Vivos Therapeutics, Inc mouthpiece finally cleared by FDA to treat sleep apnea

After being initially rejected by the FDA, Vivos Therapeutics has received clearance for its DNA appliance to be used to treat obstructive sleep apnea (OSA).

The device, which was previously classified as a Class I device by the FDA for use as a palatal expander, has now been given a Class II classification as an effective treatment for mild to moderate OSA in adults.

The device expands the palate and helps to train the tongue to rest in the correct position, converting patients to nasal breathing. It can also be used in conjunction with other treatments, such as myofunctional therapy or continuous positive airway pressure. Clinical data submitted to the FDA as part of the clearance process for the DNA appliance showed that 28% of patients had their OSA resolved, while 63% improved by one apnea-hypopnea index classification, 86% improved their airway size and 97% increased the width of their palate.

The results showed the device to have long-lasting effects and showed that it may result in permanent improvement. CEO Kirk Huntsman said that the DNA treatment "can be life-changing" for OSA patients and the company hopes to see continued adoption of the device.

References

Park, A. (2023, January 4). FDA reverses rejection of Vivos mouthpiece for sleep apnea. Fierce Biotech. Retrieved January 5, 2023, from https://www.fiercebiotech.com/medtech/after-fda-rejection-vivos-therapeutics-mouthpiece-finally-cleared-treat-sleep-apnea

Vivos Therapeutics, Inc. (2023, January 4). Vivos Therapeutics Receives FDA 510(k) Clearance of its Flagship DNA Oral Appliance for Treatment of Obstructive Sleep Apnea. GlobeNewswire. Retrieved January 5, 2023, from https://www.globenewswire.com/news-release/2023/01/04/2582808/0/en/Vivos-Therapeutics-Receives-FDA-510-k-Clearance-of-its-Flagship-DNA-Oral-Appliance-for-Treatment-of-Obstructive-Sleep-Apnea.html