Nexalin Technology, Inc. (NASDAQ: NXL) announced the launch of a 150‑patient, triple‑blind, sham‑controlled pivotal trial of its HALO Clarity device for moderate to severe insomnia. The study, conducted in partnership with Lindus Health, will enroll participants across the United States and is designed to support a planned de‑novo FDA submission for a drug‑free insomnia treatment.
The trial will be fully decentralized, with patients receiving treatments and completing assessments remotely through Nexalin’s NeuroCare virtual clinic and electronic data capture system. The HALO Clarity device uses Nexalin’s proprietary 15 mA deep intracranial frequency stimulation (DIFS™) technology, engineered to target deeper brain structures associated with sleep regulation. The company said the trial will validate safety and efficacy and bring the device closer to regulatory clearance in a market that serves approximately 30 million U.S. adults.
Nexalin’s financial profile remains challenging. For the trailing twelve months, revenue was $0.16 million, with a three‑year revenue growth rate of –14.7%. Operating and net margins were –5,638.85 % and –5,527.39 % respectively. The company also received a Nasdaq listing status notification on January 21, 2026 for not meeting the minimum bid price requirement, with a compliance deadline of July 20, 2026.
The insomnia market includes FDA‑cleared devices such as the Cerêve Sleep System, which uses thermal therapy. Nexalin’s DIFS™ platform is also being explored for Alzheimer’s disease, depression, PTSD, and traumatic brain injury, positioning the company to address multiple neurological indications beyond insomnia.
The announcement was well received by investors, reflecting optimism about the trial’s potential to open a new drug‑free treatment pathway. CEO Mark White said, "This planned pivotal trial marks an important milestone for Nexalin," underscoring the company’s confidence in its technology and regulatory strategy.
With the trial underway, Nexalin will monitor safety and efficacy data and prepare for the de‑novo FDA submission. The company’s next milestones include enrollment completion, data analysis, and submission of a pre‑market approval application, which could bring the HALO Clarity device to market and expand its portfolio of neurostimulation solutions.
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