Welcome to our dedicated page for Nexalin Tech news (Ticker: NXL), a resource for investors and traders seeking the latest updates and insights on Nexalin Tech stock.
Nexalin Technology (NXL) delivers non-invasive neurostimulation therapies for mental health and neurological conditions through its patented transcranial electrical stimulation (TES) and deep intracranial frequency stimulation (DIFS) technologies. This page provides investors and healthcare professionals with centralized access to official updates on clinical trials, regulatory milestones, and strategic initiatives.
Discover timely announcements including FDA clearances, partnerships with medical institutions, and advancements in AI-integrated treatment platforms. All content is sourced directly from company releases to ensure accuracy, with a focus on developments impacting mental health innovation and neurostimulation markets.
Key updates cover device efficacy studies, intellectual property expansions, and revenue model evolution through licensing agreements. Bookmark this page to monitor Nexalin's progress in providing drug-free alternatives for anxiety, depression, and neurological disorders while maintaining compliance with financial disclosure standards.
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.
Nexalin Technology (Nasdaq: NXL) has received a Notice of Allowance from the USPTO for a patent covering its Deep Intracranial Frequency Stimulation (DIFS™) technology for treating substance use disorders. The patent, titled 'Alternating Current Dynamic Frequency Stimulation Method for Opioid Use Disorder (OUD) and Substance Use Disorder (SUD),' encompasses treatment for opioid, alcohol, cocaine, and methamphetamine use disorders.
The DIFS™ technology represents a non-invasive, drug-free approach that aims to modulate neural pathways associated with addiction and withdrawal symptoms. This technology could offer an alternative to traditional medication-assisted treatment (MAT) and behavioral therapy, potentially avoiding their associated challenges like accessibility issues and side effects.
Nexalin Technology (NXL) has initiated patient recruitment for a clinical trial at the University of California, San Diego (UCSD) following IRB approval. The study will evaluate the company's HALO™ Clarity device for treating mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) in military and civilian populations.
The trial will test Nexalin's proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology, which provides non-invasive deep-brain stimulation without drugs or invasive procedures. The first batch of HALO devices has been delivered, randomized, and integrated with app-controlled remote monitoring. An additional 40-50 devices will be supplied as the study progresses.
Key features of the HALO™ Clarity device include:
- Non-invasive, drug-free therapy
- At-home usage capability
- AI-integrated remote monitoring through Electronic Data Capture platform
Nexalin Technology (Nasdaq: NXL), specializing in Deep Intracranial Frequency Stimulation (DIFS™), has announced that General Wesley K. Clark, former NATO Supreme Allied Commander Europe, has joined its Military & Government Advisory Board. He will work alongside David F. Lasseter and William A. Hudson, Jr. to advance the company's neurostimulation solutions in military and government sectors.
The appointment supports Nexalin's ongoing 'Nexalin America' initiative, which focuses on addressing post-traumatic stress disorder, traumatic brain injury, and substance use disorder. The company's technology offers non-invasive, frequency-based, deep-brain stimulation devices aimed at treating various mental health conditions affecting service members and veterans.
Nexalin Technology (NXL) has received IRB approval from UCSD for clinical testing of its HALO™ Clarity headset. UCSD will conduct independent research using 50 HALO devices to evaluate its efficacy in treating mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD), particularly in military personnel.
The HALO device utilizes Nexalin's proprietary Deep Intracranial Frequency Stimulation (DIFS) technology, offering non-invasive, drug-free brain stimulation. The system includes a virtual clinic model featuring AI integration, patient monitoring, and telemedicine capabilities through a smartphone application.
Key features include at-home treatment administration, remote physician monitoring, and an AI-powered Electronic Data Capture platform. The device is currently under FDA evaluation and not yet approved for these uses in the United States.
