Nexalin Technology initiates FDA Q-Submission process for Gen-2 SYNC

Nexalin Technology (NXL) plans to submit a Q-Submission to the U.S. Food and Drug Administration related to its Gen-2 SYNC system. This regulatory milestone is intended to facilitate structured dialogue with the FDA regarding clinical trial design for the treatment of Alzheimer’s disease, dementia, and mild cognitive impairment. The Company’s decision to proceed with the Q-Sub follows recent publications, a review of new encouraging internal data, and preliminary feedback received from the FDA. Nexalin believes this next phase of regulatory engagement marks a critical step toward advancing Gen-2 SYNC as a potential non-invasive therapeutic option for patients affected by debilitating cognitive conditions.