Core Viewpoint - Nexalin Technology, Inc. has successfully closed a public offering of 3,850,000 shares at a price of $1.30 per share, raising approximately $5.0 million in gross proceeds before expenses [1]. Company Overview - Nexalin Technology, Inc. specializes in developing innovative neurostimulation products aimed at addressing the global mental health crisis. The company's products are designed to be non-invasive and are believed to provide relief for mental health issues [5]. - The company utilizes bioelectronic medical technology to treat mental health disorders, with a focus on penetrating deep brain structures associated with these conditions. Nexalin's next-generation devices are expected to enhance patient response without adverse side effects [5]. - The Nexalin Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, and Oman [5]. Offering Details - The public offering was conducted under an effective shelf registration statement filed with the U.S. Securities and Exchange Commission (SEC) on April 23, 2025, and declared effective on April 29, 2025 [3]. - Maxim Group LLC served as the sole book-running manager for the offering [2].

Company Overview - Nexalin Technology, Inc. is a leader in Deep Intracranial Frequency Stimulation (DIFS™) technology aimed at addressing mental health issues through innovative neurostimulation products [5] - The company's products are designed to be non-invasive and are believed to provide relief for individuals suffering from mental health disorders [5] Public Offering Details - Nexalin announced a public offering of 3,850,000 shares of common stock priced at $1.30 per share, with expected gross proceeds of approximately $5.0 million [1] - The offering is set to close on or about May 6, 2025, subject to customary closing conditions [1] - An additional 577,500 shares may be purchased by underwriters within a 45-day option period at the public offering price [1] Use of Proceeds - The net proceeds from the offering will be utilized for working capital and general corporate purposes, including sales and marketing, product development, and capital expenditures [2] Regulatory Compliance - A shelf registration statement for the shares was filed with the SEC on April 23, 2025, and was declared effective on April 29, 2025 [3] - The offering is being conducted through a written prospectus and prospectus supplement available on the SEC's website [3]

Core Viewpoint - Nexalin Technology, Inc. is initiating formal regulatory engagement with the FDA for its Gen-2 SYNC system, aimed at treating Alzheimer's disease, dementia, and mild cognitive impairment (MCI) [1][2]. Regulatory Engagement - The company plans to submit a Q-Submission ("Q-Sub") to the FDA to facilitate structured dialogue regarding clinical trial design [1][2]. - This decision follows recent publications, encouraging internal data, and preliminary feedback from the FDA, marking a critical step in advancing Gen-2 SYNC as a non-invasive therapeutic option [2]. Product Development - The Gen-2 SYNC system features technical enhancements over prior generations, including a redesigned enclosure and a proprietary 15 milliamp advanced waveform [3]. - The company is rebranding the device to clearly differentiate it from earlier versions, marketing it as "Gen-2 SYNC" [3]. Company Focus - Nexalin is committed to progressing regulatory engagement and advancing its neuromodulation platform as a promising therapeutic alternative for cognitive and neuropsychiatric disorders [3]. - The company designs and develops innovative neurostimulation products aimed at addressing the global mental health epidemic, utilizing bioelectronic medical technology [5].

Core Insights - Nexalin Technology, Inc. has received IRB approval in Brazil for a clinical trial of its Gen-2 neurostimulation device aimed at treating anxiety disorders and chronic insomnia [1][3] - The Phase II clinical trial will involve 30 adult participants and will assess the efficacy of the device in reducing anxiety symptoms and improving sleep quality [2][3] - The study is being conducted in collaboration with the prestigious Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo [1][3] Company Developments - The first Nexalin device has been shipped to São Paulo, with more units and disposable electrodes to follow, supporting the launch of the clinical trial [2] - The trial's primary endpoint is a reduction in anxiety symptoms measured by the Hamilton Anxiety Rating Scale (HAM-A), with secondary endpoints including assessments of depressive symptoms and sleep quality [3][4] - Dr. Andre Russowsky Brunoni, a recognized expert in neuromodulation, is leading the study, which is seen as a significant step in Nexalin's global strategy [4][5] Industry Context - Anxiety and insomnia are prevalent conditions that often occur together, significantly impacting quality of life, highlighting the need for innovative treatment options [5] - Nexalin's non-invasive neurostimulation technology aims to provide a safe and effective alternative for improving mental health, addressing the ongoing global mental health epidemic [6]

Core Insights - Nexalin Technology, Inc. has successfully completed and launched phases one through five of its proprietary virtual clinic and digital research ecosystem, which supports data capture, remote monitoring, and virtual treatment with its HALO™ headset [1][2][3] Group 1: Virtual Clinic Launch - The virtual clinic was launched at the University of California, San Diego (UCSD) to facilitate patient recruitment for a military study on TBI/PTSD [1] - The platform enables real-time data capture and clinical oversight, allowing patients to receive treatment in their homes while ensuring compliance with research protocols [1][2] Group 2: Digital Infrastructure - Nexalin has established a comprehensive digital infrastructure that includes an AI-integrated Electronic Data Capture (EDC) platform and a Patient Monitoring System (PMS) [2][7] - This infrastructure enhances capabilities for remote research studies and streamlines patient care using non-invasive DIFS™ technology [2][4] Group 3: Clinical Research and Treatment - The virtual clinic facilitates clinical research on the HALO™ device, focusing on mental health disorders, traumatic brain injury, addiction, and neurodegenerative conditions [3][4] - The system allows for remote monitoring of treatment adherence and tracking of patient outcomes, optimizing clinical protocols [4][7] Group 4: Future Prospects - The completion of the virtual clinic positions Nexalin to expand research collaborations, advance regulatory approvals, and accelerate commercialization efforts for HALO™ and future DIFS™ technology applications [4]

Core Viewpoint - Proposed bipartisan legislation, the Health Tech Investment Act, aims to expand Medicare reimbursement pathways for AI-enabled medical devices, supporting Nexalin's Gen-3 HALO Clarity™ neurostimulation device integrated with AI [1][2] Group 1: Legislation Overview - The Health Tech Investment Act (S. 1399) is sponsored by Senators Mike Rounds and Martin Heinrich, proposing a transitional reimbursement mechanism under Medicare for FDA-cleared or approved AI-enabled technologies [2] - The legislation would assign New Technology Ambulatory Payment Classification (APC) codes for up to five years to AI-enabled devices, allowing CMS to collect clinical data for long-term reimbursement decisions [2] Group 2: Nexalin's Gen-3 HALO Clarity™ Device - Nexalin's Gen-3 HALO Clarity™ device is a next-generation neurostimulation system that integrates advanced AI capabilities for treatment delivery and patient monitoring, targeting mental health conditions such as anxiety and depression [3][5] - The device is designed to work with a proprietary virtual clinic ecosystem that utilizes AI for remote treatment and real-time clinical feedback, enhancing mental health care through technology [4][5] Group 3: Strategic Importance of Legislation - The Health Tech Investment Act is viewed as a legislative milestone that prioritizes innovation and accessibility in mental health care, addressing the limitations of traditional care options [6] - The legislation provides a reimbursement framework that aligns with Nexalin's strategy to enhance care coordination and monitoring through intelligent, patient-centered innovations [5][6] Group 4: Company Developments - Nexalin has completed Phase 1 of its AI-powered virtual clinic infrastructure, allowing patients to initiate therapy at home via a secure mobile app while providing clinicians with automated insights [4] - The company is preparing for FDA submission of the Gen-3 device following planned clinical trials, indicating a focus on regulatory and clinical milestones [7]

Core Viewpoint - Nexalin Technology, Inc. has received a patent for its Deep Intracranial Frequency Stimulation (DIFS™) technology, which aims to provide a non-invasive and drug-free treatment for substance use disorders, including opioid use disorder and alcohol use disorder [1][2][3] Company Overview - Nexalin Technology focuses on developing innovative neurostimulation products to address the global mental health crisis, utilizing bioelectronic medical technology to treat mental health issues [5] - The company's DIFS™ technology is designed to regulate neural pathways associated with addiction and withdrawal symptoms, potentially improving treatment outcomes for individuals with substance use disorders [1][2] Patent Significance - The patent granted by the USPTO for the "Alternating Current Dynamic Frequency Stimulation Method for Opioid Use Disorder and Substance Use Disorder" enhances Nexalin's intellectual property portfolio and validates the innovative nature of its DIFS™ technology [1][3] - This patent is seen as a significant achievement for the company, reinforcing its position as a pioneer in non-invasive brain stimulation for addiction and mental health therapy [2][3] Market Context - Substance use disorders, including opioid dependency and alcoholism, represent a major public health challenge globally, with traditional treatment methods often facing issues of accessibility and side effects [2] - Nexalin's DIFS™ technology offers a forward-thinking alternative to conventional therapies, aiming to alleviate withdrawal symptoms and support long-term recovery without the risks associated with pharmaceutical treatments [2][3]

Core Viewpoint - Nexalin Technology, Inc. has successfully enrolled the first patients in a clinical trial for its Deep Intracranial Frequency Stimulation (DIFS™) technology, aiming to treat mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) [1][2][3] Company Overview - Nexalin Technology focuses on developing innovative neurostimulation products to address the global mental health crisis, utilizing non-invasive bioelectronic medical technology [5] - The company's DIFS™ technology is designed to penetrate deep brain structures associated with mental health disorders, potentially offering enhanced patient responses without adverse side effects [5] Clinical Trial Details - The clinical trial is being conducted in collaboration with the University of California, San Diego (UCSD) and the VA San Diego Healthcare System, marking a significant step in evaluating the efficacy of Nexalin's HALO™ Clarity devices [2][3] - The trial aims to gather comprehensive data on the impact of DIFS™ technology on mental health conditions, particularly for underserved populations such as veterans [3][4] Technology and Devices - The HALO™ Clarity device is currently under evaluation and is not yet approved for marketing in the U.S., with its safety and efficacy still being assessed by the FDA [6] - Nexalin's HALO™ Clarity devices provide non-invasive, at-home neurostimulation therapy, integrated with AI for remote monitoring of patient adherence and treatment progress [4]

Company Overview - Nexalin Technology, Inc. is focused on developing innovative neurostimulation products aimed at addressing the global mental health epidemic, utilizing non-invasive bioelectronic medical technology [4] - 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 [4] Upcoming Event - Nexalin will host a webinar on April 3, 2025, at 4:15 p.m. ET, featuring CEO Mark White, who will discuss the company's clinical data and advancements in its Gen-3 HALO™ Clarity & Virtual Clinic model [2][3] - The webinar will include a live Q&A session, allowing investors to engage directly with the CEO [2] Market Potential - Nexalin's solutions have demonstrated clinically meaningful improvements in treating conditions such as insomnia, PTSD, and traumatic brain injuries, which affect millions and have limited effective treatments [2] - The mental health market is projected to reach $537 billion by 2030, indicating substantial growth potential for Nexalin's products [2]

Core Insights - Nexalin Technology, Inc. is hosting a webinar on April 3, 2025, to discuss its clinical data and advancements in neurostimulation technology [1][2] - The company is focusing on its non-invasive deep brain stimulation device, which has shown effectiveness in treating conditions like insomnia, PTSD, and traumatic brain injuries, addressing a significant market need [2] - The mental health market is projected to grow substantially, reaching $537 billion by 2030, positioning Nexalin as a potential leader in this space [2] Company Overview - Nexalin designs and develops innovative neurostimulation products aimed at addressing the global mental health crisis [4] - The company's products are non-invasive and utilize bioelectronic medical technology to target deep brain structures associated with mental health disorders [4] - The Nexalin Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, and Oman, indicating its international market presence [4]