Mouthpiece developed by Vivos Therapeutics and previously designated as a Class I device for use as a palatal dilator has been approved by the FDA as a Class II device with a new indication for Obstructive Sleep Apnea (OSA) it was done.
The decision ends a two-year waiting period after Vivos was the first to file for this indication on an earlier device model and was rejected in 2021.
Kirk Huntsman, Chairman and CEO of Vivos Therapeutics, said: “For the first time, the FDA has formally recognized the benefits of our proprietary core technology in our His DNA device (no mandibular advancement) as an effective treatment for his mild to moderate OSA in adults. ”
The Day-Night Device (DNA) serves as a new alternative to existing treatment options for mild to moderate obstructive sleep apnea. According to a statement issued by Vivos, the device addresses the root causes of obstructive sleep apnea and snoring by opening the airway and properly resting the tongue, making it easier to breathe through the nose instead of mouth. .
It is important that patients follow clinical instructions and additional protocols as needed, which may be beneficial on their own or in conjunction with myofunctional therapy and continuous positive airway pressure (CPAP). Other non-surgical interventions for OSA are effective, but treatment adherence and unpleasant complications continue to impede their overall success.
Clinical data submitted to the FDA supporting this decision show that 28% of patients had OSA resolution, 63% had improved Apnea Hypopnea Index (API) scores by one category, and 86% had airway size improvement. showed improvement, with 97% showing a dilated palate. Proper tongue placement avoids common airway blockages.
“The FDA has now joined other international regulatory bodies in acknowledging the effectiveness of our patented technology in alleviating and resolving many symptoms of OSA due to underdeveloped jaws and oral cavity,” continued Huntman. “We believe DNA therapy can change the lives of many OSA patients and look forward to the continued market adoption of our expanded treatment menu for this debilitating condition.” increase.”
