Vivos unites influential women leaders in medicine and dentistry to drive collaboration following first ever FDA 510(k) clearance of an oral device to treat severe OSA
LITTLETON, Colo., Dec. 11, 2023 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (the “Company” or “Vivos”) (NASDAQ:VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders (including mild to severe obstructive sleep apnea (OSA)), is excited to announce “Empowering Women to Champion Airway”, a pioneering event that will transcend international boundaries and unite prominent women in the medical and dental fields to shed light on the pivotal role of airway health in human well-being.
The “Empowering Women to Champion Airway” conference will be held at the Vivos Institute in Denver, CO on February 1 and 2, 2024. This unprecedented assembly aims to forge stronger bonds between medical and dental professionals, with a specific emphasis on empowering women to spearhead positive transformations in the healthcare landscape through a focus on airway health.
Vivos was granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) on November 28, 2023 for treating severe OSA in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances. Vivos’ CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance. This represents the first time the FDA has ever granted an oral appliance a clearance to treat moderate and severe OSA in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.
Dr. Manisha Witmans, a Board-Certified Sleep Specialist licensed in both the United States and Canada, expressed, "I’m grateful to be speaking at the Empowering Women to Champion Airway event which is a tremendous opportunity to enhance collaboration between medical and dental professionals regarding treatment of patients with OSA. The recent FDA 510(k) clearance for Vivos’ CARE devices to address severe OSA is encouraging for both patients and clinicians as this gives medical professionals a new and potentially more desirable option to offer to their patients. Severe OSA is a prevalent and often underdiagnosed condition and immediate treatment is critical as it can worsen the outcomes of various diseases and contribute to premature death. Unfortunately, many patients have remained untreated due to the drawbacks of CPAP or invasive surgeries. Collaborative efforts between medical doctors and dentists are essential to provide optimal treatment solutions for all patients."
Susie McCullough, Executive Vice President of Vivos stated, “We are honored to host such an all-star lineup of world-renowned speakers with expertise in a variety of healthcare specialties—including medical sleep specialists, cardiologists, primary care physicians, pediatric specialists, orthodontists, and general dentists—all of whom work in one way or another with sleep and breathing disorders. Fostering this type of interdisciplinary collaboration is necessary to increase the awareness that there is a new alternative to CPAP or surgery for treating severe OSA.”
McCullough continued, “Not only are today’s women assuming an ever-increasing level of prominence and leadership roles within healthcare, but women continue to exert the greatest influence over family healthcare decisions. As spouses, mothers and caregivers, we are often on the frontlines of dealing with the effects of OSA, snoring, insomnia and other breathing and sleep problems. We need to know what we’re dealing with and the latest remedies that are available, with a particular emphasis on ensuring the well-being of young patients through early intervention Vivos is proud to host this first-of-its-kind event, offering a special opportunity to glean insights into how women can drive innovation and progress in this critical facet of healthcare.”
Dental and medical professionals interested in attending the conference may register here.
About Vivos Therapeutics, Inc.
Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as obstructive sleep apnea (OSA) and snoring in adults. The Vivos Method represents the first clinically effective nonsurgical, noninvasive, nonpharmaceutical and cost-effective solution for treating mild to severe OSA. It has proven effective in approximately 40,000 patients treated worldwide by more than 1,850 trained dentists.
The Vivos Method includes treatment regimens that employ the proprietary Vivos Complete Airway Repositioning and/or Expansion (CARE) appliance therapy and other modalities that alter the size, shape and position of the soft tissues that comprise a patient’s upper airway and/or palate. The Vivos Method opens airway space and may significantly reduce symptoms and conditions associated with mild-to-severe OSA, such as lowering Apnea Hypopnea Index scores. Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program for home sleep testing in adults and children. The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method.
This press release, the upcoming event described herein, and statements of the Company’s management made in connection therewith contain “forward-looking statements” (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events, including the anticipated benefits of the 510(k) approval described herein. Words such as “may”, “should”, “expects”, “projects,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve significant known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to: (i) the risk that Vivos may be unable to implement revenue, sales and marketing strategies that increase revenues, (ii) the risk that some patients may not achieve the desired results as obtained in the clinical trial, (iii) risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea treatment sector; (iv) the risk that Vivos may be unable to secure additional financing on reasonable terms when needed, if at all and (v) other risk factors described in Vivos’ filings with the Securities and Exchange Commission (“SEC”). Vivos’ filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos’ expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based.
