Transforming Mental Health Treatment. Drug-Free. Non-Invasive. Globally Scalable.
Nexalin is pioneering a drug-free, clinically proven treatment with the potential to scale worldwide.
WHY INVEST IN NEXALIN?
Massive Unmet Need
- Over 1B people suffer from Alzheimer’s, TBI, PTSD, depression, addiction, and other mood disorders
- Global mental health therapeutics market projected to exceed $500B by 2030
Lack of effective treatments, side effects and lifetime of treatment
- Antidepressants effective in only 42–53% of patients, with serious side effects1
- Lack of effective drug treatments for Alzheimer’s or TBI
- 70% of patients prefer drug-free alternatives2
- Current non-invasive neurostimulation technologies are limited by safety and efficacy
Proven Technology & Clinical Validation
- Deep Intracranial Frequency Stimulation (DIFS®): drug-free, non-invasive treatment that stimulates natural brain rhythms
- Validated in 13+ clinical trials in the last 30 months, including 3 focused on Alzheimer’s/dementia in the past 12 months
- Peer-reviewed data: up to 75% of patients experience >70% symptom improvement
- Gen-1 device previously FDA cleared, establishing U.S. precedent
Regulatory & Commercial Momentum
- Gen-2 device approved in Asia, South America, and the Middle East
- U.S. pivotal trials for anxiety and insomnia set for 2026
- HALO Gen-3 at-home platform enables physician-monitored, telemedicine-driven treatment
Strong Investor Positioning
- High gross margins (65–95%)
- Zero debt and strong IP portfolio (18 patents pending, 7 issued)
- Strategic partnerships with military and government agencies
Gen-3 Halo device for home use with physician supervision through “virtual clinic”
The Nexalin Solution
- Deep Intracranial Frequency Stimulation (DIFS®): treats Alzheimer’s, TBI, PTSD, depression, addiction, and other mood disorders
- Validated in over 13 clinical trials, with growing focus on Alzheimer’s/dementia and PTSD
- Strong safety profile; drug-free alternative to antidepressants and invasive devices
- Recurring revenue model built on devices, consumables, subscriptions
CEO Mark White & Congressman Don Davis, House Armed Services Committee
HALO Gen-3 – Next Catalyst
- At-home treatment system: headset, remote, app, physician-monitored via telemedicine
- Builds on precedent from Gen-1 FDA clearance and validated Gen-2
- FDA pilot and pivotal trials underway at UC San Diego and the VA, covering PTSD and TBI
- Designed to integrate frequency-based neurostimulation into everyday life
Global Expansion
- China JV: Approved and commencing sales of Gen-2 devices
- Regulatory approvals secured in Asia, South America, and the Middle East
- U.S. Veterans & Department of Defense: Studies in development for TBI/PTSD; active congressional and military engagement
- Future markets: Europe, India, expanded Asia-Pacific rollout
Clinical Validation
- 13+ clinical trials in the past 30 months, including 3 in Alzheimer’s/dementia in the past 12 months
- Randomized controlled trials confirm efficacy in depression and insomnia
- Studies underway for PTSD and TBI in veterans, with measurable neurological improvements
- U.S. pivotal trials for anxiety and insomnia set for 2026
Financial Strength, IP Protection & Strategic Partnerships
- Cash & equivalents: $5.4M
- Debt: $0
- Shares outstanding: 17.4M
- Insider ownership: 25%
- Strong IP protections: 18 patents pending, 7 issued
- Partnerships with U.S. military and government agencies
Nexalin is delivering a drug-free, non-invasive, clinically validated, and globally scalable mental health solution.
Strong pipeline, validated DIFS® technology, high-margin recurring revenue model, and near-term U.S. catalysts
Nexalin is the future of mental health
The Nexalin Gen-1 device was previously FDA cleared. Nexalin’s Gen-2 and Gen-3 devices are not currently FDA cleared in the United States. These devices are investigational in the U.S. and are not available for commercial sale. Clinical and regulatory development activities are ongoing.
This website contains statements that constitute “forward-looking statements,” These statements relate to future events or Nexalin’s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that Nexalin or its management “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward looking statements that involve risks and uncertainties which could cause actual events or Nexalin’s actual results to differ materially from those indicated by the forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company’s Report on Form 10-K for the year ended December 31, 2024 and other filings as filed with the Securities and Exchange Commission. Copies of such filings are available on the SEC’s website, www.sec.gov. Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
- Talaz, D., Spinrad, A., Barzilay, R. et al. Optimizing prediction of response to antidepressant medications using machine learning and integrated genetic, clinical, and demographic data. Transl Psychiatry 11, 381 (2021). https://doi.org/10.1038/s41398-021-01488-3
- McHugh, R. K., Whitton, S. W., Peckham, A. D., Welge, J. A., & Otto, M. W. (2013). Patient preference for psychological vs pharmacologic treatment of psychiatric disorders: a meta-analytic review. The Journal of clinical psychiatry, 74(6)
- Benjafield AV, Kuniyoshi FS, Malhotra A, et al. Estimation of the global prevalence and burden of insomnia: a systematic literature review-based analysis. Sleep Medicine Reviews. 2025;82:102121-102121. doi:https://doi.org/10.1016/j.smrv.2025.102121
- World Health Organization
- Yan J, Wang C, Sun B. Global, regional, and national burdens of traumatic brain injury from 1990 to 2021. Front Public Health. 2025;13:1556147. Published 2025 Apr 14. doi:10.3389/fpubh.2025.1556147
- Insomnia Clinical Trial -Effect of Transcranial Alternating Current Stimulation for the Treatment of Chronic Insomnia: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Clinical Trial. https://pubmed.ncbi.nlm.nih.gov/31846980/
- Depression Clinical Trial – Transcranial alternating current stimulation for treating depression: a randomized controlled trial. https://pubmed.ncbi.nlm.nih.gov/35353887/