Vivos Therapeutics Secures FDA Clearance for OSA Devices

Introduction

Vivos Therapeutics Inc (NASDAQ: VVOS) is a medical technology company based in Littleton, Colorado, specializing in noninvasive oral appliance treatments for obstructive sleep apnea (OSA) and dentofacial abnormalities. Its proprietary Vivos Method incorporates multidisciplinary care provided by trained dentists and medical professionals to reshape and expand the oral cavity, addressing anatomical causes of OSA. As of July 1, 2025, VVOS shares traded on the NASDAQ at $4.5912, reflecting a 45.29% increase on a volume of 6,615,135 shares.

Corporate Structure and Expertise

Founded in 2016, Vivos Therapeutics employs between 51 and 200 professionals across clinical, research and development, and administrative functions. Leadership is guided by R. Kirk Huntsman, Co-Founder, Chairman, and Chief Executive Officer. Vivos integrates the operating assets of The Sleep Center of Nevada (SCN), acquired in April 2025, which includes a network of seven testing locations and nearly 50 overnight polysomnogram beds under Vivos’s management.

Sleep apnea by Krista Mangulsone

Recent Developments and News

On November 29, 2023, the U.S. Food and Drug Administration granted Vivos its first 510(k) clearance for treating severe adult OSA with its Complete Airway Repositioning and/or Expansion (CARE) removable oral appliances. This clearance followed an earlier 510(k) approval for mild-to-moderate OSA, making Vivos the only company with FDA-cleared oral devices for all severity levels of OSA in adults.

On April 16, 2025, Vivos signed a definitive agreement to acquire SCN for up to $9 million—comprising $6 million in cash and $1.5 million in common stock at closing, plus an additional $1.5 million contingent on financial milestones. The acquisition is intended to enhance Vivos’s direct-to-patient model in the Las Vegas market, where SCN tests approximately 3,000 new patients per month.

On May 15, 2025, Vivos released its first quarter 2025 financial results, reporting growth in patient case starts and revenue. Earlier, on March 31, 2025, Vivos had discussed its full year 2024 results, detailing advancements in distribution alliances and clinical trial data.

In early 2025, Vivos received Medicare approval for its VidaSleep™ oral appliance, allowing for broader reimbursement options for its treatments in the senior patient population.

Financial and Strategic Aspects

Vivos’s share price increase in mid-2025 indicates investor interest in its technology and growth strategies. The SCN acquisition is financed primarily through a senior debt facility and potential equity issuance, with the upfront payment structured according to performance milestones. Data submitted to the FDA from 73 severe OSA patients indicated that 80% experienced at least one classification improvement or a 50% reduction in the Apnea-Hypopnea Index, reinforcing the company’s value to payors and distribution partners.

Management anticipates further synergies from integrating sleep testing services and increasing acceptance of Vivos treatments, particularly as evidence suggests that two-thirds of patients in its Colorado alliance preferred Vivos treatment over continuous positive airway pressure (CPAP) or surgical alternatives.

Market Position and Industry Context

Obstructive sleep apnea affects over one billion individuals globally, with up to 90% remaining undiagnosed. Standard treatments such as CPAP therapy or surgical implants often require lifelong adherence or invasive procedures. Vivos’s CARE devices, cleared for use in adults and children ages 6–17, represent the only FDA-cleared oral appliance option for severe OSA. By addressing anatomical root causes—such as underdeveloped jaws and narrow dental arches—the Vivos Method offers a treatment period of approximately 9–12 months rather than continuous intervention. The acquisition of SCN is expected to expand Vivos’s clinical testing and patient referral capabilities, positioning the company to capture a larger share of the OSA treatment market.

tl;dr

• VVOS shares rose 45.29% on July 1, 2025, at $4.5912, with a volume of 6.6 million shares traded.
• On May 15, 2025, Vivos reported Q1 2025 results highlighting revenue growth from new sleep center partnerships.
• The April 16, 2025 acquisition of The Sleep Center of Nevada (up to $9 million) broadens direct-to-patient access, adding seven locations and 3,000 new monthly patient tests.
• Vivos holds the only FDA 510(k) clearances for treating severe adult OSA and moderate-to-severe pediatric OSA with noninvasive oral appliances.
• Management anticipates increased revenues from integrated service offerings and higher patient case starts in H2 2025.