NeuroSigma Launches Second-Generation Monarch eTNS System For Children With ADHD In The U.S.

NeuroSigma, Inc., a Los Angeles-based bioelectronic medical device company, has announced the U.S. commercial launch of its second-generation Monarch® external Trigeminal Nerve Stimulation (eTNS) System. The Monarch eTNS System is currently the only non-drug treatment for pediatric attention-deficit/hyperactivity disorder (ADHD) that has received clearance from the U.S. Food and Drug Administration (FDA). The new generation device is designed to provide the same therapeutic benefits as the original system while offering several improvements that make it easier for children and families to use during daily treatment.

The second-generation Monarch device features a smaller and more modern design, making it more convenient for home use. It includes a color display, a simplified user interface, and a built-in rechargeable battery capable of supporting up to three therapy sessions on a single charge. The updated system also provides more precise control over stimulation, helping improve comfort during the nightly therapy sessions while maintaining the same external trigeminal nerve stimulation technology that has been shown to reduce ADHD symptoms in children.

Dr. Colin Kealey, Chief Executive Officer of NeuroSigma, described the commercial launch as an important milestone for the company. He said that following the pilot launch of the first-generation device, NeuroSigma received strong interest from families and healthcare providers looking for an effective non-drug treatment option for pediatric ADHD. According to Dr. Kealey, the company already has a waiting list of more than 1,500 patients, caregivers, and clinicians, indicating significant demand for the new device as it becomes available across the United States.

Dr. Kealey also highlighted the challenges many children face when living with untreated ADHD, including difficulties with attention, executive functioning, emotional regulation, classroom performance, social interaction, and self-confidence. He explained that the newly designed Monarch device offers families an alternative to medication while delivering therapy that targets brain regions associated with ADHD. He noted that recent positron emission tomography (PET) imaging studies have shown that external trigeminal nerve stimulation activates areas of the brain linked to the condition, providing additional insight into how the therapy may help improve symptoms.

Tom Paschall, Chief Executive Officer of Checkmate Capital and a member of NeuroSigma's Board of Directors, said the launch represents a significant commercial milestone for the company and an important advancement for families seeking additional treatment options. He noted that pediatric ADHD continues to have substantial unmet medical needs, and many parents are interested in alternatives to prescription stimulant medications. According to Paschall, the second-generation Monarch device makes NeuroSigma's FDA-cleared non-drug therapy more accessible to both clinicians and families while reducing reliance on stimulant-based treatments.

With the nationwide launch of the second-generation Monarch eTNS System, NeuroSigma is expanding access to an FDA-cleared, non-drug treatment option for children with ADHD. The upgraded device combines improved usability, enhanced comfort, and modern design with clinically established external trigeminal nerve stimulation technology, supporting the company's goal of providing effective treatment alternatives for pediatric patients and their families.