NXL News & Events

Nexalin Technology entered into agreements to advance its planned pivotal clinical trial evaluating the HALO Clarity device for the treatment of moderate-to-severe insomnia, with patient enrollment currently expected to begin in Q2 of 2026. The 160-participant, randomized, triple-blinded, sham-controlled clinical trial is intended to support Nexalin's planned De Novo Classification Request to the U.S. Food and Drug Administration. If granted, the FDA's De Novo pathway would establish the Nexalin Halo Clarity as a new product category. This regulatory approach is intended to distinguish Nexalin Technology's potentially groundbreaking DIFS neurostimulator from currently available stimulation devices. The study is expected to mark a significant milestone in the Company's FDA strategy and broader insomnia program. Nexalin's program builds on previously published, peer-reviewed clinical data demonstrating statistically significant improvements across a range of treatment parameters compared with sham treatment. The trial is being conducted in collaboration with Lindus Health, an Accountable Research Organization. Lindus Health has been selected to provide full-scope trial execution from protocol finalization through database lock, including regulatory and ethics submissions, patient identification, data oversight, biostatistics and medical writing.

Nexalin Technology announced the completion of a series of high-level meetings in the United States and China focused on advancing the Company's global clinical strategy for the treatment of Alzheimer's disease and dementia related cognitive decline. These meetings, including a productive Q-Submission interaction with the U.S. Food and Drug Administration, represent key milestones in the preparation of Nexalin's De Novo application with the FDA for the treatment of Alzheimer's disease. The FDA provided clinical guidance on the proposed Alzheimer's symptom reduction FDA clinical trial and regulatory pathway. The Nexalin clinical and research teams are currently finalizing the clinical design that will provide primary and secondary endpoints to follow FDA guidance on clinical relevance and treatment response in the Alzheimer's patient population. The Company plans to submit an amended FDA Q-Submission application based on these strategy meetings in Q2. The high-level meetings brought together Nexalin leadership, American-based academic research teams and members of the international Alzheimer's clinical community. Insights gained from these discussions are directly informing Nexalin's FDA strategy and shaping the final design of its upcoming FDA clinical trial focused on Alzheimer's disease and age-related cognitive vulnerability. "These meetings marked a critical step in aligning our global clinical experience with a disciplined U.S. regulatory and clinical strategy," said Mark White, CEO. "The meeting insights and observations are directly informing our planned FDA application amendments and design of our FDA Alzheimer's clinical trial. We believe this regulatory strategy will position Nexalin to become the leader in drug-free, non-invasive treatment focused on the core mechanisms of cognitive decline and the reduction of Alzheimer's-related symptoms."

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.