New Clinical Trial Data Published Showing Positive Results from Use of Vivos Technology to Treat Obstructive Sleep Apnea in Children

Rhea-AI Summary

Vivos Therapeutics (NASDAQ: VVOS) announced the publication of groundbreaking clinical trial results in the European Journal of Pediatrics, demonstrating the effectiveness of their Daytime-Nighttime Appliance (DNA) in treating pediatric obstructive sleep apnea (OSA). The study showed 79% of patients experienced OSA improvement, with 61.7% improving by 50% or more.

The trial results validate Vivos' FDA 510(k) clearance received in September 2024 for treating moderate to severe OSA in children. Notably, 93% of children with severe OSA saw symptoms decrease by at least 50%. The DNA device presents a non-surgical alternative to adenotonsillectomy, which has a 68% symptom relapse rate within three years.

Positive

• Clinical trial showed 79% of patients experienced OSA improvement using DNA device
• 93% of children with severe OSA saw symptoms decrease by at least 50%
• FDA 510(k) clearance received for treating moderate to severe OSA in children
• No safety issues or concerns reported in the clinical trial
• Recent Sleep Center of Nevada acquisition expanding patient access to treatments

Negative

• None.

Insights

Medical Device Analyst

Vivos reports strong pediatric OSA trial results (79% improvement) for non-surgical DNA device, potentially disrupting current surgical standard-of-care with lasting benefits.

Vivos Therapeutics' clinical trial results published in the European Journal of Pediatrics represent a significant advancement in pediatric obstructive sleep apnea (OSA) treatment. The data shows the company's Daytime-Nighttime Appliance (DNA) device achieved 79% improvement rate among patients, with 61.7% improving by half or more, and 17% experiencing complete OSA resolution. Most impressive is the 93% improvement rate among severe OSA cases, with symptoms decreasing by at least 50%.

The current standard treatment—adenotonsillectomy (removal of tonsils and adenoids)—has significant limitations. While 500,000+ children undergo this surgery annually in the US, 68% experience symptom relapse within three years. Vivos' non-surgical approach potentially offers more durable results, addressing a $10+ million patient market where up to 90% remain undiagnosed and untreated.

The FDA 510(k) clearance Vivos received in September 2024 for moderate-to-severe pediatric OSA gives the company a regulatory advantage in this space. This publication provides external validation of that clearance while potentially accelerating insurance coverage decisions and physician adoption.

The timing aligns with Vivos' strategic expansion through its Sleep Center of Nevada acquisition and planned additional practice partnerships, positioning the company to rapidly scale access to this treatment. If the company can effectively commercialize this technology through these channels, it could disrupt the current surgical paradigm while addressing the concerns raised in the recent MAHA Report about overtreatment in pediatric healthcare.

Important Study Shows Vivos Technology to be a Safe and Highly Effective, Non-Surgical Alternative to Surgical Removal of Tonsils and Adenoids in Children

LITTLETON, Colo., June 26, 2025 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company”) (NASDAQ: VVOS), a leader in proprietary, non-invasive treatments for obstructive sleep apnea (OSA), today announced that the European Journal of Pediatrics has published the results of a groundbreaking multicenter clinical trial evidencing positive results for the treatment of OSA in children using Vivos’ patented Daytime-Nighttime Appliance (DNA).

The study importantly noted that “This is the first study demonstrating that the [Vivos DNA] device is safe and efficacious in treating children with OSA.” In September 2024, Vivos received an unprecedented FDA 510(k) clearance for the DNA device to treat moderate to severe OSA in children. This latest study confirms and reinforces the safety and efficacy underlying that clearance.

In the study, 79% of patients showed OSA improvement, with 61.7% improving by 50% or more, and 17% experiencing resolution of their OSA. Ninety three percent (93%) of children in the study with severe OSA saw their symptoms decrease by at least 50%. There were no safety issues or concerns. The study examined recognized endpoints for measuring treatment of OSA, including a Pediatric Sleep Questionnaire (PSQ), apnea-hypopnea index (AHI), and intermolar width. Forty-seven participants were included in the analytic dataset following trial completion after 12–24 months.

Dr. Tammarie Heit, co-author of the study, said “I have been treating and having success in resolving OSA in my pediatric patients using Vivos oral medical devices for nearly a decade. In my clinical practice, my patients have experienced life-changing results and have avoided the need for risky, painful, and invasive surgeries. The findings of this study are not surprising to me and validate my many years of real world experience with Vivos treatment technologies that generate positive OSA treatment results in both children and adults.”

The Problem of OSA and Current Treatment

An estimated 10 million (20.4%) of children in the United States suffer from a breathing and sleep disorder such as OSA, with up to 90% currently undiagnosed and untreated. Such disorders have been highly correlated with many common childhood health challenges such as ADD/ADHD, bedwetting, chronic allergies, mouth breathing, snoring, crowded and crooked teeth, lower IQ, anxiety, delayed onset puberty, and more.

Currently, the main treatment for pediatric OSA has been adenotonsillectomy surgery (removal of tonsils and adenoids). Over 500,000 children receive adenotonsillectomies each year in the United States. Although 51% to 83% of those children experience initial relief from OSA symptoms, 68% see their OSA symptoms relapse and return by the three-year mark.

In stark contrast, the current study concluded that “…it is expected that the [Vivos] treatment will have a permanent effect past the 24-month study duration. Compared to CPAP, adenotonsillectomy, and [rapid maxillary expansion], which have limitations such as adherence, complications, and 24/7 use, respectively, [the Vivos DNA device] offers a new option for pediatric OSA treatment.”

The MAHA Report, released on May 22, 2025 by Health and Human Services Secretary, Robert F. Kennedy Jr. and recently covered in the journal Sleep Review, delivers a stark warning about the dangers of overtreatment in pediatric healthcare, particularly adenotonsillectomies for sleep apnea. “There exists a robust evidence base demonstrating significant and costly (both financially and in terms of human suffering) harms experienced by children due to overtreatment at the hands of American healthcare,” the report states. For parents seeking alternatives to risky surgeries, the Vivos DNA appliance offers a non-invasive solution—addressing airway obstruction through natural jaw development without the financial burden or physical trauma of unnecessary procedures. As the report urges a shift toward safer, evidence-based care, Vivos provides a way to address debilitating OSA in children without resorting to irreversible interventions.

“The significance of this study and what it means for children with OSA cannot be overstated,” said R. Kirk Huntsman, Chairman and CEO of Vivos. “This is welcome news for all parents with children who suffer from OSA. No longer is their only option to subject their children to a painful and often ineffective surgical procedure with a high relapse rate. They and their OSA healthcare providers now have further confirmation that a safe, effective, and non-surgical treatment option with lasting results is available. Moreover, the study comes at an excellent time as we work to integrate our recent Sleep Center of Nevada acquisition and pursue other sleep medical practice collaborations or acquisitions to significantly increase the number of patients who have access to our cutting-edge treatments.”

About Vivos Therapeutics

Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods that promote sleep wellness and health for patients suffering from breathing and sleep issues such as obstructive sleep apnea (OSA) and snoring in adults. Vivos’ Complete Airway Repositioning and/or Expansion (CARE) devices are the only oral appliances cleared by the U.S. Food and Drug Administration (FDA) for adult patients diagnosed with all severity levels of OSA (including severe OSA) and moderate-to-severe OSA in children ages 6 to 17 within the FDA cleared usage for such devices.

Obstructive sleep apnea (OSA) affects over 1 billion people worldwide, yet 90% remain undiagnosed and unaware of their condition. This chronic disorder is not just a sleep issue—it’s 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, solutions are often mechanistic and fail to address the root causes of OSA. 

Vivos Therapeutics, founded in 2016 and based in Littleton, CO, is changing this. Through innovative technology, education, and collaborations with or acquisitions of functional medicine doctors, and sleep specialists, Vivos is empowering healthcare providers to more thoroughly address the complex needs of patients suffering with OSA.

Vivos’ portfolio of cutting-edge oral appliances offer a proprietary, clinically effective OSA 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 herein, 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 anticipated benefits to Vivos of the new published study data 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. Readers are cautioned that actual results 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 successfully integrate the Sleep Center of Nevada business 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) the risk that the study data described herein may not be predictive of results with Vivos treatment for all patients, (iv) risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea diagnosis and treatment sector; (v) the risk that Vivos may be unable to secure additional financing when needed, if at all, or maintain its Nasdaq listing, (vi) market and other conditions that could impact Vivos’ business or ability to obtain financing, and (vii) 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.

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FAQ

What were the results of Vivos Therapeutics (VVOS) clinical trial for pediatric sleep apnea?

The trial showed 79% of patients experienced OSA improvement, with 61.7% improving by 50% or more. Additionally, 93% of children with severe OSA saw symptoms decrease by at least 50%.

How does Vivos DNA device compare to traditional adenotonsillectomy for treating pediatric OSA?

Unlike adenotonsillectomy which has a 68% symptom relapse rate within three years, the Vivos DNA device offers a non-surgical, safe alternative with expected permanent effects past 24 months.

What FDA clearance did Vivos (VVOS) receive for their DNA device?

In September 2024, Vivos received an FDA 510(k) clearance for their DNA device to treat moderate to severe obstructive sleep apnea in children.

How many children in the US suffer from breathing and sleep disorders like OSA?

An estimated 10 million children (20.4%) in the United States suffer from breathing and sleep disorders such as OSA, with up to 90% currently undiagnosed and untreated.

What is Vivos Therapeutics' expansion strategy for their sleep apnea treatments?

Vivos is working to integrate their recent Sleep Center of Nevada acquisition and pursuing other sleep medical practice collaborations or acquisitions to increase patient access to their treatments.