NASDAQ: VVOS
Report of Organizational Actions Affecting Basis of Securities
Vivos®
Breathe New Life
The Vivos CARE appliances (DNA, mRNA, mmRNA) are FDA 510(k) cleared (K230947) to treat mild-to-severe obstructive sleep apnea (OSA) in adults. The DNA appliance is FDA cleared (K234089) for moderate-to-severe pediatric OSA (Ages 6-17).
Copyright © 2026 Vivos Inc. All rights reserved.
Pursuant to a March 2026 Settlement Agreement between Vivos and Ortho-Tain, the parties have agreed to post the following Corrective Statement for a period of not less than six (6) months:
Corrective Statement
In 2020, Vivos Therapeutics, Inc. filed a lawsuit in Colorado, Case No. 20 cv 1637. In July of 2020, Ortho-Tain, Inc. filed a lawsuit against Vivos in Illinois, Case No. 20 cv 0301.
Vivos and Ortho-Tain have agreed to settle and dismiss their respective lawsuits and, as part of the settlement, have agreed to issue this joint, Corrective Statement.
Vivos believes it made reasonable attempts to make proper disclaimers and disclosures in its continuing educational programs stating, in effect, that the patient cases shown had been treated with a variety of oral appliances from several different manufacturers, including naming the product companies. Ortho-Tain disagrees and claimed that Vivos failed to make proper attribution for certain cases being treated with Ortho-Tain products and further failed to give proper credit to Ortho-Tain’s founder, Dr. Earl Bergersen on a single specific handwritten drawing.
Between the latter part of 2019 and into 2021, Vivos’ continuing educational programs included the display of certain before-and-after-treatment photographs of select pediatric dental patients. Such continuing educational programs were entitled “Learn How the Vivos System Induces the Remodeling of Human Airway Tissues” and “2020 Wellness Summit” (the “Continuing Ed programs”). A Vivos “Patient Education Video” (PEV) that has been available from 2019 through the present that included images of pediatric dental patients along with a single handwritten drawing on pediatric craniofacial growth and development. Some of the names of children whose photographs were included in the Continuing Ed programs and PEV were: Isaac, Nicholas, Hunter, Paige, Michael, Allie, Emma, Ava, Mattthew, Ella and Ian. None of the aforementioned children had been treated with a Vivos appliance.
Vivos has agreed to stop using the photographs demonstrating those pediatric outcomes. Some, but not all, of the children depicted in the Continuing Ed programs and the PEV had used oral appliances supplied by Ortho- Tain, Inc.
