Business
Vivos Therapeutics Announces Multiple Regulatory Clearances in Australia for Its Entire Line of Oral Appliances
Australia clears Vivos technology to treat obstructive sleep apnea for all ages and regardless of severity in broad regulatory win. LITTLETON,
About this update from Vivos Therapeutics, Inc.
[{"type":"text","content":"\nAustralia clears Vivos technology to treat obstructive sleep apnea for all ages and regardless of severity in broad regulatory win.\n\n LITTLETON, Colo.--(BUSINESS WIRE)--\nVivos Therapeutics, Inc. (NASDAQ: VVOS) is pleased to announce that it has received multiple Class I clearances by the Therapeutic Goods Administration for multiple indications to include the treatment of snoring and obstructive sleep apnea (mild, moderate and severe) for both adults and children for its series of oral appliances.\n\n“These recent clearances provide further validation to our technology and extend the scope of our international market,” said Kirk Huntsman, co-founder and CEO of Vivos Therapeutics. “The Australian regulators recognized and accepted the clinical data we presented showing the clinical safety and efficacy of our technology regardless of age or the severity of the OSA. We are progressively moving forward with other domestic and international regulatory agencies with high expectations that our applications will be as well received as they have been in Australia. Poor sleep is a global epidemic. Vivos has developed a safe, comfortable, non-invasive, non-surgical solution, and we intend to offer it worldwide. We have already received clearances in the United States and Canada, and now, Australia will become part of our expanding international network. We will continue to grow and spread into other parts of the world.”\n\nAustralia follows the standards applied by the International Organization for Standardization (ISO), which is currently made up of 165 members/countries. These new clearances will allow Vivos to share its innovative technology and distribute devices that will help not only adults, but also children who suffer from sleep breathing disorders. These latest clearances include all classes of OSA as defined by the newly received Global Medical Device Nomenclature (GMDN) Vivos has received in Australia.\n\nThe clearances are as follows:\n\nClass I device clearances for the mRNA and mmRNA, for mandibular repositioning, palate lifting (jaw expansion causing airway enhancement) and as an anti-snoring orthosis. These appliances can be used for the purpose of reducing snoring and alleviating the symptoms of OSA and mild, moderate and severe sleep-disordered breathing.\n\nClass I device clearances for the DNA and Vivos Guide/Way...