Littleton, Colo. — August 5, 2026 — Leads & Copy — Vivos Therapeutics, Inc., a company specializing in diagnostic and treatment modalities for obstructive sleep apnea (OSA) and other sleep-related breathing disorders, announced it has been issued U.S. Patent No. 12,697,190, titled “Vibrational Oral Appliance with Mandibular Advancements.” This new patent is a continuation of the company’s previously issued U.S. Patent No. 12,048,608, which was granted on July 30, 2024.
Collectively, these patents enhance the intellectual property protection for Vivos’ Vivos CARE devices, a line of proprietary oral medical devices. In 2023 and 2024, the U.S. Food and Drug Administration (FDA) provided two distinct 510K clearances for these devices, enabling their use in treating severe OSA in adults and moderate to severe OSA in children aged 6 to 17. To date, no other oral appliances have received similar clearances from the FDA. Studies indicate that approximately 80% of patients utilizing Vivos CARE devices experience substantial reductions or complete resolution of OSA symptoms, as measured by industry-standard Apnea-Hypopnea Index (AHI) scores.
The announcement comes at a time when concerns regarding the safety and efficacy of Continuous Positive Airway Pressure (CPAP) therapy are growing, particularly in light of recent discoveries about its associated health risks and mortality. Furthermore, the FDA has mandated recalls of over 5 million CPAP units since 2021. Vivos believes that the market for a safe and effective alternative to CPAP for treating severe OSA is substantial and the expanded patent protection offered by the new continuation patent is expected to reinforce the company’s leadership position and technological advantages.
The newly issued ‘190 Patent expands upon the protection originally established by the ‘608 Patent, providing Vivos with layered and complementary coverage for its core technology. The ‘608 Patent, with its detailed, structure-specific claims, remains in force and offers focused protection for its particular design. Together, the two patents provide Vivos with comprehensive, difficult-to-circumvent protection along with specific, embodiment-focused coverage for its key innovations.
Kirk Huntsman, Chairman and CEO of Vivos, commented on the patent issuance, stating, “We believe this new patent meaningfully strengthens our intellectual property position around the technology at the heart of our most important and advanced product lines. Broader, more resilient patent claims make it harder for competitors to design around our innovations, and they reflect the continued investment we’re making in protecting the science behind better outcomes for patients suffering from OSA.”
Sleep apnea affects more than one billion people globally, with up to 90 million Americans experiencing the condition, and an estimated 80% of whom remain undiagnosed. OSA is a serious chronic illness that elevates the risk of comorbidities such as high blood pressure, heart failure, stroke, diabetes, dementia, chronic pain, fibromyalgia, and other life-threatening diseases.
Vivos Therapeutics, Inc. is a medical technology and healthcare services company focused on developing and commercializing innovative diagnostic and treatment methods for patients with breathing and sleep issues stemming from dentofacial abnormalities, including OSA and snoring in adults. The company’s devices have received FDA clearance for adult patients with all severity levels of OSA and for children aged 6 to 17 diagnosed with moderate-to-severe OSA. Vivos’ CARE devices are the only FDA 510(k) cleared technology for treating severe OSA in adults, and the DNA appliance is the first to receive clearance for treating moderate to severe OSA in children.
OSA and insomnia impact over one billion adults worldwide aged 30-69, with a significant majority remaining undiagnosed. These chronic disorders are linked to numerous serious health conditions. Vivos CARE oral medical devices are designed to address the underlying physiological and anatomical deficiencies often associated with OSA, offering an alternative to legacy treatments like CPAP that may not address root causes.
Through its innovative technology, educational initiatives, and strategic collaborations, Vivos aims to empower healthcare providers to manage OSA patients more comprehensively. The company’s proprietary Vivos Method offers a non-surgical, noninvasive, and non-pharmaceutical solution for treating OSA, providing patients with an alternative that aims to improve their breathing and sleep health.
Source: Vivos Therapeutics, Inc.
