Firefly and NeuroSigma partner to expand pediatric ADHD treatment

Firefly Neuroscience (NASDAQ: AIFF) and NeuroSigma announced a partnership to distribute NeuroSigma's Monarch eTNS® System through Firefly's nationwide network of Evoke™ clinicians, according to a press release dated Sept. 25, 2026.

The Monarch eTNS® System is the first non-drug treatment for pediatric attention-deficit/hyperactivity disorder cleared by the U.S. Food and Drug Administration. The prescription-only device delivers mild external trigeminal nerve stimulation through an adhesive patch placed on a child's forehead during sleep. It is cleared as a monotherapy for children ages 7 through 12 who are not currently taking prescription ADHD medication.

NeuroSigma began U.S. sales of its second-generation Monarch device in July 2026, following the development of a waitlist of more than 1,500 patients, caregivers, and healthcare providers. In September 2026, the company expanded payment options to include third-party installment plans.

Under the agreement, Firefly will introduce the Monarch device to psychiatry, neurology, and behavioral health practices that use its FDA 510(k)-cleared Evoke™ EEG/ERP platform. NeuroSigma will provide clinical training, prescribing support, and product fulfillment through a specialty pharmacy partner.

Firefly's Evoke™ platform uses quantitative electroencephalography and event-related potential testing with AI-powered analytics, drawing on a database the company states contains more than 200,000 EEG/ERP brain scans.

A 2024 study published in the Journal of Clinical Child & Adolescent Psychology estimated that approximately 7.1 million U.S. children have received an ADHD diagnosis, with nearly one-third of those with current ADHD receiving no ADHD-specific treatment.

"By introducing NeuroSigma's FDA-cleared, non-drug therapy to our Evoke clinician network, we are connecting measurement-driven practices with an important treatment option for eligible children and their families," said Greg Lipschitz, Chief Executive Officer of Firefly.

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