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Vivos Achieves Historic FDA Clearance for DNA Appliance to Treat Pediatric Obstructive Sleep Apnea!​

We’re beyond thrilled to share some truly game-changing news with you! Vivos Therapeutics has just reached a monumental milestone: we’ve received FDA 510(k) clearance for our DNA appliances to treat moderate to severe pediatric obstructive sleep apnea (OSA) and snoring in children aged 6-17. This groundbreaking approval marks the first-ever clearance of its kind for an oral medical device aimed at addressing sleep-disordered breathing in this age group—and we couldn’t be prouder to share this historic achievement with you!

Why Is This Such a Big Deal?

Recent studies reveal that over 10 million children in the U.S. suffer from pediatric OSA, a condition that has been steadily rising. These children often face related health challenges such as ADD/ADHD, night terrors, mouth breathing, and dental malocclusion. Standard treatments like tonsillectomies, adenoidectomies, and CPAP devices come with mixed results and potential long-term risks. But now, with FDA approval of our DNA appliance, families finally have access to a safe, non-invasive, and highly effective solution!

A Life-Changing Solution for Pediatric OSA

This isn’t just a breakthrough for Vivos—it’s a victory for every one of you in the Vivos Integrated Provider (VIP) network. Our DNA appliance offers a transformative option for children grappling with sleep-related breathing disorders. Unlike traditional treatments that only manage symptoms, the DNA appliance works to increase airway volume, reduce snoring, and offers significant improvements in apnea-hypopnea index (AHI) scores—the key measure of OSA severity.

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. This means real, measurable results for children who’ve been struggling to breathe easy.

Revolutionizing Pediatric Sleep Care

The pediatric OSA space has long been in need of innovation, and now, with this FDA clearance, Vivos is ready to disrupt the market. Traditionally, the first line of treatment for pediatric OSA has been surgical, but these interventions often have mixed outcomes, leaving some children in need of further treatments. The DNA appliance provides a much-needed alternative—a non-invasive, comfortable, and cost-effective option that addresses the root cause of OSA rather than just treating the symptoms.

A Breakthrough for Your Practice Too

But that’s not all! This FDA clearance is a major leap forward in our mission to revolutionize sleep and airway health—and it’s just the beginning of what we can achieve together. As VIPs, you’re in a unique position to harness this breakthrough by offering cutting-edge treatment to pediatric patients. Not only does this provide a powerful new solution for your current patients, but it also opens the door to significant practice growth as more families seek real, long-term solutions for their children’s sleep disorders.

Scaling Pediatric Care in Your Practice

To help you integrate pediatric care seamlessly into your practice, we’re rolling out a new marketing and distribution model. This model is designed to scale quickly, ensuring that the benefits of our FDA-cleared DNA appliance reach as many children as possible, while also boosting your practice’s potential for growth. Even better? This strategy isn’t just limited to children. We’re seeing more opportunities to treat entire families as the word spreads about the incredible effectiveness of Vivos technology.

You’re Leading the Way in Pediatric Sleep Care

We know how passionate you are about making a difference in the lives of your patients. This is an unprecedented opportunity to do just that. You’re now at the forefront of a movement that’s revolutionizing pediatric sleep care, and we’re honored to be on this journey with you.

What’s Next?

Stay tuned! We’ll be rolling out resources to support you every step of the way, from training and marketing materials to patient education tools. You’ll have everything you need to begin treating pediatric OSA with confidence and deliver life-changing results to your patients.

Together, we’re not just improving sleep—we’re changing lives and shaping the future of pediatric healthcare. We can’t wait to see the incredible impact you’ll make as you bring this revolutionary treatment to the families who need it most.

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Antoinette Smith

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