Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) has announced its intention to initiate a Q-Submission to the U.S. Food and Drug Administration (FDA) related to its Gen-2 SYNC system. This regulatory process aims to facilitate dialogue with the FDA regarding the clinical trial design for treating Alzheimer's disease, dementia, and mild cognitive impairment $(MCI)$. The company's decision follows encouraging internal data and preliminary feedback from the FDA. Nexalin's Gen-2 SYNC system, featuring technical enhancements and a proprietary 15 milliamp advanced waveform, is positioned as a promising non-invasive therapeutic option for cognitive conditions. The company views this regulatory milestone as a critical step towards advancing its neuromodulation platform for cognitive and neuropsychiatric disorders.
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