Vivos Therapeutics Receives First Ever FDA 510(k) Clearance for Oral Device Treatment of Severe Obstructive Sleep Apnea

Rhea-AI Summary

Vivos Therapeutics, Inc. (NASDAQ: VVOS) has received FDA clearance for treating severe obstructive sleep apnea (OSA) in adults using the Vivos' removable CARE oral appliances, marking the first time the FDA has approved an oral appliance to treat moderate and severe OSA in adults. The statistically significant data submitted to the FDA from 73 severe OSA patients showed that 80% of patients experienced an improvement of at least 1 classification or at least a 50% improvement in the Apnea Hypopnea Index (AHI), and 97% of patients improved or stayed the same, with an average treatment time of just 9.7 months. The company believes this unprecedented decision by the FDA will generate broader acceptance throughout the medical community for Vivos treatment options, leading to the potential for higher patient referrals and case starts as well as collaboration with medical professionals, enhancing their value proposition to third-party distribution partners such as durable medical equipment (DME) companies, and clearing the way for greater reimbursement levels from medical insurance payors and Medicare, favorably impacting their ability to grow revenues in 2024 and beyond.

Positive

• FDA clearance for treating severe obstructive sleep apnea in adults using Vivos' CARE oral appliances
• 80% of patients experienced an improvement of at least 1 classification or at least a 50% improvement in the Apnea Hypopnea Index (AHI)
• Vivos' products represent the first time that an effective resolution of OSA has been clearly demonstrated over a limited treatment time

Negative

• None.

With this unprecedented FDA clearance, Vivos redefines what it means to have a truly non-invasive treatment for all levels of OSA severity, opening new revenue opportunities for Vivos

LITTLETON, Colo., Nov. 29, 2023 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (the “Company” or “Vivos”) (NASDAQ:VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders, today announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for treating severe obstructive sleep apnea (OSA) in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances. Vivos’ CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance.

As a result of this FDA clearance, Vivos becomes the first company ever to have approved and bring to market a clear alternative treatment to CPAP or surgical neurostimulation implants for patients with severe OSA. This latest clearance comes just eleven months after the FDA granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-to-moderate OSA, and represents the first time the FDA has ever granted an oral appliance a clearance to treat moderate and severe OSA in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.

Nationally renowned medical sleep specialist, author and lecturer, Dr. David McCarty, MD, elaborated on the impact of this landmark decision, stating “Make no mistake: this is a huge development on the landscape of treatments for OSA. As the medical profession has gained a better understanding of the complex factors contributing to OSA, we now recognize that a critical component to this condition is the form and functionality of the oral vault. This is where medical collaboration with an airway-centered dentistry approach like Vivos offers is a game-changer. This decision by the FDA could be life changing for patients who suffer from severe OSA and for whom other treatments have failed.”

Kirk Huntsman, Chairman and CEO of Vivos, stated, “This achievement is a pivotal milestone for Vivos, and elevates our proven treatment options right into the mainstream of sleep medicine. It is even more important for the millions of severe OSA patients who are desperate for an effective alternative treatment. Before this, severe OSA patients’ only realistic treatment options were CPAP, neurostimulation implants or other invasive surgeries. Today, they have what we believe is a far more desirable option that is very affordable and doesn’t require surgery or a lifetime of nightly use and intervention.”

“Vivos trained providers can now treat patients with OSA and conditions associated with OSA comprehensively using our suite of FDA cleared devices, without regard to the severity of their OSA condition and across a range of price point options,” continued Mr. Huntsman. “We believe this unprecedented decision by the FDA will generate broader acceptance throughout the medical community for Vivos treatment options, leading to the potential for higher patient referrals and case starts as well as collaboration with medical professionals. We also believe it will enhance our value proposition to third-party distribution partners such as durable medical equipment (DME) companies. This approval could also clear the way for greater reimbursement levels from medical insurance payors and Medicare. We believe that all these factors should favorably impact our ability to grow our revenues in 2024 and beyond.”

The statistically significant data submitted to the FDA from 73 severe OSA patients showed that 80% of patients experienced an improvement of at least 1 classification or at least a 50% improvement in the Apnea Hypopnea Index (AHI), and 97% of patients improved or stayed the same. Average treatment time was just 9.7 months. Treatment results with severe sleep apnea patients were actually better than with mild and moderate patients. All pre- and post-treatment testing was conducted with no device in the mouth. Unlike all other oral appliances on the market, Vivos’ proprietary CARE appliances gradually reposition the hard and soft tissues that define the airway, thereby opening it up and optimizing its function and flow.

In a separate peer reviewed study published in the Journal of Sleep Medicine in 2022, 1 out of 4 Vivos patients experienced a complete resolution of their OSA symptoms. Vivos believes its products represent the first time that an effective resolution of OSA has been clearly demonstrated over a limited treatment time, unlike the lifetime intervention required for CPAP or surgical neurostimulation implants.

No persistent safety issues were found in any patient cohort published or submitted to date, although some patients required aligners following treatment.

Vivos DNA appliance^®

Vivos mRNA appliance^®

Vivos mmRNA appliance^®

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 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 severe OSA. It has proven effective in approximately 40,000 patients treated worldwide by more than 1,850 trained dentists.

The Vivos Method includes treatment regimens that employ the proprietary Vivos Complete Airway Repositioning and/or Expansion (CARE) appliance therapy and other modalities 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-severe 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, including the anticipated benefits of the 510(k) approval described herein. Words such as “may”, “should”, “expects”, “projects,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve significant 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 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: (i) the risk that Vivos may be unable to implement revenue, sales and marketing strategies that increase revenues, (ii) the risk that some patients may not achieve the desired results as obtained in the clinical trial, (iii) risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea treatment sector; (iv) the risk that Vivos may be unable to secure additional financings on reasonable terms when needed, if at all and (v) other 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 

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/93fa4580-447f-476d-a8e7-fe3bfab4a76f
https://www.globenewswire.com/NewsRoom/AttachmentNg/8906a168-b7af-44e4-a33c-f63db4815e21
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FAQ

What is the significance of Vivos Therapeutics, Inc. (NASDAQ: VVOS) receiving FDA clearance for treating severe obstructive sleep apnea (OSA) in adults?

The FDA clearance marks the first time the FDA has approved an oral appliance to treat moderate and severe OSA in adults, opening new revenue opportunities for Vivos.

What were the treatment results with severe sleep apnea patients using Vivos' CARE oral appliances?

Statistically significant data submitted to the FDA from 73 severe OSA patients showed that 80% of patients experienced an improvement of at least 1 classification or at least a 50% improvement in the Apnea Hypopnea Index (AHI), and 97% of patients improved or stayed the same, with an average treatment time of just 9.7 months.

How does Vivos Therapeutics, Inc. (NASDAQ: VVOS) believe the FDA clearance will impact their business?

The company believes the FDA clearance will lead to broader acceptance throughout the medical community, higher patient referrals and case starts, collaboration with medical professionals, enhanced value proposition to third-party distribution partners, and greater reimbursement levels from medical insurance payors and Medicare, favorably impacting their ability to grow revenues in 2024 and beyond.