Frequen-ZZZ^® is an investigational device intended for use during sleep
that emits a low-intensity radiofrequency gradient designed to modulate the
vagal regulatory network and stabilize resting neural dynamics.

A randomized, double-blind, controlled, proof-of-concept crossover clinical study was conducted by Kunasan Inc. in collaboration with The Pennsylvania State University. The trial began in July 2023, with final data collection completed on May 10, 2024.

Participants were enrolled based on an Insomnia Severity
Index (ISI) score ≥ 8, targeting individuals with clinically significant sleep
disruption. The study was designed to evaluate whether nightly use of
FREQUEN-ZZZ^® could improve objective and subjective measures of sleep quality while demonstrating good safety and tolerability.