Full Press Release Details
Therapeutics Announces Multiple Regulatory Clearances in Australia for its Entire Line of Oral Appliances
clears Vivos technology to treat obstructive sleep apnea for all ages and regardless of severity in broad regulatory win.
COLO., JULY 14, 2022 - Vivos Therapeutics, Inc. (NASDAQ: VVOS) is pleased to announce that it 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
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."
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.
clearances are as follows:
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.
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.
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.
of the professional dental community are excited to introduce The Vivos Method into their practices.
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."
more information, please visit vivos.com.
Vivos Therapeutics, Inc.
Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and
treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as mild-to-moderate
obstructive sleep apnea (OSA) and snoring in adults. The Vivos Method represents the first clinically effective nonsurgical, noninvasive,
nonpharmaceutical and cost-effective solution. It has proven effective in approximately 27,000 patients treated worldwide by more than
1,500 trained dentists.
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.
Note Regarding Forward-Looking Statements
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 Securities and Exchange Commission ("SEC"). Vivos'
filings can be obtained free of charge on the SEC's website at sec.gov. Except to the extent required by law, Vivos expressly disclaims
any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect
any change in Vivos' expectations with respect thereto or any change in events, conditions or circumstances on which any statement
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