Vivos Therapeutics Stock Is Moving Higher On FDA Approval For Its Sleep Apnea Device

Benzinga2021-08-23

The FDA has granted 510(k) clearance to Vivos Therapeutics Inc's mmRNA (modified mandibular Repositioning Nighttime Appliance) obstructive sleep apnea (OSA) device.

The device is indicated for mild to moderate OSA, sleep-disordered breathing, and snoring in adults.

The approval paves the way for expanded insurance reimbursement coverage for the mmRNA device and potential future government contracts and reimbursement.

Separately, the FDA has denied Vivos' previously submitted, additional 510(k) application for its DNA appliance.

The DNA appliance is already registered with the FDA as a Class I device for palatal expansion and is currently being used by Vivos-trained clinicians accordingly.

Vivos expects to appeal the FDA's decision or resubmit the 510(k) application to the FDA in the coming weeks.

Price Action: VVOS shares are up 41.9% at $5.45 during the premarket session on the last check Monday.

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