LOS ANGELES, Nov. 18, 2025 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company, today announced the successful completion of its pilot commercialization program for the first-generation Monarch eTNS® System and the launch of a new website in preparation for release of its second-generation Monarch device. The pilot program validated strong market demand, with over 1,000 Monarch eTNS Systems and 100,000 disposable patches dispensed since introducing the product in the United States.
New Website Supports Second-Generation Launch
NeuroSigma has launched a new website to support the commercialization of its second-generation Monarch device. The website provides product information and allows physicians, parents, and caregivers to join an advance reservation list for the upcoming launch. www.monarch-etns.com
Second-Generation Device Offers Improved Design
The first-generation Monarch eTNS System was the first-ever wearable medical device to receive 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 device, but with an efficient, more modern design and a simplified user interface. The new device is scheduled for U.S. launch in the first quarter of 2026. The Monarch eTNS System is also the only eTNS-based neurostimulation device with peer-reviewed data from double-blinded, placebo-controlled studies. These studies were conducted at elite universities and institutions, using the FDA-cleared Monarch eTNS System, with results published in reputable academic journals.
"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," said Colin Kealey, M.D., President and CEO of NeuroSigma. "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."
"The results of our pilot commercial program, including substantial recurring revenue through the sale of daily disposable patches, demonstrated strong demand for this innovative product and validation for NeuroSigma’s business model," added Tom Paschall, Director of NeuroSigma and CEO of Checkmate Capital. "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."
About NeuroSigma
NeuroSigma is a Los Angeles, California-based bioelectronic medical device company developing technologies to transform medical practice and patients' lives. The company's lead product is the Monarch eTNS System, which is 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. For more information about NeuroSigma, please visit www.neurosigma.com. For more information on the Monarch eTNS System, please visit www.monarch-etns.com.
Contact:
Colin Kealey, M.D., President of NeuroSigma at CKealey@neurosigma.com
