Vivos Therapeutics Files for US Patent on Proprietary New Clinical Protocols After Seeing Further Significant Improvement in Reduction of Key Sleep Apnea Metric

Rhea-AI Summary

Vivos Therapeutics has filed a new U.S. patent application for enhanced clinical methods in treating obstructive sleep apnea (OSA) using its proprietary Vivos Method. Early data show a significant 58% improvement in Apnea Hypopnea Index (AHI) score reductions among patients treated with the revised protocols. This initiative is part of Vivos' Continuous Clinical Improvement Program aimed at refining treatment and optimizing patient outcomes. Currently, around 54 million Americans suffer from sleep apnea, highlighting the necessity for effective, non-invasive treatment alternatives.

Positive

• 58% average improvement in AHI scores among OSA patients with new protocols.
• 97% of Vivos patients achieved desired clinical objectives.
• 98% of patients would refer Vivos' treatment to others.
• Over 1 in 4 treated patients returned to normal AHI scores post-treatment.

Negative

• None.

Vivos’ Continuous Clinical Improvement Program Yields Promising Data in AHI Score Reductions for Patients with Obstructive Sleep Apnea

HIGHLANDS RANCH, Colo., Jan. 27, 2022 (GLOBE NEWSWIRE) -- 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.

About Vivos Therapeutics, Inc.

Vivos Therapeutics Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for adult patients suffering from mild-to-moderate obstructive sleep apnea (OSA). The Vivos Method represents the first clinically effective non-surgical, non-invasive, non-pharmaceutical and cost-effective solution for patients with dentofacial anomalies and/or mild-to-moderate OSA. Vivos also sells orthodontic appliances for adults and children. Vivos’ oral appliances have proven effective in over 24,000 patients treated worldwide by more than 1,350 trained dentists.

Combining proprietary technologies and 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, powered by VivoScore for Home Sleep Testing in adults and children. 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.vivoslife.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 (i) whether the Company’s patent applications will result in approved patents and (ii) the anticipated benefits of the Company’s enhanced methods and protocols, each as described herein) 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 www.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.

Vivos Investor Relations Contact:
Julie Gannon
Investor Relations Officer
720-442-8113
jgannon@vivoslife.com

Vivos Media Relations Contact:
Francesca DeMauro / Jenny Robles
KCSA Strategic Communications
(917) 880-9771 / (212) 896-1231
fdemauro@kcsa.com / jrobles@kcsa.com

FAQ

What are the recent advancements announced by Vivos Therapeutics regarding OSA treatments?

Vivos Therapeutics announced a new patent application for improved clinical methods in treating obstructive sleep apnea, showing a 58% average improvement in AHI scores.

What is the Apnea Hypopnea Index (AHI) and its significance in sleep apnea treatment?

The AHI measures the severity of sleep apnea; lower scores indicate better treatment outcomes.

How many American patients suffer from obstructive sleep apnea according to Vivos' press release?

According to Vivos, approximately 54 million Americans suffer from obstructive sleep apnea.

What are the reported patient outcomes following treatment with Vivos' methods?

97% of Vivos patients reported achieving their clinical objectives, and over 25% returned to normal AHI scores post-treatment.

What is the Vivos Method in treating obstructive sleep apnea?

The Vivos Method is a non-surgical, non-invasive treatment protocol that uses proprietary oral appliances to address the causes of obstructive sleep apnea.