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Recent Study Confirms Fundamental Correlation Between Severity of Obstructive Sleep Apnea and Oral Anatomy

Vivos Therapeutics (NASDAQ: VVOS) highlighted a peer-reviewed study linking narrower maxillary intermolar distance and higher palatal height to greater obstructive sleep apnea (OSA) severity, reporting a strong association (p<0.001) across 100 patients.

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Vivos Therapeutics (NASDAQ: VVOS) highlighted a peer-reviewed study linking narrower maxillary intermolar distance and higher palatal height to greater obstructive sleep apnea (OSA) severity, reporting a strong association (p<0.001) across 100 patients.

The company noted its FDA 510(k) clearance in November 2024 for Vivos CARE devices to treat severe OSA, U.S. clearance for adults and children, and asserted many patients finish treatment in under 12 months, often reducing the need for nightly CPAP or other lifetime interventions.

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Positive

  • FDA 510(k) clearance granted in November 2024 to treat severe OSA
  • Study association between IMD/PH and AHI with statistical significance (p<0.001)
  • Clinical reach—Vivos-trained providers treated tens of thousands of OSA patients
  • Short treatment claim: many patients finish therapy in less than 12 months

Negative

  • Study sample size was 100 patients, limiting broad generalizability
  • Correlation study links anatomy to OSA severity but does not alone prove long-term treatment outcomes
Argus Mar 17 session
+1.54% close to close Open Argus
Details

News Market Reaction – VVOS

In the Mar 17 session, VVOS gained 1.54%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights peer-reviewed evidence linking craniofacial anatomy to OSA severity and...
Analysis

This announcement highlights peer-reviewed evidence linking craniofacial anatomy to OSA severity and reinforces FDA-cleared Vivos CARE devices, including a unique 510(k) clearance from November 2024 for severe OSA. The study’s 100-patient cohort and strong significance (p<0.001) support the airway-remodeling mechanism. In context of prior collaborations and financing moves, key items to watch include additional clinical publications, adoption across the 2,000+ provider network, and how capital-structure tools such as outstanding warrants interact with growth plans.

Key Figures

Study participants: 100 patients OSA group size: 50 patients Control group size: 50 controls +5 more
Study participants
100 patients
Adults in Journal of Clinical Medicine OSA morphology study
OSA group size
50 patients
Adults with obstructive sleep apnea in the study
Control group size
50 controls
Non-OSA adult controls in the study
Statistical significance
p<0.001
Association between craniofacial parameters and OSA severity
Vivos-trained providers
2,000+ providers
Providers using Vivos CARE devices in clinical practice
Pediatric indication age
6 to 17 years
FDA-cleared age range for moderate-to-severe OSA in children
Typical treatment duration
Less than 12 months
Time for many patients to complete Vivos CARE treatment
510(k) clearance date
November 2024
FDA 510(k) clearance for treating severe OSA with Vivos CARE devices

Historical Context

5 past events · Latest: Feb 05
5 events
  1. Feb 05

    Technology collaboration

    24h Move
    +0.0%

    Collaboration with SoundHealth to distribute FDA-cleared sleep and allergy devices.

  2. Jan 20

    Warrant exercise close

    24h Move
    -7.1%

    Closing of warrant exercises raising $4.64M gross proceeds at reduced prices.

  3. Jan 16

    Warrant exercise deal

    24h Move
    -3.3%

    Agreement for immediate warrant exercise and issuance of new private warrants.

  4. Dec 16

    Sleep center opening

    24h Move
    +0.0%

    Opening of affiliated sleep testing and treatment center in Auburn Hills, Michigan.

  5. Dec 15

    Investor fireside chat

    24h Move
    +0.0%

    Announcement of CEO/CFO participation in a Water Tower Research fireside chat.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

obstructive sleep apnea, apnea-hypopnea index, cpap, neurostimulation implants, +3 more
7 terms
obstructive sleep apnea medical
"directly correlated to the prevalence and severity of obstructive sleep apnea (OSA)"
Obstructive sleep apnea is a common medical condition where the throat repeatedly narrows or closes during sleep, causing short pauses in breathing, drops in blood oxygen and fragmented rest. It matters to investors because it creates ongoing demand for medical devices, diagnostics, treatments and sleep-monitoring services, and it can affect population health, workforce productivity and healthcare spending—like a recurring leak in a system that requires continual repair and monitoring.
apnea-hypopnea index medical
"linked to higher Apnea-Hypopnea Index (AHI). Larger airways are less prone"
A measure of how often a person has pauses or shallow breaths during sleep, calculated as the average number of these events per hour. Investors care because this single number is used by doctors and insurers to diagnose sleep-disordered breathing and decide on treatments and device coverage, so higher or lower values can affect demand for diagnostic tools, therapies, and related healthcare spending—think of it as counting traffic jams per hour to judge road congestion.
cpap medical
"no need for nightly lifetime intervention with CPAP, traditional oral appliances"
A CPAP (continuous positive airway pressure) device is a machine that gently blows a steady stream of air through a mask to keep a person’s breathing passages open during sleep, commonly used to treat sleep apnea. For investors, CPAPs matter because they represent a medical-device market with recurring sales of equipment and disposable supplies, subject to safety reviews, insurance reimbursement rules and regulatory approvals that can affect a maker’s revenue and reputation.
neurostimulation implants medical
"CPAP, traditional oral appliances, or neurostimulation implants. The recent study"
Neurostimulation implants are small medical devices surgically placed near the brain, spinal cord, or peripheral nerves that deliver controlled electrical pulses to alter nerve activity—think of them as a pacemaker for pain, movement, or mood. Investors care because these devices can create long-term revenue from implant procedures, follow-up services and upgrades, but their commercial success depends heavily on clinical effectiveness, safety, regulatory approvals, and insurance reimbursement.
510(k) clearance regulatory
"in November 2024 the FDA granted Vivos CARE devices an unprecedented 510(k) clearance"
A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.
mandibular advancement oral appliances medical
"Traditional treatments such as CPAP, mandibular advancement oral appliances, and neurostimulation"
Mandibular advancement oral appliances are small, custom-fit devices worn in the mouth during sleep that gently push the lower jaw forward to keep the upper airway open and reduce snoring or pauses in breathing. Investors care because these devices represent a growing, lower-cost alternative to continuous positive airway pressure (CPAP) machines; their adoption, regulatory approvals, reimbursement rules, and evidence of effectiveness directly affect sales, recurring revenue and competitive dynamics in the sleep-disorder device market.
hypoxia medical
"less blood oxygen desaturation (hypoxia) and better overall sleep architecture."
Hypoxia is a condition in which tissues or organs do not get enough oxygen to function properly, similar to being in a room with the air partly taken away. It matters to investors because it drives demand and risk for medical products, clinical trial outcomes, regulatory decisions, and workplace or equipment safety—factors that can affect a company’s revenue, costs, and valuation when treatments, devices, or safety measures are required or tested.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Vivos CARE Oral Medical Devices Proven to Enhance Airways by Redeveloping Dental Arch Forms and Jaws

LITTLETON, Colo., March 17, 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 and associated chronic health conditions, today announced that an a recent study published in the Journal of Clinical Medicine supports Vivos’ long maintained belief that dental and facial morphology characterized by narrow palatal (upper) dental arches, high peaked palates, and recessed lower jaws were directly correlated to the prevalence and severity of obstructive sleep apnea (OSA) in adults and children.

Over the past decade, Vivos-trained providers have successfully treated tens of thousands of OSA patients using Vivos CARE devices to redevelop and enhance airways.   Vivos CARE devices have been cleared by the U.S. Food and Drug Administration (FDA) for adult patients diagnosed with mild, moderate and severe OSA and moderate-to-severe OSA in children ages 6 to 17. Many Vivos patients finish treatment in less than 12 months with little or no remaining OSA symptoms. Thus, in the majority of such Vivos patients, there is no need for nightly lifetime intervention with CPAP, traditional oral appliances, or neurostimulation implants.

The recent study, the “Correlation Between Severity of Obstructive Sleep Apnea and Dental Arch Form in Adults,” first published in October 2025, affirms what the over 2,000 Vivos-trained providers see every day in clinical practice—that very small changes in the size, shape, and position of the dentition and jaws evoke significant changes in the form, function and patency of the human airway. The study conclusions indicate that maxillary morphology is associated with OSA severity, narrower intermolar distance (IMD) and greater palatal height (PH) linked to higher Apnea-Hypopnea Index (AHI). Larger airways are less prone to collapse (apnea / hypopnea events) during sleep. Fewer apnea / hypopnea events often means less sleep disruption, less blood oxygen desaturation (hypoxia) and better overall sleep architecture.

One hundred patients participated in the study, with 50 OSA patients and 50 controls. The OSA group exhibited significantly narrower transverse intermolar distance and higher palatal height compared to the control group. Linear regression analysis demonstrated a strong association (p<0.001) between these two key craniofacial parameters and OSA severity, as measured by the industry standard measure AHI. These results held true across all demographics. The figure below reflects the strong anatomical correlations in the study.

Matrix plot AHI vs. IMD and PH.

After years of research and product development, in November 2024 the FDA granted Vivos CARE devices an unprecedented 510(k) clearance to treat severe OSA patients. No other oral appliance had ever received such a clearance, nor has any similar clearance been granted since. Moreover, the mechanism of action in Vivos CARE devices is unique and capable of creating what are believed to be lasting results by gradually redeveloping and repositioning the dental arches and jaws.     

Kirk Huntsman, CEO of Vivos Therapeutics, said, “This study reaffirms our longstanding view that cranial and oral morphology is directly correlated to not only the presence of OSA, but also its severity. Traditional treatments such as CPAP, mandibular advancement oral appliances, and neurostimulation implants, all act to temporarily manage symptoms, but require repeated nightly use over a lifetime to remain effective. Vivos CARE devices rehabilitate and restore optimal airway size and shape, allowing patients to breathe more fully and sleep more deeply. After nearly 50 years of limited and undesirable treatment options, patients now have a real choice that is both safe and effective.”

"This year, we estimate that several million Americans will undergo a sleep test. In our experience, nearly half of them will test positive for OSA. Those patients will need to make a serious and life-changing decision—what they will do about their serious medical condition. OSA doesn’t go away on its own, and it will likely get worse with time. If left untreated, it will affect their cardiovascular system, their neurocognitive abilities, their risk of diabetes, chronic fatigue, mental health and more. Yet over 90% will still receive a medical prescription for CPAP, the “Gold Standard” treatment that, statistically, will soon be abandoned by over half of those patients. Then what? That’s why we’re seeing more and more such OSA patients turning to Vivos devices for OSA treatment," concluded Mr. Huntsman.

About Vivos Therapeutics, Inc.

Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology 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 affects over 1 billion people worldwide, yet 80% or more remain undiagnosed and unaware of their condition. This chronic disorder is not just a sleep issue—it is 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 of OSA. 

Founded in 2016 and based in Littleton, Colorado, Vivos is working to change this. 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, contain “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, those relating to the actual future impact on Vivos’ revenue and profitability from its operations or the benefits to Vivos of the study as described herein. These statements involve significant known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Actual results (including the actual results from the study and individual results of OSA treatment) may differ materially and adversely from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to: (i) the risk that Vivos may be unable to effectively market or continue to integrate business from the acquisition and alliance model into its own or otherwise implement sales, marketing and other strategies that increase revenues, (ii) the risk that some patients may not achieve the desired results from using Vivos’ products, (iii) risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea diagnosis and treatment sector; (iv) the risk that Vivos may be unable to secure additional financing to continue operations, acquire additional sleep centers practices on reasonable terms, or maintain its Nasdaq listing when needed, if at all, (v) market and other conditions that could impact Vivos’ business or ability to obtain financing, and (vi) other risk factors described in Vivos’ filings with the Securities and Exchange Commission (“SEC”). Vivos’ filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligations 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 statement is based.

Media Inquiries: 

Jennifer Hauser, Executive Assistant to the CEO

Investor Relations Contact
investors@vivoslife.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2bbc6139-7151-4edd-89dd-5253307b498b


FAQ

What did the March 17, 2026 study say about OSA severity and dental arch form for VVOS?

The study found narrower intermolar distance and higher palatal height correlate with greater OSA severity (p<0.001). According to the company, the result held across demographics in a 100-patient case-control comparison.

Does VVOS have FDA clearance to treat severe obstructive sleep apnea?

Yes. Vivos CARE devices received a 510(k) clearance in November 2024 to treat severe OSA. According to the company, the clearance is unique among oral appliances for severe OSA treatment.

How long does VVOS say treatment with Vivos CARE devices typically takes for VVOS patients?

The company reports many patients finish treatment in less than 12 months. According to the company, this often leaves little or no remaining OSA symptoms, reducing nightly device dependence.

Who is eligible for Vivos CARE treatment under current approvals (VVOS)?

Vivos CARE devices are cleared for adults with mild, moderate and severe OSA and children ages 6–17 with moderate-to-severe OSA. According to the company, trained providers deliver individualized therapy.

Will VVOS devices replace CPAP for patients according to the company?

The company says many treated patients no longer require nightly CPAP after Vivos therapy. According to the company, Vivos devices aim to rehabilitate airway anatomy rather than only manage symptoms nightly.

What mechanism does VVOS claim for how Vivos CARE devices improve airway function?

Vivos states the devices gradually redevelop dental arches and reposition jaws to enlarge the airway. According to the company, this unique mechanism is believed to produce lasting anatomical and functional improvements.

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