Vivos Therapeutics Releases Additional Clinical Data Showing Marked Improvement in Pediatric ADHD from Use of Vivos DNA Device

Rhea-AI Summary

Vivos Therapeutics (NASDAQ:VVOS) has released new clinical data demonstrating significant improvements in children with ADHD and OSA using their FDA-cleared Daytime-Nighttime Appliance (DNA). The study showed remarkable results, including a 50% decrease in pediatric sleep issues and a 58% decrease in ADHD symptoms.

The clinical trial, involving 48 children with an average age of 10.6 years, demonstrated 100% of patients experienced increased transpalatal width (+13.6%) and airway volume (+40%), while OSA severity decreased by 51.4%. The DNA appliance represents the only FDA-cleared non-surgical, non-pharmaceutical treatment for moderate to severe pediatric OSA in children ages 6-17.

The majority of improvements occurred within the first six months of treatment, offering a promising alternative to traditional adenotonsillectomy surgery and pharmaceutical interventions.

Positive

• FDA-cleared DNA device showed 50% reduction in pediatric sleep issues
• 58% decrease in sleep disordered breathing and ADHD symptoms
• 100% of patients showed increased airway volume (+40%) and transpalatal width (+13.6%)
• 51.4% reduction in OSA severity (AHI scores)
• Only FDA-cleared non-surgical, non-pharmaceutical treatment for moderate to severe pediatric OSA

Negative

• DNA appliance not yet FDA cleared specifically for ADHD treatment

Previously Unpublished Data Confirms Vivos DNA Devices Offer a Safe and Effective Alternative Treatment for Children with ADHD and Obstructive Sleep Apnea

LITTLETON, Colo., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company’’) (NASDAQ: VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders, including obstructive sleep apnea (OSA), today released previously unpublished clinical data confirming that treatment with Vivos’ FDA-cleared Daytime-Nighttime Appliance (DNA) can provide children with Attention-Deficit/Hyperactivity Disorder (ADHD) and OSA significant relief and improvement in their quality of life.

Vivos’ DNA appliance is the only FDA 510k cleared non-surgical, non-pharmaceutical treatment for moderate to severe pediatric OSA in children ages 6-17, and is increasingly seen as a viable alternative to adenotonsillectomy surgery for OSA. The DNA appliance is part of Vivos’ Complete Airway Repositioning and Expansion (“C.A.R.E.”) line of devices cleared by the FDA to treat OSA in both children and adults.

The diagnosed rates of ADHD in the United States have roughly quadrupled since the 1980s—from an estimated 2–3% of school-aged children (circa 1985) to just over 11% by 2022, according to the Centers for Disease Control and Prevention (CDC). The prevalence of OSA in a preschool pediatric population similarly increased from 3 - 9% before 2014, to 13 - 20% by 2022. Children with OSA are often misdiagnosed as having ADHD due to the bidirectional nature and overlap of these two conditions in the pediatric population.

Multiple studies show a strong link between pediatric OSA and the incidence of ADHD symptoms, with attention deficits reported in up to 95% of pediatric OSA patients. Other studies show moderate to severe pediatric OSA patients are most likely to exhibit ADHD symptoms. By 2022, an estimated 7.1 million U.S. children and adolescents (about 1 in 9) had been diagnosed with (ADHD), according to the CDC. Multiple studies (see Sedky et al 2014) have shown that treatment for OSA can dramatically reduce or eliminate ADHD symptoms.

“We are seeing a large and untapped market to effectively address ADHD symptoms by treating a child’s OSA using Vivos’ non-surgical and non-pharmaceutical approach. Parents are wary of putting their children through painful surgeries or giving them drugs. Vivos is the first to offer a safe and effective FDA-cleared alternative. And although our Vivos DNA treatment is not yet FDA cleared to treat ADHD per se, we believe this data strongly suggests that by successfully treating a child’s OSA it is possible to reduce or eliminate ADHD symptoms and behaviors,” said Kirk Huntsman, Chairman and CEO of Vivos.

In this current dataset just released by Vivos, children treated with the Vivos DNA appliance reported a 50% decrease in the validated Pediatric Sleep Questionnaire (PSQ), which measures snoring, sleep apnea, and restless legs (p<0.00001). Moreover, these children showed a 58% decrease in symptoms of sleep disordered breathing and ADHD symptoms such as disruptive behavior and hyperactivity.

Forty-eight (48) of the original 55 patients completed the clinical trial. There were 28 males and 20 females, with an average age of 10.6 years. As expected from previous studies, 100% of patients increased both their transpalatal width (+13.6%) and their airway volume (+40%), while the severity of their OSA decreased by 51.4% (as measured by their Apnea-Hypopnea Index (AHI) scores). All improvements were statistically significant.  

Vivos believes these significant improvements in OSA and ADHD symptoms may allow these children to improve their behavioral performance in school and their academics, making a profound difference in their quality of life. The majority of this improvement was shown to occur in the first six months of treatment.

About Vivos Therapeutics

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 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 in both children and adults. 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, and the temporary positive effects of painful surgical interventions such as adenotonsillectomies in children tend to diminish over time.

Founded in 2016 and based in Littleton, CO, 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 more thoroughly address the complex needs of OSA patients.

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 and the 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 of the clinical data described herein on general patient outcomes and Vivos’ future revenues and results of operations. 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. 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:

Andrew Ballou
(914) 522-0861

Investor Inquiries:
R. Kirk Huntsman
Chief Executive Officer
investors@vivoslife.com 

FAQ

What were the key results of Vivos Therapeutics (VVOS) clinical trial for pediatric ADHD and OSA?

The trial showed a 50% decrease in sleep issues, 58% decrease in ADHD symptoms, and 51.4% reduction in OSA severity. 100% of patients experienced improved airway volume and transpalatal width.

How many children participated in the Vivos Therapeutics DNA device clinical trial?

48 patients (28 males, 20 females) with an average age of 10.6 years completed the clinical trial.

Is the Vivos DNA device FDA-approved for treating ADHD in children?

No, the DNA device is not yet FDA-cleared specifically for ADHD treatment. However, it is FDA-cleared for treating moderate to severe pediatric OSA in children ages 6-17.

How long does it take to see improvements with the Vivos DNA device?

The majority of improvements were observed within the first six months of treatment.

What makes Vivos DNA device unique in treating pediatric OSA?

It is the only FDA-cleared non-surgical, non-pharmaceutical treatment for moderate to severe pediatric OSA in children ages 6-17, offering an alternative to adenotonsillectomy surgery.