regulatory
confidence high
sentiment positive
materiality 0.70
Nexalin announces pivotal HALO Clarity trial for insomnia to support FDA de novo submission
Nexalin Technology, Inc.
- 150-patient, triple-blinded, sham-controlled randomized study via decentralized NeuroCare virtual clinic with Lindus Health.
- Designed to support planned FDA de novo submission for moderate to severe insomnia treatment.
- Builds on prior published 120-patient study showing significant sleep improvements with no adverse effects.
- Targets $multi-billion insomnia market; ~30M U.S. adults seek drug-free options.