{"id":906092,"date":"2025-11-05T15:55:21","date_gmt":"2025-11-05T20:55:21","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-technologys-q-submission-for-gen-2-sync-accepted-by-u-s-fda-for-the-treatment-of-alzheimers-disease-and-dementia\/"},"modified":"2025-11-05T15:55:21","modified_gmt":"2025-11-05T20:55:21","slug":"nexalin-technologys-q-submission-for-gen-2-sync-accepted-by-u-s-fda-for-the-treatment-of-alzheimers-disease-and-dementia","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-technologys-q-submission-for-gen-2-sync-accepted-by-u-s-fda-for-the-treatment-of-alzheimers-disease-and-dementia\/","title":{"rendered":"Nexalin Technology\u2019s Q-Submission for Gen-2 SYNC Accepted by U.S. FDA for the Treatment of Alzheimer\u2019s Disease and Dementia"},"content":{"rendered":"

\nThis strategic filing with the FDA follows encouraging internal data and recent published studies supporting Nexalin\u2019s frequency neurostimulator as a potential non-invasive therapy for cognitive disorders associated with Alzheimer\u2019s disease
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HOUSTON, TX, Nov. 05, 2025 (GLOBE NEWSWIRE) — Nexalin Technology, Inc. (Nasdaq: NXL)<\/b> (the \u201cCompany\u201d or \u201cNexalin\u201d), the leader in Deep Intracranial Frequency Stimulation (DIFS\u2122) of the brain, today announced that the U.S. Food and Drug Administration (\u201cFDA\u201d) has formally accepted its Q-Submission (\u201cQ-Sub\u201d) related to the Company\u2019s Gen-2 Console (\u201cSYNC\u201d) system for the treatment of Alzheimer\u2019s disease and dementia, with a regulatory meeting scheduled for later this year.<\/p>\n

This acceptance of the Company\u2019s request for interaction with the FDA with respect to its Gen-2 SYNC system represents a significant step toward Nexalin\u2019s goal of achieving FDA authorization to begin U.S. clinical studies targeting Alzheimer\u2019s and dementia \u2014 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\u2019s disease.<\/p>\n

This regulatory milestone follows encouraging internal data and recently published findings highlighting the potential of Nexalin\u2019s non-invasive neurostimulator to improve cognitive function and memory in Alzheimer\u2019s and other related neurodegenerative conditions. Nexalin\u2019s Gen-2 SYNC platform delivers a proprietary, undetectable 15-milliamp, deep-penetrating waveform designed to stimulate brain structures associated with cognition and mood\u2014without the use of drugs or surgical procedures.<\/p>\n

\u201cThe FDA\u2019s acceptance of our Q-Submission marks an important step in Nexalin\u2019s mission to redefine how cognitive disorders associated with Alzheimer\u2019s are treated,\u201d said Mark White, CEO of Nexalin Technology<\/b>. \u201cThis milestone builds upon supportive internal data, compelling published results, and growing clinical interest in Nexalin\u2019s neurostimulator for Alzheimer\u2019s 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.\u201d<\/p>\n

\n Recent company data and independent published research have demonstrated:<\/b>\n <\/p>\n