1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Valuation
Discussion
Symbol
VVOS
Event Date
2020-12-11
IPO Date (Actual)
2020-12-09
Sector
Health Care
Subsector
Health Care Equipment & Supplies
Offer Range
$6.00-$6.00
Shares Offered
3.5M
18.21M
$109.3M
19.2%
Implied Upside vs Midpoint
Description
We are a revenue stage medical technology company focused on the development and commercialization of a highly differentiated technology offering a clinically effective non-surgical, non-invasive, non-pharmaceutical, and low-cost solution for patients with sleep disordered breathing (SDB), including mild-to-moderate obstructive sleep apnea (OSA). We offer novel and proprietary alternatives for treating mild-to-moderate OSA as well as certain craniofacial and anatomical anomalies known to be associated with mild-to-moderate OSA. We believe our products and technology represent a significant improvement in the treatment of mild-to-moderate OSA versus other treatments such as continuous positive airway pressure (or CPAP). Sleep apnea is a serious and chronic disease that negatively impacts a patient’s sleep, health and quality of life. According to a 2019 article published in Chest Physician, it is estimated that OSA afflicts 54 million adults in the U.S. alone, and according to a 2016 report by Frost & Sullivan, OSA has an annual societal cost of over $149.6 billion. According to the study “Global Prevalence of Obstructive Sleep Apnea (OSA)” conducted by an international panel of leading researchers, nearly 1 billion people worldwide have sleep apnea. OSA occurs when a person’s breathing is interrupted during sleep by a partially or completely blocked airway. OSA causes breathing to repeatedly stop and start (an apnea event) during sleep and affects patients of all ages, sexes and body types. The severity of OSA is often measured by the number of partial or complete airway blockages lasting 10 seconds or longer that a patient experiences in an hour, referred to as the apnea-hypopnea index (or AHI). Left untreated, OSA may increase the risk of high blood pressure/hypertension, heart failure, stroke, coronary artery disease and other debilitating and life-threatening diseases. According to publicly available data, in up to 98% of patients with OSA, the condition is due to abnormal anatomical features of the soft tissues and/or the structures of the maxillomandibular skeleton that cause a disproportionate anatomy of the airway, or a constricted airway. Our treatment for mild-to-moderate OSA involves specially designed and customized oral appliances and treatment protocols that we call the Vivos System. We believe the Vivos System technology represents the first non-surgical, non-invasive and cost-effective solution that normally does not require lifetime use or intervention for the hundreds of millions of people globally who suffer from mild-to-moderate OSA. Our oral appliances have proven effective (within the scope of the U.S. Food and Drug Administration (or FDA) cleared uses as described below) in over 15,000 patients treated worldwide by more than 1,200 trained dentists. The Vivos System combines both patented and proprietary technologies that we believe opens airway space and can eliminate or significantly reduce symptoms and conditions associated with mild-to-moderate OSA. Studies have shown that the patented and proprietary technologies and protocols incorporated into the Vivos System technology alter the size, shape and position of the tissues that comprise the human airway. In 17 published, peer-reviewed studies (on which our founder and Chief Medical Officer was an author) that examined the impact of our technologies and protocols on the AHI scores of patients with varying degrees of OSA, patient AHI scores were reduced from a low of 38% to a high of 98.6%, with the mean AHI reduction shown in such studies being 67.4%. The severity of OSA is often measured by the AHI. We are not aware of any additional published studies that evaluate the impact of the Vivos System technology on AHI scores in patients with OSA. We intend to more rapidly expand the use of the Vivos System by actively recruiting dentists and training them about OSA and the use and application of our products and technology to treat mild-to-moderate OSA. Traditionally, dentists have had only a limited role in helping identify and treat sleep related breathing disorders. However, the House of Delegates of the American Dental Association in 2017 adopted a policy statement describing the important role dentists can play in helping identify patients at greater risk of sleep related breathing disorders. By focusing our business model around dentists, we are helping to assist dentists to fulfill this role. We teach dentists, medical doctors and other healthcare providers about the many ways the Vivos System can help their patients. Our program to train dentists and offer them other value-added services as described below is called the Vivos Integrated Practice (VIP) program. The VIP program gives dentists the opportunity to become ambassadors of the Vivos System and offer their patients critical, and sometimes lifesaving, diagnosis and treatment of mild-to-moderate OSA through the use of the Vivos System. Importantly, the VIP program also provides dentists with a strong economic incentive to provide this treatment and prescribe the Vivos System, together with practice support services. We also train our VIP dentists to identify patients that may have OSA and to discuss OSA with their patients. Trained dentists use the Vivos System to treat conditions associated with SDB and mild-to-moderate OSA. The treatment by a dentist of SBD and mild-to-moderate OSA with the Vivos System follows a required diagnosis of these conditions (typically through the use of either a polysomnogram or home sleep apnea test) by a medical doctor which is often provided by the sleep test provider. In addition to the Vivos System, we also separately market our own line of pre-formed oral guides and rescue appliances used by dentists in the treatment of various developmental and orthodontic conditions, some of which have been associated with SDB or OSA (which we refer to collectively as Vivos Guides or Guides). Our clinical education and training is delivered via online and in-person training through our Institute for Craniofacial Sleep Medicine (ICSM). The Vivos System features our patented Mandibular Repositioning Nighttime Appliance (or mRNA appliance®), which incorporates the same patented technology built into our Daytime Nighttime Appliance (DNA appliance®). The regulatory status of our products is as follows: . The mRNA appliance® has 510(k) clearance from the FDA as a Class II medical device for the treatment of snoring, mild-to-moderate OSA and SDB. . The DNA appliance® is registered with the FDA as a Class I device for palatal expansion, and is currently used by Vivos-trained clinicians accordingly. The DNA appliance® also currently has a pending 510(k) application to include additional indications of use for the treatment of mild-to-moderate OSA, snoring, and SDB in adults. This use would require the DNA appliance® to be registered as a Class II device. We have validated this 510(k) request with retrospective clinical data. This DNA appliance® 510(k) review and approval process is expected to take another three to six months, meaning we would expect to hear from the FDA during the fourth quarter of 2020 or 2021. However, it is possible that we may not receive this FDA additional clearance. Nevertheless, the DNA appliance® is exempt from 510(k) clearance as a Class I device. We instruct all dentists prescribing the DNA appliance about the device’s approved indications of use and of the fact that the DNA appliance is a Class I FDA registered oral appliance. Dentists, as licensed clinicians within the scope of their practice, are free to diagnose, treat and prescribe the appropriate oral appliance therapy as they see fit, including uses which might be “off-label”, based on their professional judgement. Given the fact that our dentists regularly prescribe the DNA appliance to treat conditions closely associated with OSA, we do not believe a failure to receive FDA Class II clearance would materially impact our results or financial condition. Any potential consequences of off-label use of the DNA appliance are the responsibility of the treating dentist; however, we may face consequences related to such off-label use. . The Guides are registered with the FDA as Class I devices for orthodontic tooth positioning. We are conducting two separate Western Institutional Review Board (WIRB) approved pediatric clinical trials with seven private dental sites around the country. The purpose of the first study is to evaluate the safety and efficacy of the DNA appliance® to reduce SDB, including snoring, mild to moderate OSA, and Upper Airway Resistance Syndrome (or UARS), and to establish nasal breathing in children. The purpose of the second study is to evaluate the safety and efficacy of the Guides (which we call the Vivos Grow and Vivos Way appliances) to reduce SDB, including snoring, mild-to-moderate OSA, and Upper Airway Resistance Syndrome (or UARS). Upon completion of these WIRB pediatric clinical trials (expected to be completed in the next 12 to 18 months), we plan to submit two separate 510(k) applications to the FDA requesting additional pediatric clearances and indications of use for the DNA appliance® as well as the Guides. Our mission is to rid the world of OSA. We believe we are well-positioned with what we consider to be a disruptive technology aimed at treating mild-to-moderate OSA, with a clear first-mover strategy, compelling economics at each level of the delivery chain, and a talented team of experienced professionals who are passionate about what we do and are driven to deliver results. --- Our principal offices are located at 9137 Ridgeline Boulevard, Suite 135, Highlands Ranch, Colorado 80129, and our telephone number is (866) 908-4867. Our website is www.vivoslife.com. We were originally organized on July 7, 2016 as a Wyoming corporation under the name as Corrective BioTechnologies, Inc. On September 6, 2016, we changed our name from Corrective BioTechnologies, Inc. to Vivos BioTechnologies, Inc., and on March 2, 2018, we changed our name from Vivos BioTechnologies, Inc. to Vivos Therapeutics, Inc.
Vivos Therapeutics, Inc. annual income statement and balance sheet, FY 2021 to FY 2025, as reported in SEC filings.
| Metric | FY 2021 | FY 2023 | FY 2024 | FY 2025 |
|---|---|---|---|---|
| Revenue | $16.9M | — | $15.0M | $17.4M |
| Gross profit | $12.6M | — | $9.0M | $10.5M |
| Operating income | ($20.4M) | — | ($11.2M) | ($19.9M) |
| Net income | ($20.3M) | — | ($11.1M) | ($21.2M) |
| Metric | FY 2021 | FY 2023 | FY 2024 | FY 2025 |
|---|---|---|---|---|
| Total assets | $33.7M | — | $15.3M | $25.2M |
| Total liabilities | $8.2M | — | $7.3M | $26.7M |
| Total equity | $25.5M | $411K | $8.0M | ($1.6M) |
| Cash & equivalents | $24.0M | — | $6.3M | $2.0M |