Vivos Therapeutics has received multiple Class I clearances by the Therapeutic Goods Administration for multiple indications to include the treatment of snoring and obstructive sleep apnoea (mild, moderate and severe) for both adults and children for its series of oral appliances.
“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 recognised and accepted the clinical data we presented showing the clinical safety and efficacy of our technology regardless of age or the severity of the obstructive sleep apnoea (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 US 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.”
Australia 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.
The clearances are as follows:
- Class 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.
- Class I device clearances for the DNA and Vivos Guide/Way for palate lifting (jaw expansion causing airway enhancement), repositioning/straightening teeth, and as an anti-snoring orthosis. These appliances can be used for the purposes of reducing night-time snoring, to encourage nasal breathing in adults and children (limiting oral breathing) and for obstructive sleep apnoea and sleep-disordered breathing in children and adults. This is an important new clearance for Vivos.
Equivalent to the Food and Drug Administration (FDA) in the United States, the Therapeutic Goods Administration (TGA) regulates the manufacturing and distribution of therapeutic goods in Australia. These clearances allow Vivos Therapeutics to distribute its appliances for several approved indications inclusive of snoring, sleep-disordered breathing and obstructive sleep apnea within the Australian market.
Members of the professional dental community are excited to introduce The Vivos Method into their practices.
“After 20 years of practicing airway breathing and dental sleep medicine, it excites me to find Vivos,” said Dr Mark Levi, who runs a predominantly airway dental practice in Sydney. “Vivos has changed the way I look at treating adults and allows me to improve the wellness of young children. I’m thrilled to be able to integrate Vivos into my practice.”