Nexalin Technology Reports Compelling Clinical Trial Results in Brazil to Support Product Launch. Trial Demonstrates 77.8% Anxiety Response Rate and Durable Benefits Across Depression, Insomnia and Quality of Life as Company Advances Brazilian Sales Plan.
Study using Nexalin's proprietary DIFS™ 15 mA 77.5 Hz treatment platform demonstrated rapid, large-magnitude improvements in anxiety and depression with benefits maintained at 8-week follow-up
Results further validate Nexalin's prior clinical data and support the Company's differentiated, non-invasive approach to deep frequency-based neurostimulation
No serious adverse events, seizures or manic/hypomanic switches were reported, reinforcing the favorable tolerability profile of Nexalin's technology
HOUSTON, June 10, 2026 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (NASDAQ:NXL) (the "Company" or "Nexalin"), the leader in non-invasive Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced the successful completion of an 8-week, single-center, prospective, open-label clinical trial evaluating Nexalin's proprietary 15 milliamp (mA), 77.5 Hz neurostimulation protocol in adults with generalized anxiety disorder and comorbid insomnia.
The clinical trial was conducted at the Institute of Psychiatry, Hospital das Clínicas, University of São Paulo. Participants received 20 sessions of transcranial alternating current stimulation over four weeks, followed by a four-week follow-up period. Each 40-minute session was administered using the Nexalin DIFS™ device at 15 mA and 77.5 Hz.
The completed trial demonstrated rapid, large-magnitude and durable improvements across multiple high-burden neuropsychiatric domains, including anxiety, depressive symptoms, insomnia and quality of life. Importantly, improvements were observed early in the treatment course, continued through the end of treatment, and were maintained at 8-week follow-up.
"This is another major clinical milestone for Nexalin and another powerful validation point for our proprietary non-invasive treatment platform," said Mark White, Chief Executive Officer of Nexalin Technology. "These results continue to affirm the positive clinical signals observed in prior Nexalin studies and strengthen our conviction that Nexalin is developing a fundamentally differentiated and advanced neuro-technology platform, not a ‘me-too' neurostimulation device. We believe our non-invasive, frequency-based approach has the potential to represent a breakthrough in the treatment of neuropsychiatric conditions where patients urgently need new options."
Key results from the completed pilot trial include:
- 77.8% anxiety response rate at end of treatment: Anxiety response rates reached 77.8% at Session 20.
- Rapid anxiety improvement: Hamilton Anxiety Rating Scale (HAM-A) scores decreased by 14.73 points by Session 5.
- Durable anxiety benefit: HAM-A scores decreased by 18.30 points by Session 20, with reductions maintained at 8-week follow-up.
- Depressive symptom improvement: Hamilton Depression Rating Scale (HAMD) scores decreased by 9.90 points by Session 20.
- High depressive symptom response and remission: HAMD response and remission rates both reached 66.7% at the end of treatment.
- Sustained insomnia improvement: Pittsburgh Sleep Quality Index (PSQI) scores improved significantly at the end of treatment and remained significantly improved at 8-week follow-up, with large effect sizes reported.
- Quality-of-life improvement: Overall quality of life improved significantly at the end of treatment, with favorable directional trends across additional quality-of-life domains.
- Favorable tolerability profile: No serious adverse events, seizures or manic/hypomanic switches were reported.
Mr. White continued, "Mental health remains one of the largest and most urgent healthcare challenges in the world. Existing treatment options often involve delayed onset of benefit, incomplete response, side effects, adherence challenges, or limited durability. Nexalin is pursuing a new category of non-invasive, drug-free neurostimulation techniques designed to address these limitations in current non-invasive stimulators. We believe these data provide additional evidence that our platform can deliver meaningful clinical improvements across interconnected symptoms that commonly occur together, including anxiety, mood disruption, insomnia, and impaired quality of life."
Nexalin believes the completed Brazilian trial provides important support for the Company's broader clinical and sales strategy in Brazil. The Company believes the data are particularly meaningful because they build upon and further validate prior published Nexalin clinical findings. Nexalin is currently preparing a product launch and sales campaign in Brazil that will benefit from the Brazilian trial.
"These findings are highly encouraging because they show improvement across multiple clinically relevant outcomes, not just a single endpoint," said Dr. David Owens, Chief Medical Officer of Nexalin Technology. "The trial demonstrated rapid improvement in anxiety and depressive symptoms, sustained improvement in sleep quality, and a favorable tolerability profile. While these results should be interpreted in the context of an open-label pilot study, they provide a strong rationale for validation of all current published studies demonstrating Nexalin's strong clinical utility."
Unlike many neurostimulation technologies that are based on incremental modifications of existing approaches, Nexalin's platform is designed to deliver proprietary high-power frequency-based stimulation that the Company believes can penetrate deeper brain regions associated with mood, sleep and other neuropsychiatric disorders. Nexalin believes this differentiated approach may provide a meaningful competitive advantage as the Company advances its FDA De Novo regulatory pathway, clinical development programs and commercialization strategy.
"These results strengthen our confidence that Nexalin's platform is differentiated within the neurostimulation landscape," added Mr. White. "The data sets are consistent with our broader clinical thesis: a non-invasive, outpatient-friendly, drug-free platform designed to deliver meaningful improvements across deep-brain-related neuropsychiatric conditions. We believe this study further supports Nexalin's position as an innovator in one of the most important areas of healthcare."
About Nexalin Technology, Inc.
Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. Nexalin's medical devices are non-invasive and undetectable to the human body. Nexalin products are developed to provide relief to those afflicted with mental health issues using frequency based bioelectronic medical technology. Nexalin believes its neurostimulation medical devices can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin believes the deeper-penetrating waveform in its next-generation devices will generate enhanced patient response without any adverse side effects. The Nexalin Gen-2 15 milliamp neurostimulation device has been approved in China, Brazil, Oman and Israel. Additional information about the Company is available at: https://nexalin.com/.
FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). These forward-looking statements relate to future events, future performance, or management's current expectations, beliefs, assumptions, plans, estimates, intentions, or projections relating to the future, and are not guarantees of future performance. Any statements that are not statements of historical fact, or that refer to expectations, projections, or other characterizations of future events or circumstances (including, without limitation, statements containing the words "believes," "expects," "anticipates," "plans," "intends," "will," "may," "could," "should," "would," "designed to," "positioned to," "potential," "targeted," "seeking," "continues," "strategy," "opportunity," "estimates," "projects," "forecasts," "predicts," "outlook," "guidance," or similar expressions, or the negative of such terms), are forward-looking statements. Forward-looking statements are based on Nexalin's current expectations, assumptions, estimates, projections, and beliefs as of the date hereof, including assumptions regarding the Company's future clinical, regulatory, and commercial programs. These statements are subject to significant risks, uncertainties, and other factors, many of which are beyond the Company's control, that could cause actual results, performance, or achievements to differ materially from those expressed or implied by the forward-looking statements. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release.
Forward-looking statements in this press release include, but are not limited to, statements regarding: the interpretation, validation, and clinical significance of the Company's clinical trial results, including the Brazilian pilot trial; the Company's ability to replicate pilot trial results in larger, randomized, or controlled clinical studies; the mechanism of action, depth of penetration, and differentiation of Nexalin's DIFS™ platform; the broader relevance and clinical applicability of the Company's technology across multiple indications, including anxiety, depression, insomnia, and other neuropsychiatric conditions; the design, enrollment, timing, progress, results, and potential outcomes of the HALO™ Clarity pivotal program and other future clinical trials; the potential for future development, regulatory progress (including any planned De Novo FDA submission), and commercialization of the Company's products and technology; the Company's beliefs regarding its competitive position, market opportunity, and value proposition; management's expectations regarding future regulatory submissions, clearances, and approvals; the Company's product launch and sales strategy in Brazil; and the Company's strategic plans, business prospects, and capital needs. These forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties, and other factors that may cause the Company's actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. No assurance can be given that future studies will be initiated or completed on a timely basis or at all, that the results of pilot or open-label studies will be replicated in larger, randomized, or controlled trials, or that the Company's technology will receive regulatory clearance or approval for any particular indication or on any anticipated timeline.
Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the Company's control. Such risks include, but are not limited to: the inherent limitations of open-label, single-center pilot studies, including the absence of a placebo control group and the potential for placebo effects; uncertainties regarding the design, enrollment, execution, timing, results, and completion of clinical trials, including the HALO™ Clarity pivotal program; the ability to obtain regulatory clearance or approval from the U.S. Food and Drug Administration (the "FDA") or other regulatory bodies, including with respect to any planned De Novo submission; the sufficiency of clinical and non-clinical data to support regulatory submissions; the potential for adverse events, safety concerns, or product performance issues; market acceptance of, and reimbursement for, the Company's products; the Company's ability to protect and enforce its intellectual property rights; competition from existing and new treatment alternatives; the Company's reliance on third-party manufacturers, suppliers, and clinical investigators; the Company's ability to commercialize its products in Brazil and other international markets; the Company's ability to secure adequate funding on acceptable terms to complete its planned clinical, regulatory, and commercial programs; and general economic, political, regulatory, and market conditions. Additional risks and uncertainties that could cause actual results to differ materially are described under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K for the year ended December 31, 2025, and in the Company's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings the Company makes from time to time with the U.S. Securities and Exchange Commission (the "SEC"). Copies of these filings are available free of charge on the SEC's website at www.sec.gov and on the Company's investor relations website. New risk factors emerge from time to time, and it is not possible for the Company to predict all such risk factors or to assess the impact of all such risk factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
All forward-looking statements in this press release are qualified in their entirety by this cautionary statement and the risk factors and other cautionary statements set forth in the Company's SEC filings referenced above, and speak only as of the date they are made. Except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances, or otherwise, after the date of this press release.
Contact:
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com
