Drug-free neurostimulation with multiple shots on goal.
Nexalin is advancing a non-invasive neurostimulation platform for the drug-free treatment of insomnia, anxiety, depression, Alzheimer's disease and dementia, TBI/PTSD and ADHD, built around proprietary Deep Intracranial Frequency Stimulation (DIFS™), with a growing evidence base, next-generation in-clinic and at-home devices, a virtual clinic model, and visible U.S. regulatory catalysts.
Nexalin treatment administers a stimulating waveform which is non-invasive, safe and virtually undetectable.
And best of all, without medication.
Research suggests anxiety and insomnia may be associated with dysregulation in brain networks and neurochemical pathways.
Through our patented, frequency-related, advanced waveform that interacts with the deep centers of the midbrain, our Nexalin device is designed to modulate deep brain networks associated with sleep, mood and cognition.
See Nexalin in action.
A clearer view of the opportunity.
Nexalin combines a differentiated neurostimulation platform, multiple large therapeutic indications, a growing body of clinical and neuroimaging support, and visible regulatory and commercial milestones.
A platform, not one product.
Gen-2 SYNC™, HALO™ Clarity, NeuroCare® and a recurring-revenue model make this broader than a one-device story.
Nexalin extends beyond the clinic. SYNC™ and HALO™ together expand the platform across in-clinic and home-use settings, while NeuroCare® adds remote physician oversight, protocol management and digitally connected treatment across Alzheimer's, mood disorders, TBI and PTSD.
Gen-2 SYNC™ — in-clinic console
The next-generation in-clinic platform targeting deeper brain structures at 15 mA output, with FDA Q-Submission meeting completed for the Alzheimer's disease program.
HALO™ Clarity — at-home headset
A physician-supervised at-home neurostimulation headset designed to extend DIFS™ beyond the clinic, with a planned pivotal insomnia study supporting a De Novo FDA submission.
NeuroCare® — virtual clinic
Remote physician oversight, protocol management and digitally connected treatment across Alzheimer's, mood disorders, TBI and PTSD — an AI-driven virtual clinic designed to expand access.
Recent developments and milestones.
Recent company developments include insomnia trial planning, the NeuroCare® launch, expanding neuroimaging validation, the January 2026 ADHD publication and Alzheimer's-focused FDA engagement.
HALO™ Clarity extends Nexalin beyond the clinic.
The at-home headset, virtual clinic infrastructure and physician-supervised treatment model support a broader and more scalable care-delivery framework.
Pivotal HALO™ Clarity insomnia study
A planned 160-patient, triple-blinded, sham-controlled, decentralized clinical trial with Lindus Health, designed to support a planned De Novo FDA submission targeting moderate to severe insomnia.
NeuroCare® — AI-driven virtual clinic
NeuroCare® adds remote physician oversight, protocol management and digitally connected treatment across Alzheimer's, mood disorders, TBI and PTSD — designed to expand access across multiple indications.
Global approvals and international footprint.
Gen-2 approvals have been highlighted in China, Brazil, Oman and Israel, while U.S. programs continue to advance. These international markets underscore the platform's scalability beyond the U.S. regulatory path.
Technology is the foundation of the platform.
Nexalin's proprietary DIFS™ technology is the core differentiator underpinning the company's platform, enabling non-invasive, drug-free stimulation intended to engage deeper brain structures than conventional low-power superficial neurostimulation approaches.
DIFS™ — Deep Intracranial Frequency Stimulation
DIFS™ is a non-invasive, 15 mA waveform profile designed to engage deeper brain structures associated with mood, sleep, cognition and trauma-related conditions. The platform spans next-generation in-clinic (Gen-2 SYNC™) and at-home (HALO™ Clarity) devices, supported by a virtual clinic model and a growing body of peer-reviewed and neuroimaging-validated evidence.
Mental Health is a Global Epidemic.
The global burden of mental health conditions continues to underscore the need for scalable, drug-free treatment alternatives. Nexalin's platform targets a portfolio of large, underserved indications — creating multiple paths for expansion rather than a single binary bet.
A simple narrative.
Non-invasive brain stimulation. Multiple large indications. Widening evidence. Upcoming U.S. catalysts.
Recent Developments
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