Vivos’ Vida® Appliance Shows Statistically Significant Improvement in Insomnia Severity in 100% of Study Participants

About this update from Vivos Therapeutics, Inc.

LITTLETON, Colo., June 30, 2026 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. ("Vivos" or the "Company") (NASDAQ: VVOS), a leading medical device and healthcare services company focused on the treatment of breathing‑related sleep disorders such as obstructive sleep apnea (OSA), insomnia, and associated chronic health conditions, today announced compelling clinical data showing that treatment with its FDA‑cleared Vida® oral appliance led to statistically significant improvement in insomnia severity in 100% of study participants, underscoring what the Company believes could be a major new commercial opportunity in the large and underserved global insomnia market. Newly Released Vida® Data Supports Potential Entry into Large Insomnia Market Insomnia is a widespread sleep disorder, with an estimated prevalence of 10–30% of adults experiencing chronic insomnia and 25–35% reporting transient or occasional insomnia. In patients with moderate to severe OSA, co‑morbid insomnia (COMISA) is present in up to about 60% or more of OSA patients. This heightened burden of COMISA underscores the potential for the Vida® appliance to address overlapping sleep complaints in a large subset of Vivos' existing target population. In the Company's operations at Sleep Centers of Nevada (SCN), for example, more than 36,000 patients are referred each year for OSA testing and treatment. Assuming 50% have COMISA, the Company projects there could be as many as 18,000 potential insomnia patients at SCN requiring testing and treatment, representing an annual addressable market of roughly $36 million just in Las Vegas, and only taking into account newly diagnosed patients. Since 2019, SCN has tested close to 245,000 additional patients of record, a portion of which could also be candidates for insomnia testing and treatment. Given this potential patient population and the limitations of many existing pharmacologic and behavioral therapies, Vivos believes that a non‑pharmacologic, non‑battery‑operated, FDA‑cleared oral appliance that demonstrates statistically significant symptom improvement in all treated patients could represent a meaningful new revenue growth driver for the Company over time. The Vida® appliance (formerly the Pod® oral appliance developed by Advanced Facialdontics and acquired by Vivos in early 2023) is currently cleared by the FDA as a Class II device for indicatio...

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