LITTLETON, Colo. - Vivos Therapeutics, Inc. (NASDAQ:VVOS), a medical technology company specializing in treatments for sleep-related breathing disorders, including obstructive sleep apnea (OSA), has identified new market opportunities following recent developments in the medical device industry. The company's Vivos CARE oral appliances have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to treat moderate and severe OSA in adults, marking the first time such clearance has been granted for severe OSA cases.
This clearance comes at a crucial time, as competitors like Philips Respironics have halted U.S. sales of CPAP and other respiratory units due to recalls and safety concerns. The Philips recall alone has impacted over 5 million CPAP units, with the FDA receiving numerous reports of adverse effects, including some fatalities. These developments have led both medical providers and patients to seek alternative OSA treatments.
Vivos, with a network of over 1,850 trained providers, is set to assist patients transitioning from CPAP devices, offering the only approved oral appliance therapy for severe OSA patients. This is significant as the $6B U.S. CPAP market is currently in a state of flux, with a shortage of devices due to recalls.
Additionally, in January 2024, United Healthcare updated its medical policy to require OSA patients to undergo oral appliance therapy before considering hypoglossal nerve stimulation implants. This policy change could lead other insurers to adopt similar guidelines, potentially increasing the demand for Vivos's oral appliance therapies.
Kirk Huntsman (NYSE:HUN), CEO of Vivos, believes these factors, combined with the company's proprietary technology, position Vivos to capture a significant share of the market. The Vivos Method, which includes the CARE appliance therapy, has been proven effective in treating OSA symptoms and may significantly reduce associated conditions, such as lowering Apnea Hypopnea Index scores.
The information in this article is based on a press release statement from Vivos Therapeutics, Inc.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.