checkmate Capital CEO Tom Paschall said. “2026 will be a transformative year for NeuroSigma as we launch the second-generation device and expand our commercial efforts to patients, caregivers, and physicians throughout the United States.”

NeuroSigma is a Los Angeles-based bioelectronic medical device company. Its lead product is the Monarch eTNS System, the first non-drug treatment for pediatric ADHD cleared by the FDA. Pipeline indications for the Monarch eTNS System include neurodevelopmental disorders such as autism spectrum disorder (ASD), learning disabilities, and epilepsy. NeuroSigma has received Breakthrough Device Designation for the Monarch eTNS System from the FDA in drug-resistant epilepsy.