Vivos Therapeutics to Begin Clinical Trial at Stanford Medicine

Rhea-AI Summary

Vivos Therapeutics announces clinical trial using DNA Oral Appliance Therapy to study impact on OSA versus CPAP

Positive

• Vivos' DNA appliance will be tested in a clinical trial at Stanford Medicine
• DNA appliance received FDA clearance for the treatment of mild-to-moderate OSA in adults
• Retrospective review shows Vivos' oral appliance therapy decreases AHI by 49%

Negative

• None.

Randomized controlled clinical trial using Vivos’ DNA Oral Appliance Therapy to study the DNA’s impact on OSA versus CPAP

LITTLETON, Colo., Oct. 11, 2023 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company") (NASDAQ: VVOS), a medical technology company focused on developing innovative treatments for patients suffering from mild-to-moderate obstructive sleep apnea (OSA) and snoring in adults, announced that its flagship daytime-nighttime appliance (DNA) will be tested in a clinical trial at Stanford Medicine.

The protocol has been finalized and participant enrollment will begin in early 2024. Study participants with moderate to severe OSA will be randomly assigned to either treatment with Vivos’ DNA appliance or CPAP (continuous positive airway pressure), the current industry standard for OSA treatment. Sleep studies will be performed prior to and following a course of treatment using in-lab polysomnography to assess changes in the patients’ apnea-hypopnea index (AHI).

The DNA appliance recently received 510(k) clearance by the FDA for the treatment of mild-to-moderate OSA in adults and represents an entirely novel modality of treatment for a disease that is estimated to afflict 1 in 4 adults in the United States.

“In a retrospective review of 220 patients¹, we have seen that Vivos’ oral appliance therapy decreases the apnea-hypopnea index (AHI) while increasing airway volume. The median reduction in AHI was 49% in this cohort and a quarter of patients resolved their OSA completely. These end results were measured after a 12-18 month course of therapy without the appliance in the mouth - meaning the effects persisted while not using treatment - something not seen with CPAP,” says Cecilia Wu MD, Co-Chair of the Clinical Advisory Board at Vivos Therapeutics. “While Vivos believes in these results, it is important to apply the highest standards in medical research in the form of a prospective randomized controlled trial. This will truly test Vivos’ treatment to the same standard as all other modalities.”

“We are extremely excited to be starting this trial at Stanford Medicine, which has been in the works for some time” added R. Kirk Huntsman, Chairman and CEO of Vivos. “I am confident that our technology will bear the scrutiny of a well-designed, prospective clinical trial. There is no better place to for our technology to undergo rigorous scientific testing than at a respected institution like Stanford. Our treatment is comfortable, safe and non-invasive, and we believe that at the end of this study, the conclusion will be that Vivos should become an essential part of every OSA care plan.”

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. The Vivos Method represents the first clinically effective nonsurgical, noninvasive, nonpharmaceutical and cost-effective solution for treating mild to moderate OSA in adults. It has proven effective in approximately 40,000 patients treated worldwide by more than 1,800 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 soft tissues that comprise a patient’s upper airway and/or palate. 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. 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, the conference call referred to herein, 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,” “expect,” “may,” “could," “should”, “expect,” “project,” “intend,” “plan,” “believe,” “predict,” “anticipates,” “hopeful,” “estimate” 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 the Company’s control. Actual results (including, without limitation, (1) the ability to enroll an adequate number of individuals meeting required criteria to provide statistically significant results from the clinical trial, (ii) lack of adequate positive outcomes from following the protocols outlined in the clinical trial to prove efficacy, and (iii) if positive outcomes do occur, the ability to receive additional FDA clearances from the clinical outcomes or otherwise capitalize on such outcomes on a timely or cost effective basis) may differ materially and adversely 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, uncertainties relating to the design and execution of the study referred to herein as well as impact the Company’s ability to generate additional revenue if the clinical trial fails to demonstrate that the DNA is effective and the other risk factors relating to the Company and its business described in the Company’s filings with the Securities and Exchange Commission (“SEC”). The Company’s filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, the Company 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 the Company’s 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

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¹Katz D, Demaria S, Heckman S, Lin F, Kushida C. Use of the Complete Airway Repositioning and Expansion (CARE) approach in 220 patients with Obstructive Sleep Apnea (OSA): A retrospective cohort study. Sleep Med. 2022 Nov;99:18-22.

 

FAQ

What is Vivos Therapeutics testing in the clinical trial at Stanford Medicine?

Vivos' DNA appliance

What clearance did the DNA appliance receive from the FDA?

510(k) clearance for the treatment of mild-to-moderate OSA in adults

What were the results of the retrospective review of Vivos' oral appliance therapy?

AHI decreased by 49% in the cohort and a quarter of patients resolved their OSA completely