Vivos Therapeutics, Inc. has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its DNA appliance for treating mild-to-moderate obstructive sleep apnea (OSA) in children aged 5 to 12. This clearance marks a significant milestone for the company, offering a non-surgical alternative for a condition that affects a notable percentage of the pediatric population.
Addressing Pediatric OSA
Obstructive Sleep Apnea in children is characterized by disrupted breathing patterns during sleep, often leading to various health and developmental issues. Traditional treatments have often involved surgical procedures or continuous positive airway pressure (CPAP) machines, which can be invasive or uncomfortable for young patients. The Vivos DNA appliance offers a new approach by naturally expanding the upper airway, potentially mitigating the need for more invasive interventions.
The DNA appliance is designed to promote craniofacial development, addressing the underlying anatomical issues that contribute to OSA. By guiding the natural growth of the jaw and palate, the appliance aims to create more space in the airway, facilitating easier breathing during sleep. This method aligns with a growing trend in pediatric medicine towards early intervention and preventative care.
Reimbursement and Market Access
In addition to the FDA clearance, Vivos Therapeutics has also secured new Current Procedural Terminology (CPT) codes from the American Medical Association (AMA). These codes are crucial for healthcare providers to bill insurance companies for the DNA appliance treatment, which will significantly improve patient access to this innovative therapy. The new CPT codes are expected to streamline the reimbursement process, making the treatment more affordable and accessible to families seeking solutions for their children's OSA.
Clinical Significance
The FDA clearance and the new CPT codes represent a major step forward for Vivos Therapeutics, positioning the company as a key player in the pediatric OSA treatment landscape. With a non-surgical option now available and the ability to obtain insurance reimbursement, the DNA appliance has the potential to improve the quality of life for many children suffering from this common sleep disorder.
