
Celebrating National Children’s Health Month: Honoring Our Milestone with FDA Clearance for Vivos DNA Appliances!
As we reflect on Children’s Health Month, we want to take a moment to remind our Vivos community about the incredible milestone we achieved together earlier this year. Vivos Therapeutics proudly announced that we received FDA 510(k) clearance for our innovative DNA appliances designed to treat moderate to severe pediatric obstructive sleep apnea (OSA) and snoring in children aged 6-17. This groundbreaking approval marked the first-ever clearance of its kind for an oral medical device targeting sleep-disordered breathing in this critical age group.
The Importance of This Achievement
With over 10 million children in the U.S. suffering from pediatric OSA, this milestone could not be more timely. Many of these children face related health challenges, including ADD/ADHD, night terrors, mouth breathing, and dental malocclusion. While traditional treatments like tonsillectomies, adenoidectomies, and CPAP devices are available, they often come with mixed results and potential long-term risks. The approval of our DNA appliance means families now have access to a safe, non-invasive, and highly effective solution to address these pressing health concerns.
Transformative Benefits for Pediatric Patients
The Vivos DNA appliance represents a life-changing option for children struggling with sleep-related breathing disorders. Unlike conventional treatments that only manage symptoms, our appliance works to increase airway volume, reduce snoring, and improve the apnea-hypopnea index (AHI) scores, essential indicators of OSA severity.
In fact, a recent multi-site study showed that treated children experienced an average 40% increase in airway volume, with 96% of patients improving or maintaining their status. These results highlight the tangible, positive impact our treatment can have on children’s health and well-being.
Revolutionizing Pediatric Sleep Care
This FDA clearance positions Vivos to disrupt the pediatric OSA market significantly. Traditionally, surgical interventions have been the first line of treatment, often leaving children needing additional care. The DNA appliance provides a much-needed alternative: a non-invasive, comfortable, and cost-effective option that addresses the root causes of OSA, paving the way for better health outcomes for our young patients.
Opportunities for Your Practice
As members of the Vivos Integrated Provider (VIP) network, you are uniquely positioned to leverage this breakthrough. This FDA clearance not only equips you with a powerful new solution for your current patients but also opens doors for substantial practice growth. Families are actively seeking long-term solutions for their children’s sleep disorders, making this an ideal time to expand your services.
Seamless Integration into Pediatric Care
To assist you in incorporating pediatric care into your practice, we are excited to offer a new marketing and distribution model designed for rapid scalability. This model ensures that the benefits of our FDA-cleared DNA appliance reach as many children as possible, while also enhancing your practice’s growth potential. Even more exciting is the opportunity to treat entire families, as the effectiveness of Vivos technology continues to gain recognition.
Leading the Charge in Pediatric Sleep Health
As we celebrate Children’s Health Month, we want to reiterate how important your role is in making a difference in the lives of children struggling with sleep-related issues. This milestone represents a significant leap forward in our shared mission to revolutionize pediatric sleep care, and we are honored to be on this journey with you.
What’s Next?
As we move forward, we encourage you to stay engaged and keep an eye out for more resources. We will provide you with training materials, marketing tools, and patient education resources to help you confidently integrate the treatment of pediatric OSA into your practice.
Together, we are not just improving sleep—we are changing lives and shaping the future of pediatric healthcare. Let’s continue to make a meaningful impact as we bring this revolutionary treatment to the families who need it most.