Core Insights - Nexalin Technology, Inc. has launched its AI-designed virtual clinic platform, NeuroCare®, in collaboration with UC San Diego, aimed at enhancing patient access and reducing costs in brain health care [1][5] - The NeuroCare platform will facilitate remote treatment for conditions such as Alzheimer's, mood disorders, and military-related conditions, utilizing the Gen-3 HALO™ headset for neurostimulation [2][4] Group 1: Product and Technology - The NeuroCare platform integrates with Nexalin's Gen-3 HALO™ headset, providing a comprehensive ecosystem for remote monitoring and treatment of brain health issues [4] - The Gen-3 HALO™ headset is designed to deliver improved Deep Intracranial Frequency Stimulation (DIFS™) in a home setting, enhancing patient experience and treatment outcomes [4][6] Group 2: Business Model and Market Strategy - Nexalin's business model is subscription-based, promoting sustainable revenue and long-term patient engagement through remote monitoring and care continuity [2][3] - The company aims to scale its operations beyond device sales, focusing on data-driven revenue growth and long-term patient retention in global markets [4][5] Group 3: Clinical Research and Collaboration - The launch of the NeuroCare platform coincides with ongoing clinical trials at UC San Diego, where patient enrollment has begun for evaluating Nexalin's non-invasive treatment methods [1][4] - This collaboration is expected to enhance the clinical infrastructure and support the deployment of Nexalin's digital health ecosystem [1][4]

Core Viewpoint - Nexalin Technology, Inc. has launched a new AI-designed virtual clinic platform, NeuroCare®, in partnership with UC San Diego, aimed at enhancing access to neurotherapy for brain health disorders while reducing costs and stigma associated with treatment [1][5] Group 1: Product and Technology - The NeuroCare platform allows patients with conditions such as Alzheimer's, mood disorders, and military-related issues to use Nexalin's HALO headset for neurostimulation treatment at home [2][4] - The Gen-3 HALO™ headset integrates with the NeuroCare platform, providing a comprehensive ecosystem for remote physician oversight and advanced therapy delivery [4] Group 2: Business Model and Market Strategy - The NeuroCare platform operates on a subscription-based model, promoting sustainable revenue and long-term patient outcomes [2][3] - Nexalin aims to transition from device sales to long-term recurring revenue through data-driven clinical outcomes and patient retention strategies [4][5] Group 3: Clinical Research and Development - The collaboration with UC San Diego builds on ongoing clinical research, with patient enrollment already underway for trials evaluating Nexalin's non-invasive treatment methods [1][4] - The launch of the Gen-3 HALO headset is part of a broader strategy to address the global mental health epidemic through innovative neurostimulation technology [6]

Peer-Reviewed Imaging Across Multiple Indications Validates Nexalin’s Ability to Modulate Deep Brain Networks, Differentiating It from other Superficial Neurostimulation TechniquesHOUSTON, TX, Feb. 02, 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, today highlighted Nexalin’s rigorous peer-reviewed clinical research validating its proprietary neurostimulation technology acr ...

HOUSTON, TX, Jan. 23, 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, today announced that it has received a notification letter (the "Notification Letter") from the Nasdaq Stock Market LLC (the "NASDAQ") dated January 21, 2026, notifying the Company that it is not in compliance with the minimum bid price requirement as set forth under NASDAQ Listing Rule 5550(a)(2) for cont ...

Four weeks of non-invasive DIFS™ neurostimulation delivers meaningful attention gains alongside objective brain imaging changesHOUSTON, TX, Jan. 14, 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, today announced the publication of a new peer-reviewed clinical study in Molecular Psychiatry demonstrating Nexalin’s Deep Intracranial Frequency Stimulation (DIFS™) technology pro ...

Core Insights - Nexalin Technology, Inc. has successfully completed a Q-Submission meeting with the FDA regarding its Gen-2 SYNC neurostimulation console for Alzheimer's disease, indicating a clear regulatory pathway for the device [1][2][5] Group 1: FDA Interaction and Regulatory Pathway - The meeting focused on Nexalin's clinical development plan and regulatory strategy, discussing the potential use of the De Novo classification pathway due to the novel mechanism of action of the technology [2][3] - Feedback from the FDA provided clarity on primary and secondary endpoints for measuring clinically meaningful outcomes in Alzheimer's disease, which will support Nexalin's upcoming clinical protocol and Investigational Device Exemption (IDE) submission [4][7] Group 2: Clinical Study Plans - Nexalin plans to conduct new U.S.-based Pilot Studies followed by a large pivotal study to demonstrate the safety and efficacy of the Gen-2 SYNC console in patients with mild to moderate Alzheimer's disease [3][5] - The design of both pilot and pivotal trials has been discussed, with alignment on key components such as patient population, dosing paradigm, and statistical analysis plan [3][4] Group 3: Technology and Efficacy - The Gen-2 SYNC console utilizes a proprietary 15-milliamp DIFS waveform, employing a 100 kHz carrier frequency modulated at gamma frequencies (40 Hz and 77.5 Hz) to non-invasively stimulate brain structures associated with cognition and mood [5] - Independent peer-reviewed studies have shown that Nexalin's DIFS technology can significantly improve cognitive performance and enhance functional brain connectivity in Alzheimer's patients, supporting the company's development strategy [6]

Core Insights - Nexalin Technology, Inc. is hosting a webinar on December 4, 2025, to discuss its innovative approach to mental healthcare using its proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology [1][2] - The company is positioned in a $537 billion mental health market, with international regulatory approvals and U.S. expansion plans underway [2] Company Overview - Nexalin develops non-invasive neurostimulation products aimed at addressing the global mental health epidemic, utilizing bioelectronic frequency-based medical technology [4] - The company's devices, including the Gen-2 and Gen-3 models, are designed to penetrate deep brain structures associated with mental health disorders, enhancing patient response without adverse side effects [4] - The Gen-2 15 milliamp neurostimulation device has received approvals in multiple countries, including China, Brazil, Israel, and Oman [4] Webinar Details - The webinar will feature CEO Mark White, who will present clinical evidence and updates on the Gen-3 HALO™ Clarity headset and Virtual Clinic model for scalable at-home treatment [2] - A live Q&A session will follow the presentation, allowing investors to engage directly with the CEO [2][3]

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].

Core Insights - Nexalin Technology, Inc. has entered into an exclusive distribution agreement with Carmi Masha Technologies Ltd. to market and sell its Gen-2 SYNC device in Israel following regulatory approval from the Israeli Ministry of Health [1][2][3] Group 1: Agreement Details - The agreement allows Carmi Masha to manage sales, marketing, clinical education, importation, registration, and distribution of the SYNC device across various healthcare facilities in Israel [2] - The Gen-2 SYNC device is a non-invasive neurostimulation device designed to treat mental health disorders such as insomnia, depression, and anxiety [2][4] Group 2: Future Applications - Nexalin and Carmi Masha plan to explore future applications of the SYNC technology for conditions like PTSD, TBI, Alzheimer's disease, and other forms of dementia [2] Group 3: Company Strategy - The partnership is part of Nexalin's broader strategy to expand its global presence in high-value international markets and strengthen its footprint in the Middle East [3] - Nexalin's products are designed to be non-invasive and aim to provide relief for mental health issues using bioelectronic frequency-based medical technology [4]