Vivos Therapeutics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its DNA oral appliance (daytime-nighttime appliance) to treat obstructive sleep apnea (OSA).
The clearance enables the use of the class II device as a new treatment regimen for mild-to-moderate OSA.
The new treatment offered by the DNA appliance involves opening the airway by extending the palate and training the tongue to rest in the proper position as well as converting patients to nasal instead of oral breathing.
Furthermore, the appliance can be used in combination with other treatment modalities, such as myofunctional therapy or continuous positive airway pressure (CPAP).
At present, treatment modalities of OSA include CPAP, mandibular advancement devices (MAD) and surgical intervention, which can involve hypoglossal nerve stimulation therapy.
The pre and post-treatment Apnea Hypopnea Index (AHI) scores received with no appliance in the mouth were included in the clinical data submitted to the FDA as part of the clearance process for the DNA.
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According to the company, the data revealed that 28% of patients had their OSA resolved, 63% of them improved by one AHI classification and 86% improved their airway size.
It also demonstrated that 97% of patients increased the width of their palate, which enables the tongue to rest in the proper position.
Vivo Therapeutics chairman and CEO Kirk Huntsman said: “For the first time, the FDA has formally recognised 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.
“The FDA now joins other international regulatory bodies in recognising the efficacy of our patented technology in the reduction and resolution of many of the symptoms of OSA that result from a lack of development of the jaws and oral cavity.”