Vivos Therapeutics (NASDAQ:VVOS) announced that it has been granted 510(k) clearance from the US Food and Drug Administration (FDA) for treating severe obstructive sleep apnea (OSA) in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances.
Its shares skyrocketed 589% to $30.25, on volume of more than 40 million shares, in late afternoon trading on Wednesday.
The medical technology firm said with the unprecedented FDA clearance, Vivos redefines what it means to have a truly non-invasive treatment for all levels of OSA severity, opening new revenue opportunities for the company.
"This achievement is a pivotal milestone for Vivos and elevates our proven treatment options right into the mainstream of sleep medicine," Vivos Therapeutics (NASDAQ:VVOS) CEO Kirk Huntsman said in a statement.
"Before this, severe OSA patients’ only realistic treatment options were CPAP (continuous positive airway pressure), neurostimulation implants or other invasive surgeries," he added.
Huntsman also called the company’s CARE appliances "a far more desirable option that is very affordable and doesn’t require surgery or a lifetime of nightly use and intervention."
Vivos noted that as a result of the FDA clearance, it became 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.
The company added that 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.
Vivos’ CARE appliances include its flagship DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance.
Vivos Therapeutics (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 mild-to-moderate obstructive sleep apnea and snoring in adults.
Contact Sean at sean@proactiveinvestors.com