Australia Clears Vivos Technology to Treat Obstructive Sleep Apnea for All Ages and Severities in a Large Regulatory Victory.
LITTLETON, Col., July 14, 2022 /PRNewswire-PRWeb/ — Vivos Therapeutics, Inc.. (NASDAQ: VVOS) is pleased to announce that it has received multiple Class I clearances from the Administration of Therapeutic Goods (TGA) of Australiaa Level 1 regulator for multiple indications, including the treatment of snoring and obstructive sleep apnea (mild, moderate and severe) for adults and children for its oral appliance series.
“These recent clearances provide further validation to our technology and expand our international market reach,” said kirk hunter, co-founder and CEO of Vivos Therapeutics. “Australian regulators have acknowledged and accepted the clinical data we presented showing the clinical safety and efficacy of our technology, regardless of age or severity of OSA. We are moving forward with other regulatory agencies. national and international regulations with high expectations that our applications be as well received as they have been in Australia. Sleep deprivation is a global epidemic. Vivos has developed a safe, comfortable, non-invasive and non-surgical solution, and we intend to bring it to the world. We have already received authorizations in United States and Canadaand now, Australia will be part of our growing international network. We will continue to grow and expand into other parts of the world.”
Australia follows the standards applied by the International Organization for Standardization (ISO), which currently has 165 members/countries. These new authorizations will allow Vivos to share its innovative technology and distribute devices that will help not only adults, but also children with sleep-disordered breathing. These latest clearances include all classes of OSAs as defined by the new Global Medical Device Nomenclature (GMDN) that Vivos received in Australia.
The clearances are as follows:
Class I device clearances for mRNA and mRNA, for mandibular repositioning, palate lifting (expanding the jaw causing the airway to improve), and as an anti-snoring splint. These devices can be used to reduce snoring and relieve symptoms of OSAS and mild, moderate and severe sleep-disordered breathing.
Class I device clearances for DNA and Vivos Guide/Way for palate lifting (jaw expansion causing improved airway), teeth repositioning/straightening and as an anti-snoring splint. These devices can be used to reduce nocturnal snoring, to promote nasal breathing in adults and children (limitation of mouth breathing) and in obstructive sleep apnea and sleep breathing disorders in children. child and adult. This is an important new authorization for Vivos.
Food and Drug Administration (FDA) equivalent in United StatesTherapeutic Goods Administration (TGA) regulates the manufacture and distribution of therapeutic goods in Australia. These authorizations allow Vivos Therapeutics to distribute its devices for several approved indications, including snoring, sleep-disordered breathing and obstructive sleep apnea in the Australian market.
Members of the professional dental community are excited to bring the Vivos method to their practice.
“After 20 years of practicing airway breathing and dental sleep medicine, I am excited to find Vivos,” said Dr. Marc Leviwho runs a dental practice mainly specializing in the respiratory tract in sydney. “Vivos has changed the way I treat adults and allows me to improve the well-being of young children. I am delighted to be able to incorporate Vivos into my practice.”
For more information, please visit vivos.com.
About Vivos Therapeutics, Inc.
Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on the development and commercialization of innovative diagnostic and treatment methods for patients suffering from breathing and sleep problems resulting from certain dentofacial abnormalities such as Mild to moderate obstructive sleep apnea (OSA) and snoring in adults. The Vivos method represents the first non-surgical, non-invasive, non-pharmaceutical and clinically cost-effective solution. It has been shown to be effective in approximately 27,000 patients treated worldwide by over 1,500 trained dentists.
The Vivos Method includes the Vivos Complete Airway Repositioning and/or Expansion (CARE) device therapy and associated protocols that alter the size, shape, and position of the tissues that make up a patient’s upper airway. The Vivos Method opens the airway space and can significantly reduce symptoms and conditions associated with mild to moderate OSA, such as lower apnea-hypopnea index scores. Vivos also markets and distributes SleepImage diagnostic technology through its VivoScore program for home sleep testing of adults and children, as well as GM Instruments’ NR6 rhinomanometer, the only four-phase rhinomanometer approved by the FDA. available in the United States. The Vivos Integrated Practice (VIP) program provides dentist training and other value-added services related to the use of the Vivos method.
Caution Regarding Forward-Looking Statements
This press release and the 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) regarding future events, including with respect to the public offering described herein. Words such as “aim”, “may”, “could”, “expect”, “plan”, “intend”, “plan”, “believe”, “predict”, “anticipate” , “hopes”, “estimates” and variations of these similar words and expressions are intended to identify forward-looking statements. These statements involve known and unknown risks and are based on various 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 herein on the Company’s sales and ability to obtain regulatory approvals in other countries) may differ materially from those expressed or implied by these 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 for free from the SEC’s website at sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligation or undertaking to publicly release 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 is based.
Amy CookVivos Therapeutics, (949) 813-0182, [email protected]
SOURCE Vivos Therapeutics