NXL News & Events

Nexalin Technology announced continued advancement toward its planned pivotal clinical trial evaluating HALO Clarity for the treatment of moderate to severe insomnia, designed to support Nexalin's planned de novo submission to the U.S. Food and Drug Administration. The study is being conducted in collaboration with Lindus Health, a full-service clinical research organization engaged to oversee trial execution, regulatory preparation, and patient recruitment.

Nexalin Technology "commended" the recent series of bipartisan Congressional initiatives expanding federal focus on deep brain neurostimulation and related neuromodulation research within the U.S. Department of Veterans Affairs and the National Institutes of Health, NIH. Nexalin's team participated in and helped shape specific portions of the legislation to expand veterans' access to emerging treatments, and commends Congress on the recent passage of appropriations packages that included provisions to support neurostimulation research. "These legislative developments reflect growing national recognition of neurostimulation technologies as a potential breakthrough category of care. We deeply appreciate Congress's strong voice in helping to bolster potentially transformational therapies for America's heroes. We urge Congress to advance H.R. 7091 to help ensure that 'veterans have access to emerging therapies," said Mark White, Chief Executive Officer of Nexalin. "Veterans face disproportionately high rates of TBI, PTSD, and neurodegenerative disorders. We believe Nexalin America is well positioned to contribute to the advancement of innovative therapies that may improve outcomes for these patients."

Nexalin Technology announced the launch of its new AI-designed virtual clinic platform, NeuroCare, in collaboration with the University of California, San Diego. This marks the first step in deploying Nexalin's digital health ecosystem, designed to increase patient access, reduce costs, and provide long-term physician-patient care and monitoring across critical brain-health indications. This collaboration builds upon Nexalin's ongoing clinical research relationship with UC San Diego where patient enrollment has begun in trials evaluating Nexalin's non-invasive Deep Intracranial Frequency Stimulation. This clinical trial marks the official launch of Nexalin's new Gen-3 HALO headset that is now managed and monitored during treatment through the Nexalin NeuroCare virtual clinic.

Nexalin Technology highlighted Nexalin's peer-reviewed clinical research validating its proprietary neurostimulation technology across multiple neurological and psychiatric conditions. Currently, Nexalin is advancing its "mood-military-memory" clinical business plan with the FDA by publishing and submitting extensive clinical data. "Across multiple independent studies, we are not just observing that patients feel better-we are seeing measurable changes in how the brain functions," said Mark White, CEO of Nexalin Technology. "That distinction matters. Nexalin is a powerful whole-brain neurostimulation medical device that evidence indicates can penetrate deep in the brain to dramatically increase positive treatment response. Nexalin is not another battery-operated internet device sold to consumers. Our DIFS technology is designed to regulate abnormal neural signaling and normalize disrupted brain networks, and we have objective imaging data to support that mechanism."