Vivos Therapeutics, Inc. Stock Rises: FDA Clears mmRNA Device

September 30, 2021

The Vivos Therapeutics, Inc. stock is on the rise, surging after the U.S. Food and Drug Administration (FDA) granted 510(k) market clearance to the mmRNA device (modified mandibular Repositioning Nighttime Appliance), a protocol for treating mild-to-moderate obstructive sleep apnea (OSA). OSA is a sleep disorder that causes the individual affected to repeatedly stop breathing for periods of 10 to 30 seconds. In the case of OSA, the individual stops breathing due to a blockage, often the tongue, as it fails to hold suction high in the palette and falls back into the airway.

The timing is uncanny, as the recent Philips CPAP machine recall will impact millions of individuals worldwide, forcing them to scramble for new alternatives to treat their OSA.

Clearance by the FDA paves the way for expanded insurance coverage for the mmRNA device, including Medicare, allowing more individuals to see this as a viable treatment option for their OSA.

“The FDA’s market clearance of Vivos’ newest device, the mmRNA appliance, represents a significant milestone in our ongoing efforts to provide the best possible treatment for people who continue to suffer needlessly from OSA,” stated Kirk Huntsman, Vivos chairman and CEO. “Further, this FDA clearance for the mmRNA enables us to expand commercial insurance reimbursement, soon to include Medicare, making this a more cost-effective solution for patients suffering from OSA.”

Studies estimate that nearly one billion individuals worldwide suffer from sleep apnea, with 80 percent of them going undiagnosed. Sleep apnea can cause severe comorbidities, such as high blood pressure, heart disease, stroke, diabetes, dementia, and more. In addition, individuals affected may experience one or many daily symptoms, including the following:

  • Extreme fatigue
  • Mental fog
  • Headache
  • An inability to concentrate
  • Moodiness
  • Depression
  • And more

The mmRNA appliance is part of The Vivos System, a revolutionary approach to treating OSA. The protocol seeks to provide patients with a lasting solution to their root problem, and patients undergoing therapy (typically 12–24 months) usually require no further intervention.

On a separate note, the FDA has denied 510(k) clearance for the DNA appliance, though it is currently registered as a Class I device for palatal expansion. Vivos plans to appeal this decision and resubmit the 510(k) application in the coming weeks.

In the past year, Vivos Therapeutics, Inc. stock has traded between $14.41 and $2.61. At the time of this article at 12 p.m. ET on August 25, one share is currently valued at $5.26, up from $3.81 at market close on Friday, August 20.

About Vivos Therapeutics, Inc.

Vivos Therapeutics Inc. (NASDAQ: VVOS) is an innovative company that specializes in advanced medical technology. With a focus on developing oral appliance devices to treat mild-to-moderate obstructive sleep apnea (OSA), the company has revolutionized dentistry and healthcare with The Vivos System, the first clinically effective nonpharmaceutical, noninvasive, nonsurgical, and cost-effective solution for adults. The Vivos System has shown to be an effective solution for over 19,000 patients worldwide.

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