mmRNA is the first and only appliance of its kind covered by Medicare
Part of the Vivos System treatment, the mmRNA appliance represents a highly effective, nonsurgical, noninvasive, and nonpharmaceutical alternative for patients suffering from OSA and snoring.
Colorado, December 14, 2021
Vivos Therapeutics, Inc. (“Vivos” or “the Company”) (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for patients suffering from mild to moderate obstructive sleep apnea (OSA) and snoring, today announced that it has received acceptance from a Centers for Medicare & Medicaid Services Pricing, Data Analysis and Coding (“PDAC”) contractor for its mmRNA (modified mandibular Repositioning Nighttime Appliance) device for treating mild to moderate OSA and snoring in adults. This acceptance places the mmRNA device on the PDAC list of oral appliances covered by and billable to Medicare.
This development immediately makes benefits of the mmRNA device available to millions of Medicare beneficiaries who seek effective treatment for mild to moderate OSA. The mmRNA is the first and only appliance on the PDAC list that offers patients the compelling clinical advantages of Vivos’ proprietary technology.
Acceptance on the PDAC list marks a positive leap toward increasing commercial insurance coverage, making the mmRNA appliance a cost-effective solution for non-Medicare beneficiaries. With its novel design, the mmRNA appliance also allows Vivos-trained dentists to help patients in a variety of clinical applications, such as a standalone therapy for mild to moderate OSA or as an alternative to or an adjunctive therapy with continuous positive airway pressure (CPAP) therapy.
“This latest regulatory milestone opens the door for Vivos-trained dentists across the country to deliver our life-changing therapeutic technology to the millions of OSA sufferers in the US who are either on Medicare or who have commercial medical insurance coverage that follows Medicare guidelines,” said Kirk Huntsman, Vivos CEO and chairman. “The latest data from our SleepImage home sleep apnea test screening shows that 47% of patients screened were positive for OSA, a far higher prevalence of OSA than has previously been assumed in the industry.”
More than 1 billion people globally and 54 million Americans suffer from sleep apnea, 80 percent of whom remain undiagnosed. A serious chronic illness, sleep apnea increases the risk of comorbidities, including high blood pressure, heart failure, stroke, diabetes, dementia, and other life-threatening diseases. Vivos’ oral appliances nonsurgically address the dental tissue anomalies and malformations known to be associated with OSA. Unlike current standard-of-care interventions, such as lifetime use of CPAP machines or surgical procedures, patients treated with the Vivos System typically complete their therapy in 12 to 24 months, and in many cases do not require further intervention.
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, particularly with respect to the public offering described herein. Words such as “aim,” “may,” “could,” “expects,” “projects,” “intends,” “plans,” “believes,” “predicts,” “anticipates,” “hopes,” “estimates” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve 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, without limitation, the anticipated benefits of Australian regulatory approval described here on the Company’s sales and ability to obtain regulatory approvals in other countries) may differ materially 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, the 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 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.