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.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.