Nexalin Technology's Q-Submission for Gen-2 SYNC Approved by U.S. FDA for Alzheimer's Disease and Dementia Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 05 2025
0mins
Source: Newsfilter
FDA Acceptance: Nexalin Technology's Q-Submission for its Gen-2 Console ("SYNC") system aimed at treating Alzheimer's disease and dementia has been accepted by the FDA, marking a significant step towards initiating U.S. clinical studies.
Clinical Trial Discussion: The upcoming regulatory meeting with the FDA will focus on clinical trial design, study endpoints, and the regulatory pathway for evaluating the SYNC system as a non-invasive therapy for cognitive impairments.
Positive Internal Data: Recent internal data and published research indicate improvements in cognitive performance and a favorable safety profile for Nexalin's neurostimulator, which utilizes a proprietary waveform technology.
Strategic Collaborations: Nexalin is exploring partnerships with leading research institutions to expedite both U.S. and international studies involving its Gen-2 SYNC and next-generation Gen-3 HALO platforms.
Discover Tomorrow's Bullish Stocks Today
Receive free daily stock recommendations and professional analysis to optimize your portfolio's potential.
Sign up now to unlock expert insights and stay one step ahead of the market trends.
Analyst Views on NXL
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.
Nexalin Technology (NXL) Receives Nasdaq Compliance Notification, 180 Days to Regain Minimum Bid Price
- Compliance Notification: Nexalin Technology received a Nasdaq notification on January 21, 2026, indicating non-compliance with the $1 minimum bid price requirement, which could negatively impact investor confidence and market performance.
- 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.
- Operational Evaluation: Nexalin is evaluating operational and financial measures to improve its share price performance, indicating the company's commitment to restoring its stock price and potentially adopting various strategies to enhance market confidence.
- No Reverse Split Consideration: The company is currently not considering a reverse stock split, reflecting management's confidence in the existing capital structure while also indicating a cautious approach to market conditions.
Continue Reading
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.
- Price Monitoring Measures: In response to the declining stock price, Nexalin intends to continuously monitor its bid price and is considering various strategies to improve its financial position, aiming to mitigate short-term adverse effects on its trading price.
- Product Market Outlook: Nexalin's neurostimulation devices have been approved in China, Brazil, Oman, and Israel, and despite facing stock price pressures, the company remains committed to addressing the global mental health crisis through innovative technology, maintaining its competitive edge in the market.
Continue Reading