The CARE (complete airway repositioning and/or expansion) line includes the flagship DNA, mRNA and mmRNA oral appliances. Littleton, Colorado–based Vivos says its clearance makes it the first company bringing a clear alternative to CPAP or neurostimulation implants to market to treat OSA.
The state of the sleep apnea treatment space remains up in the air amid the major device recall at Philips. A new wrinkle was added to the mix yesterday when the FDA warned of thermal issues with certain Philips CPAP devices.
ResMed took hold of the sleep respiratory market as Philips still works through the recall. However, the company had its own struggles, leading to layoffs and an overall operating model shift. Inspire Medical, meanwhile, offers the main neurostimulation implant alternative.
A regulatory nod for treating moderate and severe OSA
Vivos Therapeutics’ offering represents another alternative, with FDA clearance already garnered less than a year ago for the DNA device to treat mild-to-moderate OSA. This latest clearance marks the first such regulatory nod for an oral appliance for treating moderate and severe OSA in adults.
The company submitted data to the FDA demonstrating that 80% of patients experienced an improvement of at least one classification or at least a 50% improvement in the Apnea Hypopnea Index (AHI). Vivos said 97% improved or stayed the same with its oral appliances.
A separate peer-reviewed study showed that one in four Vivos patients experienced a complete resolution of their OSA symptoms.
“This achievement is a pivotal milestone for Vivos, and elevates our proven treatment options right into the mainstream of sleep medicine,” said Kirk Huntsman, Vivos chair and CEO. “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.”