Nexalin Completes Q-Submission Meeting with FDA to Advance Alzheimer's Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 03 2025
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Source: Newsfilter
- Successful FDA Meeting: Nexalin's completion of the Q-Submission meeting with the FDA marks a significant advancement in its clinical development plan for the Gen-2 SYNC™ neurostimulation console aimed at treating Alzheimer's disease.
- Exploring New Pathways: The discussion included the potential use of the De Novo classification pathway, reflecting the innovative mechanism of Nexalin's deep frequency-specific neurostimulation technology, laying the groundwork for future regulatory approvals.
- Clinical Trial Design: Nexalin and the FDA reached alignment on foundational elements of trial design, including patient population and statistical analysis plans, ensuring scientific rigor and efficacy for upcoming pilot and pivotal studies.
- Safety and Efficacy: The Gen-2 SYNC console has demonstrated a favorable safety profile in international trials, with studies indicating significant improvements in cognitive performance for Alzheimer's patients, supporting the company's U.S. development strategy.
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About NXL
Nexalin Technology, Inc. is engaged in designing and developing neurostimulation products for the mental health epidemic. The Company has developed an easy-to-administer medical device (Generation 1 or Gen-1) that utilizes bioelectronic medical technology to treat anxiety, depression and insomnia, without the need for drugs or psychotherapy. Its original Gen-1 devices are cranial electrotherapy stimulation (CES) devices that emit a waveform at 4 milliamps during treatment. It has also designed and developed a new advanced waveform technology to be emitted at 15 milliamps through new and improved medical devices referred to as (Generation 2 or Gen-2) and (Gen-3). Gen-2 is a clinical use device with a modern enclosure to emit the new 15 milliamp advanced waveform. Gen-3 is a new patient headset that will be prescribed by licensed medical professionals in a virtual clinic setting like existing telehealth platforms. Its products are non-invasive and undetectable to the human body.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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Nexalin Technology Receives Nasdaq Warning for Non-Compliance with Minimum Bid Price
- Nasdaq Warning: Nexalin Technology received a notification on January 21, 2026, from Nasdaq regarding non-compliance with the minimum bid price requirement of $1.00 per share, posing a risk to its continued listing on the exchange.
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