Benzinga - by Vandana Singh, Benzinga Editor.
Vivos Therapeutics Inc (NASDAQ: VVOS) received FDA 510(k) clearance for treating severe obstructive sleep apnea (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.
As a result of this FDA clearance, Vivos became the first company ever to have approved and bring to market a clear alternative treatment to continuous positive airway pressure (CPAP) or surgical neurostimulation implants for patients with severe OSA.
This latest clearance comes just eleven months after the FDA granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-to-moderate OSA and represents the first time the FDA has ever granted an oral appliance a 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.
The data submitted to the FDA from 73 severe OSA patients showed that 80% of patients experienced an improvement of at least one classification or at least a 50% improvement in the Apnea Hypopnea Index (AHI), and 97% of patients improved or stayed the same.
The average treatment time was just 9.7 months. Treatment results with severe sleep apnea patients were better than with mild and moderate patients.
Price Action: VVOS shares are up 169.70% at $11.84 on the last check Wednesday.
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