8-K: Vivos DNA Appliance Proves Safe, Effective for Pediatric OSA

Vivos Therapeutics announced peer-reviewed data confirming its DNA appliance is safe and effective for treating obstructive sleep apnea in children, published in the European Journal of Pediatrics.

Summary

• Vivos Therapeutics announced first-time, peer-reviewed data confirming its Vivos DNA (Daytime-Nighttime Appliance) is both safe and efficacious in treating children suffering from obstructive sleep apnea (OSA).
• The results from a multicenter clinical trial were published in the European Journal of Pediatrics.
• 77% of participants experienced at least a 50% reduction in OSA severity.
• Among children with severe OSA, 93% achieved a 50% reduction in OSA severity.
• 17% of patients in the study achieved complete resolution of their OSA.
• Airway volume increased by an average of 67.8%, which was a primary endpoint of the study.
• Pediatric Sleep Questionnaire (PSQ) symptom scores decreased by 31%, indicating a statistically significant improvement.
• Pediatric OSA affects up to 20.4% of U.S. children (approximately 10 million), with up to 90% remaining undiagnosed.
• The current standard of care, adenotonsillectomy (AT) surgery, is invasive, painful, and only 20-40% effective, with symptoms recurring in up to a quarter of cases.

Sentiment

Score: 9

Explanation: The filing presents overwhelmingly positive clinical trial results for a key product addressing a significant unmet medical need. The data is peer-reviewed and demonstrates high efficacy, offering a superior alternative to current invasive treatments. This is a major positive catalyst for the company.

Positives

• The Vivos DNA appliance demonstrated high efficacy, with 77% of participants achieving at least a 50% reduction in OSA severity and 17% achieving complete resolution.
• For children with severe OSA, the appliance was particularly effective, with 93% experiencing a 50% reduction in severity.
• Significant anatomical improvement was observed, with an average 67.8% increase in airway volume.
• Patient-reported symptoms improved significantly, with PSQ scores decreasing by 31%.
• The Vivos DNA appliance offers a safe, non-surgical, and non-pharmaceutical alternative to invasive adenotonsillectomy surgery, which has limited efficacy and high recurrence rates.
• The data is peer-reviewed and published in a reputable medical journal, adding significant credibility.
• Vivos C.A.R.E. devices are FDA 510(k) cleared for treating moderate-to-severe OSA in children ages 6 to 17, and severe OSA in adults.

Risks

• The actual future impact of the clinical trial results on general patient outcomes and Vivos's future revenues and results of operations may differ from expectations.
• Statements involve significant known and unknown risks, uncertainties, and contingencies, many of which are beyond Vivos's control.

Future Outlook

Management believes this data signals a new era in pediatric OSA treatment, providing strong evidence for the DNA appliance as a safe, non-surgical alternative to traditional surgery. The company anticipates increased adoption by parents and healthcare providers, and authors of the study have been invited to present findings globally, further supporting Vivos's device technology.

Management Comments

• "We believe this data signals a new era in pediatric OSA treatment. For over a century, surgery has been the go-to treatment for children with OSA. With these results, parents and providers now have strong evidence supporting our DNA appliance as a safe, non-surgical alternative. No child should face invasive surgery without first considering our FDA cleared appliance available through Vivos-trained healthcare providers."

Industry Context

Pediatric obstructive sleep apnea is a significantly underdiagnosed and undertreated condition affecting up to 10 million U.S. children, linked to serious health and developmental issues. The current standard of care, adenotonsillectomy surgery, is invasive, painful, and often ineffective, with high recurrence rates. Vivos's non-surgical DNA appliance offers a potentially transformative alternative, addressing a critical unmet need in the market and challenging established, less effective treatment paradigms.

Comparison to Industry Standards

• The Vivos DNA appliance offers a non-surgical, non-invasive, and non-pharmaceutical alternative to the current standard of care, adenotonsillectomy (AT) surgery.
• AT surgery is described as invasive, painful, and only 20-40% effective for pediatric patients, with symptoms recurring in up to a quarter of cases.
• In contrast, the Vivos DNA appliance achieved at least a 50% reduction in OSA severity for 77% of participants, and 17% achieved complete resolution.
• For children with severe OSA, the Vivos DNA appliance showed a 93% rate of at least a 50% reduction in severity, significantly outperforming the reported efficacy of AT surgery.
• The Vivos DNA appliance also demonstrated an average 67.8% increase in airway volume and a 31% decrease in PSQ symptom scores, indicating comprehensive improvement beyond what is typically achieved by AT surgery alone.

Stakeholder Impact

• **Shareholders:** Positive impact due to strong clinical data validating a key product, potentially leading to increased market adoption and revenue.
• **Patients (Children with OSA):** Significant positive impact by offering a safe, non-surgical, and highly effective treatment alternative to invasive surgery, improving health outcomes and quality of life.
• **Parents:** Provides a less invasive and more effective treatment option for their children's OSA, potentially reducing anxiety and improving family well-being.
• **Healthcare Providers:** Offers a new, evidence-based, FDA-cleared treatment modality to address pediatric OSA, expanding their treatment toolkit and improving patient care.
• **Regulatory Authorities:** The peer-reviewed publication and FDA clearance reinforce the scientific and regulatory validity of Vivos's technology.

Next Steps

• Authors of the study have been invited to present the findings of this and other Vivos research to medical and dental audiences around the world.
• Vivos will continue to commercialize its DNA appliance and other C.A.R.E. devices through Vivos-trained healthcare providers.

Key Dates

Recommendation

The filing presents groundbreaking, peer-reviewed clinical trial results demonstrating the Vivos DNA appliance's safety and high efficacy in treating pediatric obstructive sleep apnea. This addresses a massive, largely undiagnosed market with a superior, non-surgical alternative to the current ineffective and invasive standard of care. This significant validation, coupled with FDA clearance, positions Vivos for substantial market penetration and revenue growth, making it a compelling 'strong buy' for investors.

Keywords

Vivos Therapeutics, Obstructive Sleep Apnea, Pediatric OSA, Vivos DNA appliance, C.A.R.E. devices, Sleep related breathing disorders, Non-surgical treatment, Clinical trial results, European Journal of Pediatrics, FDA cleared, Airway repositioning, Craniofacial growth, Medical device, VVOS