Clinical TrialJun 30, 2026, 08:47 AM
Vivos Vida® Appliance Shows 100% Insomnia Improvement
AI Summary
Vivos Therapeutics announced compelling clinical data for its FDA-cleared Vida® oral appliance, demonstrating statistically significant improvement in insomnia severity in 100% of study participants. A single-site study of 37 adults showed an average Insomnia Severity Index (ISI) score reduction of approximately 65%, with all patients improving to no or subthreshold insomnia. This data suggests a major new commercial opportunity in the large global insomnia market, potentially expanding Vivos' addressable market beyond obstructive sleep apnea (OSA).
Key Highlights
- Vida® oral appliance showed statistically significant improvement in insomnia severity in 100% of study participants.
- Patients experienced an average Insomnia Severity Index (ISI) score reduction of approximately 65%.
- All 37 adult patients improved by at least one ISI classification level, reaching no or subthreshold insomnia.
- The study results were statistically significant with a p-value on the order of 0.0000001.
- Company projects an annual addressable market of roughly $36 million in Las Vegas for newly diagnosed insomnia patients.
- Vivos estimates approximately $2,000 per insomnia patient from both testing and treatment.
- The Vida® appliance is currently FDA-cleared for TMJ disorders, migraine headaches, and nasal airway dilation.
Price Impact
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