Firefly (NASDAQ: AIFF) and NeuroSigma Partner to Expand Access to First FDA-Cleared, Non-Drug Treatment for Pediatric ADHD

Firefly will handle clinician education, while NeuroSigma will provide prescribing support and specialty-pharmacy fulfillment.

Rhea-AI Summary

Firefly Neuroscience (AIFF) and NeuroSigma announced a partnership on September 25, 2026, to introduce Monarch to Evoke clinicians.

Firefly will present NeuroSigma's second-generation Monarch eTNS System to practices using its FDA 510(k)-cleared Evoke brain-function assessment platform. Firefly will support clinician education, while NeuroSigma will provide clinical training, prescribing support and fulfillment through a specialty pharmacy partner. Monarch is FDA-cleared for pediatric ADHD as a prescription-only, non-drug treatment for children ages 7 through 12 who are not taking prescription ADHD medication. It is used at home during sleep under caregiver supervision.

NeuroSigma began U.S. sales of the second-generation Monarch in July 2026, after building a waitlist of more than 1,500 patients, caregivers and healthcare providers. Firefly identified potential ADHD-related EEG/ERP biomarkers in March 2026; those findings require further research and validation.

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Key Figures

Eligible patient ages: 7 through 12 years

Eligible patient ages

7 through 12 years

FDA-cleared Monarch eTNS monotherapy indication

Key Terms

510(k), qEEG, event-related potential, etns, +1 more

5 terms

510(k) regulatory

"FDA 510(k)-cleared, AI-powered Evoke™ EEG/ERP platform"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

qEEG medical

"combines quantitative electroencephalography (“qEEG”)"

Quantitative electroencephalography (qEEG) is a medical technique that records the brain’s electrical signals with sensors and uses computer analysis to convert those signals into visual maps and numeric patterns—like turning the brain’s radio waves into a visual equalizer. For investors, qEEG matters because its accuracy, clinical acceptance and regulatory or insurance support can drive demand for related diagnostic devices, therapies and services, affecting revenue potential and regulatory risk.

event-related potential medical

"and event-related potential (“ERP”) testing"

A measurable change in the brain’s electrical activity that occurs at a consistent time after a specific stimulus or task, recorded noninvasively with EEG sensors placed on the scalp. Investors care because event-related potentials (ERPs) are used as objective biomarkers in clinical research, device testing, and regulatory studies to show whether a drug, therapy, or neurotechnology changes brain processing; think of an ERP like an electrical echo that reveals how the brain reacts to a particular event.

etns medical

"delivers mild external trigeminal nerve stimulation (eTNS)"

Exchange-traded notes (ETNs) are unsecured debt securities issued by financial institutions that trade on an exchange and aim to deliver the return of a specific index, commodity, or strategy, minus fees. They do not own the underlying assets; instead the issuer promises to pay the index performance. For investors, ETNs provide a way to access particular markets or strategies through a single, tradable instrument, but their value depends on the issuer’s creditworthiness and the product’s liquidity and fee structure — think of an ETN as an IOU tied to an index rather than direct ownership of the index components.

monotherapy medical

"cleared as a monotherapy for children ages 7 through 12"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

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– Partnership will introduce NeuroSigma’s second-generation Monarch eTNS^® System to Firefly’s nationwide network of Evoke™ clinicians –

– Collaboration brings together an FDA-cleared pediatric ADHD treatment and Firefly’s objective brain-function assessment platform and AI-driven ADHD biomarker research –

– Monarch offers an at-home, non-medication treatment option for eligible children ages 7 through 12 ––

KENMORE, N.Y. and LOS ANGELES, Sept. 25, 2026 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly”) (NASDAQ: AIFF), an artificial intelligence (“AI”) company advancing precision neuroscience, and NeuroSigma, Inc. (“NeuroSigma”), a bioelectronic medical device company, today announced a strategic partnership to expand clinician awareness of and access to NeuroSigma’s Monarch eTNS^® System through Firefly’s growing nationwide network of Evoke™ clinician customers.

The Monarch eTNS^® System is the first non-drug treatment for pediatric attention-deficit/hyperactivity disorder (“ADHD”) cleared by the U.S. Food and Drug Administration (“FDA”). Under the partnership, Firefly will introduce the Monarch device to psychiatry, neurology and behavioral health practices that use its FDA 510(k)-cleared, AI-powered Evoke™ EEG/ERP platform.

The collaboration brings together complementary technologies designed to address two significant needs in pediatric ADHD care: access to objective information about brain function and availability of a non-medication treatment option for eligible patients.

According to a 2024 study published in the Journal of Clinical Child & Adolescent Psychology, approximately one in nine U.S. children has received an ADHD diagnosis, representing an estimated 7.1 million children. And among the approximately 6.5 million children with current ADHD, nearly one-third received no ADHD-specific treatment.¹ At the same time, many families are seeking alternatives to stimulant medication for their children.²^, ³

“This partnership represents an important step toward a more objective and personalized approach to pediatric ADHD care,” said Greg Lipschitz, Chief Executive Officer of Firefly. “Clinicians need better tools to understand how an individual patient’s brain is functioning, more treatment options from which to choose and objective ways to evaluate changes over time. 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.”

Firefly’s Evoke™ platform combines quantitative electroencephalography (“qEEG”) and event-related potential (“ERP”) testing with AI-powered analytics. Drawing upon Firefly’s proprietary database of more than 200,000 EEG/ERP brain scans, Evoke™ provides clinicians with objective information about individual brain function, including in patients whose symptoms may overlap across multiple conditions, and enables clinicians to track changes over time.

In March 2026, Firefly announced the discovery of EEG/ERP biomarkers, identified using data collected through Evoke™, that may help differentiate among the three ADHD presentations: predominantly inattentive, predominantly hyperactive-impulsive and combined. Subject to further research and validation, Firefly believes these findings could ultimately help clinicians better match patients with appropriate treatment approaches and objectively monitor their response to intervention.

The prescription-only Monarch eTNS^® System is a palm-sized device that delivers mild external trigeminal nerve stimulation (eTNS) through a small adhesive patch placed on a child’s forehead while the child sleeps. It is FDA-cleared as a monotherapy for children ages 7 through 12 with ADHD who are not currently taking prescription ADHD medication.

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

“For too long, we have relied on symptom checklists and traditional evaluations alone to understand a child's brain,” said Lauren Hernandez, M.D., a board-certified pediatrician with advanced certification in genomic medicine, and Chief Medical Officer of the pediatric program for NuWell Medicine. “Advanced qEEG technology, such as Evoke™, allows us to see how a child's brain is actually functioning in real time, giving us a deeper understanding of attention, learning, emotional regulation, and overall neurological health. This technology helps identify the unique patterns behind challenges often labeled as ADHD, while also revealing when symptoms may be driven by anxiety, sensory processing differences, autonomic nervous system dysregulation, or other underlying factors. By understanding how the brain, gut, and autonomic nervous system work together, we can create more personalized and effective roadmaps that support resilience, health, and lifelong success. Evoke™ provides valuable insights that can help validate the need for medication when appropriate, while also helping families avoid unnecessary treatment when the root cause lies elsewhere. We are also excited about emerging tools, such as the Monarch eTNS^® System, which offer new opportunities to support children with ADHD and autism. For the first time, we have objective tools to measure progress and improvement over time, aligning perfectly with the Reformative Medicine approach of identifying what’s off balance, optimizing function, and restoring balance across the body's interconnected systems.”

Under the agreement, Firefly will introduce the Monarch eTNS^® System to its Evoke™ clinician customers and support clinician education regarding the therapy. NeuroSigma will provide clinical training, prescribing support and product fulfillment through its specialty pharmacy partner.

“Firefly has built a network of clinicians who are already embracing a more objective, measurement-driven approach to brain health,” said Colin Kealey, M.D., President and Chief Executive Officer of NeuroSigma. “These clinics are well positioned to evaluate innovative treatment options for children and families seeking an alternative to medication. With our second-generation Monarch device now shipping and expanded payment options available, this partnership gives us an efficient pathway to educate more clinicians and broaden access to the first FDA-cleared, non-drug treatment for pediatric ADHD.”

Sources

¹ Danielson ML, Claussen AH, Bitsko RH, Katz SM, Newsome K, Blumberg SJ, Kogan MD, Ghandour R. ADHD Prevalence Among U.S. Children and Adolescents in 2022: Diagnosis, Severity, Co-Occurring Disorders, and Treatment. J Clin Child Adolesc Psychol. 2024 May-Jun;53(3):343-360. doi: 10.1080/15374416.2024.2335625. Epub 2024 May 22. PMID: 38778436; PMCID: PMC11334226.

² Lu SV, Leung BMY, Bruton AM, Millington E, Alexander E, Camden K, Hatsu I, Johnstone JM, Arnold LE. Parents' priorities and preferences for treatment of children with ADHD: Qualitative inquiry in the MADDY study. Child Care Health Dev. 2022 Sep;48(5):852-861. doi: 10.1111/cch.12995. Epub 2022 Mar 25. PMID: 35244227; PMCID: PMC10215012.

³ Drechsler R, Brem S, Brandeis D, Grünblatt E, Berger G, Walitza S. ADHD: Current Concepts and Treatments in Children and Adolescents. Neuropediatrics. 2020 Oct;51(5):315-335. doi: 10.1055/s-0040-1701658. Epub 2020 Jun 19. PMID: 32559806; PMCID: PMC7508636.

About NeuroSigma

NeuroSigma is a bioelectronic medical device company based in Los Angeles, California. Its lead product, the Monarch eTNS^® System, is the first non-drug treatment for pediatric ADHD cleared by the FDA. NeuroSigma is also investigating the Monarch eTNS^® System in additional neurodevelopmental and neurological indications, including autism spectrum disorder, learning disabilities and drug-resistant epilepsy, for which the FDA has granted Breakthrough Device Designation; these pipeline indications are investigational and not FDA-cleared.

For more information, visit www.neurosigma.com and www.monarch-etns.com.

About Firefly Neuroscience

Firefly Neuroscience, Inc. (NASDAQ: AIFF) is an Artificial Intelligence ("AI") company advancing precision neuroscience, applying AI and large-scale electrophysiological data to give clinicians a more complete, objective picture of how an individual patient's brain is functioning. Firefly's proprietary database consists of over 200,000 EEG/ERP brain scans, which the Company believes to be the world's largest known standardized EEG/ERP repository. Firefly's EEG-based, AI-driven, and FDA-510(k)-cleared Evoke™ System is designed to support diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, ADHD, and PTSD.

Please visit www.fireflyneuro.com for more information.

Forward-Looking Statements

Certain statements in this press release may constitute "forward-looking statements" for purposes of the federal securities laws concerning Firefly, including statements regarding the anticipated benefits, scope, and results of the collaboration between Firefly and NeruSigma, statements regarding NeruSigma's business, business, product and commercial plans; Firefly's ADHD biomarker research and product development; and statements relating to Firefly's management team's expectations, hopes, beliefs, intentions, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Firefly will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Firefly's control) and other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading "Risk Factors" in the reports and other filings of Firefly with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of Firefly's assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. It is not possible to predict or identify all such risks. Forward-looking statements included in this press release only speak as of the date they are made, and Firefly does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Important Safety Information

The Monarch eTNS^® System is available by prescription only. It is indicated for the treatment of pediatric ADHD as a monotherapy for patients ages 7 through 12 who are not currently taking prescription ADHD medication and is intended for home use during sleep under the supervision of a caregiver. Monarch should not be used by patients with an implanted cardiac or neurostimulation system or an implanted metallic or electronic device in the head. Do not apply the device to the neck or chest, do not use it in the bath or shower, and do not use it in the presence of electrical monitoring equipment such as cardiac monitors. Apply the patch only to healthy, clean, intact skin. The most commonly reported side effects are drowsiness, increased appetite, trouble sleeping, teeth clenching, headache, and fatigue. Talk with your child’s clinician about whether Monarch is right for your child.

For complete safety information, see the Instructions for Use.

Investor & Media Contacts

For Firefly
Stephen Kilmer
(646) 274-3580
stephen.kilmer@fireflyneuro.com

For NeuroSigma
Colin Kealey, M.D.
President and Chief Executive Officer
ckealey@neurosigma.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What does Firefly Neuroscience's partnership with NeuroSigma involve?

Firefly will introduce NeuroSigma's Monarch eTNS System to clinicians using its Evoke platform and support their education about the therapy. NeuroSigma will provide clinical training, prescribing support and product fulfillment through a specialty pharmacy partner.

Which children are eligible for the Monarch device introduced through Firefly's Evoke network?

Monarch is FDA-cleared as a prescription-only treatment for children ages 7 through 12 with ADHD who are not currently taking prescription ADHD medication. It is intended for use at home during sleep under a caregiver's supervision.

What safety restrictions and side effects apply to Monarch in the Firefly-NeuroSigma partnership?

Monarch should not be used by patients with certain implanted cardiac, neurostimulation, metallic or electronic devices. The most commonly reported side effects are drowsiness, increased appetite, trouble sleeping, teeth clenching, headache and fatigue.