Vivos Therapeutics breaks even with one FDA clearance, one rejection for sleep apnea treatment devices

You win some, you lose some—and that’s certainly true for Vivos Therapeutics, which reported on Monday the FDA’s clearance of one device to treat obstructive sleep apnea alongside the denial of another of the company’s applications to the agency.

First, the good news: Vivos’ modified mandibular repositioning nighttime appliance, trendily nicknamed the mmRNA, received 510(k) clearance to treat mild to moderate cases of sleep apnea and other sleep-disordered breathing conditions.

The mmRNA is an upgraded version of Vivos’ previously cleared mRNA device. In contrast to other apnea treatments like surgical implants or CPAP machines, Vivos’ device aims to lessen the symptoms of sleep-disordered breathing by addressing developmental deficiencies in the lower jaw that can contribute to the condition.

Vivos’ mouthpieces resemble standard orthodontic retainers and are custom-fitted to each patient. They’re meant to be worn for one to two years, during which time they’re periodically adjusted to progressively shift the wearer’s jaw to improve airflow and prevent the tongue and other tissues in the mouth from blocking the airway.

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Meanwhile, Vivos’ DNA, named for its daytime-nighttime wearing schedule, works by widening the upper jaw when worn for 10 to 12 hours per day.

The DNA has already been cleared as a Class I device by the FDA for use as a palatal expander, which are prescribed by dentists for a variety of indications, from creating more space in a young patient’s mouth to treating sleep-disordered breathing.

Vivos announced this week that the FDA had rejected its additional Class II application to include obstructive sleep apnea treatment as a specific indication for the DNA’s use, but said it would either appeal the agency’s decision or re-submit the application in the coming weeks.

Still, while Vivos can’t expressly market the DNA as a treatment for sleep apnea, dentists can still choose to prescribe the device as such, since it has already been cleared as a Class I device for palatal expansion.

“Dentists, as licensed clinicians within the scope of their practice, are free to diagnose, treat and prescribe the appropriate oral appliance therapy as they see fit, including uses which might be ‘off-label,’ based on their professional judgment,” the company noted in an SEC filing after submitting the additional 510(k) application. “Given the fact that our dentists regularly prescribe the DNA appliance to treat conditions closely associated with OSA, we do not believe a failure to receive FDA Class II clearance would materially impact our results or financial condition.”

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All of Vivos’ devices are personalized to fit each patient’s physical anatomy and health needs. The process begins with a range of assessments, including an in-home sleep test, CT imaging and 3D oral scans, a review of each patient’s health history and other diagnostic measurements.

That information is fed into Vivos’ Airway Intelligence system, which uses an algorithm to analyze the data and produce a report detailing a treatment plan to address any developmental deficiencies in the upper and lower jaws to treat sleep-disordered breathing.

A recent study commissioned by the company found that more than one-quarter of patients reported an almost complete reduction in their symptoms of obstructive sleep apnea after wearing a Vivos device for the prescribed one to two years. In total, more than 80% of participants recorded at least some improvement in their apnea symptoms after using the device.

So far, the devices have been prescribed to more than 19,000 patients, according to Vivos’ second-quarter earnings report. During that time, the company registered $4.5 million in revenues, up nearly 40% from the same period last year and about 30% from the previous quarter of this year.