MedPath

Vivos Therapeutics' DNA Appliance Receives FDA Clearance for Pediatric Sleep Apnea

  • Vivos Therapeutics received FDA 510(k) clearance for its DNA oral appliance to treat moderate to severe obstructive sleep apnea (OSA) and snoring in children aged 6-17.
  • Clinical trials showed a 50% reduction in sleep-related breathing disorder symptoms and a 58% decrease in snoring among pediatric patients using the Vivos DNA appliance.
  • The DNA appliance offers a non-invasive alternative to CPAP or surgical interventions, potentially capturing a significant share of the pediatric OSA market.
  • Vivos plans to integrate pediatric care into its marketing model, aiming to scale revenue quickly with this newly approved treatment option.
Vivos Therapeutics, Inc. (NASDAQ: VVOS) has announced FDA 510(k) clearance for its flagship DNA oral appliance, designed to treat moderate to severe obstructive sleep apnea (OSA) and snoring in children aged 6 to 17. This clearance marks a significant milestone for Vivos, positioning the company to potentially disrupt the pediatric sleep apnea market with a non-invasive alternative to existing treatments.

Clinical Trial Results

The FDA approval was based on the results of a clinical trial involving 48 patients. The study demonstrated a significant reduction in sleep-related breathing disorder (SRBD) symptoms, decreasing from 0.28 to 0.14, representing a 50% improvement. Snoring was also reduced by 58%. Furthermore, the improvement in moderate and severe Apnea-Hypopnea Index (AHI) measurements was 62.7%, with 96% of patients showing improvement or remaining stable. Notably, 92% of patients improved by greater than 50% or 1 classification in the moderate and severe categories, with 100% of the severe patients achieving this milestone. Airway volumes increased by 40% on average.

Device Details and Intended Use

The Vivos DNA appliance is a non-invasive, removable oral appliance intended for children diagnosed with snoring and/or OSA requiring orthodontic treatment. The device is designed to be safe, comfortable, and affordable, offering a patient-friendly alternative to continuous positive airway pressure (CPAP) therapy or surgical interventions.

Market Opportunity

Recent studies estimate that up to 10.1 million children in the U.S. (ages 6-17) suffer from pediatric OSA. Vivos believes that this FDA clearance presents a substantial opportunity to capture a significant share of this market. The company plans to leverage this approval by integrating pediatric care into its provider-based marketing and distribution model, aiming for rapid revenue scaling with minimal investment.

Vivos' Broader Portfolio

In November, Vivos also received FDA 510(k) clearance for treating severe OSA in adults using its CARE (Complete Airway Repositioning and/or Expansion) oral appliances, which include the DNA, mRNA, and mmRNA devices. This earlier clearance positioned Vivos as the first company to offer an approved alternative to CPAP or surgical neurostimulation implants for adults with severe OSA.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Accepts Sobi's Avatrombopag (DOPTELET®) Application for Pediatric ITP Treatment

The FDA has accepted Sobi's sNDA for avatrombopag (DOPTELET®) to treat thrombocytopenia in pediatric patients with persistent or chronic immune thrombocytopenia (ITP).

Zorevunersen Receives FDA Breakthrough Therapy Designation for Dravet Syndrome

Stoke Therapeutics' zorevunersen has received FDA Breakthrough Therapy Designation for Dravet syndrome with confirmed SCN1A gene mutation.

enVVeno Medical Seeks FDA Approval for VenoValve and Completes enVVe Study

enVVeno Medical has submitted its PMA application to the FDA for VenoValve, a breakthrough device for severe deep venous Chronic Venous Insufficiency (CVI).

FDA Grants Rare Pediatric Disease Designation to AlveoGene's AVG-002 for SP-B Deficiency

The FDA has granted Rare Pediatric Disease Designation to AlveoGene's AVG-002, an inhaled gene therapy, for lethal neonatal Surfactant Protein B (SP-B) deficiency.

Livanova's Aura6000 Meets Endpoints in Sleep Apnea Implant Trial

Livanova's aura6000 hypoglossal nerve stimulator met primary safety and efficacy endpoints in a randomized trial for obstructive sleep apnea (OSA).

Neurovalens Launches FDA-Cleared Modius Sleep for Chronic Insomnia

Neurovalens has launched Modius Sleep, an FDA-cleared, non-invasive device, to treat chronic insomnia, offering a drug-free alternative.

Neurovalens Launches FDA-Cleared Modius Sleep for Chronic Insomnia

Neurovalens has launched Modius Sleep, an FDA-cleared, non-invasive device, for treating chronic insomnia, offering a drug-free alternative.

Neurovalens Launches FDA-Cleared Modius Sleep for Chronic Insomnia

Neurovalens has launched Modius Sleep, an FDA-cleared device, available via prescription, for treating chronic insomnia.

FDA Updates: Approvals for RSV Vaccine, Pneumococcal Vaccine, and TB Drug Alongside Device Recalls

The FDA granted traditional approval to Sirturo (bedaquiline) for treating rifampin- and isoniazid-resistant tuberculosis in adults and children, based on Phase 3 STREAM study data.

FDA Approves New Manufacturing Line for Sanofi and AstraZeneca's Beyfortus, Boosting RSV Protection for Infants

The FDA has approved a new manufacturing line for Sanofi and AstraZeneca's Beyfortus, an RSV antibody, to increase U.S. supply for the upcoming season.

Reference News

[1]
Vivos Therapeutics Says It Is Poised To Disrupt Pediatric Sleep Apnea Market, Secures FDA ...
finance.yahoo.com · Sep 18, 2024

Vivos Therapeutics secures FDA approval for its DNA Appliance to treat snoring in children, aiming to disrupt the pediat...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy