Nexalin Technology Advances Pivotal Clinical Trial of HALO Clarity Toward Q2 2026 Enrollment

160-participant, triple-blinded, sham-controlled study designed to support planned De Novo FDA submission for moderate-to-severe insomnia

HOUSTON, TX, April 22, 2026 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in non-invasive Deep Intracranial Frequency Stimulation (DIFS) of the brain, today announced it has 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 (FDA). 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 (ARO). 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. Nexalin believes this collaboration will support a rigorous and efficient execution model as the Company progresses toward enrollment and future regulatory milestones.

“Advancing this pivotal clinical trial toward enrollment marks an important step in the continued execution of our FDA regulatory strategy,” said Mark White, Chief Executive Officer of Nexalin Technology. “We believe the Nexalin HALO Clarity medical device represents a unique and advanced approach to non-invasive drug-free treatment for patients with moderate-to-severe insomnia. This study is designed to initiate our planned De Novo FDA submission strategy and, assuming it is successful, would further strengthen the clinical and regulatory case for mental health treatment in a large and underserved market. According to Precedence Research, the global sleep tech devices market was estimated at $29.3 billion in 2025 and is projected to reach approximately $153.7 billion by 2035.”

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