Previously Unpublished Data Confirms Vivos DNA Devices Offer a Safe and Effective Alternative Treatment for Children with ADHD and Obstructive Sleep ApneaLITTLETON, Colo., Sept. 30, 2025 (GLOBE NEWSWIRE) -- 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 obstructive sleep apnea (OSA), today relea ...

Several small- and mid-cap biotech and medical stocks saw notable after-hours price action on Friday, September 26, following a mix of clinical updates, investor presentations, and strategic announcements.Enanta Pharmaceuticals Inc. (ENTA) surged sharply in after-hours trading on Friday, September 26, following a modest gain during the regular session. The stock closed the day at $7.90, up 1.94%, before vaulting another 20% after hours to reach $9.48. This dramatic post-close rally was driven by investor r ...

Core Insights - Vivos Therapeutics has published peer-reviewed data confirming the safety and efficacy of its Vivos DNA appliance in treating pediatric obstructive sleep apnea (OSA) [1][2][4] - The study highlights a significant milestone in addressing pediatric OSA, a condition affecting up to 20.4% of U.S. children, with many remaining undiagnosed [3][10] Group 1: Clinical Trial Results - The multicenter clinical trial results published in the European Journal of Pediatrics show that 77% of participants experienced at least a 50% reduction in OSA severity [7] - Among children with severe OSA, 93% achieved a 50% reduction in severity, and 17% of patients experienced complete resolution of their OSA [7] - The average airway volume increased by 67.8%, and Pediatric Sleep Questionnaire symptom scores decreased by 31%, indicating statistically significant improvement [7] Group 2: Treatment Alternatives - The Vivos DNA appliance is positioned as a non-surgical alternative to the current standard of care, which is adenotonsillectomy (AT) surgery, effective in only 20-40% of pediatric cases [3][4] - Vivos also offers Vivos Guides, which support proper craniofacial growth and have shown to alleviate symptoms associated with underdeveloped jaw growth, including ADHD behaviors and bedwetting [6][15] - Clinical data indicates that Vivos Guides can virtually eliminate bedwetting in children, with 50% seeing results within two weeks and 97.4% resolving within 60 days [6] Group 3: Industry Context - OSA affects over 1 billion people globally, with 90% undiagnosed, linking it to serious chronic health conditions [10] - Vivos Therapeutics aims to address the complex needs of OSA patients through innovative technology and collaborations with healthcare providers [11] - The company’s Complete Airway Repositioning and Expansion (C.A.R.E.) devices are the only FDA-cleared technology for treating severe OSA in adults and moderate to severe OSA in children [9]

[Q2 2025 Earnings Release Highlights](index=1&type=section&id=Q2%202025%20Earnings%20Release%20Highlights) Vivos Therapeutics' Q2 2025 highlights include a strategic pivot in its sales model through the SCN acquisition and a decline in financial performance due to this transition [Business and Strategic Highlights](index=1&type=section&id=Business%20and%20Strategic%20Highlights) The second quarter of 2025 was marked by Vivos Therapeutics' strategic pivot in its sales, marketing, and distribution model, highlighted by the acquisition of The Sleep Center of Nevada (SCN) - Vivos completed the key acquisition of The Sleep Center of Nevada (SCN), the largest operator of medical sleep centers in Nevada, marking a pivot in its core sales, marketing, and distribution model[3](index=3&type=chunk) - The new model allows Vivos to capture both OSA diagnostic and treatment revenue through more direct relationships with patients[3](index=3&type=chunk) - SCN generated approximately **$500,000** of diagnostic sleep testing services revenue over just twenty days from the June 10 closing to the end of the quarter[3](index=3&type=chunk) - Patient demand at SCN locations adapted to the Vivos model so far continues to exceed current capacity, with appointments booked out for weeks and less than **40% of patients** currently being served, validating the new model[3](index=3&type=chunk) [Financial Performance Summary](index=1&type=section&id=Financial%20Performance%20Summary) Vivos Therapeutics reported a decline in Q2 2025 revenue and gross profit, primarily due to its strategic pivot in sales and distribution model, leading to a larger operating loss Q2 2025 and YTD June 30, 2025 Key Financials | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | Change (YoY) | YTD 2025 (Millions USD) | YTD 2024 (Millions USD) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | :---------------------- | :---------------------- | :----------- | | Revenue | $3.8 | $4.1 | -7.3% | $6.8 | $7.5 | -9.3% | | Gross Profit | $2.1 | $2.7 | -22.2% | $3.6 | $4.6 | -21.7% | | Gross Margin | 55% | 65% | -10 pp | 53% | 61% | -8 pp | | Operating Expenses | $7.0 | $4.6 | +52.2% | $12.4 | $10.3 | +20.4% | | Operating Loss | $(4.9) | $(1.9) | +157.9% | $(8.8) | $(5.7) | +54.4% | Cash and Stockholders' Equity | Metric | June 30, 2025 (Millions USD) | Dec 31, 2024 (Millions USD) | Change | | :----- | :--------------------------- | :-------------------------- | :----- | | Cash and Cash Equivalents | $4.4 | $6.2 | -29.0% | | Stockholders' Equity | $4.6 | $8.0 | -42.5% | - The decline in revenue and gross profit was expected and attributed to the ongoing pivot in Vivos' sales, marketing, and distribution model, focusing on sleep center provider-based alliances and acquisitions[4](index=4&type=chunk)[7](index=7&type=chunk) - The increase in operating expenses was due to higher general and administrative costs, including professional fees related to equity and debt financings for the SCN acquisition and integration, much of which is expected to be non-recurring[7](index=7&type=chunk) [Strategic Business Model Transformation](index=1&type=section&id=Strategic%20Business%20Model%20Transformation) Vivos Therapeutics is strategically transforming its business model through the acquisition of SCN and the development of a new OSA provider management model [Acquisition of The Sleep Center of Nevada (SCN)](index=1&type=section&id=Acquisition%20of%20The%20Sleep%20Center%20of%20Nevada%20(SCN)) Vivos completed the acquisition of The Sleep Center of Nevada (SCN) on June 10, 2025, as a cornerstone of its strategic shift, aiming to directly engage patients for OSA diagnosis and treatment - Vivos acquired The Sleep Center of Nevada (SCN) on June 10, 2025, pivoting its sales, marketing, and distribution model[3](index=3&type=chunk)[4](index=4&type=chunk) - The acquisition enables Vivos to capture both OSA diagnostic and treatment revenue through direct patient relationships, moving away from a model solely reliant on dentists[3](index=3&type=chunk) - SCN generated approximately **$500,000** in diagnostic sleep testing services revenue in the 20 days following the acquisition[3](index=3&type=chunk) - Patient demand at SCN locations, adapted to the Vivos model, currently exceeds capacity, with appointments booked for weeks and less than **40% of patients** being served, validating the new model[3](index=3&type=chunk) - Vivos plans to scale this model in the future through additional sleep center alliances or acquisitions[3](index=3&type=chunk) [Updated OSA Provider Management Model](index=2&type=section&id=Updated%20OSA%20Provider%20Management%20Model) Vivos is developing a new sleep practice management model, exemplified by its agreement with MISleep Solutions LLC, to offer its full suite of OSA treatments and services through equity stakes in management companies - Vivos is developing an updated sleep practice management model for medical practices not interested in being purchased but willing to offer Vivos' OSA diagnostic and treatment options[5](index=5&type=chunk) - On July 14, 2025, Vivos entered its first management agreement with MISleep Solutions LLC in Auburn Hills, Michigan, to provide its full suite of Vivos treatments and services[6](index=6&type=chunk) - Vivos holds a **supermajority equity stake** in the management services company under this model, with sleep doctors having minority ownership[6](index=6&type=chunk) - Facilities for these operations are being remodeled, with an estimated opening in October 2025, and Vivos is exploring similar arrangements in other states[6](index=6&type=chunk) [Detailed Financial Results](index=5&type=section&id=Detailed%20Financial%20Results) Detailed financial results for Q2 2025 show decreased revenue and increased operating losses, alongside significant balance sheet changes reflecting recent acquisitions and debt [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q2 2025, Vivos Therapeutics experienced a decrease in total revenue and gross profit compared to Q2 2024, primarily driven by lower service revenue, leading to a substantial rise in operating and net loss Condensed Consolidated Statements of Operations (Q2 2025 vs Q2 2024) | Metric (Thousands USD) | Q2 2025 | Q2 2024 | Change | | :-------------------- | :------ | :------ | :----- | | Product revenue | $1,885 | $1,975 | -4.6% | | Service revenue | $1,935 | $2,079 | -6.9% | | **Total revenue** | **$3,820** | **$4,054** | **-5.8%** | | Cost of sales | $1,710 | $1,403 | +21.9% | | **Gross profit** | **$2,110** | **$2,651** | **-20.4%** | | General and administrative | $6,409 | $4,122 | +55.5% | | Sales and marketing | $260 | $320 | -18.8% | | Depreciation and amortization | $306 | $145 | +111.0% | | **Total operating expenses** | **$6,975** | **$4,587** | **+52.1%** | | **Operating loss** | **$(4,865)** | **$(1,936)** | **+151.3%** | | **Net loss** | **$(5,013)** | **$(1,930)** | **+159.7%** | | Net loss per share (basic and diluted) | $(0.55) | $(0.60) | -8.3% | | Weighted average shares outstanding | 9,087,202 | 3,228,363 | +181.5% | Condensed Consolidated Statements of Operations (Six Months Ended June 30, 2025 vs 2024) | Metric (Thousands USD) | YTD 2025 | YTD 2024 | Change | | :-------------------- | :------- | :------- | :----- | | Product revenue | $3,698 | $3,650 | +1.3% | | Service revenue | $3,137 | $3,823 | -17.9% | | **Total revenue** | **$6,835** | **$7,473** | **-8.5%** | | Cost of sales | $3,219 | $2,885 | +11.6% | | **Gross profit** | **$3,616** | **$4,588** | **-21.2%** | | General and administrative | $11,298 | $9,043 | +24.9% | | Sales and marketing | $615 | $973 | -36.8% | | Depreciation and amortization | $483 | $291 | +66.0% | | **Total operating expenses** | **$12,396** | **$10,307** | **+20.3%** | | **Operating loss** | **$(8,780)** | **$(5,719)** | **+53.5%** | | **Net loss** | **$(8,877)** | **$(5,692)** | **+55.9%** | | Net loss per share (basic and diluted) | $(1.00) | $(2.06) | -51.4% | | Weighted average shares outstanding | 8,842,604 | 2,768,934 | +219.3% | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Vivos Therapeutics reported a significant increase in total assets, primarily driven by goodwill, property and equipment, and intangible assets, reflecting recent acquisitions Condensed Consolidated Balance Sheets (June 30, 2025 vs Dec 31, 2024) | Metric (Thousands USD) | June 30, 2025 | Dec 31, 2024 | Change | | :-------------------- | :------------ | :----------- | :----- | | Cash and cash equivalents | $4,402 | $6,260 | -29.7% | | Accounts receivable, net | $1,633 | $430 | +279.8% | | Total current assets | $6,730 | $7,473 | -9.9% | | Goodwill | $8,450 | $2,843 | +197.2% | | Property and equipment, net | $5,129 | $3,350 | +53.1% | | Intangible assets, net | $2,225 | $370 | +501.4% | | **Total assets** | **$26,033** | **$15,284** | **+70.3%** | | Accounts payable | $1,763 | $1,098 | +60.6% | | Total current liabilities | $6,426 | $4,978 | +29.1% | | Employee retention credit liability | $2,904 | $1,220 | +138.0% | | Debt, net of current portion | $7,760 | $0 | N/A | | **Total liabilities** | **$21,450** | **$7,330** | **+192.6%** | | **Total stockholders' equity** | **$4,583** | **$7,954** | **-42.4%** | [Company Information](index=3&type=section&id=Company%20Information) Vivos Therapeutics is a medical technology company focused on innovative diagnostic and treatment methods for Obstructive Sleep Apnea (OSA) using FDA-cleared CARE devices [About Vivos Therapeutics, Inc.](index=3&type=section&id=About%20Vivos%20Therapeutics%2C%20Inc.) Vivos Therapeutics is a medical technology company specializing in innovative diagnostic and treatment methods for breathing and sleep issues, particularly Obstructive Sleep Apnea (OSA) - Vivos Therapeutics (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing diagnostic and treatment methods for breathing and sleep issues, including Obstructive Sleep Apnea (OSA) and snoring[11](index=11&type=chunk) - Vivos' CARE devices are FDA 510(k) cleared for all severity levels of OSA in adults and moderate-to-severe OSA in children (ages 6-17), being the only technology cleared for **severe OSA in adults** and the first for children[11](index=11&type=chunk) - OSA affects over **1 billion people worldwide**, with **90% remaining undiagnosed**, and is closely linked to many serious chronic health conditions[12](index=12&type=chunk) - The Vivos Method offers a proprietary, clinically effective solution that is nonsurgical, noninvasive, and nonpharmaceutical, providing hope to allow patients to Breathe New Life[14](index=14&type=chunk) - Founded in 2016 and based in Littleton, CO, Vivos aims to empower healthcare providers through innovative technology, education, and acquisitions of, or commercial collaborations with, sleep healthcare providers[13](index=13&type=chunk) [Additional Information](index=3&type=section&id=Additional%20Information) This section provides details on the Q2 2025 investor conference call and a cautionary note regarding forward-looking statements and associated risks [Investor Conference Call and 10-Q Filing](index=3&type=section&id=Investor%20Conference%20Call%20and%2010-Q%20Filing) Vivos Therapeutics hosted an investor conference call on August 19, 2025, to discuss Q2 2025 financial results, strategic collaborations, and their anticipated impact on revenue growth and cash burn - Vivos hosted an investor conference call on August 19, 2025, at 5:00 p.m. ET to discuss Q2 2025 results, strategic collaborations, and their effect on near-term revenue growth and cash burn[8](index=8&type=chunk) - Details for accessing the live call, replay, and webcast are provided, with the replay available until September 2, 2025[9](index=9&type=chunk) - Further financial information is included in the attached unaudited condensed consolidated balance sheets and statements of operations, and the full Quarterly Report on Form 10-Q will be filed with the SEC[10](index=10&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=4&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section highlights that the press release contains forward-looking statements regarding the future impact of the SCN acquisition and the benefits of Vivos' new marketing model, warning of potential material differences in actual results - The press release contains forward-looking statements concerning future events, including the actual future impact of the SCN acquisition on Vivos' future revenues and results of operations and the anticipated benefits and potential expansion of Vivos' marketing and distribution model[16](index=16&type=chunk) - 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[16](index=16&type=chunk) - Factors that could cause actual results to differ materially include the risk that Vivos may be unable to successfully integrate SCN's business, the risk that some patients may not achieve desired results, risks associated with regulatory scrutiny, and the risk that Vivos may be unable to secure additional financing[16](index=16&type=chunk) - Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements, except to the extent required by law[16](index=16&type=chunk)

Financial Data and Key Metrics Changes - In Q2 2025, revenue decreased by approximately 6% to $3.8 million compared to $4.1 million in 2024, reflecting additional expenses related to the transition and integration of the Sleep Center of Nevada (SCN) [8][10] - Operating loss widened to $4.9 million in Q2 and $8.8 million for 2025, primarily due to higher expenses and lower revenues during the strategic transition [11][12] - Cash and cash equivalents stood at $4.4 million with total liabilities of $21.5 million as of June 30, 2025 [12] Business Line Data and Key Metrics Changes - VIP enrollment revenue declined by $1 million in Q2, while sleep testing service revenue saw an uplift of $500,000 attributable to SCN [9][10] - Oral appliance sales decreased by 5% in Q2, with 4,116 units sold for $1.9 million, reflecting a shift towards higher volume guide sales [10][11] Market Data and Key Metrics Changes - The integration of SCN has led to increased patient demand, with the company currently servicing significantly less than 40% of potential new patients being tested each month at SCN [18][19] - The company has identified a significant number of legacy SCN patients dissatisfied with CPAP units, indicating a strong market opportunity for VIVOS's treatment alternatives [18] Company Strategy and Development Direction - The company is focusing on a new sales, marketing, and distribution model centered around sleep center provider alliances and acquisitions, with the SCN acquisition being a key milestone [6][12] - VIVOS plans to expand its operations by deploying additional Sleep Optimization (SO) teams to meet growing patient demand, with potential for up to eight teams at SCN based on current demand [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the integration of SCN and the initial patient demand exceeding expectations, leading to plans for facility expansion and additional staff recruitment [14][18] - The company anticipates becoming cash flow positive by the fourth quarter of 2025 as it ramps up the deployment of SO teams [49] Other Important Information - The company has secured significant debt and equity financing, providing $11.5 million in net cash from financing activities [11][12] - VIVOS is actively pursuing additional acquisition and affiliation opportunities across the country, with ongoing negotiations with several potential candidates [22][39] Q&A Session Summary Question: How should revenue in Q3 and Q4 be viewed relative to Q2? - Management indicated that revenue will track the deployment of SO teams, with expectations for growth as the new model replaces the old one [26][27] Question: Will the strength in sleep testing services continue? - Management noted that the increase in testing revenue is a direct reflection of SCN's operations and expects continued growth as more testing centers are brought online [28][29] Question: What is the expected operating expense moving forward? - Management acknowledged that there were one-time costs associated with the SCN acquisition, but some ongoing costs will remain [31][32] Question: How is the recruitment of SO teams progressing? - Management reported robust demand for positions and efficient training processes for new teams [35][36] Question: What is the financial strategy regarding debt? - Management is focused on reducing the cost of capital and is exploring opportunities for refinancing as the business model matures [44][45] Question: When does management expect to reach cash breakeven? - Management is targeting cash flow positivity by the fourth quarter of 2025 as they expand operations [49]

Core Viewpoint - Vivos Therapeutics, Inc. has made a significant acquisition of The Sleep Center of Nevada, which is expected to enhance its revenue generation and patient demand for its obstructive sleep apnea (OSA) treatments. The company is transitioning its business model to focus on direct patient relationships and sleep center alliances [1][3]. Financial Performance - For the second quarter of 2025, Vivos reported revenue of $3.8 million, a decrease from $4.1 million in the same period of 2024. For the six months ended June 30, 2025, revenue was $6.8 million compared to $7.5 million in 2024 [4]. - Gross profit for the second quarter of 2025 was $2.1 million, down from $2.7 million in the second quarter of 2024. For the six months ended June 30, 2025, gross profit was $3.6 million compared to $4.6 million in 2024 [4]. - The gross margin declined to 55% in the second quarter of 2025 from 65% in the same period of 2024, attributed to pricing discounts and the transition to a new sales model [4]. - Operating expenses increased by 52% to $7.0 million in the second quarter of 2025, compared to $4.6 million in the same period of 2024, largely due to costs associated with the acquisition and integration of SCN [4]. Strategic Initiatives - The acquisition of The Sleep Center of Nevada marks a strategic shift in Vivos' sales and marketing approach, moving from a dentist-reliant model to a more comprehensive model that includes direct patient engagement [3]. - Vivos is also developing a new sleep practice management model to partner with sleep centers that are not interested in acquisition but want to offer Vivos' OSA diagnostic and treatment options [5][6]. - The company is actively seeking additional sleep center alliances or acquisitions to scale its new model, as demand at SCN locations has exceeded current capacity [3]. Market Context - OSA affects over 1 billion people globally, with a significant portion remaining undiagnosed. This presents a substantial market opportunity for innovative treatments that address the root causes of OSA [11]. - Vivos' proprietary treatments, including the Complete Airway Repositioning and Expansion (CARE) devices, are FDA-cleared for various severity levels of OSA, positioning the company favorably in the medical device market [10].

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%2E%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201%2E%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents Vivos Therapeutics, Inc.'s unaudited condensed consolidated financial statements for June 30, 2025, and the three and six-month periods then ended, including balance sheets, statements of operations, statements of stockholders' equity, statements of cash flows, and detailed notes on accounting policies, the SCN acquisition, and liquidity issues [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets increased to **$26.0 million** from **$15.3 million** at year-end 2024, primarily due to the SCN acquisition, while total liabilities rose to **$21.5 million** from **$7.3 million**, mainly from new debt, and stockholders' equity decreased to **$4.6 million** from **$8.0 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $4,402 | $6,260 | | Goodwill | $8,450 | $2,843 | | Total assets | $26,033 | $15,284 | | **Liabilities & Equity** | | | | Total current liabilities | $6,426 | $4,978 | | Debt, net of current portion | $7,760 | $- | | Total liabilities | $21,450 | $7,330 | | Total stockholders' equity | $4,583 | $7,954 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2025, total revenue slightly decreased to **$3.8 million** from **$4.1 million** year-over-year, while the operating loss significantly widened to **$4.9 million** from **$1.9 million**, primarily due to a **$2.3 million** increase in general and administrative expenses, resulting in a net loss of **$5.0 million** Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $3,820 | $4,054 | $6,835 | $7,473 | | Gross Profit | $2,110 | $2,651 | $3,616 | $4,588 | | Operating Loss | $(4,865) | $(1,936) | $(8,780) | $(5,719) | | Net Loss | $(5,013) | $(1,930) | $(8,877) | $(5,692) | | Net Loss Per Share | $(0.55) | $(0.60) | $(1.00) | $(2.06) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities increased to **$7.3 million**, net cash used in investing activities was **$6.0 million** for the SCN acquisition, and net cash provided by financing activities was **$11.5 million**, resulting in a net decrease in cash of **$1.9 million** and an ending cash balance of **$4.4 million** Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,290) | $(5,564) | | Net cash used in investing activities | $(6,028) | $(211) | | Net cash provided by financing activities | $11,460 | $11,035 | | **Net (decrease) increase in cash** | **$(1,858)** | **$5,260** | | Cash and cash equivalents at end of period | $4,402 | $6,903 | [Notes to the Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's strategic pivot to an acquisition and alliance model, exemplified by the June 2025 acquisition of The Sleep Center of Nevada (SCN), and address significant accounting policies, revenue recognition changes, new debt structure, and a going concern warning due to recurring losses and negative cash flow - The company is pivoting its business strategy away from its legacy model of enrolling dentists (VIPs) and towards a new model focused on contractual alliances with and acquisitions of sleep centers, intended to align revenue generation more directly with appliance sales[32](index=32&type=chunk)[35](index=35&type=chunk) - On June 10, 2025, the company acquired the operating assets of The Sleep Center of Nevada (SCN) for total consideration of **$8.7 million**, consisting of **$6.0 million** in cash, **$1.3 million** in stock, and **$1.4 million** in contingent consideration, adding **$5.6 million** in goodwill[27](index=27&type=chunk)[86](index=86&type=chunk)[87](index=87&type=chunk) - The company has incurred losses since inception, with a net loss of **$8.9 million** for the first six months of 2025 and an accumulated deficit of **$113.1 million**, leading management to conclude there is substantial doubt about the company's ability to continue as a going concern without additional financing[78](index=78&type=chunk)[80](index=80&type=chunk) - To fund the SCN acquisition, the company issued a senior secured term note for **$8.2 million** with a 9% annual interest rate and an 18-month maturity, and also raised **$3.65 million** in a private placement of equity instruments[85](index=85&type=chunk)[101](index=101&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=39&type=section&id=Item%202%2E%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic pivot from its legacy VIP dentist enrollment model to a new sales model focused on acquiring and forming alliances with sleep centers, exemplified by the recent acquisition of The Sleep Center of Nevada (SCN), covering the financial impact of this transition, including decreased service revenue, increased G&A expenses, and liquidity challenges that raise substantial doubt about its going concern ability - The company has pivoted its business model away from enrolling individual dentists (VIPs) towards acquiring or forming alliances with sleep centers to drive appliance sales more directly[164](index=164&type=chunk)[165](index=165&type=chunk) - A key milestone in the new strategy was the June 10, 2025 acquisition of The Sleep Center of Nevada (SCN), a seven-location operator, funded through an **$8.2 million** senior secured note and a **$3.7 million** private placement[159](index=159&type=chunk)[160](index=160&type=chunk) - The company faces significant liquidity challenges, with recurring losses and negative operating cash flow, leading management to state there is substantial doubt about the company's ability to continue as a going concern without additional financing[226](index=226&type=chunk)[229](index=229&type=chunk) [Results of Operations](index=47&type=section&id=Results%20of%20Operations) For Q2 2025, revenue decreased **6%** to **$3.8 million** year-over-year, as a **$1.0 million** decline in legacy VIP enrollment revenue was partially offset by new revenue from the SCN acquisition, while gross margin fell from **65%** to **55%**, and general and administrative expenses surged **55%** to **$6.4 million**, primarily due to **$1.8 million** in SCN acquisition costs, leading to a significant increase in the quarterly net loss to **$5.0 million** Financial Performance Comparison (in thousands) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $3,820 | $4,054 | $(234) | | Gross Profit | $2,110 | $2,651 | $(541) | | Gross Profit % | 55% | 65% | -10% | | General and administrative | $6,409 | $4,122 | $2,287 | | Operating Loss | $(4,865) | $(1,936) | $(2,929) | | Net Loss | $(5,013) | $(1,930) | $(3,083) | - The decrease in service revenue was driven by a **$1.0 million** decline in VIP enrollment revenue, reflecting the strategic pivot, partially offset by a **$0.5 million** increase in sleep testing services, primarily from the newly acquired SCN[208](index=208&type=chunk) - The **$2.3 million** increase in G&A expenses for Q2 2025 was primarily caused by **$1.8 million** in costs related to acquiring and integrating SCN, including professional fees, salaries, and infrastructure costs[213](index=213&type=chunk) [Liquidity and Capital Resources](index=50&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces significant liquidity constraints, with an accumulated deficit of **$113.1 million** and net cash used in operations of **$7.3 million** for the first six months of 2025, and as of June 30, 2025, the company had **$4.4 million** in cash, which is insufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern, necessitating reliance on debt and equity financing for operations and the SCN acquisition - As of June 30, 2025, the company had **$4.4 million** in cash, which is not sufficient to fund operations and strategic objectives for the next twelve months[229](index=229&type=chunk) - The company has a history of losses, including a net loss of **$8.9 million** for the first six months of 2025, and an accumulated deficit of **$113.1 million**[226](index=226&type=chunk) - Net cash used in operating activities increased to **$7.3 million** for the first half of 2025, up from **$5.6 million** in the prior-year period[227](index=227&type=chunk)[233](index=233&type=chunk) - The company financed the SCN acquisition and its operations through the issuance of senior secured debt and equity securities, and management is reviewing all options for additional financing[231](index=231&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=52&type=section&id=Item%203%2E%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - Disclosure is not required as the registrant is a smaller reporting company[238](index=238&type=chunk) [Item 4. Controls and Procedures](index=52&type=section&id=Item%204%2E%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2025, excluding the internal controls of The Sleep Center of Nevada (SCN), acquired on June 10, 2025, which the company is currently integrating into its framework - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[239](index=239&type=chunk) - The evaluation of disclosure controls excluded The Sleep Center of Nevada (SCN), which was acquired on June 10, 2025, and represented approximately **33%** of consolidated total assets as of June 30, 2025[240](index=240&type=chunk) - The company is in the process of integrating SCN's operations and controls, with completion expected within one year of the acquisition date[242](index=242&type=chunk) [PART II. OTHER INFORMATION](index=53&type=section&id=PART%20II%2E%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=53&type=section&id=Item%201%2E%20Legal%20Proceedings) The company is involved in ongoing litigation with Ortho-Tain, Inc., with Vivos initiating a lawsuit in Colorado for alleged false and defamatory statements, and Ortho-Tain filing a countersuit in Illinois alleging Lanham Act violations, both cases proceeding through various motions and discovery phases - Vivos filed a suit against Ortho-Tain, Inc. in Colorado, alleging false, threatening, and defamatory statements that interfered with a business relationship[245](index=245&type=chunk) - Ortho-Tain filed a countersuit in Illinois against Vivos, its CEO, and others, alleging violations of the Lanham Act and civil conspiracy related to a presentation at a Vivos-sponsored event[247](index=247&type=chunk) - The Illinois case was initially stayed pending the outcome of the Colorado case, but the stay was lifted in March 2023, and both cases are currently active with ongoing discovery and legal motions[249](index=249&type=chunk)[251](index=251&type=chunk) [Item 1A. Risk Factors](index=54&type=section&id=Item%201A%2E%20Risk%20Factors) This section details updated risk factors associated with the company's new business model and the acquisition of The Sleep Center of Nevada (SCN), including the unproven nature of the new sales and distribution model, substantial indebtedness incurred for the SCN acquisition, potential difficulties in integrating SCN's operations, and legal risks related to healthcare regulations such as the corporate practice of medicine and fee-splitting laws - The company's new sales, marketing, and distribution model, centered on acquiring sleep centers like SCN, is unproven and may not produce the anticipated benefits, making future prospects difficult to evaluate[253](index=253&type=chunk)[254](index=254&type=chunk) - The company incurred substantial debt (**$8.25 million** principal) to finance the SCN acquisition, and servicing this debt could adversely affect financial condition, with no guarantee that cash flow will be sufficient to meet debt obligations[258](index=258&type=chunk)[259](index=259&type=chunk) - Integrating SCN's operations may be more difficult, costly, or time-consuming than expected, potentially disrupting business and relationships with patients and employees[260](index=260&type=chunk) - Contractual arrangements with physicians at SCN may be found to violate state laws prohibiting the corporate practice of medicine or fee-splitting, which could require restructuring and result in penalties or loss of revenue[261](index=261&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=58&type=section&id=Item%202%2E%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section is not applicable - Not applicable[273](index=273&type=chunk) [Item 3. Defaults Upon Senior Securities](index=58&type=section&id=Item%203%2E%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[274](index=274&type=chunk) [Item 6. Exhibits, Financial Statement Schedules](index=58&type=section&id=Item%206%2E%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the documents filed as exhibits to the Quarterly Report on Form 10-Q, including certifications from the CEO and CFO and Inline XBRL data files - The exhibits filed with this report include CEO and CFO certifications pursuant to Sarbanes-Oxley Act Sections 302 and 906, as well as Inline XBRL documents[277](index=277&type=chunk)[278](index=278&type=chunk)

Core Viewpoint - Vivos Therapeutics, Inc. is set to release its second quarter 2025 financial results and will conduct a conference call to discuss these results and recent developments in the company [1][2][3] Company Overview - Vivos Therapeutics, Inc. specializes in developing and commercializing treatments for sleep-related breathing disorders, particularly obstructive sleep apnea (OSA) [4] - The company’s devices are FDA-cleared for all severity levels of OSA in adults and moderate to severe OSA in children aged 6 to 17 [4] - Vivos' Complete Airway Repositioning and Expansion (CARE) devices are the only FDA 510(k) cleared technology for treating severe OSA in adults and the first for moderate to severe OSA in children [4] Market Context - OSA affects over 1 billion people globally, with 90% undiagnosed, linking it to serious chronic health conditions [5] - Traditional treatments like CPAP often fail to address the root causes of OSA, indicating a need for innovative solutions [5] Strategic Initiatives - Founded in 2016, Vivos aims to empower healthcare providers to better address the needs of OSA patients through innovative technology and collaborations [6] - The company promotes The Vivos Method, a proprietary, clinically effective, nonsurgical, noninvasive, and nonpharmaceutical solution for OSA [7]

Core Insights - Vivos Therapeutics has received approval from the Centers for Medicare & Medicaid Services (CMS) for its VidaSleep™ oral appliance, which is designed to treat mild to moderate obstructive sleep apnea (OSA) and snoring in adults [1][4][5] - The approval allows Vivos to significantly expand its market presence, as it now has two Medicare-covered oral appliances, enhancing its competitive position in the sleep therapy market [5][6] Company Overview - Vivos Therapeutics, Inc. is a medical technology company focused on innovative treatments for OSA and snoring, with its products cleared by the FDA for various severity levels of OSA [10][12] - The company aims to address the structural root causes of OSA through its proprietary oral appliances, which are non-invasive and non-pharmaceutical [13] Market Opportunity - With over 80% of OSA cases in the U.S. undiagnosed and an estimated 80 million Americans affected, Vivos is positioned to capture a significant share of the underpenetrated sleep therapy market [4][11] - The dual-PDAC approval of VidaSleep™ and mmRNA® appliances allows Vivos to serve a broader range of patients, from Medicare beneficiaries to those covered by commercial payers, tapping into the estimated $36 billion sleep therapy market [6][8] Clinical and Commercial Advantages - The VidaSleep™ device is designed to be a standalone therapy or an adjunct to CPAP, providing flexibility for both providers and patients [7][8] - The streamlined design and efficient manufacturing process of VidaSleep™ enable Vivos to offer high-impact therapy at a cost-effective price, increasing adoption across Medicare and commercial insurance networks [8] Health Implications - OSA is linked to severe comorbidities such as heart disease, stroke, and dementia, yet remains largely underdiagnosed [9][11] - Vivos' oral appliances have shown significant improvements in airway patency and symptom resolution, as evidenced by peer-reviewed studies [9]

Core Insights - Vivos Therapeutics has announced a significant study published in the European Journal of Pediatrics, demonstrating the safety and efficacy of its Daytime-Nighttime Appliance (DNA) for treating obstructive sleep apnea (OSA) in children [1][2] - The study indicates that 79% of participants showed improvement in OSA symptoms, with 61.7% improving by 50% or more, and 17% experiencing complete resolution of their OSA [3] - The findings support Vivos' FDA 510(k) clearance for the DNA device, reinforcing its position as a non-surgical alternative to traditional adenotonsillectomy surgery [2][7] Company Overview - Vivos Therapeutics, Inc. is focused on developing non-invasive treatments for OSA, with its DNA device being a key product cleared for use in children aged 6 to 17 [9][12] - The company aims to address the significant number of undiagnosed OSA cases among children, estimated at 10 million in the U.S., with many linked to various health issues [5][10] - Vivos is actively pursuing collaborations and acquisitions to expand access to its treatments, including the recent acquisition of the Sleep Center of Nevada [9][11] Industry Context - The current standard treatment for pediatric OSA is adenotonsillectomy, with over 500,000 surgeries performed annually in the U.S., but with a high relapse rate of 68% within three years [6][7] - The study highlights the need for safer, evidence-based alternatives to invasive procedures, aligning with recent reports warning against overtreatment in pediatric healthcare [7][8] - Vivos' approach offers a non-invasive solution that promotes natural jaw development, potentially reducing the need for costly and traumatic surgeries [7][8]