Vivos’ Continuous Clinical Improvement Program Yields Promising Data in AHI Score Reductions for Patients with Obstructive Sleep Apnea
Colorado, January 27, 2022
Vivos Therapeutics, Inc. (“Vivos” or “the Company”) (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for patients suffering from mild to moderate obstructive sleep apnea (OSA) and snoring, today announced the filing of a U.S. patent application related to certain new and enhanced clinical methods and protocols developed within Vivos’ proprietary Vivos Method treatment for OSA. The Vivos Method, inclusive of the Vivos System, seeks to treat OSA through a combination of Vivos’ proprietary oral appliances and devices as well as proprietary clinical methods and protocols.
This new patent application was based on early field data which revealed an additional 58% average improvement in Apnea Hypopnea Index (AHI) score reductions in OSA patients who had received treatment with the Vivos Method where the revised clinical protocols were implemented.
The Vivos Continuous Clinical Improvement Program is a multidisciplinary effort by numerous medical, dental, and other healthcare professionals who passionately share the Vivos mission of “ridding the world of obstructive sleep apnea”. Initiatives seeking further clinical enhancements and outcomes are overseen by Vivos personnel working in close collaboration with the members of Vivos’ Medical and Clinical Advisory Boards, outside university clinicians and researchers, and through collaboration with other companies with innovative and complimentary technologies.
Dr. Cecilia Wu of University of Alberta, who co-chairs the Vivos Medical Advisory Board along with Dr. Clete Kushida of Stanford University, states, “My team and I continue to work in support of Vivos’ goal of optimizing patient outcomes for patients suffering with OSA and it has been impressive to see the dedication of the Vivos team in enhancing and refining treatment protocols to maximize results for these patients. OSA is a deadly and destructive disease and must be treated. Apart from Vivos therapy, current treatment options for OSA are limited and often invasive; providing a viable alternative solution is exciting and achievable.”
Commenting on the new protocols and related patent applications, Vivos Chairman and CEO Kirk Huntsman stated, “As an emerging market leader in technologies and protocols to treat patients with OSA, we continually seek to find new and innovative ways to further improve both patient experiences and clinical outcomes. We believe these new methods and protocols are not only patentable but will enhance the positive experience that Vivos Method patients have reported.”
“Last year we announced that 97% of Vivos patients reported having achieved their desired clinical objectives, and that 98% would gladly refer a friend or family member,” continued Mr. Huntsman. “We also announced data showing over 1 in 4 post-Vivos treatment OSA patients restored to normal AHI scores with no further intervention — something we believe to be an unprecedented achievement. However, to the extent we can continue to develop and implement new methods and protocols (including those described in our new patent application) that further improve treatment outcomes, our case for being the preferred go-to treatment option for OSA becomes even more compelling.”
More than one billion people globally and 54 million Americans suffer from sleep apnea, 80 percent of whom remain undiagnosed. A serious chronic illness, sleep apnea increases the risk of comorbidities, including high blood pressure, heart failure, stroke, diabetes, dementia, chronic pain, fibromyalgia, and other life-threatening diseases. The Vivos Method treatment protocol non-surgically addresses the dental tissue anomalies and malformations known to be associated with OSA. Unlike current standard-of-care interventions, such as lifetime-use of CPAP machines or surgical procedures, patients treated with the Vivos Method typically complete their therapy in 12 to 24 months, and in many cases, do not require further intervention.
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.