Vivos Therapeutics recently received 510(k) market clearance from the FDA for its mmRNA (modified mandibular repositioning nighttime appliance) device to treat mild to moderate obstructive sleep apnea (OSA), sleep-disordered breathing and snoring in adults.
The oral appliance is part of the company’s Vivos System Treatment and is a non-surgical, non-invasive and non-pharmaceutical option for patients with OSA, according to a press release. The approval paves the way for expanded insurance reimbursement coverage for the device, including Medicare, as well as potential future government contracts and reimbursement from commercial payers that follow Medicare guidelines.
Combining proprietary technologies and protocols that alter the size, shape and position of the tissues that comprise a patient’s upper airway, the Vivos System opens airway space and may significantly reduce symptoms and conditions associated with mild to moderate OSA, such as lowering Apnea Hypopnea Index scores. Patients treated with the Vivos System typically complete therapy in 12 to 24 months and, in most cases, do not require lifetime intervention.
“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,” Vivos Chairman and CEO Kirk Huntsman said, according to the release. “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. Further, this FDA clearance for the mmRNA enables us to expand commercial insurance reimbursement, soon to include Medicare, making this a more cost-effective solution for patients suffering from OSA.”
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Source: Vivos Therapeutics