Vivos Therapeutics Receives FDA 510(k) Clearance of its Flagship DNA Oral Appliance for Treatment of Obstructive Sleep Apnea

Rhea-AI Summary

Vivos Therapeutics (NASDAQ: VVOS) announced a significant milestone with the FDA granting clearance for its DNA appliance, marking the first formal recognition of Vivos' proprietary technology for treating mild-to-moderate obstructive sleep apnea (OSA). This 510(k) clearance is Vivos' third FDA approval for its oral devices, enhancing the company's position in the sleep treatment market. Clinical data revealed 28% of patients saw resolution of OSA. The device aims to expand palates and improve airway function, providing a non-invasive alternative to traditional OSA therapies.

Positive

• FDA's 510(k) clearance for the DNA appliance is a major achievement, recognizing Vivos' proprietary technology.
• Clinical data shows 28% of patients had their OSA resolved, with 63% improving by an AHI classification.
• The DNA appliance provides a non-invasive treatment alternative to traditional modalities like CPAP.

Negative

• None.

Approval represents third FDA clearance for Vivos’ oral appliances and first clearance specifically recognizing Vivos’ proprietary core technology

LITTLETON, Colo., Jan. 04, 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 dentofacial abnormalities and/or mild-to-moderate obstructive sleep apnea (OSA) and snoring in adults, today announced a brand new clearance from the U.S. Food and Drug Administration (FDA) for its proprietary DNA appliance (daytime-nighttime appliance).

The FDA 510(k) clearance for the DNA appliance as a Class II device gives rise to a completely new treatment regimen for mild-to-moderate OSA. Making this development even more meaningful is that the DNA device for palatal expansion is Vivos’ longest standing appliance with the widest use among Vivos-trained dentists, which Vivos anticipates will now increase the ease of adoption of the DNA for treating OSA.

Current modalities for the treatment of OSA include:

	(i)	continuous positive airway pressure (CPAP). Approximately 50% of patients discontinue use of CPAP because it is uncomfortable to wear and cumbersome to transport, not to speak of the loud noise that disrupts your partner.
	(ii)	mandibular advancement devices (MAD). Some people have issues using appliances that move the jaw forward causing temporomandibular joint pain and discomfort.
	(iii)	surgical intervention, including hypoglossal nerve stimulation therapy. Many people simply do not want to undergo anesthesia or the cost of a surgical procedure.

With the latest FDA clearance achieved, the DNA appliance offers a new treatment regimen (when combined with associated protocols that are a part of The Vivos Method) which opens the airway by expanding the palate and training the tongue to rest in proper position and converts patients to nasal as opposed to oral breathing. Unlike other treatments, The Vivos Method is differentiated in that it addresses the root cause of snoring and/or OSA in many patients. While the appliance is effective by itself, it can also be used in conjunction with other treatment modalities such as, myofunctional therapy or CPAP.

The clinical data submitted to the FDA as part of the clearance process for the DNA included pre- and post-treatment Apnea Hypopnea Index (AHI) scores obtained with no appliance in the mouth, demonstrating that:

• 28% of patients had their OSA resolved
• 63% of patients improved by one AHI classification (i.e., severe to moderate, moderate to mild, or mild to no OSA)
• 86% of patients improved their airway size
• 97% of patients increased the width of their palate which allows the tongue to rest in proper position, thus avoiding a potential airway obstruction

In a study of patient satisfaction with DNA treatment, 97% of patients achieved the desired outcome, while 98% of patients were highly satisfied or very satisfied and likely to recommend the treatment to a friend.

Another benefit of this new treatment is that results are typically long-lasting post treatment and may result in permanent improvement. Unlike treatments with CPAP or MAD, where the AHI measurements must be taken during active use of the device to show improvement, Vivos DNA efficacy measurements were taken without the device in the mouth. Other non-surgical treatments for OSA, such as CPAP and traditional oral appliances, require lifetime nightly use in order to maintain efficacy.

The DNA appliance has been marketed for several years for orthodontic treatment such as expansion of the jaw and positioning of teeth in adults and children and is still available to be used for those applications. The 510(k) clearance for the DNA represents the third FDA clearance Vivos has received for its oral appliances and the first clearance explicitly recognizing Vivos’ proprietary core technology. Previously, the FDA approved Vivos’ mRNA (mandibular Repositioning Nighttime Appliance) and mmRNA (modified mandibular Nighttime Appliance), which are both FDA Class II devices used in the treatment of mild-to-moderate OSA and/or snoring in adults. However, prior FDA clearances were based on those devices’ mandibular advancement feature sets, even though the core Vivos technology was also incorporated into those appliances. Vivos believes its patented appliances and related proprietary protocols offer significant advantages over existing OSA treatments.

“This clearance is the culmination of years of pioneering clinical work,” said Kirk Huntsman, Vivos’ Chairman and Chief Executive Officer. “For the first time, the FDA has formally recognized the benefits of our proprietary core technology in our DNA appliance (without mandibular advancement) as an effective treatment for mild-to-moderate OSA in adults. The FDA now joins other international regulatory bodies in recognizing the efficacy of our patented technology in the reduction and resolution of many of the symptoms of OSA that result from a lack of development of the jaws and oral cavity. We believe the DNA treatment can be life changing for many OSA patients, and we look forward to continued market adoption of our expanded menu of treatments for this debilitating condition.”

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. It has proven effective in over 31,000 patients treated worldwide by more than 1,650 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 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 “may”, “should”, “expects”, “projects,” “intends”, “plans”, “believes”, “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 the anticipated benefits to the Company of the FDA 510(k) approval 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 and Media Contact:
Julie Gannon
Investor Relations Officer
720-442-8113
jgannon@vivoslife.com

FAQ

What recent FDA clearance did Vivos Therapeutics receive for its DNA appliance?

Vivos Therapeutics received FDA 510(k) clearance for its DNA appliance, which is designed for treating mild-to-moderate obstructive sleep apnea.

What are the benefits of the DNA appliance by Vivos (VVOS)?

The DNA appliance offers a non-invasive solution for OSA, with clinical data showing significant improvements, including a 28% resolution rate in patients.

How does the DNA appliance compare to CPAP for OSA treatment?

Unlike CPAP, which many patients find uncomfortable, the DNA appliance aims to address the root cause of OSA by expanding the palate and improving airway function.

What percentage of patients reported satisfaction with the DNA treatment?

97% of patients achieved the desired outcome with the DNA treatment, with 98% reporting high satisfaction.

When was the FDA clearance for the DNA appliance announced?

The FDA clearance for the DNA appliance was announced on January 4, 2023.