Effectively Immediately, Vivos to be Exclusive Distributor for Novel Diagnostic Equipment to Evaluate Nasal Breathing and Function in Dental Patients with Sleep and Breathing Issues
Colorado, June, 29, 2022
(GLOBE NEWSWIRE) —
— Vivos Therapeutics, Inc. (NASDAQ: VVOS) (“Vivos” or “the Company”), a revenue-stage medical technology company focused on developing innovative treatments for patients suffering from dentofacial abnormalities and/or mild to moderate obstructive sleep apnea (OSA) and snoring in adults, today announced it has entered into an exclusive distribution agreement with GM Instruments, Ltd. for the distribution of GM Instruments’ NR6 Rhinomanometer, the only FDA approved 4-phase rhinomanometer available in the U.S. used to calculate nasal airway resistance by measuring nasal flow and the pressure producing that flow.
Under this new agreement, effectively immediately, Vivos becomes the exclusive U.S. and Canadian distributor of this specialized diagnostic equipment for evaluating nasal breathing and function in dental patients with sleep and breathing issues. The objective measurement of nasal breathing can be an essential data point in determining the appropriate breathing and sleep issue treatment pathway as well as a predictor of potential Continuous Positive Airway Pressure (CPAP) intolerance or other treatment failure.
“With this new agreement, every U.S. or Canadian dentist who wishes to evaluate the breathing function of a patient will need to engage with Vivos for this diagnostic equipment. We expect this will provide Vivos an immediate new revenue stream as well as a substantial competitive advantage and opportunity to present Vivos’ proprietary oral appliance technology to a wider audience,” said Vivos Chairman and CEO, Kirk Huntsman.
Based in the United Kingdom, GM Instruments is a global manufacturer and distributor of diagnostic technology for assessing nasal and respiratory flow and function. The GM Instruments’ NR6 Rhinomanometer offers a quick non-invasive test to measure the function of the nose during active breathing. These test results are being used by Vivos-trained dentists and others to measure outcomes of improvement for pre- mid- and post-treatment of patients undergoing a variety of treatment modalities. Additionally, GM Instruments products are planned for use as part of research protocols to improve and support the outcomes of Vivos products and methods for OSA diagnosis and treatment.
The NR6 Rhinomanometer is used across the world in specialties that address nasal obstruction and nasal flow limitations. Recent studies show the impact of nasal resistance on the distribution of apneas and hypopneas in OSA. Such studies have also highlighted the use of Rhinomanometry in patient selection for probable success or failure with CPAP and oral appliance therapy. The research findings emphasize the importance of measuring nasal flow and transnasal pressure in reducing disease and improving breathing.
Dr. Martha Cortes, a Vivos-trained dentist in New York City who has used Vivos technology to treat over 1,600 patients in her Manhattan practice, emphasized the importance of having NR6 rhinomanometry available to her patients, stating, “For the first time, I have a dynamic and objective measurement that I can take multiple times throughout treatment to measure and demonstrate the impact that Vivos therapy may have on the nasal cavity which could affect the upper airway. As I frequently remind my patients and colleagues, it is only an opinion without data.”
“Many medical problems such as OSA, overall lung function, and even spinal and posture issues are related to nasal resistance and poor breathing, and our breathing is disrupted before our sleep is disrupted. With this strong collaboration with Vivos, we believe we have the opportunity to change the standard of care for OSA to improve patient outcomes and manage their health with better testing and assessments,” said Dr. Karen Parker Davidson, RN, Vice President of Sales for GM-Instruments, North America.
The clinical evaluation of breathing flow and function has recently taken center stage in the treatment of sleep apnea as research continues to forge links between breathing and sleep. With this exclusive distribution agreement for the NR6 Rhinomanometer, which is utilized by dentists worldwide, Vivos solidifies its leadership role as the first company in the global effort to identify and address sleep and breathing issues through the collaborative efforts of dental and medical professionals.
About GM Instruments, Ltd.
Based in the United Kingdom, with sales in North America and global distribution partners, the company was founded in 1992 by Eric Greig and has been at the forefront of the development of new and innovative products for the nasal measurement, audiometry, and respiratory flow markets.
About Vivos Therapeutics, Inc.
Vivos 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. Our Vivos Method represents the first clinically effective non-surgical, non-invasive, non-pharmaceutical and cost-effective solution and has proven effective in approximately 27,000 patients treated worldwide by more than 1,500 trained dentists.
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 4-phase rhinomanometer available in the U.S. The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method.
For more information, visit www.vivos.com.
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 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 is based.