Nexalin Technology enters agreements to advance HALO Clarity trial

Nexalin Technology (NXL) 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.