{"id":845339,"date":"2025-05-01T10:33:07","date_gmt":"2025-05-01T14:33:07","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-technology-initiates-fda-q-submission-process-for-gen-2-sync-following-encouraging-data-and-preliminary-fda-feedback\/"},"modified":"2025-05-01T10:33:07","modified_gmt":"2025-05-01T14:33:07","slug":"nexalin-technology-initiates-fda-q-submission-process-for-gen-2-sync-following-encouraging-data-and-preliminary-fda-feedback","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-technology-initiates-fda-q-submission-process-for-gen-2-sync-following-encouraging-data-and-preliminary-fda-feedback\/","title":{"rendered":"Nexalin Technology Initiates FDA Q-Submission Process for Gen-2 SYNC Following Encouraging Data and Preliminary FDA Feedback"},"content":{"rendered":"

\nCompany initiates formal regulatory engagement on trial design for Alzheimer\u2019s, dementia, and MCI indications
\n<\/h2>\n
\n

HOUSTON, TX, May 01, 2025 (GLOBE NEWSWIRE) — Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) <\/b>(the \u201cCompany\u201d or \u201cNexalin\u201d), today announced that it plans to submit a Q-Submission (\u201cQ-Sub\u201d) to the U.S. Food and Drug Administration (FDA) 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\u2019s disease, dementia, and mild cognitive impairment (MCI).<\/p>\n

The Company\u2019s 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.<\/p>\n

\u201cWe are encouraged by our internal findings and preliminary interactions with the FDA, which support our view that there may be a viable path forward for our Gen-2 SYNC system as a potential treatment for Alzheimer\u2019s, dementia, and MCI,\u201d said Mark White, CEO of Nexalin. \u201cThe upcoming Q-Submission represents an important opportunity to align with the FDA on clinical study design and regulatory strategy as we continue to be in a position to provide safe, effective, and non-invasive neuromodulation therapies to patients in need.\u201d<\/p>\n

The Gen-2 SYNC system reflects technical enhancements from prior-generation devices, including a newly redesigned enclosure and the integration of Nexalin\u2019s proprietary 15 milliamp advanced waveform. To clearly differentiate the system from earlier versions, the Company has initiated a rebranding initiative, and the device will be marketed as \u201cGen-2 SYNC.\u201d<\/p>\n

Nexalin remains focused on progressing regulatory engagement and advancing its neuromodulation platform as a promising therapeutic alternative in the treatment of cognitive and neuropsychiatric disorders.<\/p>\n

For more information about Nexalin Technology and its digital neurotherapeutic ecosystem, please visit www.nexalin.com<\/a>.<\/p>\n

\n About Nexalin Technology, Inc.<\/b>\n <\/p>\n

Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. All of Nexalin\u2019s products are non-invasive and undetectable to the human body and are developed to provide relief to those afflicted with mental health issues. Nexalin utilizes bioelectronic medical technology to treat mental health issues. Nexalin believes its neurostimulation medical devices can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin believes the deeper-penetrating waveform in its next-generation devices will generate enhanced patient response without any adverse side effects. The Nexalin Gen-2 15 milliamp neurostimulation device has been approved in China, Brazil, and Oman. Additional information about the Company is available at: https:\/\/nexalin.com\/<\/a>.<\/p>\n

\n Forward-looking statements<\/b>\n <\/p>\n

\n This press release contains statements that constitute \u201cforward-looking statements,\u201d These statements relate to future events or Nexalin\u2019s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that Nexalin or its management \u201cbelieves\u201d, \u201cexpects\u201d, \u201canticipates\u201d, \u201cplans\u201d, \u201cintends\u201d and similar expressions) should be considered forward-looking statements that involve risks and uncertainties which could cause actual events or Nexalin\u2019s actual results to differ materially from those indicated by the forward-looking statements.\u00a0 Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company’s Report on Form 10-K for the year ended December 31, 2024, and other filings as filed with the Securities and Exchange Commission. Copies of such filings are available on the SEC\u2019s website, <\/i>
\n
\n www.sec.gov<\/i>
\n <\/a>
\n . Such forward-looking statements are made as of the date hereof and may become outdated over time. Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. <\/i>\n <\/p>\n

\n Contact:<\/strong>
\n
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com<\/a>\u00a0<\/p>\n

\n \n <\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Company initiates formal regulatory engagement on trial design for Alzheimer\u2019s, dementia, and MCI indications HOUSTON, TX, May 01, 2025 (GLOBE NEWSWIRE) — Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the \u201cCompany\u201d or \u201cNexalin\u201d), today announced that it plans to submit a Q-Submission (\u201cQ-Sub\u201d) to the U.S. Food and Drug Administration (FDA) 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\u2019s disease, dementia, and mild cognitive impairment (MCI). The Company\u2019s 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 … <\/p>\n

Continue reading “Nexalin Technology Initiates FDA Q-Submission Process for Gen-2 SYNC Following Encouraging Data and Preliminary FDA Feedback”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-845339","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nNexalin Technology Initiates FDA Q-Submission Process for Gen-2 SYNC Following Encouraging Data and Preliminary FDA Feedback - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-technology-initiates-fda-q-submission-process-for-gen-2-sync-following-encouraging-data-and-preliminary-fda-feedback\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nexalin Technology Initiates FDA Q-Submission Process for Gen-2 SYNC Following Encouraging Data and Preliminary FDA Feedback - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Company initiates formal regulatory engagement on trial design for Alzheimer\u2019s, dementia, and MCI indications HOUSTON, TX, May 01, 2025 (GLOBE NEWSWIRE) — Nexalin Technology, Inc. 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