Vivos’ Vida® Appliance Shows Statistically Significant Improvement in Insomnia Severity in 100% of Study Participants
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 indications including temporomandibular joint (TMJ) disorders, migraine headaches, and nasal airway dilation. The Company believes the new insomnia data, combined with the appliance’s existing regulatory status and prior clinical experience, may enable Vivos to leverage its established provider network, clinical protocols, and patient education platforms to expand usage of the Vida® appliance into a broader spectrum of sleep and autonomic‑related conditions.
Key Study Results and Strategic Implications
In a single‑site clinical study conducted between 2022 and 2025, 37 adult patients (30 females, 7 males), aged 28–77 years, with longstanding clinically moderate to severe insomnia as defined by the validated Insomnia Severity Index (ISI), were treated with the Vida® appliance worn nightly for an average of 3.7 months (range: 2–6 months). The ISI is a standardized instrument widely used to quantify insomnia symptoms and their functional impact, with categorical cut‑points for no clinically significant insomnia, subthreshold insomnia, moderate insomnia, and severe insomnia.
Patients experienced an average ISI score reduction of approximately 65%, with every participant improving by at least one ISI classification level and all patients ultimately classified as having either no clinically significant insomnia or subthreshold insomnia; the results were statistically significant, with a p‑value on the order of 0.0000001, indicating that the likelihood these findings occurred by chance is low.
Vivos believes that this data, while early and subject to further validation, may support the potential expansion of its addressable market beyond OSA and into a broader multi‑billion‑dollar global market that includes TMJ‑related conditions such as insomnia, where non‑pharmacologic, device‑based solutions remain limited. If future multi‑center studies corroborate these findings and provider adoption follows, the Company sees the opportunity to integrate Vida®‑based insomnia care into its growing ecosystem of sleep‑focused practices, specialized holistic diagnostic and treatment centers, and strategic partnerships, with the potential to increase recurring appliance sales, service revenues, and overall practice engagement with the Vivos platform.
Management Commentary on Market Impact
Vivos’ Chairman and CEO, R. Kirk Huntsman, commented:
“The results of this clinical study are consistent with what we’ve seen with thousands of COMISA patients—symptomatic relief comes fast, with no material safety issues, and appears to have lasting effects—all at a reasonable cost. We recently announced a broad-scale diagnostic and treatment initiative for COMISA patients. The best news is that we already have the testing equipment, manufacturing capacity, and trained provider network capable of addressing a large population of insomnia and COMISA patients. 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. With chronic insomnia affecting tens of millions of U.S. adults and driving significant sleep deprivation, chronic disease, and healthcare utilization, we believe this positions Vivos at the forefront of a substantial new market opportunity. While we recognize the need for larger studies, we believe this insomnia data has the potential to expand our total addressable market and create a new growth engine for Vivos over the coming years.”
Dr. Scott Simonetti, the clinician who conducted the study and the inventor of the Unilateral BiteBlock Technology® used in the Vida® oral appliance, added:
“For patients and providers who are looking for effective, non‑pharmacologic options for chronic insomnia, the clinical response we observed with nightly use of the Vida® appliance is encouraging. I’ve personally used the Vida® appliance to successfully treat close to 6,000 patients for a variety of conditions, including insomnia, and have consistently found this treatment to be safe and effective. I believe the Vida® helps modulate autonomic nervous system balance during sleep, and the consistency of improvement across all 37 patients in the study suggests real potential for broader clinical adoption as awareness and supporting data continue to emerge.”
Strategic Fit with Vivos’ Platform
The Vida® appliance’s potential role in insomnia care aligns with Vivos’ broader mission to provide innovative, non‑invasive therapies for breathing‑related sleep disorders and associated chronic conditions, including OSA. Insomnia frequently co‑occurs with OSA, TMJ disorders, migraine, PTSD, and autonomic dysregulation, which are already areas of interest within the Vivos provider network; as a result, the Company believes it is uniquely positioned to offer an integrated, multi‑indication appliance‑based solution that can be deployed within existing clinical workflows.
By layering insomnia‑focused protocols and education onto its current training programs and practice development services, Vivos intends—subject to further data as it emerges—to explore how the Vida® appliance might be used more broadly by its dentists, physicians, and affiliated centers, as well as in transportation, government, and military applications to address overlapping sleep complaints.
Important Regulatory Notice
The Vida® oral appliance is currently FDA‑cleared as a Class II medical device for indications including treatment of TMJ disorders, reduction of migraine headaches, nasal airway dilation and their related symptoms. Insomnia symptoms frequently co-occur with TMJ disorders, and some studies suggest TMJ-directed therapies may influence sleep quality. The clinical data described in this press release relating to insomnia symptom improvement have not been reviewed or cleared by the U.S. Food and Drug Administration, however, the Company has been advised that the present clinical data are sufficient to proceed without such regulatory clearance.
About Vivos Therapeutics, Inc.
Vivos Therapeutics, Inc. (Nasdaq: VVOS) is a medical technology and healthcare services company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as obstructive sleep apnea (OSA) and snoring in adults. Vivos’ devices have been cleared by the U.S. Food and Drug Administration (FDA) for adult patients diagnosed with all severity levels of OSA and moderate-to-severe OSA in children ages 6 to 17. Vivos’ groundbreaking Complete Airway Repositioning and Expansion (CARE) devices are the only FDA 510(k) cleared technology for treating severe OSA in adults and the first to receive clearance for treating moderate to severe OSA in children.
OSA and insomnia affect over 1 Billion adults aged 30-69 years old worldwide, yet 80% or more remain undiagnosed and unaware of their condition. These chronic disorders are not just a sleep issue—they are closely linked to many serious chronic health conditions. While the medical community has made strides in treating sleep disorders, breathing and sleep health remain areas that are still not fully understood. As a result, legacy OSA treatments like CPAP are often mechanistic and fail to address the root causes. In the case of insomnia, clinical diagnosis begins with a questionnaire such as the validated ISI, with a follow-on EEG test. Earlier in 2026, Vivos launched a comprehensive home EEG testing program for Nevada patients who met the criteria set forth on the ISI. Insurance reimbursements from such tests currently average over $700 per two-night test, which may be repeated up to three times per year to monitor and verify treatment efficacy. The Company estimates that it may realize approximately $2,000 per insomnia patient from both testing and treatment. At the present time, the Vida® appliance treatment is not typically reimbursed by most insurance carriers, and would thus be paid for out of pocket.
Through innovative technology, education, and acquisitions of, or commercial collaborations with, sleep healthcare providers, Vivos is empowering healthcare providers to address the complex needs of OSA patients more thoroughly.
Vivos calls the use of its appliances and protocols to treat OSA The Vivos Method, which offers a proprietary, clinically effective solution that is nonsurgical, noninvasive, and nonpharmaceutical, providing hope to allow patients to Breathe New Life.
For more information, visit www.vivos.com.
Cautionary Note Regarding Forward‑Looking Statements
This press release, including statements of the Company's management and other parties made in connection therewith, contains "forward-looking statements" (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events. Words such as "may," "would," "should," "expects," "projects," "potential," "intends," "plans," "believes," "anticipates," "hopes," "estimates," "goal," "aim," and variations of such words and similar expressions are intended to identify forward-looking statements. In this press release, forward-looking statements include, without limitation, statements regarding: the potential for the Vida® appliance to address insomnia, co-morbid insomnia (COMISA), and other sleep- and autonomic-related conditions; the clinical significance, durability, and reproducibility of the study results described herein; the size, value, and addressability of the global insomnia market and the Company's projected addressable market and per-patient revenue estimates; the prospect of future multi-center studies corroborating the Company's findings; the potential for provider adoption and integration of Vida®-based insomnia care into the Company's existing platform, provider network, and clinical workflows; anticipated regulatory engagement with the FDA and the prospect of any future clearance, indication, or label expansion; expected insurance reimbursement levels and the frequency of reimbursable testing; and the potential impact of the foregoing on the Company's revenues, recurring appliance sales, service revenues, profitability, and overall growth.
These statements involve significant known and unknown risks and are based upon a number of assumptions and estimates that are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos' control. Actual results may differ materially and adversely from those expressed or implied by such forward-looking statements as a result of various factors, including, but not limited to: (i) the risk that the study results described herein, which are derived from a single-site study of a small number of patients, may not be predictive of, or may differ materially from, results obtained in larger, multi-center, or controlled studies, and that individual patient results from OSA, insomnia, and COMISA treatment may vary; (ii) the risk that the Vida® appliance has not been reviewed or cleared by the FDA for the treatment of insomnia or COMISA, that any such clearance or indication may not be obtained on the timeline the Company expects or at all, and that any use of the appliance for insomnia or other indications not covered by its existing clearances is off-label and at the sole discretion of the treating clinician; (iii) the risk that the Company's estimates regarding the size of the insomnia and COMISA markets, its addressable market, projected patient volumes, and per-patient or per-test revenue may prove inaccurate or may not be realized; (iv) the risk that insurance reimbursement for diagnostic testing may be reduced, denied, or discontinued, and that the Vida® appliance is generally not reimbursed and must be paid out of pocket, which may limit adoption; (v) the risk that Vivos may be unable to effectively market the Vida® appliance, expand provider adoption, or integrate insomnia-focused protocols into its existing training programs, practices, and provider network, or otherwise implement strategies that increase revenues; (vi) risks associated with regulatory scrutiny of, and adverse publicity in, the sleep apnea and sleep disorder diagnosis and treatment sector; (vii) the risk that Vivos may be unable to secure additional financing to continue operations, acquire or affiliate with additional sleep center practices, or maintain its Nasdaq listing, when needed, if at all; (viii) market and other conditions that could impact Vivos' business or ability to obtain financing; and (ix) other risk factors described in Vivos' filings with the Securities and Exchange Commission (the "SEC"), which are available free of charge on the SEC's website at www.sec.gov.
Except to the extent required by law, Vivos expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos' expectations with respect thereto or any change in events, conditions, or circumstances on which any such statement is based.
Investor and Media Inquiries
R. Kirk Huntsman
Chief Executive Officer, Vivos Therapeutics, Inc.
Email: investors@vivoslife.com
Phone: (720) 399-9322
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