Welcome to our dedicated page for Nexalin Tech news (Ticker: NXLIW), a resource for investors and traders seeking the latest updates and insights on Nexalin Tech stock.
Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) generates news centered on its non-invasive, frequency-based neurostimulation devices and their application in mental health and neurological disorders. News coverage for Nexalin often highlights developments related to its proprietary Deep Intracranial Frequency Stimulation (DIFS™) platform, including clinical data, regulatory milestones, and international commercialization activities.
Investors and followers of Nexalin’s news can expect updates on peer-reviewed studies involving the company’s technology in conditions such as Alzheimer’s disease, dementia, attention deficit hyperactivity disorder (ADHD), and gambling disorder with alcohol use disorder comorbidity. Recent announcements have described randomized, sham-controlled trials and case reports that examine changes in cognition, attention, and brain network function using tools like EEG, MEG, and functional MRI, as well as reported safety and tolerability outcomes.
Nexalin’s news flow also includes regulatory and strategic updates, such as Q-Submission interactions with the U.S. Food and Drug Administration for the Gen-2 SYNC™ console in Alzheimer’s disease, acceptance of FDA filings, and discussions of potential De Novo pathways. Internationally, the company reports on regulatory approvals in markets including China, Brazil, Oman, and Israel, along with distribution agreements like its exclusive partnership with Carmi Masha Technologies Ltd. in Israel.
Additional coverage may feature corporate events, investor webinars, conference participation, and Scientific Advisory Board appointments that relate to Nexalin’s focus on mental health, Alzheimer’s disease, and traumatic brain injury research. For users tracking NXLIW and NXL, this news page offers a centralized view of clinical, regulatory, and corporate developments that shape Nexalin’s progress in the neurostimulation and mental health space.
Nexalin Technology (NASDAQ: NXL) has reconstituted its Scientific Advisory Board (SAB) with three leading experts to advance its Alzheimer's disease program. The company appointed Dr. Mingxiong Huang, Dr. David Owens, and Dr. Abe Scheer to guide its clinical development of Deep Intracranial Frequency Stimulation (DIFS™) technology.
Nexalin's Gen-2 SYNC and Gen-3 Halo™ headset delivers DIFS™, a proprietary waveform technology that can penetrate deep brain structures. Recent data suggests DIFS™ may promote neuroplasticity and functional recovery in memory and executive function regions. The company plans to initiate new Alzheimer's-focused clinical studies in Q3 2025, incorporating cognitive testing, imaging biomarkers, and MEG-guided metrics.
Nexalin Technology (NASDAQ: NXL), a company specializing in Deep Intracranial Frequency Stimulation (DIFS™) technology, has successfully closed its previously announced underwritten public offering. The company issued 3,850,000 shares of common stock at $1.30 per share, raising approximately $5.0 million in gross proceeds before deducting underwriting costs and other expenses.
The offering was conducted through Maxim Group LLC as the sole book-running manager, under an effective shelf registration statement on Form S-3. The securities were offered through a prospectus and prospectus supplement, with documentation available on the SEC's website.
Nexalin Technology (NASDAQ: NXL), specializing in Deep Intracranial Frequency Stimulation (DIFS™), has announced a $5.0 million public offering of common stock. The company is offering 3,850,000 shares at $1.30 per share, with an additional 45-day option for underwriters to purchase up to 577,500 shares.
The offering, managed by Maxim Group LLC as the sole book-runner, is expected to close around May 6, 2025. Nexalin plans to use the proceeds for working capital and general corporate purposes, including sales and marketing activities, product development, and capital expenditures. The offering is made through a shelf registration statement filed with the SEC on April 23, 2025, and declared effective on April 29, 2025.
Nexalin Technology (NASDAQ: NXL) has announced plans to submit a Q-Submission to the FDA for its Gen-2 SYNC system, marking a crucial step in its regulatory pathway. The Q-Sub aims to facilitate discussions with the FDA regarding clinical trial design for treating Alzheimer's disease, dementia, and mild cognitive impairment (MCI).
This decision follows encouraging internal data and preliminary FDA feedback. The Gen-2 SYNC system features technical improvements, including a redesigned enclosure and integration of Nexalin's proprietary 15 milliamp advanced waveform. The company is also undertaking a rebranding initiative to differentiate this system from previous versions.
Nexalin Technology (Nasdaq: NXL) has received institutional review board (IRB) approval in Brazil to begin a Phase II clinical trial for its Gen-2 neurostimulation device. The study will evaluate the treatment of anxiety disorders and chronic insomnia at the Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo.
The trial will enroll 30 adult patients to assess the efficacy of Nexalin's Deep Intracranial Frequency Stimulation (DIFS™) technology. The primary endpoint will measure anxiety reduction using the Hamilton Anxiety Rating Scale (HAM-A), with secondary endpoints including assessments of depression symptoms, sleep quality, and clinical improvement.
Led by Dr. Andre Russowsky Brunoni, the study marks Nexalin's first IRB-approved trial in Brazil. The first device has been shipped to São Paulo, with additional units and disposable electrodes scheduled for delivery soon. Results will be published in a peer-reviewed scientific journal.
Nexalin Technology (Nasdaq: NXL) has announced the successful completion and launch of phases one through five of its proprietary virtual clinic and digital research ecosystem. The AI-powered platform, launched at UCSD, will support the recently announced TBI/PTSD military study using the HALO™ headset.
The virtual clinic features include:
- AI-Powered Electronic Data Capture (EDC) for real-time data collection
- Remote Patient Monitoring System (PMS) for treatment oversight
- Telemedicine integration for virtual treatment
- Cloud-based compliance management
The system enables civilian and military patients to receive Deep Intracranial Frequency Stimulation (DIFS™) treatment at home while ensuring protocol compliance. This digital infrastructure manages clinical research, tracks patient progress, and optimizes treatment delivery for mental health disorders, TBI, addiction, and neurodegenerative conditions.
Nexalin Technology (Nasdaq: NXL) has announced its support for the Health Tech Investment Act (S. 1399), a bipartisan legislation that would expand Medicare reimbursement for AI-enabled medical devices. The bill proposes a transitional reimbursement mechanism through New Technology Ambulatory Payment Classification codes for up to five years.
The company's upcoming Gen-3 HALO Clarity™ device, currently in development for FDA submission, integrates AI capabilities for treating anxiety, depression, and insomnia through non-invasive neurostimulation. Nexalin has completed Phase 1 of its AI-powered virtual clinic infrastructure, enabling home-based therapy initiation and real-time clinical monitoring through a secure mobile app.
The legislation, sponsored by Senators Mike Rounds and Martin Heinrich, aims to bridge the gap between device approval and coverage, supporting Nexalin's strategy of combining precision neurostimulation with AI-driven healthcare solutions.
Nexalin Technology (Nasdaq: NXL) has received USPTO patent approval for its Deep Intracranial Frequency Stimulation (DIFS™) technology, specifically for treating Substance Use Disorders (SUDs). The patent, titled 'Alternating Current Dynamic Frequency Stimulation Method for Opioid Use Disorder (OUD) and Substance Use Disorder (SUD),' strengthens the company's intellectual property portfolio.
DIFS™ is a non-invasive, drug-free treatment designed to help individuals with various substance use disorders, including opioid, alcohol, and stimulant addictions. The technology works by applying deep-brain stimulation at dynamic frequencies to regulate neural pathways associated with addiction and withdrawal symptoms.
The technology aims to address chronic relapse by targeting underlying anxiety, depression, and cravings through neuromodulation, potentially offering an alternative to traditional treatments like medication-assisted therapy (MAT) that may have accessibility issues and side effects.
Nexalin Technology (Nasdaq: NXL) has initiated patient treatment in its clinical trial at the University of California, San Diego (UCSD) in collaboration with the VA San Diego Healthcare System. The trial evaluates the company's proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology, delivered through HALO™ Clarity devices, for treating mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) in both military and civilian populations.
The study marks a transition from recruitment to active participation, utilizing non-invasive, at-home neurostimulation therapy with AI-integrated remote monitoring. The company's Electronic Data Capture (EDC) platform and Patient Monitoring System (PMS) enable real-time tracking of patient adherence and treatment progress. Additional HALO™ Clarity devices will be deployed as the study advances to ensure comprehensive patient coverage and data collection.
Nexalin Technology (Nasdaq: NXL) announces an upcoming investor webinar scheduled for April 3, 2025, at 4:15 p.m. ET. The event, hosted by RedChip Companies, will feature CEO Mark White presenting insights on the company's:
1. Non-invasive frequency-based deep brain stimulation device
2. Growing clinical data supporting their technology
3. Progress on the new Gen-3 HALO™ Clarity & Virtual Clinic model
The company's solutions have demonstrated clinically meaningful improvements in treating insomnia, PTSD, and traumatic brain injuries. These conditions, affecting millions with treatment options, position Nexalin in a market projected to reach $537 billion by 2030. The webinar will conclude with a live Q&A session.