Nexalin Technology, Inc. (NXL) is advancing its HALO Clarity program with the initiation of a pivotal clinical trial designed to support a planned de novo submission to the U.S. FDA for the treatment of moderate to severe insomnia.
The company is positioning its non-drug, Deep Intracranial Frequency Stimulation (DIFS) technology as a potential alternative in a multi-billion-dollar insomnia market.
Insomnia affects an estimated 30 million adults in the United States, with many patients reporting dissatisfaction with current treatment options due to concerns about dependency, tolerability, or long-term use. Nexalin aims to address this unmet need through a non-pharmacologic neuromodulation approach delivered via its next-generation HALO device.
The pivotal HALO Clarity study is a randomized, triple-blinded, sham-controlled trial designed to enroll at least 150 adults across the United States. Conducted in collaboration with Lindus Health, the trial will be fully decentralized, allowing participants to complete treatments and assessments remotely through Nexalin's NeuroCare virtual clinic and its integrated electronic data capture system. This virtual model is intended to eliminate traditional site visits and broaden patient access.
The study builds on previously published clinical data, including a 120-participant randomized, double-blind, placebo-controlled trial in chronic insomnia that demonstrated clinically meaningful and statically significant improvements in key sleep parameters compared to placebo.
Nexalin's Gen-2 15 mA device has also received international regulatory approvals for insomnia and related indications.
According to the company, the HALO Clarity trial represents a major milestone in Nexalin's broader strategy to expand its DIFS platform into high-prevalence neuropsychiatric conditions. The results of this pivotal study are expected to form the foundation of the company's planned de novo submission to the FDA.
NXL has traded between $0.36 and $2.80 over the past year. The stock closed Monday's session at $0.49, down 1.63%. In pre-market trading Tuesday, the stock is up 16% at $0.56.
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