Nexalin Technology Inc. (NASDAQ: NXL) announced it has entered agreements to advance a pivotal clinical trial for its HALO Clarity device to treat moderate-to-severe insomnia, with patient enrollment expected to begin in the second quarter of 2026.

The 160-participant, randomized, triple-blinded, sham-controlled study is designed to support a De Novo Classification Request to the U.S. Food and Drug Administration. The De Novo pathway would establish the HALO Clarity as a new product category, distinguishing it from existing stimulation devices.

Nexalin will conduct the trial in collaboration with Lindus Health, an Accountable Research Organization that will provide full-scope trial execution from protocol finalization through database lock, including regulatory submissions, patient identification, data oversight, biostatistics and medical writing.

"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.

The Houston-based company develops non-invasive neurostimulation devices using what it calls Deep Intracranial Frequency Stimulation technology. The HALO Clarity device is intended as a non-pharmacologic treatment option for insomnia patients.

According to the company, its clinical program builds on previously published, peer-reviewed data showing statistically significant improvements across treatment parameters compared with sham treatment. The company also cited research from Precedence Research estimating the global sleep tech devices market at $29.3 billion in 2025, projected to reach $153.7 billion by 2035.

Nexalin's Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, Oman and Israel. The company plans to provide updates on site activation and enrollment timing as the pivotal trial progresses.