Vivos Therapeutics, Inc. (NASDAQ: VVOS) has received FDA clearance for its flagship sleep apnea treatment device, which it says is a result of years of pioneering clinical work.
The Colorado company announced the news on Wednesday and says receiving the federal agency’s approval for its daytime-nighttime appliance (DNA) will help to establish a novel new treatment regimen for obstructive sleep apnea (OSA).
This accomplishment is also particularly significant considering that Vivos applied for this 510(k) Class II device clearance for the DNA in August 2021 and had its application rejected by the FDA at that time.
The device opens an individual’s airway by expanding their palate, which Vivos says trains the tongue to rest in a proper position, therefore enabling users to breathe through their nose throughout the course of the night rather than their mouth.
Clinical data provided to the FDA by Vivos as part of the clearance process for the device included pre and post-treatment statistics showing that 28 per cent of patients had their OSA resolved by being treated with the DNA; 63 per cent saw a substantial improvement in their condition; 86 per cent of users gained an improved airway size; and 97 per cent of subjects increased the width of their palate, enabling the tongue to rest properly while avoiding an obstructed airway.
Vivos says a study on patient satisfaction with the DNA device showed that 98 per cent of subjects were either highly satisfied or very satisfied.
Vivo also says those who are treated with the device typically see long-lasting positive results or permanent improvement after they have stopped using it. Other non-surgical treatments for sleep apnea such as CPAP machines or other oral appliances require lifetime nightly use to remain effective.
“This clearance is the culmination of years of pioneering clinical work,” said Kirk Huntsman, CEO of Vivos.
“For the first time, the FDA has formally recognized the benefits of our proprietary core technology in our DNA appliance (without mandibular advancement) as an effective treatment for mild-to-moderate OSA in adults,” added Huntsman.
Huntsman also added that the FDA had now joined other regulatory bodies across the globe that recognize the efficacy of the company’s patented technology for reducing or resolving symptoms of sleep apnea resulting from a lack of jaw and oral cavity development.
He says Vivos believes the DNA treatment can be a life changer for those suffering from OSA and that the company is looking forward to seeing the device attain an increasing rate of market adoption.