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.

Key Figures

Stimulation current 15 milliamps Gen-2 SYNC DIFS waveform amplitude

Carrier frequency 100 kHz Deep-penetrating DIFS carrier frequency

Gamma frequency 1 40 Hz Modulation frequency for neurostimulation

Gamma frequency 2 77.5 Hz Additional modulation frequency for neurostimulation

Market Reality Check

$0.0138 Last Close

Volume Volume 78,411 is below the 20-day average of 118,897, indicating muted pre-news trading interest. low

Technical Shares at 0.9899 are below the 200-day MA of 1.32 and sit 77.45% under the 52-week high of 4.39.

Peers on Argus 1 Down

NXL was down 2.01% while several close medical-device peers (INBS, NVNO, AIMD, ALUR) were positive on the day, and only CODX was modestly negative, suggesting a stock-specific setup rather than a sector-wide move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 03	FDA Q-Sub meeting	Positive	+1.6%	FDA Q-Submission meeting completed with alignment on pilot and pivotal trial design.
Dec 02	Investor webinar	Positive	+5.4%	Announcement of investor webinar highlighting DIFS tech, Gen-3 headset, and virtual clinic.
Nov 18	Clinical case report	Positive	-1.9%	Peer-reviewed case report showing promising 15 mA device results in gambling disorder.
Nov 13	Distribution agreement	Positive	-7.1%	Exclusive Israeli distribution deal for Gen-2 SYNC after local regulatory approval.
Nov 05	FDA Q-Sub accepted	Positive	-4.3%	FDA acceptance of Q-Submission for Gen-2 SYNC in Alzheimer’s and dementia.

Pattern Detected

Recent news has been mostly positive, but 3 of the last 5 events saw negative price reactions, indicating a tendency for the stock to sell off or underperform around favorable developments.

Recent Company History

Over the last month, Nexalin reported multiple milestones around its Gen-2 SYNC neurostimulation platform. On Nov 5, the FDA accepted its Q-Submission for Alzheimer’s and dementia, followed by an Israeli distribution deal on Nov 13 and a promising gambling-disorder case report on Nov 18. An investor webinar was announced on Dec 2. Today’s Dec 3 news shows successful completion of the FDA Q-Submission meeting, aligning trial design and a potential De Novo pathway, extending the regulatory progress highlighted in earlier filings.

Market Pulse Summary

This announcement details a completed FDA Q-Submission meeting for Nexalin’s Gen-2 SYNC console in Alzheimer’s disease, with alignment on pilot and pivotal trial design and a potential De Novo pathway. It builds on earlier acceptance of the Q-Submission and supportive published data showing cognitive improvements. Investors may focus on execution of the planned U.S. IDE, upcoming pilot study milestones, and the company’s ability to fund longer pivotal programs given prior disclosures of operating losses.

Key Terms

q-submission regulatory

"announced the successful completion of a substantive Q-Submission (“Q-Sub”) meeting"

A Q-Submission is a formal request a medical product developer sends to regulators asking for written feedback or a meeting about planned studies, device design, or regulatory steps before filing for approval. For investors, it matters because this early interaction can clarify the approval pathway, reduce surprises and delays, and give a clearer timeline and risk picture—like checking a route with a traffic officer before a long trip.

de novo classification pathway regulatory

"discussed the potential use of the De Novo classification pathway for this indication"

A de novo classification pathway is a regulatory route that lets a developer get formal approval for a novel medical device that has no existing “predicate” device to compare against, by demonstrating it is reasonably safe and effective for low-to-moderate risk uses. For investors, it matters because clearing this pathway can be faster and less costly than the higher-risk routes, enabling earlier market access, revenue potential, and a clearer competitive position for a new product.

investigational device exemption (ide) regulatory

"support Nexalin’s upcoming clinical protocol and Investigational Device Exemption (IDE) submission"

An investigational device exemption (IDE) is a regulatory permission that allows a medical device to be used in clinical studies so companies can gather safety and effectiveness data before full market approval. For investors, an IDE is a key milestone because it lets a company test real-world performance and move toward commercial clearance or approval—much like a trial run that, if successful, can unlock larger revenue opportunities and reduce regulatory risk.

pet scans medical

"endpoints to measure clinically meaningful outcomes... including standardized cognitive assessments, PET scans"

A PET scan (positron emission tomography) is an imaging test that uses a tiny, safe amount of radioactive tracer to create pictures of how organs and tissues are functioning, like a heat map or live camera showing where biological activity is highest. Investors track PET scans because they are key tools in diagnosing disease, measuring how well drugs work in clinical trials, and guiding treatment decisions—factors that can influence healthcare costs, regulatory approval, and market demand for medical products.

functional imaging medical

"including standardized cognitive assessments, PET scans, blood tests and functional imaging"

Functional imaging is a group of medical scanning techniques that show how organs, tissues or cells are working in real time rather than just what they look like, for example tracking blood flow, metabolism or electrical activity. For investors, it matters because these scans are used to test drug effects, guide clinical decisions and support regulatory approvals — like a live traffic map that reveals whether treatments actually change activity where it counts.

deep intracranial frequency stimulation (difs) medical

"the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain"

Deep intracranial frequency stimulation (difs) is a medical technique that uses tiny implanted electrodes placed deep in the brain to send controlled electrical pulses at specific rhythms. Investors care because difs can change how certain neurological or psychiatric conditions are managed, so successful trials, regulatory approvals, or broader adoption can affect device makers, treatment costs, and potential market size much like a new tool changing how a common problem is fixed.

gamma frequencies medical

"uses a 100 kHz carrier frequency, modulated at gamma frequencies (40 Hz and 77.5 Hz)"

Gamma frequencies are fast brainwave patterns, typically around 30–100 hertz, that reflect high-level mental activity such as attention, memory processing, and sensory integration. For investors, they matter because technologies, therapies, or devices that detect or alter these rhythms aim to diagnose or treat neurological and psychiatric conditions, and successful products can create commercial opportunities; think of gamma waves as the brain’s rapid timing signal that companies try to monitor or tune like an engine’s high-rev tune-up.

mmse/moca medical

"technology can significantly improve cognitive performance (MMSE/MoCA) and enhance functional brain connectivity"

MMSE (Mini‑Mental State Examination) and MoCA (Montreal Cognitive Assessment) are brief, standardized quizzes clinicians use to check thinking, memory, attention and problem‑solving — like a short cognitive checkup. Investors pay attention because these scores are common endpoints in clinical trials and routine care: they help show whether a drug or device changes mental function, influence regulatory decisions and labeling, and can materially affect market size and commercial success.

AI-generated analysis. Not financial advice.

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.