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 Technology Completes FDA Q-Submission Meeting for Gen-2 SYNC™ Neurostimulation Console in Alzheimer’s Disease ProgramGlobeNewswire
- Join Nexalin Technology’s Exclusive Live Investor Webinar and Q&A Session on December 4GlobeNewswire
- Nexalin Technology (NASDAQ:NXL) was downgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=NXL&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall StreetMarketBeat
- Nexalin Technology (NASDAQ:NXL) was downgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=NXL&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall StreetMarketBeat
- Nexalin Technology (NASDAQ:NXL) had its "sell (d-)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
NXL
Sec Filings
- 11/14/25 - Form 10-Q
- 10/15/25 - Form 424B5
- 10/15/25 - Form 8-K
- NXL's page on the SEC website