Nexalin Technology, Inc. (NASDAQ:NXL) has initiated its pivotal HALO Clarity clinical trial, a key step toward a planned de novo submission to the U.S. Food and Drug Administration seeking clearance for its insomnia treatment technology.
The study will evaluate the company’s non-drug Deep Intracranial Frequency Stimulation (DIFS) platform, which Nexalin is positioning as a potential alternative to pharmaceutical therapies in the multi-billion-dollar insomnia market.
Insomnia affects an estimated 30 million adults in the United States, with many patients dissatisfied with existing treatment options due to concerns over dependency risks, side effects, and long-term use. Nexalin aims to address these limitations through a neuromodulation-based approach delivered via its next-generation HALO device.
The HALO Clarity trial is designed as a randomized, triple-blinded, sham-controlled study expected to enroll at least 150 adult participants across the U.S. Conducted in partnership with Lindus Health, the trial will follow a fully decentralized format, allowing patients to complete treatments and evaluations remotely through Nexalin’s NeuroCare virtual clinic and integrated electronic data capture system. The company said this virtual framework is intended to remove traditional site visit requirements and expand patient accessibility.
The pivotal trial builds on earlier clinical findings, including a randomized, double-blind, placebo-controlled study involving 120 patients with chronic insomnia that demonstrated clinically meaningful and statistically significant improvements in key sleep outcomes compared with placebo.
Nexalin noted that its Gen-2 15 mA device has already received regulatory approvals in international markets for insomnia and related indications.
The company said the HALO Clarity study marks an important milestone in its broader strategy to expand the DIFS platform into high-prevalence neuropsychiatric disorders. Data from the trial are expected to support the planned FDA submission.
NXL shares have traded between $0.36 and $2.80 over the past 12 months. The stock closed Monday at $0.49, down 1.63%, and rose 16% to $0.56 in pre-market trading Tuesday.