Vivos Therapeutics Announces Multiple Regulatory Clearances in Australia for Its Entire Line of Oral Appliances
“These recent clearances provide further validation to our technology and extend the scope of our international market,” said
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
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.
For more information, please visit vivos.com.
About
The Vivos Method includes the Vivos Complete Airway Repositioning and/or Expansion (CARE) appliance therapy and associated protocols that alter the size, shape and position of the tissues that comprise a patient’s upper airway. The Vivos Method opens airway space and may significantly reduce symptoms and conditions associated with mild-to-moderate OSA, such as lowering Apnea Hypopnea Index scores. Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program for home sleep testing in adults and children, as well as GM Instruments’ NR6 Rhinomanometer, the only FDA-approved four-phase rhinomanometer available in the US. The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company’s management made in connection therewith contain “forward-looking statements” (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events, particularly with respect to the public offering described herein. Words such as “aim,” “may,” “could,” “expects,” “projects,” “intends,” “plans,” “believes,” “predicts,” “anticipates,” “hopes,” “estimates” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Actual results (including, without limitation, the anticipated benefits of Australian regulatory approval described here on the Company’s sales and ability to obtain regulatory approvals in other countries) may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the risk factors described in Vivos’ filings with the
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jgannon@vivoslife.com
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