First Medicare-Accepted Oral Appliance Treatment for All Severities of Obstructive Sleep Apnea in Adults
LITTLETON, Colo., April 9, 2024 — 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 all severities of obstructive sleep apnea (OSA) in adults), today announced receipt of all required regulatory approvals to enable Medicare reimbursement for its CARE oral medical devices. Effective immediately, this milestone achievement allows millions of Medicare beneficiaries coverage and reimbursement for allowable charges billable to Medicare.
“Prior to these latest developments, moderate to severe OSA patients on Medicare were relegated almost entirely to a lifetime of some form of CPAP—something most patients find undesirable. Our CARE oral medical devices, on the other hand, can significantly improve and even resolve OSA in about 12 months, with no further intervention required in most cases,” said Kirk Huntsman, Vivos Chairman and Chief Executive Officer. “We are very pleased the Centers for Medicare and Medicaid Services (CMS) recognizes and validates the benefits our FDA cleared devices can have on the lives of patients diagnosed with OSA. Now these novel and patented devices, which have been proven effective for all levels of OSA severity in adults from mild to severe, can be accessible to more people with less out of pocket cost. We believe this latest regulatory approval represents an inflection point for our devices and will open the door for more OSA patients who have Medicare or commercial medical insurance coverage to receive treatment from Vivos-trained professionals utilizing our proprietary core technology and treatment protocols. This should also drive increased patient count and utilization of our Vivos Devices and Method.”
Vivos provider and nationally renowned medical billing expert Chris Farrugia, DDS, DABSB, commented, “This coding decision from CMS now aligns with standard commercial billing practices for the device under the code K1027 as an oral device appliance used to reduce upper airway collapsibility, without a fixed mechanical hinge. This is a big step in making Vivos’ therapy accessible to Medicare beneficiaries as well as the millions of OSA patients covered by commercial insurers.”
According to CMS, as of December 2023, 66.9 million people were enrolled in Medicare, and many of these beneficiaries may suffer from OSA. OSA 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. 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. Research has shown that when left untreated, OSA can increase the risk of comorbidities, such as high blood pressure, heart failure, stroke, diabetes, dementia, chronic pain and other debilitating, life-threatening diseases. The Vivos Method is estimated to be indicated and potentially effective (within the scope of the FDA cleared uses) in approximately 80% of cases of OSA where patients are compliant with clinical treatments.
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. The Vivos Method represents the first clinically effective nonsurgical, noninvasive, nonpharmaceutical and cost-effective solution for treating mild to severe OSA. It has proven effective in over 42,000 patients treated worldwide by more than 1,900 trained dentists.
The Vivos Method includes treatment regimens that employ the proprietary CARE appliance therapy and other modalities that alter the size, shape and position of the soft tissues that comprise a patient’s upper airway and/or palate. The three Vivos CARE devices open airway space and may significantly reduce symptoms and conditions associated with mild-to-severe OSA, such as lowering Apnea Hypopnea Index scores. Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program for home sleep testing in adults and children. The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method.
For more information, visit www.vivos.com.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company’s management 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”, “should”, “expects”, “projects,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal” and variations of such words and similar expressions are intended to identify forward-looking statements. 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 impact of the Medicare regulatory approval described herein on Vivos’ future revenues and results of operations) 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 generate additional revenue from its receipt of the Medicare reimbursement code described herein or from other strategies aimed at increasing 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 treatment sector; (iv) the risk that Vivos may be unable to secure additional financing on reasonable terms when needed, if at all, or maintain its Nasdaq listing and (v) other risk factors described in Vivos’ filings with the 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.
Vivos Investor Relations and Media Contact:
Julie Gannon
Investor Relations Officer
720-442-8113
jgannon@vivoslife.com
