VVOS Vivos Therapeutics Inc

Vivos Therapeutics, Inc. (“Vivos” or the “Company”) (NASDAQ: VVOS), a leader in novel, non-invasive obstructive sleep apnea (OSA) treatments, today announced several significant milestone achievements in its efforts to extend its FDA cleared Vivos CARE treatment for OSA to as many patients as possible.

Vivos also announced expansion of its strategic marketing and distribution alliance with Rebis Health Holdings (Rebis Health) launched last June into two additional facilities in the greater Denver market, along with plans to extend its marketing and distribution model throughout the United States with potential additional sleep center affiliations and acquisitions.

Initial Alliance Data Shows OSA Patients Prefer Vivos Treatment 2:1 Over CPAP

Data gathered by Vivos and Rebis Health over the initial months of their strategic alliance shows an overall Vivos treatment case acceptance rate of 64%, or nearly 2:1 over continuous positive airway pressure (CPAP), which is currently the principal standard of care for OSA. These results validate Vivos’ central thesis that, when presented with all available treatment options, OSA patients select Vivos treatment by a large margin.

During the initial months of the alliance, existing Rebis Health OSA patients, some of which had previously tried CPAP and indicated they were either dissatisfied or had ceased CPAP use, and other newly diagnosed OSA patients, were approached and educated about their OSA treatment options, including Vivos CARE as a potentially rehabilitative treatment over an approximate one year time frame.

Vivos CARE treatment offers several key advantages over CPAP, a cumbersome 40-year-old technology that covers the face and must be used nightly over a patient’s lifetime to be effective. Studies have shown that Vivos CARE devices have the ability to rehabilitate and enhance airway functionality, with initial therapeutic benefits often achieved relatively quickly (in days or weeks) and final clinical results typically achieved in as little as 12 months. Importantly, Vivos CARE treatment has been shown to reduce or even eliminate OSA symptoms as measured by the Apnea Hypopnea Index (AHI). Unlike CPAP, which only manages symptoms, Vivos CARE targets and corrects the structural issues behind most OSA cases. After completing their Vivos CARE treatment, many patients may not require further intervention, though individual experiences can vary, and long-term results may differ. Of the nearly 60,000 patients treated since 2010, fewer than approximately 0.1% have required retreatment.

Rebis Health has over 90,000 legacy OSA patients and currently sees approximately 1,200 potential new OSA patients each month. After months of preparation and training during the second half of 2024, and with somewhat limited (less than 400) patient interactions, Rebis Health medical providers are now educating substantially all their OSA patients on Vivos treatment as an alternative to CPAP. Through the strategic alliance, Vivos and Rebis Health are seeking to provide each patient with the full range of treatment options, including Vivos CARE devices.

Vivos Sees Potential for Increased Revenue and Profit per Patient Via Strategic Alliance Model Amid Growing Patient Demand

The second milestone achievement is average per case revenue of over $4,700. While results are still early and overall revenue growth is expected to ramp over time starting in 2025, Vivos gross margins per patient prior to a profit split with Rebis are in the 70% range, with overall profit potential to Vivos per case of up to four times greater than what Vivos experienced in its prior distribution model. Vivos believes it can further improve net profitability per case significantly in this new model going forward as it creates additional affiliations and pursues acquisition opportunities across the country with better economics.

“We’ve worked diligently over the first months of our alliance with Rebis Health to refine and optimize it as well as gain further validation of the exciting potential for Vivos as we roll out this new model on a national scale,” said Kirk Huntsman, Chairman and CEO of Vivos. “The realization of these initial two key milestones regarding patient preferences and improved economics for Vivos is validating of our efforts to date and made our decision to expand from our initial location with Rebis into two additional locations in the greater Denver area a no-brainer. Our achievements with Rebis have been in line with our expectations, and we see a lot of room for further improvement in terms of revenue growth and margin expansion as patients continue to accept Vivos treatment options. Moreover, these initial positive developments are leading us to accelerate our exploration of additional strategic alliances or outright acquisitions of sleep centers through which we can market our products and services. We view this new business model as a critical inflection point in the history of Vivos and for OSA treatment overall. No longer will patients just blindly accept CPAP as their life sentence for being diagnosed with OSA. Patients now know they have real choices and very good alternatives.”

The new Colorado locations for the strategic alliance are located in Highlands Ranch and Westminster, both suburbs of Denver. Both locations are expected to be fully staffed and operational by April. Eventually, Vivos and Rebis Health aim to have locations and providers serving all of Colorado.

Vivos is currently exploring alliances or acquisitions of some of the more than 2,500 accredited sleep medicine and testing groups in major United States cities. If these materialize, they are expected to accelerate and enhance Vivos’ top-line revenue growth while significantly lowering or ending Vivos’ current cash burn and generating cash flow-positive operations in the future.

About VIVOS THERAPEUTICS

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). Vivos’ devices are FDA-cleared for adult patients diagnosed with all severity levels of OSA and the flagship device, the Vivos DNA is FDA cleared to treat children ages 6 to 17 who are diagnosed with snoring and or moderate or severe OSA and need orthodontic treatment. Vivos’ groundbreaking CARE devices are the only FDA 510(k) cleared technology for treating severe OSA in adults and the Vivos DNA is the first oral device to receive a 510(k) clearance for treating moderate to severe OSA in children. 

Obstructive sleep apnea (OSA) affects over 1 billion people worldwide, yet 90% remain undiagnosed and unaware of their condition. This chronic disorder is not just a sleep issue—it’s closely linked to many serious chronic health conditions. While the medical community has made strides in treating sleep disorders, breathing and sleep health remain areas that are still not fully understood. As a result, solutions are often mechanistic and fail to address the root causes of OSA. 

Vivos Therapeutics, founded in 2016 and based in Littleton, CO, is changing this. Through innovative technology, education, and partnerships with dentists, functional medicine doctors, and sleep specialists, Vivos is empowering healthcare providers to more thoroughly address the complex needs of patients.

The Vivos Method offers a proprietary, clinically effective solution that is nonsurgical, noninvasive, and nonpharmaceutical, providing hope to allow patients to Breathe New Life. 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. Words such as “may”, “should”, “expects”, “projects,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal”, “aim” and variations of such words and similar expressions are intended to identify forward-looking statements. In this press release, forward-looking statements include, without limitation, those relating to the actual future impact of the corporate achievements described herein on Vivos’ future revenues and results of operations and the anticipated benefits and potential expansion of Vivos’ marketing and distribution model as described herein. 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. Readers are cautioned that actual results may differ materially and adversely 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 from using Vivos’ products, (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 financing on reasonable terms when needed, if at all or maintain its Nasdaq listing 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.

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