HOUSTON, TX — November 5, 2025 — Leads & Copy — Nexalin Technology, Inc. (Nasdaq: NXL) announced that the FDA has accepted its Q-Submission for its Gen-2 Console (SYNC) system for Alzheimer’s and dementia treatment, scheduling a regulatory meeting later this year.
The FDA’s acceptance marks a significant step toward Nexalin’s goal of initiating U.S. clinical studies for Alzheimer’s and dementia, addressing critical healthcare needs. The Q-Submission process facilitates structured dialogue and feedback from the FDA on clinical trial design, study endpoints, and regulatory pathways for the Gen-2 SYNC system.
CEO Mark White said that the milestone builds on supportive data and growing clinical interest in Nexalin’s neurostimulator. The meeting will allow Nexalin to align with the agency on trial design, statistical analysis and regulatory framework.
Nexalin is also exploring collaborations with research institutions to advance U.S. and international studies involving its Gen-2 SYNC and Gen-3 HALO platforms.
Nexalin designs and develops neurostimulation products to combat the global mental health epidemic. Its devices aim to treat mental health issues by penetrating structures deep in the mid-brain without adverse side effects.
Contact:
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com
Source: Nexalin Technology
