Nexalin Technology, Inc. (NXL), which develops neurostimulation products, announced it has entered into agreements with Lindus Health, an Accountable Research Organisation (ARO), to advance its planned pivotal clinical trial evaluating the HALO Clarity device for the treatment of moderate-to-severe insomnia.
HALO Clarity device is designed to deliver non-invasive neuromodulation by stimulating deep brain structures associated with mental health and neurological conditions.
The 160-participant, randomised, triple-blinded, sham-controlled clinical trial is intended to support the firm's planned De Novo Classification Request to the U.S. Food and Drug Administration (FDA). The firm expects to begin patient enrollment in the second quarter of 2026.
Lindus Health will provide full-scope trial execution from protocol finalisation through database lock, including regulatory and ethics submissions, patient identification, data oversight, biostatistics, and medical writing.
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.
"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." said Mark White, Chief Executive Officer of Nexalin Technology.
NXL has traded between $0.33 and $2.00 over the last year. The stock closed Wednesday's trade at $0.46, up 8.47%.
In the pre-market, NXL is down 1.70% at $0.46.
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