Nexalin Technology entered into a Scope of Work with Lindus Health on April 17, 2026, to conduct its pivotal clinical trial for the HALO Clarity device, with patient enrollment expected to begin in Q2 2026.
Key takeaways
Entered Scope of Work with Lindus Health for pivotal HALO Clarity trial, with direct fees of approximately $944,820 plus pass-through expenses.
Pivotal trial is a 160-participant, triple-blinded, sham-controlled study designed to support a planned De Novo FDA submission for moderate-to-severe insomnia.
Patient enrollment for the trial is currently expected to begin in Q2 2026.
The De Novo pathway, if granted, would establish the HALO Clarity as a new product category.
The trial is being conducted in collaboration with Lindus Health, an Accountable Research Organization, for full-scope trial execution.