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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Vivos Therapeutics Sees Positive Preliminary Metrics Following Unprecedented FDA 510(k) Clearance of the Company’s Proprietary Oral Medical Devices to Treat Severe OSA
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.
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.
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.
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.
