Nexalin Announces Pivotal HALO Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market

150-Patient, Triple-Blinded, Sham-Controlled Study Designed to be Executed in Collaboration with Lindus Health to Support Future FDA Submission for Drug-Free Insomnia Treatment

Builds on Prior Peer-Reviewed Clinical Data and International Regulatory Approvals

HOUSTON, TX, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS) of the brain, today 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.

The randomized, triple-blinded, sham-controlled study is designed to enroll a minimum of 150 participants across the United States. Structured as a fully decentralized trial, participants are expected to complete treatments and assessments remotely within Nexalin’s recently launched NeuroCare virtual clinic and its advanced Electronic Data Capture (EDC) system. The NeuroCare virtual clinic is designed to eliminate traditional site visit requirements, while expanding access to a broader patient population.

The pivotal study is designed to support the planned de novo insomnia submission to the U.S. Food and Drug Administration and represents a key milestone in the execution of Nexalin’s global strategy to expand its DIFS platform into high-prevalence neuropsychiatric indications.

The pivotal study to support Nexalin’s planned FDA submission builds on Nexalin’s previously reported and published clinical results in chronic insomnia, including a 120-participant randomized, double-blind, placebo-controlled, multicenter study published in the Journal of Psychiatric Research. In that study, Nexalin reported clinically meaningful and statistically significant improvements across key sleep parameters compared to placebo, with no significant adverse effects reported. Nexalin’s Gen-2 15 mA device has also received regulatory approvals internationally for insomnia and related indications.

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