Following the company’s announcement that the FDA has cleared its DNA oral device for the treatment of obstructive sleep apnea, shares of Vivos Therapeutics Inc. are up 85.14%.
According to Vivos, pre- and post-treatment Apnea Hypopnea Index (AHI) scores that were acquired without the use of an oral appliance were included in the clinical data that was submitted to the FDA as part of the DNA’s clearance procedure, proving that:
- In 28% of patients, OSA was treated.
- Patients’ AHI classifications improved for 63% of patients (i.e., severe to moderate, moderate to mild, or mild to no OSA)
- 86% of patients saw an increase in airway size.
- 97% of patients had their palates widen, which allowed the tongue to rest correctly and prevented a potential airway obstruction.
This clearance is the culmination of years of pioneering clinical work, 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. The FDA now joins other international regulatory bodies in recognizing 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. We believe the DNA treatment can be life changing for many OSA patients, and we look forward to continued market adoption of our expanded menu of treatments for this debilitating condition.Kirk Huntsman, Vivos’ Chairman and Chief Executive Officer