Vivos Therapeutics has submitted a 510(k) Class II application to the US Food and Drug Administration (FDA) for its mmRNA oral appliance, which is designed to treat mild to moderate obstructive sleep apnea (OSA), sleep-disordered breathing, and snoring in adults.
The mmRNA, or modified mandibular Repositioning Nighttime Appliance, is an update of the company’s FDA-cleared Class II mRNA oral appliance. Assuming the mmRNA’s approval, Vivos expects to submit an application to a pricing, data analysis, and coding contractor for it to be added to the Centers for Medicare and Medicaid Services’ list of approved sleep apnea appliances. The process is expected to take approximately three to six months.
“Following mechanical testing on the mmRNA, this 510(k) submission marks a significant step toward Vivos continuing to offer a state of the art treatment alternative for people suffering from mild to moderate OSA,” said Kirk Huntsman, Vivos chairman and CEO.
“Furthermore, FDA clearance for the mmRNA will enable us to expand insurance reimbursement to include Medicare. Sleep apnea remains a serious, chronic disease that adversely impacts millions of people, and Vivos is steadfast in its mission to reach as many patients as possible around the country with our next-generation products,” Huntsman said.
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