Vivos Therapeutics, Inc. has received multiple Class I clearances by the Therapeutic Goods Administration (TGA) of Australia, a Tier 1 regulatory body 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. 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 nighttime snoring, to encourage nasal breathing in adults and children (limiting oral breathing) and for obstructive sleep apnea 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.