Vivos Therapeutics (NASDAQ:VVOS) is well-positioned to increase the adoption of its oral medical devices for the treatment of severe obstructive sleep apnea as patients seek alternatives to continuous positive airway pressure (CPAP).
The company's Vivos CARE oral appliance in November 2023 received US Food and Drug Administration (FDA) approval to treat moderate to severe obstructive sleep apnea in adults along with positive airway pressure and/or myofunctional therapy, as required.
Vivos believes that recent market developments, including Philips Respironics’ announcement in January that it is suspending US sales of its CPAP and other respiratory units, are favorable for the company.
CEO Kirk Huntsman joined Proactive to discuss the opportunities the company sees following these recent changes.
Proactive: Let’s start by talking about Vivos’ oral appliances getting approval from the US FDA.
KH: It’s been a flurry of activity around here and it started, as you mentioned, with this 510(k) clearance for one of our lines of oral medical devices. We got the first-ever clearance to treat severe sleep apnea, all other oral appliances on the market are only cleared for milk to moderate cases. This is a huge breakthrough for our industry.
There’s been some interesting developments within the market itself with some of the companies working on sleep apnea differently. Take us through those changes in the market.
When a patient has sleep apnea, there are limited treatment options. The go-to, gold-standard treatment is CPAP.
The CPAP market has been in turmoil since 2021 when market leader Philips Respironics was tasked by the FDA to issue a recall of 5 million CPAP units. They continue to have problems with their units and just last week, Phillips announced that it is suspending sales in the US market until they meet certain criteria for safety and address other issues. The safety issues have not been minor, they had issues with their devices falling apart and causing cancer and other serious health problems. There are 561 deaths they believe could be attributed to these issues with this equipment.
The other big leader in this space ResMed has had their own issues with their devices.
These ongoing safety issues have created upheaval as patients and providers have scrambled to look for alternative treatment options.
And what is going on with UnitedHealth Group Inc (NYSE:UNH)?
Big insurance payers like UnitedHealthcare continually update their reimbursement standards. In January they came out with a new report requiring oral appliance therapy for all of their hypoglossal nerve stimulation patients. So patients who are candidates for a hypoglossal nerve implant must not only have failed CPAP but then also go through an oral application treatment regime and only after that fails are they eligible for an implant.
This is a big breakthrough and recognition by this payer that oral appliance therapy can be effective and done in conjunction with a number of treatment options.
How are you going to capitalize on these developments?
All of these things combined have just opened the door wide for Vivos and other firms. For sleep apnea patients, the only treatment option in oral appliances is a Vivos CARE device.
We have our people out there knocking on the doors of doctors to educate the medical community about what is going on because not everybody is fully aware of these changes.
Quotes have been edited for clarity and style