Nexalin Advances FDA Alzheimer’s Strategy Following Landmark Leadership Meetings in the U.S. and China
Rhea-AI Summary
Nexalin Technology (Nasdaq: NXL) completed high-level U.S. and China meetings and a productive Q-Submission interaction with the FDA to shape its De Novo regulatory pathway for Alzheimer’s treatment. The company plans to submit an amended FDA Q-Submission in Q2 2026 and is finalizing clinical trial design with primary and secondary endpoints informed by FDA guidance.
China collaboration with Professor Yi Tang adds one of the largest single-center real-world data sets using Nexalin’s DIFS non-invasive neurostimulation in aging and dementia populations.
Positive
- Amended FDA Q-Submission planned for Q2 2026
- Completed productive Q-Submission interaction providing FDA clinical guidance
- Large single-center real-world data set in China with Professor Yi Tang
- Focus on non-invasive, drug-free DIFS therapy for Alzheimer’s symptoms
Negative
- No FDA clearance yet; De Novo application remains in preparation
- No quantitative clinical efficacy or financial results disclosed in this announcement
Key Figures
Key Terms
deep intracranial frequency stimulation (difs) medical
q-submission regulatory
de novo application regulatory
neurostimulation medical
neural plasticity medical
nasdaq capital market regulatory
form 25 regulatory
equity method financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
Company Designing FDA Application Amendments and U.S. Clinical Strategy Leveraging Extensive Real-World Neurostimulation Data Sets Reflecting Broad Clinical Experiences
HOUSTON, TX, April 15, 2026 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in non-invasive Deep Intracranial Frequency Stimulation (DIFS™) of the brain, announced the successful completion of a series of high-level meetings in the United States and China focused on advancing the Company’s global clinical strategy for the treatment of Alzheimer’s disease and dementia related cognitive decline. These meetings, including a productive Q-Submission interaction with the U.S. Food and Drug Administration (FDA), represent key milestones in the preparation of Nexalin’s De Novo application with the FDA for the treatment of Alzheimer’s disease. The FDA provided clinical guidance on the proposed Alzheimer’s symptom reduction FDA clinical trial and regulatory pathway. The Nexalin clinical and research teams are currently finalizing the clinical design that will provide primary and secondary endpoints to follow FDA guidance on clinical relevance and treatment response in the Alzheimer’s patient population. The Company plans to submit an amended FDA Q-Submission application based on these strategy meetings in Q2 2026.
The high-level meetings brought together Nexalin leadership, American-based academic research teams and members of the international Alzheimer’s clinical community. Insights gained from these discussions are directly informing Nexalin’s FDA strategy and shaping the final design of its upcoming FDA clinical trial focused on Alzheimer’s disease and age-related cognitive vulnerability.
“These meetings marked a critical step in aligning our global clinical experience with a disciplined U.S. regulatory and clinical strategy,” said Mark White, President and Chief Executive Officer of Nexalin Technology. “The meeting insights and observations are directly informing our planned FDA application amendments and design of our FDA Alzheimer’s clinical trial. We believe this regulatory strategy will position Nexalin to become the leader in drug-free, non-invasive treatment focused on the core mechanisms of cognitive decline and the reduction of Alzheimer’s-related symptoms.”
China Collaboration Highlights Scale of Real-World Clinical Experience
As part of the initiative, Nexalin’s China team continues to meet and collaborate with Professor Yi Tang M.D., PhD, a globally recognized expert in Alzheimer’s disease and geriatric neurology. Professor Tang serves as Vice Chairman of Xuanwu Hospital at Capital Medical University and holds leadership roles at China’s National Neuroscience and Research Center for Geriatric Diseases.
Professor Yi Tang M.D., PhD, brings extensive real-world clinical experience from ongoing studies using Nexalin’s medical device on Alzheimer’s patients in China, representing one of the largest single-center bodies of data involving Nexalin’s non-invasive neurostimulation in aging and dementia-related populations.
Focus on Core Disease Mechanisms
According to Nexalin leadership, the central theme of Nexalin’s clinical strategy is the importance of addressing disrupted brain networks and thereby reducing the symptoms in Alzheimer’s disease and age-related cognitive decline. Nexalin will continue to focus on resetting and stabilizing disrupted brain networks associated with mental and cognitive impairment. The clinical design and regulatory strategy is built around providing relief to both the Alzheimer’s patient and caretaker. Ultimately, Nexalin intends to provide evidence that Nexalin can slow and possibly delay the need for admission to hospitals and memory care centers for the patient.
Unlike current neurostimulator technologies, Nexalin’s proprietary DIFS technology enables direct stimulation of neurons across the entire brain, delivering targeted intervention for disrupted brain network connectivity. It modulates and encourages the brain’s neural plasticity to restore connectivity and physiological stability. Nexalin’s frequency-based treatment mitigates pathological changes associated with age-related cognitive decline, including Alzheimer’s disease.
Positioning for Future Clinical and Regulatory Catalysts
Nexalin believes its growing international clinical experience and ongoing research efforts provide a strong foundation for advancing its Alzheimer’s disease strategy in the United States and major global markets. The Company’s approach focuses on restoring disrupted brain networks and improving cognitive stability associated with Alzheimer’s disease using a safe, non-invasive, drug-free neurostimulation medical device.
Nexalin remains committed to advancing brain health in the United States and around the world through rigorous clinical research and education on the Nexalin DIFS non-invasive neurostimulation technology, while adhering to the highest scientific, ethical, and regulatory standards.
About Nexalin Technology, Inc.
Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. Nexalin's medical devices are non-invasive and undetectable to the human body. Nexalin products are developed to provide relief to those afflicted with mental health issues using bioelectronic medical technology. 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, Oman and Israel. 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 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
