Vivos Therapeutics, Inc. (NASDAQ: VVOS) released clinical data from a single-site study showing its Vida® oral appliance produced statistically significant reductions in insomnia severity among all 37 participants, according to a company press release.

The study, conducted between 2022 and 2025, enrolled adults aged 28 to 77 with moderate to severe insomnia as measured by the Insomnia Severity Index (ISI). Participants wore the appliance nightly for an average of 3.7 months. The company reported an average ISI score reduction of approximately 65%, with every participant improving by at least one ISI classification level. The study reported a p-value of approximately 0.0000001.

The Vida® appliance is FDA-cleared as a Class II device for temporomandibular joint disorders, migraine headache reduction, and nasal airway dilation. It is not FDA-cleared for insomnia, and the company noted the insomnia clinical data have not been reviewed by the agency. The company stated it has been advised that the existing data are sufficient to proceed without additional regulatory clearance for current use.

Vivos acknowledged the study's limitations, noting that results from the small, single-site trial may not be replicated in larger, controlled, multi-center studies.

The company estimated potential revenue of approximately $2,000 per insomnia patient from testing and treatment combined. It noted the Vida® appliance is generally not covered by insurance and would be paid out of pocket by patients.

CEO R. Kirk Huntsman stated: "These results suggest that the Vida® appliance could open an important new treatment modality and revenue source as we address one of the most prevalent and costly sleep disorders worldwide."

The study's clinician, Dr. Scott Simonetti, who is also the inventor of the Unilateral BiteBlock Technology® used in the appliance, said the clinical response observed was "encouraging" and that he has personally treated close to 6,000 patients with the device across various conditions.

Vivos operates Sleep Centers of Nevada, which the company says refers more than 36,000 patients annually for sleep apnea testing and treatment.