Vivos Therapeutics Receives FDA Approval for Oral Sleep Apnea Device; Shares Skyrocket 270%

Medical device and technology company, Vivos Therapeutics (Nasdaq: VVOS) has been granted 510(k) clearance by the FDA for treating severe obstructive sleep apnea (OSA) in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances. Vivos is the first company ever to have approved and bring to market a clear alternative treatment to CPAP or surgical neurostimulation implants for patients with severe OSA.

Kirk Huntsman, Chairman and CEO of Vivos, said, “This achievement is a pivotal milestone for Vivos, and elevates our proven treatment options right into the mainstream of sleep medicine. It is even more important for the millions of severe OSA patients who are desperate for an effective alternative treatment. Before this, severe OSA patients’ only realistic treatment options were CPAP, neurostimulation implants or other invasive surgeries. Today, they have what we believe is a far more desirable option that is very affordable and doesn’t require surgery or a lifetime of nightly use and intervention.”

Highlights

The statistically significant data submitted to the FDA from 73 severe OSA patients showed that 80% of patients experienced an improvement of at least 1 classification or at least a 50% improvement in the Apnea Hypopnea Index (AHI), and 97% of patients improved or stayed the same.

Treatment results for patients with severe sleep apnea were better than with the results generated for mild and moderate patients and one in four 4 Vivos patients experienced a complete resolution of their OSA symptoms.

Vivos believes this decision will enhance its value proposition to third-party distribution partners, including durable medical equipment (DME) companies, and may pave the way for greater reimbursement levels from medical insurance payors and Medicare.

Last year, the FDA granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-to-moderate OSA.

About Vivos Therapeutics, Inc.

Vivos Therapeutics, Inc. (NASDAQ: VVOS) 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 obstructive sleep apnea (OSA) and snoring in adults. The Vivos Method represents the first clinically effective nonsurgical, noninvasive, non pharmaceutical and cost-effective solution for treating mild to severe OSA. For more information, visit www.vivos.com.