Company Description
Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company in the surgical and medical instrument manufacturing industry that focuses on breathing and sleep issues such as obstructive sleep apnea (OSA) and snoring. According to the company’s disclosures, Vivos develops and commercializes diagnostic and treatment methods that promote sleep wellness and health for patients whose problems arise from certain dentofacial abnormalities. Founded in 2016 and based in Littleton, Colorado, Vivos positions its technology as nonsurgical, noninvasive and nonpharmaceutical options for both adults and children diagnosed with OSA.
Core focus on obstructive sleep apnea and snoring
Vivos states that OSA affects over 1 billion people worldwide and that a large majority of these cases remain undiagnosed. The company highlights that OSA is closely linked to serious chronic health conditions and that traditional approaches, such as continuous positive airway pressure (CPAP) devices or certain surgeries, can be mechanistic and may not address underlying structural causes of airway obstruction. Within this context, Vivos concentrates on oral appliance technologies and related protocols intended to address anatomical contributors to sleep-disordered breathing in both adults and children.
Vivos CARE devices and FDA clearances
A central element of Vivos Therapeutics’ offering is its Complete Airway Repositioning and/or Expansion (CARE) line of oral appliances. Company materials state that these 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 for moderate-to-severe OSA in children ages 6 to 17, within the FDA-cleared usage for such devices. Vivos describes these appliances as part of a broader therapeutic approach that aims to reposition and expand the airway.
Within the CARE portfolio, Vivos highlights its Daytime-Nighttime Appliance (DNA), which is FDA 510(k) cleared as a non-surgical, non-pharmaceutical treatment for moderate to severe pediatric OSA in children ages 6 to 17. The company has reported multicenter clinical trial results and additional clinical data indicating that use of the DNA appliance in pediatric OSA can reduce OSA severity and improve related symptoms, and has characterized these outcomes as evidence that the device is both safe and efficacious for children with OSA.
The Vivos Method and treatment philosophy
Vivos refers to the use of its appliances and associated clinical protocols as The Vivos Method. The company describes this method as a proprietary, clinically effective solution that is nonsurgical, noninvasive and nonpharmaceutical. Vivos indicates that its approach is designed to address breathing and sleep issues arising from dentofacial abnormalities, rather than relying solely on mechanical support of the airway. The company states that many patients who undergo a full diagnostic and therapeutic regimen with Vivos-trained providers experience a reduction or resolution of OSA and related symptoms within a treatment period that can be less than a year.
Additional device offerings: DNA, Vivos Guides and VidaSleep
Beyond the core CARE devices, Vivos describes several specific products within its portfolio. The DNA appliance is part of the CARE line and is used in both adult and pediatric OSA treatment. Vivos has reported clinical data suggesting that pediatric patients treated with the DNA appliance can experience reductions in OSA severity, increased airway volume, and improvements in symptoms that overlap with conditions such as Attention-Deficit/Hyperactivity Disorder (ADHD), although the company notes that the DNA treatment is not cleared by the FDA specifically for ADHD.
Vivos also offers Vivos Guides, which it describes as specialized devices designed for guided jaw growth and development in children. According to company communications, these appliances are intended to support proper craniofacial growth at an early age and may help reduce the likelihood that a child will require OSA treatment later in life. Clinical data cited by Vivos indicate that use of Vivos Guides has been associated with improvements in symptoms such as bedwetting and behaviors linked to underdeveloped jaw growth.
In addition, the company has announced its VidaSleep oral appliance, which features Vivos’ patented and FDA-cleared Unilateral Bite Block technology. Vivos reports that VidaSleep has been approved by the Centers for Medicare & Medicaid Services (CMS) Pricing, Data Analysis and Coding (PDAC) contractor for the treatment of mild to moderate OSA and snoring in adults. The company states that VidaSleep joins the Vivos mmRNA appliance on the PDAC list of covered oral appliances, and that together these devices provide two Medicare-covered oral appliance options based on differentiated, patented technologies.
Clinical data and pediatric OSA
Vivos regularly references peer-reviewed and internal clinical data to support its focus on pediatric OSA. The company has announced results from a multicenter clinical trial, published in the European Journal of Pediatrics, which it reports demonstrated that the DNA appliance is safe and effective in treating children with OSA. In that trial, Vivos states that a substantial proportion of pediatric participants experienced at least a 50% reduction in OSA severity, with some achieving complete resolution of OSA, and that average airway volume increased while symptom scores on validated questionnaires decreased.
Additional datasets released by Vivos describe improvements in pediatric patients with both OSA and ADHD diagnoses who were treated with the DNA appliance. The company reports reductions in sleep-disordered breathing symptoms and ADHD-related behaviors, and notes that these findings support the view that treating OSA can influence associated behavioral and quality-of-life measures. Vivos also cites studies of its Vivos Guides indicating high rates of improvement or resolution in nocturnal enuresis and OSA-related symptoms over defined treatment periods.
Business model and sleep center strategy
While Vivos began with a distribution model focused on dental practices, company communications describe a strategic pivot toward direct affiliations with, or acquisitions of, medical sleep practices and testing centers. Through this approach, Vivos aims to place its diagnostic tools and therapies within sleep centers that see significant volumes of patients with sleep-related breathing disorders.
In June 2025, Vivos completed the acquisition of The Sleep Center of Nevada (SCN), which the company describes as a large operator of medical sleep centers in Nevada. Through this acquisition, Vivos obtained operating assets related to SCN’s sleep testing, diagnostics and treatment centers. The company has reported that integrating its treatment options into SCN locations has generated new diagnostic sleep testing revenue and what it calls “treatment center” revenue tied to Vivos’ operation of those centers.
In parallel, Vivos has developed an updated sleep practice affiliation model for situations where sleep center or medical practice owners do not wish to be acquired but are interested in offering Vivos’ OSA diagnostic and treatment options. Under this model, Vivos and the practice owners form a management services entity in which Vivos holds a supermajority equity interest. The company has disclosed such an arrangement with MISleep Solutions LLC in Auburn Hills, Michigan, near Detroit, where Vivos has built and equipped a sleep testing and treatment center and provides management and support services alongside its treatment offerings.
Sleep Optimization teams and operational approach
To support its integrated sleep center operations, Vivos has described a Sleep Optimization (SO) team structure. Each SO team, as outlined by the company, includes clinical and administrative personnel such as a nurse practitioner or physician assistant, specially trained dentists, dental assistants, administrative staff and a treatment navigator. These teams are deployed across sleep center locations to deliver diagnostic services and Vivos-based treatment regimens. Vivos has indicated that it uses this team-based model to manage patient demand and to scale capacity within its owned or affiliated sleep centers.
Collaborations and provider network
Vivos emphasizes collaborations with sleep specialists, functional medicine doctors, dentists and other healthcare providers. The company states that through education and commercial collaborations or acquisitions, it seeks to empower providers to address the complex needs of OSA patients more thoroughly. Vivos-trained providers integrate the company’s appliances and protocols into their practices, and in some cases also employ adjunctive FDA 510(k)-cleared therapies, such as certain laser treatments, as part of broader care pathways for issues like swollen tonsils.
Regulatory and corporate disclosures
Vivos Therapeutics files periodic and current reports with the U.S. Securities and Exchange Commission (SEC), including Forms 10-Q, 10-K, 8-K and proxy statements. These filings describe, among other matters, its acquisitions, financing arrangements, equity incentive plans, board elections and changes in its business model. The company has noted in SEC filings that its acquisition of SCN and its revised OSA provider management model are central to its current operational strategy, and that it views alliances and acquisitions of sleep centers as a way to expand access to its diagnostic and therapeutic offerings.
Summary
In summary, Vivos Therapeutics, Inc. is a NASDAQ-listed medical technology company based in Littleton, Colorado that concentrates on obstructive sleep apnea and related sleep-disordered breathing conditions. Its business centers on FDA-cleared oral appliance technologies, including the CARE line, DNA appliance, Vivos Guides and the VidaSleep oral appliance, combined with defined clinical protocols referred to as The Vivos Method. Through acquisitions and commercial collaborations with sleep centers and medical practices, Vivos seeks to integrate its diagnostic and treatment methods into settings where patients with OSA and snoring are evaluated and treated.