Vivos Therapeutics has received 510(k) market clearance from the US Food and Drug Administration (FDA) for its mmRNA (modified mandibular Repositioning Nighttime Appliance) device to treat mild to moderate obstructive sleep apnea (OSA).
The mmRNA oral appliance is claimed to be an effective non-surgical, non-invasive and non-pharmaceutical alternative to treat adults suffering from sleep-disordered breathing and snoring.
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By GlobalDataThis approval could expand insurance reimbursement potential, including the opportunity for the device to be covered by Medicare.
It could also help in obtaining potential future government contracts and reimbursement from other commercial payers.
According to Vivos, more than one billion people across the world and 54 million individuals in the US suffer from sleep apnea, with 80% being undiagnosed.
The condition is a chronic ailment and raises the risk of comorbidities such as stroke, heart failure, dementia, high blood pressure, diabetes and other life-threatening diseases.
The company develops and commercialises diagnostic and treatment modalities for sleep-disordered breathing, including mild to moderate OSA.
Its oral appliances are intended to target the dental tissue anomalies and malformations that are known to be linked to OSA.
In contrast to existing standard of care interventions, the Vivos System generally concludes therapy in one to two years, the company noted.
Vivos Therapeutics chairman and CEO Kirk Huntsman said: “The FDA’s market clearance of Vivos’ newest device, the mmRNA appliance, represents a significant milestone in our ongoing efforts to provide the best possible treatment for people who continue to suffer needlessly from OSA, a debilitating condition that causes or contributes to a wide range of chronic health issues.
“Next-generation products like the mmRNA are vital for allowing medical doctors and dentists to continue pushing forward in their joint mission to give patients a better alternative for effectively treating their OSA.”
Meanwhile, the FDA has separately rejected an additional 510(k) application for its DNA appliance, the company announced.
The device has already been registered as a Class I device by the FDA for palatal expansion and is now in use by Vivos-trained clinicians.
Vivos said that it would appeal the FDA’s decision or resubmit the application in the coming weeks.
