globenewswire news

• U.S. Commercial launch of Gen 2 Monarch System commencing today, July 21, 2026
• Gen 2 Monarch device provides an enhanced patient experience while delivering clinically proven therapeutic stimulation of the trigeminal nerve
• U.S. launch supported by a waitlist of more than 1,500 patients, caregivers, and providers
• Visit www.monarch-etns.com for additional information on how to obtain the Gen 2 Monarch® device
  
  

LOS ANGELES, July 21, 2026 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a Los Angeles-based bioelectronic medical device company, today announced the launch of U.S. sales of its second-generation Monarch^® eTNS System, the only non-drug treatment for pediatric attention-deficit/hyperactivity disorder (ADHD) cleared by the U.S. Food and Drug Administration (FDA).

The Gen 2 Monarch device is a significant upgrade over the first-generation device. It delivers the same therapeutic external trigeminal nerve stimulation (eTNS) shown to reduce ADHD symptoms in children, but in a smaller, more modern form factor designed for everyday family use. New features include a color screen, a simplified user interface, and an integrated rechargeable battery that supports up to three therapy sessions on a single charge. The Gen 2 system also offers more precise control over stimulation, improving comfort and ease-of-use during nightly therapy.

“Commercial launch of the Gen 2 Monarch eTNS system achieves a profound milestone for NeuroSigma,” said Dr. Colin Kealey, CEO of NeuroSigma. “Following our pilot launch of the first-generation device, we have seen substantial pent-up demand from families and clinicians looking for an effective non-drug option for pediatric ADHD. With an existing waitlist of more than 1,500 patients, caregivers, and providers, we believe the Gen 2 Monarch device is well positioned for rapid adoption across the United States.”

Dr. Kealey added, “We are delighted to make our newly designed device available to patients and their families seeking an effective non-drug ADHD therapy. Without adequate treatment, too many children are struggling with the mental health, academic, and social consequences that come with ADHD, including executive dysfunction, classroom inattentiveness, inability to follow instruction, emotional dysregulation, sudden mood swings, social isolation, and low self-esteem, in addition to other physical and mental impairments. Recent studies using PET imaging have demonstrated that eTNS therapy stimulates regions of the brain associated with ADHD, indicating a potential mechanism of action for this therapy.”

“This launch is a major commercial inflection point for NeuroSigma and a meaningful step forward for the families the company serves,” said Tom Paschall, CEO of Checkmate Capital and a member of NeuroSigma’s Board of Directors. “Pediatric ADHD remains an area of significant unmet need, and many families are actively seeking alternatives to prescription stimulants. The Gen 2 Monarch device puts a modern, non-drug therapy — backed by NeuroSigma’s proprietary trigeminal nerve stimulation technology that earned its FDA clearance — directly into the hands of parents and clinicians. We are proud to support a team that treats this critical indication while reducing children’s dependence on amphetamines.”

About the Monarch eTNS System

The Monarch^® eTNS System is the first non-drug treatment for pediatric ADHD cleared by the U.S. Food and Drug Administration. It delivers low-level electrical stimulation to branches of the trigeminal nerve through a small adhesive patch worn on the forehead, and is administered at home during sleep under the supervision of a caregiver.

Indication for Use

The Monarch eTNS System is indicated for use as a monotherapy for the treatment of ADHD in pediatric patients ages 7 through 12 years old who are not currently taking prescription ADHD medication. The Monarch eTNS System is intended to be used in the home under the supervision of a caregiver during periods of sleep.

Important Safety Information

The Monarch eTNS System should not be used in children with an active implantable medical device, such as a pacemaker or neurostimulator, or with a body-worn active medical device, such as an insulin pump. The device should not be used in the presence of magnetic resonance imaging (MRI) equipment. The most common side effects associated with use of the Monarch eTNS System include drowsiness, increase in appetite, trouble sleeping, teeth clenching, headache, and fatigue. Patients and caregivers should consult a qualified healthcare provider to determine whether the Monarch eTNS System is appropriate for their child. For complete prescribing and safety information, please visit www.monarch-etns.com.

About ADHD

Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neurodevelopmental disorders of childhood and often lasts into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behaviors (e.g., acting without thinking about consequences), or being overly active. ADHD typically presents as mostly inattentive, mostly hyperactive or a combination of the two. ADHD can significantly affect academic and social performance and is typically diagnosed by a physician or other qualified healthcare professional. For more information about ADHD, please visit https://www.cdc.gov/adhd/.

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, the Monarch eTNS System, is the first non-drug treatment for pediatric ADHD cleared by the FDA. Pipeline indications for the Monarch eTNS System include neurodevelopmental and neurological disorders such as autism spectrum disorder (ASD), learning disabilities, and epilepsy. NeuroSigma has received Breakthrough Device Designation from the FDA for the Monarch eTNS System 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.

Media Contact

Colin Kealey, M.D.
Chief Executive Officer, NeuroSigma, Inc.
ckealey@neurosigma.com