Vivos Therapeutics (NASDAQ:VVOS) CEO Kirk Huntsman expects to see more medical and dental professionals recommending its oral medical devices for obstructive sleep apnea (OSA) after they secured Medicare reimbursement approval.
The company announced earlier this week that its CARE oral medical devices, an alternative to continuous positive airway pressure (CPAP) for patients with OSA, have been approved for Medicare reimbursement by the Centers for Medicare and Medicaid Services (CMS).
Huntsman joined Proactive to discuss this milestone achievement and what it means for both the company and Medicare patients suffering from OSA.
Proactive: You’ve got significant news related to your medical devices. Tell me about this line of medical devices you have.
KH: Here at Vivos, we have a uniquely designed line of oral medical devices that we call our CARE oral medical devices. These are designed to enhance the functionality of the human airway. The treatment with these devices lasts only about 12 months and at the end of that time, patients can enjoy a lifetime of potential sleep without sleep apnea. It’s a really powerful set of appliances we have here.
Last fall, we announced that we had received clearance from the Food and Drug Administration (FDA) for treating moderate to severe patients [with sleep apnea]. It’s the only line of medical oral devices in the world that can treat severe sleep apnea.
You’ve been given regulatory approval to facilitate Medicare reimbursement, obviously a big milestone for the company.
It’s a huge milestone because, in reality, most of the Medicare patients have some form of breathing or sleep disorder and we have the ability to address that without the need for lifetime intervention. We have a very unique contribution to make here. Recognition by CMS and the Medicare folks that this is a viable alternative to the traditional CPAP-type treatment is a very big step. It’s great news for the 10s of millions of Medicare patients who have moderate to severe OSA.
Getting this clearance, how does this change how you move forward with the products?
Every time we get a new clearance from the FDA or we have something that recognizes the ability or efficacy of our treatment options, we see more and more medical and dental providers recommending this treatment for their patients. And as that happens, the span and scope of our exposure as an alternative to the traditional CPAP treatments just grows and grows. We’re seeing a tremendous uptake in that awareness and every one of these things work synergistically to expand and extend that knowledge.
This could not come at a better time considering what’s happening in the world of CPAP right now.
There was the Phillips announcement recently they are withdrawing from the US market and there have been recalls of other brands and other devices. Speaking to people in the industry, it’s up to a four or five-month wait for a patient that’s newly diagnosed with CPAP to be able to get their CPAP units. The entire market for CPAP is in total disarray.
Here we come along with a brand new and highly effective treatment option that now has legitimacy from so many different sectors, the FDA and now Medicare. It just adds to the credibility of what we’re doing.
Quotes have been edited for clarity and style