Nexalin Technology Inc (NXL) News & EventsNXLNexalin Technology Inc

Nexalin Secures U.S. Patent Protection Until 2042

Nexalin Technology announced that the United States Patent and Trademark Office has issued U.S. Patent No. 12,629,519, titled: "Transcranial Alternating Current Dynamic Frequency Stimulation Method for Anxiety, Depression and Insomnia." The newly issued patent is expected to provide U.S. intellectual property protection for Nexalin's core dynamic frequency stimulation method through 2042, further strengthening the Company's long-term competitive position in frequency-based deep-brain neurostimulation for anxiety, depression and insomnia.

Nexalin Technology Advances HALO Clarity Clinical Trial

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.