Vivos Therapeutics (NASDAQ:VVOS) told investors it has experienced a surge in interest in the wake of the FDA 510(k) clearance from the US Food and Drug Administration (FDA) for its CARE (Complete Airway Repositioning and/or Expansion) oral medical devices targeting severe obstructive sleep apnea (OSA).
The medical technology firm said the groundbreaking clearance, granted on November 28, 2023, marks the first time the FDA has approved an oral appliance for treating moderate and severe OSA in adults, aged 18 and older, complemented by positive airway pressure (PAP) and/or myofunctional therapy.
During the fourth quarter of 2023, the company reported a 600% increase in new dentist inquiries to join the Vivos Integrated Practice (VIP) program compared to the previous month. The VIP sales pipeline, representing dentists in contract discussions, doubled, and signed VIP enrollment contracts rose by 38% sequentially from the third quarter of 2023. Moreover, CARE appliance orders soared, with an impressive 26% increase in the three weeks post-FDA clearance compared to the previous 12-week average.
The CARE oral appliances, including the flagship DNA, mRNA, and mmRNA models, are expected to revolutionize the treatment landscape for sleep-related breathing disorders.
"We believe this significant uptick in business development and revenue-generating activity since achieving this important milestone highlights our overall value proposition across both the dental and medical communities as a highly effective treatment alternative for OSA patients," Vivos chairman and CEO Kirk Huntsman commented in a statement.
"With this strong momentum coming into 2024, we expect these higher inquiries and expanded sales pipeline could create opportunities for revenue growth in 2024.”
As well as the considerable growth and interest in its Vivos CARE products that treat OSA in adults, Huntsman noted that Vivos has also seen a 53% increase in sales of our pediatric guided growth and development appliances, which it refers to as Vivos Guides, during the past few weeks. The company expects this trend to continue in the near term, especially considering the recent success of one of its key strategic dental service organization (DSO) distribution partners, Toothpillow.
"In December, the new patient inquiries jumped 1,500%, which is an all-time record month in new case starts." Toothpillow CEO and co-founder Chad Rasmussen added.
"Our virtual telehealth, ship-to-home model coupled with Vivos’ Guide products is proving to be a highly effective solution for pediatric patients with underdeveloped jaws and malocclusions—both conditions having been linked closely to breathing and sleep disorders and other serious health issues. Now that the word is spreading, we eagerly anticipate the upward momentum to continue.”
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 and snoring in adults.
The company's shares traded 1.8% up at $9.50 shortly before midday in New York.
~Updated with share price movement~