Nexalin Completes Key Q-Submission Meeting with FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 03 2025
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Nexalin Technology 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.
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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.
Nexalin Technology (NXL) Receives Nasdaq Compliance Notification, 180 Days to Regain Minimum Bid Price
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- Compliance Period: The company has been granted a 180-day compliance period until July 20, 2026, to regain compliance, and failure to meet this requirement may lead to more severe market consequences.
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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.
- Compliance Deadline: The company has been granted 180 days until July 20, 2026, to regain compliance; failure to do so may lead to delisting, which could negatively impact investor confidence and market perception.
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