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 diseaseHOUSTON, 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 it ...

HOUSTON, TX, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL) is pleased to invite investors to a webinar on December 4, 2025, at 4:15 p.m. ET. The exclusive event, hosted by RedChip Companies, will feature Nexalin’s CEO Mark White, who will provide an inside look at Nexalin’s game-changing approach to mental healthcare through its proprietary, non-invasive Deep Intracranial Frequency Stimulation (DIFS™) technology. White will detail the Company’s growin ...

Peer-reviewed case report published in The American Journal on Addictions highlights significant clinical improvement and sustained abstinence following Nexalin’s non-invasive therapyHOUSTON, TX, Nov. 18, 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 publication of an independent, peer-reviewed study in The American Journal on Addictions titled “High-intensity trans ...

Device Classification and Regulatory Approvals - The Gen-1 device is classified as a Class II device for anxiety and insomnia and Class III for depression, requiring a new 510(k) application for marketing approval[92][93]. - The Gen-2 device has received regulatory approval in China for treating insomnia and depression, allowing for marketing and sales in that region[112]. - The Gen-2 device has been granted regulatory approval by the Brazilian Health Regulatory Agency as of June 13, 2024[115]. - The FDA accepted a Q-Submission for the Gen-2 SYNC system targeting Alzheimer's disease and dementia, with a regulatory meeting scheduled[101]. - The Gen-2 SYNC and Gen-3 HALO devices are in the Q-submission process for FDA review, aiming for commercialization upon clearance[95][96]. Device Development and Clinical Trials - Clinical trials for the Gen-2 SYNC and Gen-3 HALO devices are planned in the U.S., Brazil, and China throughout 2025 and 2026[98]. - The new Gen-2 SYNC and Gen-3 HALO devices utilize a 15 milliamp waveform, representing a more than 400% increase in power compared to the Gen-1 device[104]. - A virtual clinic is being developed to allow physicians to diagnose and prescribe the Gen-3 HALO headset in a private tele-psychiatry setting[109]. - The company has formed a Military & Government Advisory Board to enhance relationships with U.S. federal government organizations for device deployment[113]. Financial Performance - Revenues for the three months ended September 30, 2025, were approximately $18,149,000, a decrease of 50% compared to $36,031,000 in 2024[116]. - Gross profit for the three months ended September 30, 2025, was approximately $14,201,000, down 39% from $23,337,000 in 2024, with gross profit margins of 78% and 65% respectively[118]. - Total operating expenses for the three months ended September 30, 2025, were approximately $2,359,832, a decrease of 7% from $2,531,854 in 2024[119]. - Net loss for the three months ended September 30, 2025, was $2,276,311, a reduction of 7% compared to a net loss of $2,448,257 in 2024[116]. - Revenues for the nine months ended September 30, 2025, were approximately $129,752,000, an 8% decrease from $141,542,000 in 2024[125]. - Total operating expenses for the nine months ended September 30, 2025, were approximately $6,067,122, an increase of 22% from $4,991,695 in 2024[128]. - Net cash used in operating activities for the nine months ended September 30, 2025, was approximately $3,809,636, an increase of $1,000,000 compared to $2,809,914 in 2024[135]. - Net cash used in investing activities for the nine months ended September 30, 2025, was approximately $821,171, a decrease from $2,205,079 in 2024[136]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was approximately $4,646,397, compared to $4,516,184 in 2024[137]. - Research and development expenses for the nine months ended September 30, 2025, increased by approximately $404,940, primarily due to costs associated with the Halo development project and APP development[131]. Company Outlook and Risks - As of September 30, 2025, the company had an accumulated deficit of approximately $90.49 million[139]. - For the nine months ended September 30, 2025, the company reported a loss from operations of approximately $5.85 million and negative cash flows from operations of approximately $3.81 million[139]. - The company had cash and cash equivalents of approximately $590,000 and short-term investments of approximately $3.76 million as of September 30, 2025[139]. - The company anticipates continued operating losses as it executes its development plans through 2025 and beyond[139]. - The company's ability to continue as a going concern is dependent on generating revenue from joint ventures and obtaining U.S. approval for device sales[140]. - Management concluded that the company will not have sufficient cash and short-term investments to meet anticipated cash requirements for the next twelve months[140]. - The company faces numerous risks in product development, including successful enrollment in clinical trials and compliance with regulatory requirements[138]. - The company has produced Gen-2, which is currently selling in China, but the development of future products remains highly uncertain[138]. - In September 2025, the company's warrants expired, and a Form 25 was filed with the SEC to indicate their delisting[144]. - The company is focused on protecting its intellectual property and maintaining a safety profile for its products post-approval[145].

Appointment Follows Israeli Ministry of Health Approval for Nexalin’s Gen-2 SYNC DeviceHOUSTON, TX, Nov. 13, 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 that it has entered into an exclusive distribution agreement with Carmi Masha Technologies Ltd. (“Carmi Masha”), a leading Israeli medical device distributor, to market and sell Nexalin’s Gen-2 Console (“SYNC”), 15 mi ...

Core Insights - The FDA has accepted Nexalin Technology's Q-Submission for its Gen-2 Console system aimed at treating Alzheimer's disease and dementia, marking a significant step towards clinical studies in the U.S. [1][2][4] Regulatory Milestone - The acceptance of the Q-Submission allows for structured dialogue with the FDA regarding clinical trial design, study endpoints, and regulatory pathways for the Gen-2 SYNC system [2][6]. - This regulatory milestone is based on encouraging internal data and published studies that suggest the potential of Nexalin's neurostimulator to improve cognitive function and memory [3][4]. Product and Technology - Nexalin's Gen-2 SYNC platform utilizes a proprietary 15-milliamp waveform designed to stimulate brain structures related to cognition and mood without drugs or surgical procedures [3][10]. - The company is also evaluating strategic collaborations with research institutions to accelerate studies involving its Gen-2 SYNC and next-generation Gen-3 HALO platforms [7]. Clinical Evidence - Recent data and independent research indicate observed improvements in cognitive performance in pilot studies using Nexalin's technology, with no serious adverse events reported, highlighting a favorable safety profile [9][10]. - EEG and qEEG evidence suggests that the waveform induces modulation correlated with improved neural connectivity in dementia-related conditions [9].

Core Insights - Nexalin Technology, Inc. has received regulatory approval for its Gen-2 Console ("SYNC"), a 15 milliamp neurostimulation device, for sale in Israel, marking a significant milestone for the company [1][2] - The approval in Israel enhances the global credibility of Nexalin's platform and supports its strategy for international market expansion, building on previous approvals in China, Brazil, and Oman [2][3] Company Overview - Nexalin Technology designs and develops innovative neurostimulation products aimed at addressing the global mental health epidemic, with a focus on non-invasive and undetectable treatments [3] - The company's neurostimulation devices are designed to penetrate deep brain structures associated with mental health disorders, potentially offering enhanced patient responses without adverse side effects [3] Market Strategy - Following the regulatory clearance in Israel, Nexalin is accelerating discussions with regional distribution partners to launch commercial sales of its non-invasive mental health treatment solutions [2]

Core Insights - Nexalin Technology, Inc. has demonstrated through three independent studies that its non-invasive Deep Intracranial Frequency Stimulation (DIFS™) technology can improve cognitive function and brain activity in Alzheimer's disease patients [1][2][7] Study Summaries - **TRANSFORM-AD Study**: A randomized, double-blind trial involving 46 patients showed that 30 one-hour DIFS sessions over 15 days led to immediate improvements in cognitive scores (MMSE and MoCA) and brain activity, marking the first evidence of hippocampal activation from DIFS in Alzheimer's [3] - **Altered Neuronal Activity Study**: This study utilized resting-state fMRI to reveal significant increases in functional amplitude of low-frequency fluctuations (fALFF) and regional homogeneity (ReHo) in critical brain areas, indicating DIFS' effectiveness in restoring neuronal synchronization and blood flow [4] - **Modulation of Connectivity Study**: Published in Radiology, this research found that DIFS significantly enhanced cognitive function and connectivity between the hippocampus and cortical regions, with improvements correlating with imaging findings, thus linking brain network modulation to cognitive outcomes [5] Market Context - The global Alzheimer's market is projected to exceed $20 billion annually, with current treatments primarily focused on pharmacologic therapies targeting amyloid or tau proteins, which often provide modest benefits and carry safety risks [6] - Nexalin's DIFS technology offers a fundamentally different approach, potentially positioning the company as a paradigm-shifting solution for patients seeking safe and effective alternatives to traditional drug regimens at lower costs [6][8] Company Statements - The convergence of findings from the three studies supports the efficacy of Nexalin's DIFS technology in restoring brain networks and improving cognitive function in Alzheimer's patients, representing a compelling non-invasive data set in the field [7] - The company emphasizes that its DIFS technology is drug-free, non-invasive, and has no reported serious side effects, targeting network dysfunction rather than protein accumulation [8]

Core Insights - Nexalin Technology, Inc. has appointed Dr. Robert Rothstein to its Scientific Advisory Board, enhancing its focus on addressing the global mental healthcare crisis, particularly in Alzheimer's disease and Traumatic Brain Injury (TBI) [1][3] Company Developments - Dr. Rothstein brings over 40 years of experience in emergency medicine and mental health, having held senior roles at institutions like the University of Chicago and Johns Hopkins Medicine, which positions him well to support Nexalin's neuropsychiatric therapeutic initiatives [2][4] - The expansion of the Scientific Advisory Board follows a reconstitution in May 2025, aligning with Nexalin's intensified focus on Alzheimer's disease and TBI, with plans to initiate Alzheimer's-specific trials in Q4 2025 [3][5] Strategic Focus - Nexalin's DIFS™ technology is believed to stimulate deep brain regions linked to memory and executive function, with ongoing research suggesting its potential benefits for TBI recovery, especially in military populations [3][5] - The company aims to leverage robust imaging biomarkers and MEG-guided protocols to support its clinical trials, ensuring rigorous oversight from the Scientific Advisory Board [5] Industry Context - The company is positioned at the intersection of bioelectronic medicine and unmet neuropsychiatric needs, with Dr. Rothstein expressing enthusiasm for the non-invasive nature of Nexalin's technology in treating Alzheimer's and TBI [4]

Core Insights - Nexalin Technology, Inc. is participating in the 2025 Maxim Growth Summit on October 22nd, showcasing its leadership in Deep Intracranial Frequency Stimulation (DIFS™) technology [1][2] Company Overview - Nexalin develops innovative neurostimulation products aimed at addressing the global mental health epidemic, focusing on non-invasive and undetectable treatments [3] - The company's neurostimulation devices are designed to penetrate deep brain structures associated with mental health disorders, potentially enhancing patient response without adverse side effects [3] - The Nexalin Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, and Oman, indicating its international market potential [3]