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