Nexalin Technology Completes FDA Q-Submission Meeting for Gen-2 SYNC™ Neurostimulation Console in Alzheimer’s Disease Program

Rhea-AI Summary

Nexalin Technology (NASDAQ: NXL) completed a substantive FDA Q-Submission meeting for its Gen-2 SYNC™ neurostimulation console targeting mild-to-moderate Alzheimer’s disease on December 3, 2025. The FDA provided a clear framework for Nexalin’s planned U.S. Pilot Study and discussed a potential De Novo classification pathway.

FDA and Nexalin aligned on pilot and pivotal trial design elements, patient population, dosing paradigm, statistical plan, and primary/secondary endpoints including cognitive tests, PET, blood biomarkers, and functional imaging. Company will use feedback for its U.S. IDE submission.

Positive

• FDA alignment on pilot and pivotal trial design
• Feedback supportive of a De Novo regulatory pathway
• Agreement on primary/secondary endpoints including PET and biomarkers
• Peer-reviewed publications report cognitive and connectivity improvements

Negative

• None.

Insights

Regulatory Neurotech Analyst

FDA provided constructive Q‑Sub feedback supporting a De Novo pathway and aligned on pilot and pivotal trial design.

Nexalin's Gen‑2 SYNC console applies a deep, frequency‑specific neurostimulation waveform to target cognition‑related mid‑brain structures. The FDA dialogue clarified patient population, dosing paradigm and key statistical elements, and agreed on primary and secondary endpoints including standardized cognitive tests, PET imaging, blood biomarkers and functional imaging.

Progress now depends on Nexalin finalizing its U.S. Pilot Study protocol and filing an IDE. Risks remain: the company must convert alignment into a robust protocol, secure IDE acceptance, and then execute pilot and pivotal trials. Watch for the IDE submission date and pilot study start as near‑term milestones and any FDA feedback on the filed protocol within the next clinical planning cycle.

FDA feedback provides clear framework for Nexalin’s planned U.S. Pilot Study and supports a potential De Novo pathway for the Gen-2 SYNC™ device in Alzheimer’s disease

HOUSTON, TX, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced the successful completion of a substantive Q-Submission (“Q-Sub”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding its Gen-2 SYNC™ neurostimulation console for the treatment of Alzheimer’s disease.

The meeting focused on Nexalin’s proposed clinical development plan and overall regulatory strategy for the Gen-2 SYNC console in Alzheimer’s disease. As part of the interaction, the Company and the FDA discussed the potential use of the De Novo classification pathway for this indication, reflecting the novel mechanism of action of Nexalin’s deep, frequency-specific neurostimulation technology.

The discussion provided a clear understanding of Nexalin’s existing clinical data for the treatment of Alzheimer’s disease. Additional discussions included Nexalin’s plans for new U.S.-based Pilot Studies, followed by a large pivotal study designed to demonstrate the safety and efficacy of the Gen-2 SYNC console in patients with mild to moderate Alzheimer’s disease. Key topics included the design of both the pilot and pivotal trials, with alignment reached on foundational components such as patient population, dosing paradigm, and elements of the statistical analysis plan.

Importantly, Nexalin and the FDA also reviewed appropriate primary and secondary endpoints to measure clinically meaningful outcomes in Alzheimer’s disease, including standardized cognitive assessments, PET scans, blood tests and functional imaging. The feedback from the Q-Sub meeting will be used in support Nexalin’s upcoming clinical protocol and Investigational Device Exemption (IDE) submission in the United States.

“This constructive engagement with the FDA is critical and provides us with a clearer and more collaborative path forward for our Alzheimer’s program,” said Mark White, CEO of Nexalin Technology. “We are encouraged by the dialogue and by feedback consistent with a De Novo regulatory pathway, which underscores the novelty of our approach. The clarity gained around primary and secondary endpoints allows us to finalize a robust pilot and pivotal study design, bringing us one step closer to offering a safe, non-invasive, drug-free therapeutic option for the millions of patients and families impacted by this devastating disease.”

Nexalin’s Gen-2 SYNC console utilizes a proprietary 15-milliamp, deep-penetrating DIFS™ waveform. The technology uses a 100 kHz carrier frequency, modulated at gamma frequencies (40 Hz and 77.5 Hz), to non-invasively stimulate deep mid-brain structures associated with cognition and mood. The platform has demonstrated a favorable safety profile in international use, including multiple clinical trials and thousands of treatments, with no serious adverse events reported in these studies.

Recent independent, peer-reviewed publications in leading journals – including Radiology, the Journal of Alzheimer’s Disease and Alzheimer’s Research & Therapy – have demonstrated that Nexalin’s DIFS technology can significantly improve cognitive performance (MMSE/MoCA) and enhance functional brain connectivity in patients with Alzheimer’s disease, providing mechanistic and clinical support for the Company’s planned U.S. development strategy.

Nexalin intends to incorporate the FDA’s feedback from the Q-Sub meeting into its final Pilot Study protocol and will provide further updates on the timing of clinical milestones as appropriate.

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 designated mental health issues. Nexalin utilizes bioelectronic frequency-based medical technology to treat certain mental health issues. Evidence indicates Nexalin’s neurostimulation medical devices can penetrate structures deep in the mid-brain that are associated with certain mental health disorders. Nexalin believes the deeper-penetrating waveform in its Gen-2 and Gen-3 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. The Company undertakes no obligation to update any forward-looking statements, whether because of new information, future events or otherwise, 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

What did Nexalin announce about its Gen-2 SYNC console on December 3, 2025 (NXL)?

Nexalin completed an FDA Q-Submission meeting that provided a framework for U.S. Pilot and potential De Novo pathway for Gen-2 SYNC.

How did the FDA respond to Nexalin’s proposed clinical plan for Gen-2 SYNC (NXL)?

The FDA and Nexalin aligned on trial design elements, patient population, dosing, statistical plan, and key endpoints.

What endpoints did FDA and Nexalin discuss for the Gen-2 SYNC Alzheimer’s trials (NXL)?

They reviewed cognitive assessments, PET scans, blood tests, and functional imaging as primary and secondary endpoints.

Does the FDA feedback mean Nexalin will pursue a De Novo pathway for Gen-2 SYNC (NXL)?

The FDA discussed the potential use of a De Novo pathway and provided feedback consistent with that regulatory route.

What are the next regulatory steps for Nexalin after the Q-Sub meeting (NXL)?

Nexalin will incorporate FDA feedback into its Pilot Study protocol and prepare a U.S. IDE submission.

Has Gen-2 SYNC shown safety and efficacy in prior studies referenced by Nexalin (NXL)?

Company cites international clinical trials and peer-reviewed publications reporting favorable safety and cognitive improvements in Alzheimer’s patients.