Vivos’ Oral Device Treatment OK’ed for Severe OSA

Vivos Therapeutics has been granted the first-ever U.S. Food and Drug Administration (FDA) 510(k) clearance for an oral device to treat severe obstructive sleep apnea (OSA).
 
The 510(k) was specifically for Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances to treat OSA. The CARE appliances include its flagship DNA oral appliance, mRNA oral appliance, and mmRNA oral appliance.
 
Vivos consequently became the first company to market a clear, alternative treatment to CPAP or surgical neurostimulation implants for severe OSA patients. This clearance came 11 months after Vivos gained FDA 510(k) clearance for its DNA appliance to treat mild-to-moderate OSA.
 
Nationally renowned medical sleep specialist, author and lecturer, Dr. David McCarty, MD, elaborated on the impact of this landmark decision, stating “Make no mistake: this is a huge development on the landscape of treatments for OSA. As the medical profession has gained a better understanding of the complex factors contributing to OSA, we now recognize that a critical component to this condition is the form and functionality of the oral vault. This is where medical collaboration with an airway-centered dentistry approach like Vivos offers is a game-changer. This decision by the FDA could be life changing for patients who suffer from severe OSA and for whom other treatments have failed.”
 
The statistically significant data submitted to the FDA from 73 severe OSA patients showed 80% of patients experienced an improvement of at least 1 classification or at least 50% improvement in the Apnea Hypopnea Index (AHI), and 97% of patients improved or stayed the same. Average treatment time was just 9.7 months.
 
Treatment results with severe sleep apnea patients were actually better than with mild and moderate patients. All pre- and post-treatment testing was conducted with no device in the mouth. Unlike all other oral appliances on the market, Vivos’ CARE appliances gradually reposition the hard and soft tissues that define the airway, opening it up and optimizing function and flow.
 
Kirk Huntsman, Chairman and CEO of Vivos, added, “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.”