Vivos Therapeutics (NASDAQ:VVOS) Inc’s recently announced FDA clearance for its oral appliances to treat severe obstructive sleep apnea (OSA) has sparked much investor interest, sending its stock price soaring more than 800% in a single trading session.
Vivos CEO Kirk Huntsman spoke with Proactive following the announcement to explain the significance of this milestone and why it could be so transformative for the company.
Proactive: There was significant news out from your company talking about hitting a major milestone, receiving the first ever FDA clearance for treating sleep apnea. Please explain the significance of this news?
Huntsman: The operative and most important word there is severe sleep apnea. This is a clearance by the FDA for doctors to use our devices to treat severe sleep apnea. Oral appliances, including those produced by Vivos, have had clearances from the FDA for years to treat mild to moderate sleep apnea but as every sleep specialist will tell you, the greatest amount of damage is done when apnea gets to a severe state. Then patients are at greater risk for all the comorbidities that go along with sleep apnea, hypertension, stroke, Alzheimer's, which could reduce life expectancy by as much as 10 years. So, to be able to treat, and to have the clearance to treat severe sleep apnea with this with our oral appliance technology is absolutely a breakthrough, and I would venture to say that since the advent of CPAP, there hasn't been a more important regulatory clearance than the one that we just announced.
Would you say this is a clear alternative to CPAP or surgery?
There are tens of millions of patients out there who are desperately looking for some alternative to those therapies and we now have a viable third option that is within the grasp of every person who wants to get treated.
You’ve talked recently about a distribution deal that you put in place and now with this FDA clearance in hand does it put your company on a different trajectory going into 2024?
We think it does. The Vivos option is now clearly one of the first considerations rather than a second-tier option. Since the announcement, we’ve received several incoming calls and inquiries from patients, medical doctors, and dentists. It's been really gratifying to see the way this news has been received.