Nexalin Technology Completes FDA Q-Submission Meeting for Gen-2 SYNC™ Neurostimulation Console in Alzheimer’s Disease Program
Nexalin Technology, Inc. (NXL)
Company Research
Source: GlobeNewswire
HOUSTON, TX, Dec. 03, 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 the successful completion of a substantive Q-Submission (“Q-Sub”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding its Gen-2 SYNC™ neurostimulation console for the treatment of Alzheimer’s disease. The meeting focused on Nexalin’s proposed clinical development plan and overall regulatory strategy for the Gen-2 SYNC console in Alzheimer’s disease. As part of the interaction, the Company and the FDA discussed the potential use of the De Novo classification pathway for this indication, reflecting the novel mechanism of action of Nexalin’s deep, frequency-specific neurostimulation technology. The discussion provided a clear understanding of Nexalin’s existing clinical data for the treatment of Alzheimer’s disease. Additional discussions included Nexalin’s plans
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News
- 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
- Nexalin’s 15 Milliamp Neurostimulation Device Demonstrates Promising Results in Treating Gambling Disorder with Alcohol Use ComorbidityGlobeNewswire
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