Vivos Therapeutics Sees Positive Preliminary Metrics Following Unprecedented FDA 510(k) Clearance of the Company’s Proprietary Oral Medical Devices to Treat Severe OSA
Vivos Therapeutics, Inc. (NASDAQ:VVOS) announced a significant increase in new dentist inquiries, VIP enrollment contracts, and CARE oral medical device orders following the FDA clearance of its oral medical devices to treat severe obstructive sleep apnea (OSA). The company reported a 600% rise in new dentist inquiries, 38% sequential increase in signed VIP enrollment contracts, and a 26% increase in CARE appliance orders. Vivos expects these positive metrics to drive revenue growth in 2024, with a 53% increase in sales of pediatric guided growth and development appliances. Toothpillow, a key dental service organization partner, also experienced a surge in interest and new patient inquiries, indicating a growing market for Vivos products.
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.
01/08/2024 - 07:30 AM
New Dentist Inquiries Jumped 600% and Signed Dentist Enrollment Contracts up 38% Sequentially Over Q3
CARE Oral Medical Device Unit Orders Increased 26% Following FDA Clearance
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 600% over the previous month and the VIP sales pipeline (meaning the number of dentists in VIP contract discussions) doubled. Signed VIP enrollment contracts increased by 38% sequentially compared to the third quarter of 2023.
In addition, average weekly CARE appliance orders increased 26% in the three weeks following the FDA clearance compared to the previous 12-week average for weekly sales for these same devices.
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 53% increase in sales of our pediatric guided growth and development appliances, which we call Vivos Guides. We expect this trend to continue in the near-term, especially considering the recent success of one of our key strategic dental service organization (DSO) distribution partners, Toothpillow.”
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 1,500% , which is an all-time record month in new case starts. Our virtual telehealth, ship-to-home model coupled with Vivos’ Guide products is proving to be a highly effective solution for pediatric patients with underdeveloped jaws and malocclusions—both conditions having been linked closely to breathing and sleep disorders and other serious health issues. Now that the word is spreading, we eagerly anticipate the upward momentum to continue.”
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.
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
Vivos Investor Relations Contact: jgannon@vivoslife.com
What is the ticker symbol of Vivos Therapeutics, Inc.?
The ticker symbol of Vivos Therapeutics, Inc. is VVOS.
What was the increase in new dentist inquiries following the FDA clearance?
New dentist inquiries jumped 600% following the FDA clearance.
How much did the VIP enrollment contracts increase sequentially compared to Q3?
The signed VIP enrollment contracts increased by 38% sequentially compared to the third quarter of 2023.
What was the percentage increase in CARE appliance orders after the FDA clearance?
Average weekly CARE appliance orders increased by 26% in the three weeks following the FDA clearance.
What is the significance of the FDA clearance for Vivos?
The FDA clearance allows Vivos to treat severe OSA in adults using its removable CARE oral appliances, marking the first time the FDA has granted an oral appliance clearance for this purpose.
What was the increase in sales of pediatric guided growth and development appliances?
Vivos experienced a 53% increase in sales of pediatric guided growth and development appliances following the FDA clearance.
Who is the CEO of Vivos Therapeutics, Inc.?
Kirk Huntsman is the Chairman and CEO of Vivos Therapeutics, Inc.
What impact did the FDA clearance have on Vivos' business development and revenue activity?
The FDA clearance led to a substantial increase in calls and inquiries from medical doctors, dentists, and patients regarding Vivos’ products, highlighting the overall value proposition across both the dental and medical communities.
What was the surge in interest witnessed by Toothpillow, a key DSO partner?
Toothpillow experienced a remarkable surge in interest from dentists for Vivos products, with new patient inquiries jumping 1,500% in December, an all-time record month in new case starts.
What was the strategic significance of the recent success of Toothpillow?
The recent success of Toothpillow indicated a growing market for Vivos products, particularly the virtual telehealth, ship-to-home model coupled with Vivos’ Guide products for pediatric patients with underdeveloped jaws and malocclusions.
What type of oral appliances are included in Vivos' CARE appliances?
Vivos' CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance, and the mmRNA oral appliance.
