Nexalin Technology, Inc. develops non-invasive Deep Intracranial Frequency Stimulation (DIFS™) technology for brain-health and mental-health indications. Company news centers on clinical evidence for its neurostimulation platform, including peer-reviewed studies involving insomnia, depression-related symptoms, traumatic brain injury, PTSD, Alzheimer’s disease, dementia-related cognitive decline and ADHD.
Updates also cover the HALO™ Clarity headset, the NeuroCare® virtual clinic platform, collaborations with clinical research and academic organizations, FDA De Novo strategy, international regulatory activity, and public-company events affecting Nexalin securities.
Nexalin Technology (Nasdaq: NXL) reported peer-reviewed clinical results (Radiology, Oct 8, 2025) showing its Gen-2 SYNC 40-Hz, 15 mA DIFS neurostimulation device produced statistically significant cognitive gains and measurable brain-connectivity changes in mild Alzheimer’s disease.
Key findings: significant MMSE and MoCA score improvements versus sham (P = .001 and .03), increased hippocampal-cortical and network functional connectivity on resting-state fMRI, a connectivity–naming-test correlation (r = 0.65, FDR-adjusted P = .008), and no reported adverse events. Device has regulatory approvals for other indications in China, Brazil, and Oman.
Nexalin Technology (NASDAQ: NXL) has secured U.S. Design Patent No. D1,092,758 for its HALO™ Clarity neuromodulation device, providing 15 years of design protection. The device utilizes the company's proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology to deliver non-invasive, drug-free treatment for mental health and neurological conditions.
The HALO™ Clarity system enables at-home, professionally supervised treatment with remote monitoring capabilities. The company is conducting multiple clinical studies across various indications including anxiety, insomnia, PTSD, and mild traumatic brain injury. The FDA has already provided consensus on pivotal trial designs for anxiety and insomnia indications.
The DIFS™ platform has demonstrated safety and efficacy signals in over two dozen trials worldwide. Nexalin has completed usability, safety, and design verification testing and is scaling manufacturing for broader clinical deployment.
Nexalin Technology (NASDAQ: NXL) will host a live investor webinar on September 9, 2025, at 4:15 p.m. ET. CEO Mark White will present the company's Deep Intracranial Frequency Stimulation (DIFS™) technology and its applications in mental healthcare.
The presentation will highlight clinical collaborations with institutions like UC San Diego, updates on the Gen-3 HALO™ Clarity headset, and the Virtual Clinic model for at-home treatment. Operating in a $537 billion mental health market, Nexalin's strategy includes international regulatory approvals, U.S. market expansion, and AI-driven patient monitoring.
Nexalin Technology (NASDAQ: NXL), a leader in Deep Intracranial Frequency Stimulation (DIFS™), has appointed Justin Van Fleet, CPA as Chief Financial Officer effective August 1, 2025. Van Fleet brings over 20 years of experience in public accounting and assurance services, most recently as Partner at Marcum LLP.
The appointment comes at a crucial time as Nexalin advances its Generation 2 and Generation 3 devices through FDA review. These non-invasive neurostimulation systems are designed to treat anxiety, depression, and other mental health conditions without drugs or surgery. Van Fleet will oversee the company's financial strategy, planning, and reporting functions during this critical growth phase.
Nexalin Technology (Nasdaq: NXL) will host a live investor webinar on June 3, 2025, at 4:15 p.m. ET. CEO Mark White will present the company's proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology for mental healthcare and provide updates on their Gen-3 HALO™ Clarity headset and Virtual Clinic model for at-home treatment. The presentation will highlight clinical collaborations with institutions like UC San Diego, international regulatory approvals, and U.S. expansion plans in the $537 billion mental health market. The webinar will include discussion of Nexalin's patented technology, AI-driven patient monitoring, and global expansion strategy, followed by a Q&A session.
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.