Summary: According to the Vivos Therapeutics fourth-quarter and full-year 2023 report, there has been positive momentum since the FDA clearance of its CARE oral appliances for severe OSA in adults. This momentum is evidenced by a 38% increase in Q4 VIP enrollment contracts. The report also highlights that over 42,000 patients worldwide have been treated with Vivos’ appliances, and more than 1,900 dentists have received training in The Vivos Method. Additionally, Vivos entered into an exclusive distribution agreement for the MENA region and initiated a clinical trial with Stanford Medicine. The company reported a fourth-quarter revenue of $3.2 million, with an annual total of $13.8 million.

In its fourth-quarter and full-year 2023 highlights, Vivos Therapeutics reported positive business momentum following receiving US Food and Drug Administration clearance for its oral appliances to treat severe obstructive sleep apnea (OSA).

In November, Vivos was granted 510(k) clearance for treating severe OSA in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances. Vivos’ CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance, and the mmRNA oral appliance. 

This represents the first time the FDA has ever granted an oral appliance clearance to treat moderate and severe OSA in adults 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.

“Since then, we’ve received high levels of inquiries related to our Vivos CARE products that treat OSA in adults. As a result, signed VIP enrollment contracts in the fourth quarter increased 38% sequentially. We are thrilled by this recent business momentum and expect these higher inquiries and expanded sales pipeline could create opportunities for revenue growth in 2024,” says Kirk Huntsman, Vivos’ chairman and chief executive officer, in a release. 

Vivos: FDA Clearance for Severe OSA Boosts Oral Appliance Interest
Vivos’ mRNA oral appliance is among the CARE appliances cleared to treat moderate and severe OSA.

As of Dec 31, 2023, patients treated with Vivos’ oral appliances totaled over 42,000 worldwide, compared to over 33,000 as of the end of 2022. Vivos has also trained more than 1,900 dentists in the use of The Vivos Method and Vivos’ related value-added services, compared to over 1,700 as of the end of 2022.

Vivos’ Business Highlights

Other business highlights from 2023 included: 

  • In October, Vivos announced an exclusive distribution agreement with Noum DMCC, a Dubai-based company focused on diagnostic testing and treatment product distribution for healthcare providers and hospital networks treating OSA patients throughout the Middle East-North Africa region. Subject to regulatory approvals, Vivos could see revenue from this collaboration in 2024.
  • Later in October, Vivos announced that its flagship daytime-nighttime appliance will be tested in a clinical trial at Stanford Medicine. The protocol has been finalized and participant enrollment will begin in 2024. Study participants with moderate to severe OSA will be randomly assigned to either treatment with Vivos’ DNA appliance or CPAP machine, the current industry standard for OSA treatment. Sleep studies will be performed prior to and following a course of treatment using in-lab polysomnography to assess changes in the patients’ apnea-hypopnea index.
  • In November, Vivos amended its national distribution agreement with Lincare, a supplier of in-home respiratory therapy products and services for approximately 1.8 million patients, giving Lincare a six-month exclusivity period to distribute certain designated Vivos devices. The agreement follows the successful conclusion of a distribution pilot with Lincare and marks an milestone in Vivos’ strategy to engage with leading durable medical equipment companies in the United States, according to a release from Vivos.

Revenue was $3.2 million for the fourth quarter of 2023 and $13.8 million for the full year ended Dec 31, 2023, compared to $4 million and $16 million for the fourth quarter and full year ended Dec 31, 2022, respectively, mainly due to lower appliance revenue and Vivos Integrated Provider enrollments, offset by increased revenue from home sleep testing services and seminars conducted at the Vivos Institute in Denver. 

Illustration 289493193 © Oleh Fadieiev |