Vivos Therapeutics Sees Positive Preliminary Metrics Following Unprecedented FDA 510(k) Clearance of the Company’s Proprietary Oral Medical Devices to Treat Severe OSA
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Insights
The recent announcement from Vivos Therapeutics, Inc. regarding the surge in business activity following FDA 510(k) clearance for its CARE oral medical devices is a strong indicator of market acceptance and potential growth in the sleep disorder treatment sector. The 600% increase in new dentist inquiries and the 38% rise in signed dentist enrollment contracts demonstrate a robust demand for innovative OSA treatments. This is particularly significant given the historical reliance on continuous positive airway pressure (CPAP) devices, which have faced user compliance challenges. The market is witnessing a shift towards alternative therapies that offer convenience and ease of use, which Vivos appears to be capitalizing on.
Furthermore, the 26% increase in average weekly CARE appliance orders post-FDA clearance reflects immediate market response and the potential for sustained revenue growth. The pediatric segment, denoted by a 53% sales increase in Vivos Guides, suggests an expansion in the company's demographic reach, tapping into early intervention for developmental dental issues linked to OSA. These trends are likely to attract investor attention as they signal Vivos' ability to penetrate the market and scale operations effectively.
The FDA 510(k) clearance is a pivotal milestone for Vivos, as it marks the first instance of an oral appliance being cleared to treat moderate and severe OSA in adults. The clearance not only validates the scientific and clinical credibility of Vivos' CARE appliances but also opens up a larger market segment for the company. The inclusion of the DNA, mRNA and mmRNA oral appliances in the clearance provides a range of treatment options that can be tailored to individual patient needs.
OSA is a common but often undiagnosed condition that can lead to significant health complications if left untreated. The Vivos CARE products offer a non-invasive alternative to traditional therapies such as PAP machines, which can be cumbersome for patients. The reported increase in inquiries and sales post-clearance indicates a strong demand for more accessible OSA treatments and suggests a potential shift in standard care practices. The long-term impact on public health could be substantial if these devices lead to higher patient compliance and better treatment outcomes.
Investors should note the positive financial indicators presented by Vivos Therapeutics, particularly in light of the recent FDA clearance. The substantial increases in new dentist inquiries and signed contracts, as well as the uptick in CARE appliance orders, suggest a positive trajectory for future earnings. The company's strategic partnership with Toothpillow and its successful DSO distribution model are noteworthy, as they provide scalable channels for product distribution and sales. The pediatric appliance sales surge also indicates diversification in Vivos' product portfolio, which can help mitigate market risks.
Given the reported metrics, it is plausible to anticipate that these developments will translate into higher revenue streams for Vivos in the upcoming fiscal periods. However, investors should consider the costs associated with scaling operations and increased marketing efforts that might accompany such growth. Additionally, the competitive landscape of the OSA treatment market and potential entry of new competitors could influence Vivos' market share and pricing power in the long term.
New Dentist Inquiries Jumped
Signed Dentist Enrollment Contracts up
CARE Oral Medical Device Unit Orders Increased
LITTLETON, Colo., Jan. 08, 2024 (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 (including all severities of obstructive sleep apnea (OSA)), is pleased to announce that Vivos is seeing positive preliminary metrics following its November 28, 2023 announcement regarding FDA 510(k) clearance of its CARE oral medical devices to treat severe OSA.
Vivos reported that during the fourth quarter of 2023, new dentist inquiries to participate in the Vivos Integrated Practice (VIP) program rose
In addition, average weekly CARE appliance orders increased
Kirk Huntsman Chairman and CEO of Vivos stated, “Since announcing our new FDA clearance for severe OSA, we’ve seen a substantial increase in calls and inquiries from medical doctors, dentists, and patients regarding Vivos’ products. We believe this significant uptick in business development and revenue generating activity since achieving this important milestone highlights our overall value proposition across both the dental and medical communities as a highly effective treatment alternative for OSA patients. With this strong momentum coming into 2024, we expect these higher inquiries and expanded sales pipeline could create opportunities for revenue growth in 2024.”
Mr. Huntsman continued, “Not only are we experiencing considerable growth and interest related to our Vivos CARE products that treat OSA in adults, during the past few weeks we have also seen a
Chad Rasmussen, CEO and Co-Founder of Toothpillow commented, “We're genuinely thrilled by the remarkable surge in interest we've witnessed from our dentists for Vivos products in the past few weeks. In December, the new patient inquiries jumped 1,
On November 28, 2023 Vivos was granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for treating severe 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. This 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.
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.
About Toothpillow, Inc.
The Toothpillow System is a preventative, pre-orthodontic method that corrects and supports proper jaw development, promoting nasal breathing and preventing—even fixing—dozens of health problems down the road. It gets to the root causes of misaligned teeth, often without the need for braces or tooth extraction. Toothpillow offers this treatment through both virtual care via telehealth and in-office visits with a network of trained dentists.
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 growth statistics and 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 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 the recent interest in Vivos’ products may not lead to material increases in revenue or that, in general, 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 OSA treatment sector; (iv) the risk that Vivos may be unable to secure additional financing 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
FAQ
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