Vivos Therapeutics (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, is featured in a recent Proactive Investors interview. According to the announcement, Vivos Therapeutics CEO Kirk Huntsman joined Proactive host Steve Darling to discuss a “milestone” moment for the company: the 510(k) clearance from the U.S Food and Drug Administration (“FDA”) for the treatment of severe obstructive sleep apnea (“OSA”) in adults using Vivos’ removable CARE oral appliances. The FDA approval includes Vivos’s flagship DNA oral appliance along with its mRNA and mmRNA oral appliances. During the interview, Huntsman noted that Vivos is now the first company to receive FDA approval and bring to market a treatment for patients with severe OSA that is an alternative to continuous positive airway pressure (“CPAP”) therapy or surgical neurostimulation implants. “The operative and most important word there is severe sleep apnea,” said Vivos Therapeutics CEO Kirk Huntsman during the interview. “This is a clearance by the FDA for doctors who use our devices to treat severe apnea. Other oral appliances, including our own, have had clearances for the FDA for years to treat mild to moderate sleep apnea. But as every sleep specialist will tell you, in most patients, the greatest amount of damage is done when it gets to a severe state. So patients are at greater risk for all the comorbidities that go along with sleep apnea. The hypertension, the stroke, the Alzheimer’s — all the various comorbidities of sleep apnea are made worse when you get to the severe level. And it cuts life expectancy down by as much as 10 years. So to be able to treat, and to have the clearance to treat, severe sleep apnea with our oral appliance technology is absolutely a breakthrough. I would venture to say that since the advent of CPAP, there hasn’t been a more important regulatory clearance than the one we announced this morning.”
To view the full interview, visit https://ibn.fm/FdBQD
To view the full press release, visit https://ibn.fm/v39Qb
About Vivos Therapeutics Inc.
Vivos Therapeutics 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 mild-to-moderate 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 moderate OSA. It has proven effective in the treatment of approximately 40,000 patients worldwide by more than 1,850 trained dentists. The Vivos Method includes treatment regimens that employ the proprietary Vivos Complete Airway Repositioning and/or Expansion (“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 palate. The Vivos Method opens airway space and may significantly reduce symptoms and conditions associated with mild to moderate 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 dentist training and other value-added services in connection with using the Vivos Method. For more information about this company, visit www.Vivos.com.
NOTE TO INVESTORS: The latest news and updates relating to VVOS are available in the company’s newsroom at http://ibn.fm/VVOS
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