DNA Appliance (Pediatric)
Moderate-to-Severe Obstructive Sleep Apnea (Children 6-17)
CommercialFDA Cleared (K234089)
Key Facts
Indication
Moderate-to-Severe Obstructive Sleep Apnea (Children 6-17)
Phase
Commercial
Status
FDA Cleared (K234089)
Company
About Vivos Therapeutics
Vivos Therapeutics is on a mission to redefine the standard of care for obstructive sleep apnea by addressing its underlying anatomical causes. The company has achieved FDA clearance for its Vivos CARE oral appliances for mild-to-severe OSA in adults and moderate-to-severe OSA in children, positioning it as a unique player in the sleep therapy market. Its strategy leverages a capital-light, provider-based distribution model focused on training dentists and integrating with the sleep medicine ecosystem. Vivos aims to transition patients from symptom management with CPAP to a finite therapeutic intervention with lasting physiological benefits.
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