Los Angeles, California – November 3, 2025
NeuroSigma, Inc., a Los Angeles-based bioelectronics company, has announced a groundbreaking publication in Neuromodulation: Technology at the Neural Interface, revealing real-time effects of External Trigeminal Nerve Stimulation (eTNS) on human brain activity. Using oxygen-15 PET neuroimaging, the study—led by researchers at UCLA—provides the first-ever direct evidence of how eTNS dynamically influences cerebral blood flow and neural regions associated with attention, mood regulation, and seizure control. The findings come as NeuroSigma prepares to launch the second-generation Monarch eTNS® System in early 2026.
Science Significance
This pioneering PET neuroimaging study marks a major scientific milestone in understanding the mechanism of action of eTNS, a non-invasive neuromodulation therapy. The research demonstrated that eTNS triggers distinct activation and deactivation patterns in different brain regions—notably increased activity in the medial frontal lobe and cingulate gyrus, linked to attention and mood regulation, and decreased activity in regions tied to seizure propagation. These results provide a biological foundation for eTNS’s clinical benefits in ADHD, depression, and epilepsy, validating it as a legitimate therapeutic technology within neuroscience and cognitive medicine.
Regulatory Significance
The publication strengthens the clinical and regulatory framework surrounding NeuroSigma’s FDA-cleared Monarch eTNS System, which is currently indicated for pediatric ADHD. Furthermore, the company has obtained FDA Breakthrough Device Designation for drug-resistant epilepsy, underscoring its regulatory progress. This scientific validation, combined with clear biomarker data, enhances NeuroSigma’s positioning for expanded indications and global regulatory filings. The new evidence aligns with FDA’s emphasis on mechanism-based clinical data to support safety and efficacy in neurotherapeutic devices.
Advertisement
Business Significance
From a business perspective, this publication arrives at a critical time as NeuroSigma advances toward the U.S. launch of its second-generation Monarch eTNS System in 2026. By showcasing real-time neurophysiological validation of its technology, the company strengthens its market differentiation in the growing field of digital and bioelectronic medicine. The findings not only reinforce investor confidence but also create opportunities for strategic partnerships in psychiatry, neurology, and cognitive health sectors. As a pioneer in non-invasive neuromodulation, NeuroSigma is positioned to capitalize on the rising demand for drug-free treatment modalities in mental health and neurodevelopmental disorders.
Patients’ Significance
For patients, especially children and adolescents with ADHD or individuals living with epilepsy or depression, the findings offer new hope. The demonstrated brain activity modulation supports eTNS as a safe, effective, and non-drug alternative to traditional pharmacotherapy, with the potential to reduce side effects associated with stimulant or anticonvulsant medications. The Monarch eTNS System, being both home-usable and wearable, enhances patient compliance and accessibility, improving quality of life for families seeking non-invasive therapeutic solutions for neurological conditions.
Policy Significance
The advancement of FDA-cleared neuromodulation devices like eTNS aligns with health policy priorities that promote innovation, digital health integration, and precision medicine. By bridging the gap between neuroscience and engineering, NeuroSigma contributes to broader policy objectives emphasizing safe device innovation, real-world evidence generation, and patient-centered technology adoption. The company’s progress demonstrates how regulatory science and translational research can converge to create equitable access to next-generation treatments for neurological and psychiatric disorders.
The newly published PET imaging study represents a landmark achievement for NeuroSigma and the broader neuromodulation field. With evidence showing real-time brain activity modulation through eTNS, the company has established a strong scientific and clinical foundation for its next phase of innovation. As NeuroSigma prepares for the Monarch eTNS System’s expanded rollout, it continues to lead the transformation of mental health and neurological care—moving beyond drugs toward precision bioelectronic therapy that targets the brain’s natural signaling networks.
Source: NeuroSigma, Inc. press release
