150-Patient, Triple-Blinded, Sham-Controlled Study Designed to be Executed in Collaboration with Lindus Health to Support Future FDA Submission for Drug-Free Insomnia Treatment Builds on Prior Peer-Reviewed Clinical Data and International Regulatory Approvals HOUSTON, TX, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced continued advancement toward its planned piv ...

Core Insights - The article highlights the increasing federal focus on deep brain neurostimulation as a promising therapy for conditions such as TBI, PTSD, stroke recovery, and Alzheimer's disease, with Nexalin Technology, Inc. playing a significant role in this emerging field [1][4][10] Legislative Developments - Recent bipartisan Congressional initiatives have expanded federal support for deep brain neurostimulation research, particularly through the U.S. Department of Veterans Affairs (VA) and the National Institutes of Health (NIH) [1][4] - H.R. 7091, introduced on January 15, 2026, aims to expand clinical trials for deep brain neurostimulation and establish a compassionate use pathway within the VA system [7] - The Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026, includes provisions for neuromodulation research focused on stroke recovery among veterans, signed into law by President Trump [7] - The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026, expands NIH-supported research using deep brain stimulation for Alzheimer's and Parkinson's diseases, also signed into law by President Trump [7] Company Initiatives - Nexalin Technology's DIFS™ technology is recognized as a sophisticated form of non-invasive deep brain neurostimulation and is currently being evaluated in research with UC San Diego and the San Diego VA veterans' community [2][5] - The company is actively engaged in policy advocacy to support the inclusion of deep brain neurostimulation in federal legislation, which has raised awareness of its therapeutic potential among policymakers [8][9] - Nexalin believes that the expanding federal support for neuromodulation research aligns with its strategic focus on developing non-invasive technologies to address significant unmet medical needs [5][9] Market Opportunity - Conditions such as TBI, PTSD, stroke-related neurological impairment, Alzheimer's disease, and Parkinson's disease represent multi-billion-dollar addressable markets with significant unmet medical needs [10] - As federal research initiatives expand, Nexalin is positioned to advance emerging neurostimulation therapies within the VA system and the broader healthcare infrastructure [10][11]

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 ...

Core Viewpoint - Nexalin Technology, Inc. has received a notification from NASDAQ regarding non-compliance with the minimum bid price requirement for continued listing, specifically under NASDAQ Listing Rule 5550(a)(2) [1][2] Group 1: Compliance Notification - The company is not in compliance with the minimum bid price requirement of US$1.00 per share, as its shares have not met this threshold for 30 consecutive business days [2] - The company has been given 180 calendar days, until July 20, 2026, to regain compliance by achieving a closing bid price of at least US$1.00 for a minimum of 10 consecutive trading days [3] - The receipt of the notification does not immediately affect the trading of the company's shares, which will continue to trade on NASDAQ under the ticker "NXL" [4] Group 2: Company Actions and Future Plans - The company intends to monitor its bid price continuously and is considering various measures to improve its financial position and operational results [4] - The company is not currently considering a reverse stock split as a means to address the bid price deficiency [4] Group 3: Company Overview - Nexalin Technology, Inc. specializes in developing non-invasive neurostimulation products aimed at addressing mental health issues [5] - The company's devices are designed to provide relief for mental health disorders using bioelectronic medical technology, with a focus on deep brain structures [5] - The Nexalin Gen-2 15 milliamp neurostimulation device has received approval in multiple countries, including China, Brazil, Oman, and Israel [5]

Core Insights - Nexalin Technology, Inc. announced a peer-reviewed clinical study demonstrating that its Deep Intracranial Frequency Stimulation (DIFS™) technology leads to significant improvements in attention and cognitive performance in adults with ADHD, supported by objective brain imaging data [1][9] Group 1: Study Overview - The study was a randomized, double-blind, sham-controlled trial involving 56 adults with ADHD who underwent four weeks of Nexalin's non-invasive neurostimulation [2] - Participants receiving active treatment showed a 10.1-point average improvement on the Adult ADHD Self-Report Scale, compared to a 5.5-point improvement in the sham group, indicating a statistically significant difference (p < 0.001) [2] Group 2: Brain Imaging and Functionality - The study utilized magnetoencephalography (MEG) to assess real-time neural activity, revealing that Nexalin's DIFS™ technology reduced excessive gamma-frequency brain activity, which is often linked to ADHD symptoms [3][4] - Post-treatment, there was a normalization of communication between key brain networks involved in attention, memory, and cognitive control, suggesting improved coordination across critical brain regions [5] Group 3: Clinical Outcomes and Safety - Adults receiving active stimulation experienced significant improvements in concentration, reductions in ADHD symptoms, and enhancements in mood and sleep quality, with a safety profile comparable to sham stimulation [6] - The treatment was well tolerated, with no serious adverse events reported, reinforcing the safety of Nexalin's approach [6] Group 4: Broader Implications - The findings indicate a shift in understanding mental health conditions as disorders of brain network regulation rather than isolated chemical imbalances, positioning Nexalin's DIFS™ technology as a drug-free approach to neuromodulation [9] - Nexalin's neurostimulation devices are approved in multiple international markets, and the company continues to advance research across various neurological and psychiatric conditions [10]

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]

Core Insights - Nexalin Technology, Inc. announced the publication of a peer-reviewed study demonstrating significant clinical improvement and sustained abstinence in a patient with gambling disorder and alcohol use disorder following treatment with its neurostimulation device [1][2]. Group 1: Study Findings - The study evaluated the safety and efficacy of Nexalin's 15 milliamp (mA) neurostimulation device, showing that the patient achieved complete abstinence from gambling and alcohol after 20 outpatient sessions over 10 days, with marked cognitive improvements and no adverse effects during a three-month follow-up [1][2]. - The authors concluded that Nexalin's device is a safe and effective potential treatment for comorbid gambling and alcohol use disorders, suggesting a neuroplastic mechanism that may involve deeper brain network modulation [2][3]. Group 2: Technology and Approval - Nexalin's neurostimulation system is approved in China for treating depression and insomnia, delivering a 15 mA current at 77.5 Hz for 40 minutes per session [3]. - The company emphasizes that its technology represents a breakthrough in non-invasive brain stimulation, aiming to modulate disturbed neural circuits related to mental health and addiction [4][5]. Group 3: Future Directions - The findings from the study warrant larger, controlled trials to further evaluate the efficacy of Nexalin's device in treating addiction comorbidities and other psychiatric disorders [4]. - The company is committed to advancing global research and expanding access to its drug-free therapy, highlighting the growing international recognition of its unique approach to whole brain stimulation [5].