Nexalin Technology Initiates FDA Q-Submission Process for Gen-2 SYNC Following Encouraging Data and Preliminary FDA Feedback
Rhea-AI Summary
Nexalin Technology (NASDAQ: NXL) has announced plans to submit a Q-Submission to the FDA for its Gen-2 SYNC system, marking a crucial step in its regulatory pathway. The Q-Sub aims to facilitate discussions with the FDA regarding clinical trial design for treating Alzheimer's disease, dementia, and mild cognitive impairment (MCI).
This decision follows encouraging internal data and preliminary FDA feedback. The Gen-2 SYNC system features technical improvements, including a redesigned enclosure and integration of Nexalin's proprietary 15 milliamp advanced waveform. The company is also undertaking a rebranding initiative to differentiate this system from previous versions.
Positive
- Company advancing regulatory pathway through FDA Q-Submission process
- Encouraging internal data supports potential treatment viability
- Technical enhancements implemented in Gen-2 SYNC system
- Non-invasive treatment approach for significant cognitive conditions
Negative
- No FDA approval yet for the treatment
- Clinical trials still pending design and execution
- Uncertain timeline for potential market entry
News Market Reaction
On the day this news was published, NXL declined 1.65%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Company initiates formal regulatory engagement on trial design for Alzheimer’s, dementia, and MCI indications
HOUSTON, TX, May 01, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”), today announced that it plans to submit a Q-Submission (“Q-Sub”) 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’s disease, dementia, and mild cognitive impairment (MCI).
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.
“We 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’s, dementia, and MCI,” said Mark White, CEO of Nexalin. “The 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.”
The Gen-2 SYNC system reflects technical enhancements from prior-generation devices, including a newly redesigned enclosure and the integration of Nexalin’s 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 “Gen-2 SYNC.”
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.
For more information about Nexalin Technology and its digital neurotherapeutic ecosystem, please visit www.nexalin.com.
About Nexalin Technology, Inc.
Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. All of Nexalin’s 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/.
Forward-looking statements
This press release contains statements that constitute “forward-looking statements,” These statements relate to future events or Nexalin’s 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 “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward-looking statements that involve risks and uncertainties which could cause actual events or Nexalin’s actual results to differ materially from those indicated by the forward-looking statements. 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’s website, www.sec.gov. 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.
Contact:
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com
FAQ
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