Nexalin Technology Announces Additional Positive Clinical Results in Alzheimer’s Disease with Gen-2 SYNC Neurostimulation Device

Rhea-AI Summary

Nexalin Technology (Nasdaq: NXL) reported peer-reviewed clinical results (Radiology, Oct 8, 2025) showing its Gen-2 SYNC 40-Hz, 15 mA DIFS neurostimulation device produced statistically significant cognitive gains and measurable brain-connectivity changes in mild Alzheimer’s disease.

Key findings: significant MMSE and MoCA score improvements versus sham (P = .001 and .03), increased hippocampal-cortical and network functional connectivity on resting-state fMRI, a connectivity–naming-test correlation (r = 0.65, FDR-adjusted P = .008), and no reported adverse events. Device has regulatory approvals for other indications in China, Brazil, and Oman.

Positive

• MMSE improvement vs sham with P = .001
• MoCA improvement vs sham with P = .03
• Hippocampal-cortical functional connectivity increase confirmed by resting-state fMRI
• Connectivity correlated with Boston Naming Test scores (r = 0.65)
• No adverse events reported during the treatment period
• Gen-2 SYNC 15 mA DIFS device has approvals in China, Brazil, and Oman

Negative

• Not approved by the FDA for Alzheimer’s disease indication
• Clinical evidence is limited to the published randomized, sham-controlled trial; longer-term and multicenter outcomes were not reported in this release

Insights

Clinical Neurostimulation Expert

Peer-reviewed randomized, sham-controlled 40‑Hz, 15 mA DIFS shows significant cognition and fMRI connectivity gains in mild AD.

Nexalin demonstrated statistically significant improvements on MMSE (P = .001) and MoCA (P = .03) versus sham, and a correlated hippocampus–cingulate connectivity change (r = 0.65, FDR-adjusted P = .008). The study reports resting-state fMRI increases across DMN and frontoparietal networks, linking network modulation to clinical tests and providing an imaging-confirmed mechanism for the 40‑Hz, 15 mA waveform.

Safety was reported as excellent with no adverse events during treatment, which supports tolerability for repeated non-invasive stimulation. Key short-term monitors include reproduction in larger samples, durability of cognitive gains beyond the study window, and replication of connectivity–behavior correlations; expect further validation over the next 12–36 months.

Regulatory and Commercial Strategy Expert

Positive clinical data plus peer-reviewed publication strengthens regulatory and commercial positioning for broader indications.

Nexalin now has peer-reviewed evidence tying a 40‑Hz, 15 mA DIFS waveform to measurable cognition and neuroimaging changes, and existing device approvals in China, Brazil, and Oman support a regulatory pathway. The company cites a global AD market > $20 billion, indicating clear commercial intent tied to expanding indications.

Regulatory risks remain: agencies will require larger confirmatory trials and durability/safety follow-up before label expansion; timelines will likely span multiple years. Concrete near-term items to watch include confirmatory trial registrations, larger sample data readouts, and any regulatory submissions over the next 12–36 months.

40-Hz DIFS™ significantly improves cognitive performance and brain connectivity in peer-reviewed clinical trial

Results published in Radiology, the flagship journal of the Radiological Society of North America (RSNA)

HOUSTON, TX, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced the publication of additional positive clinical data in Radiology demonstrating that its proprietary 15 milliamp (mA) Gen-2 Nexalin DIFS™ technology—Nexalin’s advanced implementation of transcranial alternating current stimulation (tACS)—improves cognitive performance and enhances brain network connectivity in patients with mild Alzheimer’s disease (AD). The randomized, sham-controlled trial provides the strongest peer-reviewed evidence to date of a non-invasive, drug-free intervention delivering measurable neurological and clinical benefits in AD. The full study is available here: https://pubs.rsna.org/doi/10.1148/radiol.241463.

Key Findings from the Clinical Study:

• Clinically Meaningful Cognitive Gains: Patients receiving Nexalin’s Gen-2 SYNC 40-Hz DIFS device showed a significant improvement in Mini-Mental State Examination (MMSE) scores and additional significant improvement in Montreal Cognitive Assessment (MoCA) scores compared to baseline. These improvements were statistically significant when compared to the sham group (P = .001 and .03, respectively).
• Neuroimaging-Confirmed Mechanism: Resting-state functional MRI (fMRI) revealed enhanced functional connectivity (FC) between the hippocampus and key cortical regions, including the middle cingulate gyrus and middle frontal gyrus, both of which are critical to memory and executive function.
• Network-Level Effects: Statistically significant increases in FC were also observed across broader cognitive networks, including the default mode network (DMN), frontoparietal networks (FPN), and visual and auditory systems, which are commonly disrupted in Alzheimer’s disease.
• Correlated Cognitive Gains: Increased connectivity between the hippocampus and middle cingulate gyrus was significantly correlated with improvement on the Boston Naming Test, providing further evidence of the link between brain network modulation and functional outcomes (r = 0.65, FDR-adjusted P = .008).
• Excellent Safety Profile: No adverse events were reported during the treatment period, reinforcing the safety and tolerability of Nexalin’s DIFS technology.

“The results of this study represent a significant milestone for Nexalin’s technology platform,” said Mark White, CEO of Nexalin. “The data clearly supports our belief that Nexalin’s non-invasive deep, frequency-specific neurostimulation can meaningfully improve cognitive performance in patients with Alzheimer’s disease. With a global AD market projected to exceed $20 billion annually, these findings further strengthen our long-term strategy to deliver safe, and effective alternatives to pharmacologic treatments for neurodegenerative conditions and their associated costs and side effects.”

This study is the first to demonstrate fMRI confirmation, that a 40-Hz, 15 mA electrical waveform can increase hippocampal-cortical connectivity in AD patients and is associated with measurable cognitive improvement. These findings illuminate the mechanism of action underlying DIFS and further validate Nexalin’s efforts in neurostimulation for neurodegenerative diseases.

Nexalin’s Gen-2 SYNC 15 mA DIFS device is already approved in China for the treatment of depression and insomnia. Nexalin is also approved in Brazil and Oman for the treatment of anxiety, depression and insomnia. This new Alzheimer’s data supports the Company’s broader global strategy to expand treatment indications with various international regulatory agency, including the FDA in the United States.

About Nexalin Technology, Inc.

Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. All of Nexalin's products are believed to be non-invasive and undetectable to the human body and are developed to provide relief to those afflicted with mental health issues. Nexalin utilizes bioelectronic medical technology to treat mental health issues. 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 SYNC 15 milliamp neurostimulation device has been approved in China, Brazil, and Oman. Additional information about the Company is available at: https://nexalin.com/.

FORWARD-LOOKING STATEMENTS

This press release 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.

Contact:

Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com

FAQ

What cognitive improvements did Nexalin (NXL) report in the Oct 8, 2025 Radiology study?

The study reported significant improvements in MMSE (P = .001) and MoCA (P = .03) versus sham.

How did Nexalin’s Gen-2 SYNC 40-Hz DIFS affect brain connectivity in the NXL study?

Resting-state fMRI showed increased hippocampal-cortical and network functional connectivity, including DMN and frontoparietal networks.

Did Nexalin report any safety issues for the 15 mA Gen-2 SYNC device in Alzheimer’s patients?

No adverse events were reported during the treatment period in the published trial.

Is Nexalin’s Gen-2 SYNC device approved for Alzheimer’s treatment in the United States (NXL)?

No; the device is approved for other indications in China, Brazil, and Oman, but not FDA-approved for Alzheimer’s.

What evidence links brain connectivity changes to clinical benefit in the NXL study?

Increased hippocampus–middle cingulate connectivity correlated with Boston Naming Test improvement (r = 0.65, FDR-adjusted P = .008).

How might Nexalin’s Oct 2025 clinical results affect NXL’s regulatory strategy?

The company said the results support efforts to expand treatment indications with international agencies, including pursuing FDA review for Alzheimer’s indications.