8-K: Vivos Opens New Michigan Sleep Center, Expands National Reach

Vivos Therapeutics announced the grand opening of its latest sleep testing and treatment center in Auburn Hills, Michigan, expanding its national presence through a capital-efficient affiliation model.

Summary

• Vivos Therapeutics, Inc. announced the grand opening of its newest sleep testing and treatment center near Detroit in Auburn Hills, Michigan, on December 16, 2025.
• This new center extends Vivos's capital-efficient and scalable sleep center affiliation model, which can involve contractual alliances or outright acquisitions of sleep medical practices.
• The Auburn Hills center is a contractual strategic alliance with MISleep Solutions, LLC, following an agreement executed in July.
• Vivos built out and equipped the center, hired and trained providers and support personnel for the grand opening.
• The national expansion strategy aims to leverage commercial affiliations with high-volume sleep clinics and physician-owned practices to deliver Vivos's FDA-cleared diagnostic and therapeutic products and services.
• Vivos expects this affiliation model to yield additional revenues and higher margin services revenue.
• Vivos is currently in discussions with other sleep center groups and specialists nationwide to establish similar affiliations.

Sentiment

Score: 8

Explanation: The announcement details a positive strategic expansion through a capital-efficient model, addressing a significant market need with FDA-cleared technology, and is expected to generate additional revenue. This indicates strong positive momentum for the company's growth strategy.

Positives

• Expansion of national presence with the grand opening of a new sleep testing and treatment center in Auburn Hills, Michigan.
• Utilizes a capital-efficient and scalable affiliation model, which is less capital-intensive than outright acquisitions while preserving accretive economics.
• Expected to generate additional revenues and higher margin services revenue for Vivos.
• Addresses a significant market need, as over 1 billion people worldwide suffer from Obstructive Sleep Apnea (OSA), with 90% remaining undiagnosed.
• Offers a differentiated, non-surgical, non-invasive, and non-pharmaceutical solution (The Vivos Method) for OSA.
• Vivos's CARE devices are FDA-cleared for all severity levels of OSA in adults and moderate-to-severe OSA in children, including being the first to receive clearance for treating moderate to severe OSA in children.

Risks

• Risk that Vivos may be unable to continue to integrate business from the acquisition and alliance model or otherwise implement sales, marketing, and other strategies that increase revenues.
• Risk that some patients may not achieve the desired results from using Vivos products.
• Risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea diagnosis and treatment sector.
• Risk that Vivos may be unable to secure additional financing to continue operations, acquire additional sleep centers/practices on reasonable terms, or maintain its Nasdaq listing when needed, if at all.
• Market and other conditions could impact Vivos's business or ability to obtain financing.
• Other risk factors described in Vivos's filings with the Securities and Exchange Commission (SEC).

Future Outlook

The contractual alliance with MISleep Solutions is expected to yield additional revenues and higher margin services revenue for Vivos. Vivos anticipates expanding the use of its products and services to additional sleep clinics and medical specialists throughout the metro Detroit area. Vivos is also in talks with other sleep center groups and physicians across the country to establish similar affiliations, signaling further national expansion and the expectation that this model will create a powerful win/win solution for providers, OSA patients, and Vivos.

Management Comments

• Kirk Huntsman, Vivos Chairman and CEO, explained that sleep testing centers and specialists have experienced tremendous pricing pressure from both government and commercial insurance payers, leading many to close or sell out.
• Huntsman noted that many providers have become disenchanted by the industry's 45-year-old, go-to solution of CPAP as the primary front-line treatment for over 90% of their patients with OSA.
• Huntsman stated that by affiliating with established sleep centers and practitioners, Vivos brings an exciting and highly differentiated set of diagnostic and treatment options to their patients, which is expected to yield additional revenues and higher margin services revenue for Vivos, creating a powerful win/win solution.

Industry Context

The sleep testing and treatment industry has faced significant pricing pressure from government and commercial insurance payers, leading to closures and consolidation among sleep labs and practices. There is also a noted dissatisfaction with traditional Obstructive Sleep Apnea (OSA) treatments like CPAP, which often fail to address the root causes of the condition. Vivos's strategy of forming capital-efficient affiliations with existing sleep centers and offering a differentiated, non-invasive treatment method positions it to capitalize on these industry challenges and the vast, underserved market of over 1 billion global OSA sufferers, 90% of whom remain undiagnosed.

Comparison to Industry Standards

• The industry's '45-year-old, go-to solution of CPAP' is described as often mechanistic and failing to address the root causes of OSA, implying Vivos's method offers a superior, root-cause focused alternative.
• Vivos's Complete Airway Repositioning and Expansion (CARE) devices are highlighted as the only FDA 510(k) cleared technology for treating severe OSA in adults and the first to receive clearance for treating moderate-to-severe OSA in children, setting a unique benchmark against other available treatments.

Stakeholder Impact

• Shareholders: Potential for increased revenue, market share, and long-term growth through a scalable, capital-efficient national expansion model.
• Patients (OSA sufferers): Access to a new, non-surgical, non-invasive, non-pharmaceutical treatment option (The Vivos Method) for OSA, potentially leading to resolution of symptoms.
• Affiliated Sleep Practices/Providers: Opportunity for additional revenues and higher margin services by offering Vivos's differentiated diagnostic and treatment options, helping them navigate industry pricing pressures.
• Employees: Creation of new roles and training opportunities for providers and support personnel at the new center and potentially future affiliated centers.

Next Steps

• Vivos plans to work closely with MISleep Solutions to expand the use of Vivos products and services to additional sleep clinics and medical specialists throughout the metro Detroit area.
• Vivos is currently in talks with other sleep center groups and sleep specialist physicians across the country to establish similar affiliations, indicating further national expansion.

Key Dates

Recommendation

The grand opening of a new sleep center through a capital-efficient affiliation model is a positive strategic move for Vivos, indicating national expansion and potential revenue growth in an underserved market. However, without specific financial projections or performance metrics in this filing, and considering the inherent risks associated with integration, patient outcomes, and securing future financing, a 'hold' recommendation is prudent. Investors should monitor the execution of this expansion strategy and future financial results for more definitive guidance.

Keywords

Vivos Therapeutics, VVOS, Sleep Apnea, OSA, Medical Device, Healthcare Services, Sleep Center, Auburn Hills Michigan, MISleep Solutions, FDA-cleared, Airway Repositioning and Expansion, CARE devices, National Expansion