Nexalin Technology’s Q-Submission for Gen-2 SYNC Accepted by U.S. FDA for the Treatment of Alzheimer’s Disease and Dementia
Nexalin Technology, Inc. (NXL)
Company Research
Source: GlobeNewswire
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 pot
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News
- Nexalin Highlights its Expanding Body of Peer-Reviewed Neuroimaging Research Confirming its DIFS™ Technology as the Leader in Evidenced-Based Non-Invasive Brain Stimulation [Yahoo! Finance]Yahoo! Finance
- Nexalin Highlights its Expanding Body of Peer-Reviewed Neuroimaging Research Confirming its DIFS™ Technology as the Leader in Evidenced-Based Non-Invasive Brain StimulationGlobeNewswire
- Nexalin Technology receives Nasdaq bid price deficiency notice [Seeking Alpha]Seeking Alpha
- Nexalin Technology Receives Nasdaq Listing Status NotificationGlobeNewswire
- Published Peer-Reviewed Study Demonstrates Nexalin’s DIFS™ Neurostimulation Improves Attention and Normalizes Brain Activity in Patients with ADHDGlobeNewswire
NXL
Sec Filings
- 1/23/26 - Form 8-K
- 12/23/25 - Form 4
- 12/23/25 - Form 4
- NXL's page on the SEC website