Nexalin Technology’s Q-Submission for Gen-2 SYNC Accepted by U.S. FDA for the Treatment of Alzheimer’s Disease and Dementia

Rhea-AI Summary

Nexalin Technology (Nasdaq: NXL) announced that the U.S. Food and Drug Administration accepted its Q-Submission for the Gen-2 SYNC console for treatment of Alzheimer’s disease and dementia on November 5, 2025.

The acceptance schedules a regulatory meeting later in 2025 to discuss clinical trial design, endpoints, statistical plans and the regulatory pathway toward a potential U.S. Investigational Device Exemption (IDE).

Company-reported supportive signals include encouraging internal data, published studies showing improved cognitive performance, no serious adverse events across international use, and EEG/qEEG evidence of waveform-induced neural connectivity changes for dementia-related conditions.

Positive

• FDA accepted Q-Submission for Gen-2 SYNC on Nov 5, 2025
• Regulatory meeting scheduled later in 2025
• Company cites no serious adverse events in international deployments
• Published and internal data reported improvements in cognitive performance
• EEG/qEEG evidence of waveform-induced neural connectivity modulation

Negative

• Q-Submission acceptance is not FDA authorization or approval
• No U.S. first-in-human clinical study authorized yet
• Efficacy claims are based on pilot/internal and published studies, not pivotal trials

Insights

Regulatory Affairs Analyst

FDA accepted Nexalin's Q-Submission for Gen-2 SYNC and scheduled a meeting, a procedural step toward U.S. clinical studies.

Nexalin Technology secured formal acceptance of its Q-Submission on Nov. 05, 2025, triggering a scheduled regulatory meeting to discuss clinical trial design, endpoints, and the pathway toward an IDE. This step creates structured FDA feedback rather than authorization to start trials; it clarifies administrative engagement and allows the company to present safety and mechanistic data for review.

The value to the company depends on the FDA’s feedback on trial scope and endpoints, plus whether safety signals and preliminary efficacy evidence satisfy regulatory expectations. The filing references observed cognitive improvements, no serious adverse events, and EEG/qEEG modulation; these are relevant but described as internal and published supportive data, not confirmatory pivotal results. Key immediate risks include requests for additional data, longer follow‑up, or changes to proposed endpoints that could delay an IDE pathway.

Watch for the agency meeting outcome and any FDA comments on study size, primary endpoints, and statistical plan within the coming months; those items will determine whether an IDE filing is feasible on the planned timeline. Also monitor any formal IDE submission language and the content of future disclosures about confirmatory safety and cognitive outcome data.

This strategic filing with the FDA follows encouraging internal data and recent published studies supporting Nexalin’s frequency neurostimulator as a potential non-invasive therapy for cognitive disorders associated with Alzheimer’s disease

HOUSTON, TX, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced that the U.S. Food and Drug Administration (“FDA”) has formally accepted its Q-Submission (“Q-Sub”) related to the Company’s Gen-2 Console (“SYNC”) system for the treatment of Alzheimer’s disease and dementia, with a regulatory meeting scheduled for later this year.

This acceptance of the Company’s request for interaction with the FDA with respect to its Gen-2 SYNC system represents a significant step toward Nexalin’s goal of achieving FDA authorization to begin U.S. clinical studies targeting Alzheimer’s and dementia — two of the most urgent unmet needs in healthcare. The Q-Submission process enables structured dialogue with and feedback from the FDA to discuss proposed clinical trial design, study endpoints, and regulatory pathway for evaluating the Gen-2 SYNC system as a potential non-invasive therapy for these debilitating neurodegenerative conditions, as well as for mild to moderate cognitive impairment (MCI) associated with Alzheimer’s disease.

This regulatory milestone follows encouraging internal data and recently published findings highlighting the potential of Nexalin’s non-invasive neurostimulator to improve cognitive function and memory in Alzheimer’s and other related neurodegenerative conditions. Nexalin’s Gen-2 SYNC platform delivers a proprietary, undetectable 15-milliamp, deep-penetrating waveform designed to stimulate brain structures associated with cognition and mood—without the use of drugs or surgical procedures.

“The FDA’s acceptance of our Q-Submission marks an important step in Nexalin’s mission to redefine how cognitive disorders associated with Alzheimer’s are treated,” said Mark White, CEO of Nexalin Technology. “This milestone builds upon supportive internal data, compelling published results, and growing clinical interest in Nexalin’s neurostimulator for Alzheimer’s and dementia. The Nexalin executive team is preparing for a pivotal discussion with the FDA on the pathway to a first-in-human U.S. clinical study.”

Recent company data and independent published research have demonstrated:

• Observed improvements in cognitive performance in pilot studies utilizing Nexalin’s frequency waveform technology.
• No serious adverse events, underscoring the favorable safety profile seen across international deployments.
• EEG and qEEG evidence of waveform-induced modulation correlated with patterns of improved neural connectivity in dementia-related conditions.

The FDA Q-Submission meeting will allow Nexalin to align with the agency on clinical trial design, study endpoints, statistical analysis plan, and regulatory framework, providing a key foundation for a potential Investigational Device Exemption (IDE) filing in the U.S.

“This milestone reflects our disciplined and data-driven regulatory strategy,” added White. “We believe Nexalin’s non-invasive digital therapeutic platform has the potential to transform the treatment landscape for millions of patients suffering from neurodegenerative disease worldwide.”

Nexalin continues to evaluate strategic collaborations with leading research institutions to accelerate both U.S. and international studies involving its Gen-2 SYNC and next-generation Gen-3 HALO platforms.

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 non-invasive and undetectable to the human body and are developed to provide relief to those afflicted with mental health issues. Nexalin utilizes bioelectronic frequency-based medical technology to treat mental health issues. Evidence indicates Nexalin’s 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 Gen-2 and Gen-3 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, 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 any forward-looking statements, whether because of new information, future events or otherwise, 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 did Nexalin (NXL) announce on November 5, 2025 regarding FDA interaction?

Nexalin announced the FDA accepted its Q-Submission for the Gen-2 SYNC system and scheduled a regulatory meeting later in 2025.

Does FDA acceptance of a Q-Submission mean Nexalin (NXL) received approval for Gen-2 SYNC?

No; Q-Submission acceptance enables formal dialogue with FDA but is not approval or an IDE.

What topics will Nexalin (NXL) discuss with FDA at the 2025 meeting?

The meeting will cover proposed clinical trial design, study endpoints, statistical analysis, and regulatory pathway.

What safety and efficacy signals did Nexalin (NXL) cite for Gen-2 SYNC?

The company cited encouraging internal and published data showing cognitive improvements, EEG/qEEG changes, and no serious adverse events internationally.

How does the Gen-2 SYNC device deliver therapy according to Nexalin (NXL)?

Gen-2 SYNC delivers a proprietary undetectable 15-milliamp deep-penetrating waveform intended to stimulate cognition-related brain structures without drugs or surgery.