Nexalin Technology’s Q-Submission for Gen-2 SYNC Accepted by U.S. FDA for the Treatment of Alzheimer’s Disease and Dementia
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:
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Observed improvements in cognitive performance in pilot studies utilizing Nexalin’s frequency waveform technology.
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No serious adverse events, underscoring the favorable safety profile seen across international deployments.
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EEG and qEEG evidence of waveform-induced modulation correlated with patterns of improved neural connectivity in dementia-related conditions.
