VVOS Vivos Therapeutics Inc

Vivos Therapeutics, Inc. (“Vivos” or the “Company” (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) in adults), today announced positive results from a 7-month, multi-site marketing pilot testing the core assumptions behind Vivos’ new affiliation and medical sleep specialist marketing and distribution model.

On June 12, 2024, Vivos announced a new marketing and distribution model under which Vivos is seeking to drive revenue through collaborations with dentists and sleep treatment providers to offer OSA patients a full spectrum of evidence-based treatments for OSA, including Vivos’ advanced, proprietary and FDA-cleared CARE oral medical devices, oral appliances and additional adjunctive therapies and methods. The pilot program results announced today provide evidence of the significant potential of this new model for Vivos.

The pilot program was conducted over a 7-month period in seven dental offices and one ear, nose, and throat specialist office located across several states with highly diverse patient demographic profiles. A total of 99 patients were seen during the pilot, which was comprised of 76 adults and 23 children under the age of 12.

The results revealed that 79% (60 out of 76) newly diagnosed adult OSA patients chose Vivos’ oral appliance therapy over either continuous positive airway pressure (CPAP) machines or choosing to do nothing, while 5% (4 out of 76) of patients declined all treatment options, and 16% (12 out of 76) patients chose to investigate CPAP as an option before making a final decision. No patients in the pilot program opted for surgical or neurostimulation implant options.

A smaller cohort of 23 pediatric patients with orofacial and developmental abnormalities potentially tied to sleep and breathing disorders such as tongue ties, mouth breathing, malocclusion and smaller jaws were also evaluated and treated using Vivos orthodontic guided growth appliances and oral myofunctional therapy.

Mike Skaff, Managing Director at Seneca Partners, which recently sponsored a $7.5 million investment in Vivos, stated, “Throughout the course of the Vivos pilot program, which was part of our due diligence of Vivos, we were impressed by the high patient acceptance rate of Vivos’ treatments’ across all price points and therapy options when compared to CPAP. We are thrilled to be a long-term fundamental investor in Vivos and view these pilot results as compelling validation to our core investment thesis of the higher revenue and gross profit opportunity from the new medical channel.”

Kirk Huntsman, Chairman and CEO of Vivos, stated, “We are excited about the positive results of this pilot program and what the data shows about the potential for our new marketing and distribution model. The message is clear: when Vivos teams up with medical professionals who treat OSA, and when patients are fully informed as to the health risks of untreated OSA and the full range of treatment options available in an open and transparent manner, they overwhelmingly chose Vivos’ CARE oral medical devices. As we continue to expand beyond dentists and move more directly and vertically into affiliations and collaborations with medical specialists, functional medicine doctors, and other sleep-related healthcare practitioners, we expect this to positively impact our new case starts, revenue growth and gross profit.”

Additional Information About the Pilot

As part of this pilot program, Vivos-trained corporate staff engaged for two-day periods at various independent dental and medical offices to engage directly with adult patients known to have mild to severe OSA to provide clinical support to the licensed healthcare professionals. The objectives of the pilot program were: (1) to assess consumer demand and preferences for OSA treatment when presented with multiple treatment options; (2) to evaluate the impact of treatment selection at various price points and levels of insurance coverage; and (3) to uncover barriers to case acceptance and see if the results were consistent, replicable, and scalable across large patient populations.

The results were generally consistent across all practices, all patient demographics and all price points. Insurance coverage was a factor in some patients selecting lower cost treatment options, but not a factor for the majority of patients who chose Vivos CARE, Vivos’ premier product line. Results were similar at both medical and dental offices. Dental offices who focus on airway full time or for specific days experience similar results. Vivos corporate sponsored events were deemed highly successful by the participating providers and their teams and Vivos oral medical devices were accepted at a higher frequency than prior to the event.

Vivos believes it can begin to leverage its new provider-based marketing and distribution model and rapidly scale revenue with relatively minimal investment.

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 over 42,600 patients treated worldwide by more than 1,950 trained dentists.

The Vivos Method includes treatment regimens that employ proprietary 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 in adults, 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. Vivos also as a marketing and distribution model where in collaborates with sleep-treatment providers to offer patients OSA treatment options and help promote sales of its appliances.

For more information, visit www.vivos.com.

About Seneca Partners

Seneca Partners is an active independent private equity sponsor located in Metropolitan Detroit, Michigan. Seneca works closely with institutional capital partners, family offices, ultra-high net worth and high net worth individuals to invest in businesses based in the U.S. and Canada.

Seneca’s focus is on businesses where Seneca can play an active role to add value, as well as industries where the firm or its partners have a deep understanding of the dynamics, trends, and potential growth strategies. Seneca has completed dozens of transactions across multiple industries and geographic locations during its nearly 25-year history. Its professionals leverage over 85 years of collective transaction experience in private equity and providing guidance on mergers and acquisitions, capital raising, and profitable growth strategies. Seneca invests and partners in businesses where its experience and acumen can play an active role in their growth and development.

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. 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 whether the pilot program results described herein will be replicated as the program scales or the anticipated benefits of the Company’s new business model 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 GannonInvestor Relations Officer720-442-8113jgannon@vivoslife.com