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Vivos Therapeutics Receives FDA Clearance for Breakthrough Sleep Apnea Treatment

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Vivos Therapeutics, Inc. has secured FDA 510(k) clearance for its CARE (Complete Airway Repositioning and/or Expansion) oral appliances designed for adults with severe obstructive sleep apnea (OSA). This milestone includes approval for three oral appliance models: the flagship DNA oral appliance, the mRNA oral appliance, and the mmRNA oral appliance.

The significance of this clearance lies in Vivos becoming the pioneer in offering an alternative treatment option to continuous positive airway pressure (CPAP) machines and surgical neurostimulation implants for individuals suffering from severe obstructive sleep apnea. Previously, Vivos had received FDA clearance for its DNA oral appliance, catering to mild-to-moderate obstructive sleep apnea.

Dr. David McCarty, a medical sleep specialist, acknowledged the groundbreaking nature of this development, highlighting the importance of addressing the oral vault’s form and functionality in obstructive sleep apnea treatment. He expressed optimism about the potentially life-changing impact of this FDA decision on severe OSA patients who have found little success with other therapies. Notably, this marks the first time the FDA has granted clearance for an oral appliance indicated for moderate and severe OSA in adults aged 18 and above, alongside positive airway pressure (PAP) and/or myofunctional therapy.

Affordable Obstructive Sleep Apnea Treatment Without Surgery for Severe Patients

Kirk Huntsman, CEO of Vivos, emphasized the significance of this achievement, stating that it places Vivos at the forefront of sleep medicine. Severe OSA patients, who previously had limited treatment options like CPAP, neurostimulation implants, or invasive surgeries, now have a more desirable and affordable alternative that doesn’t necessitate surgery or lifelong nightly intervention.

OSA is characterized by interrupted breathing during sleep, occurring at least five times per hour, with each interruption lasting at least 10 seconds. Risk factors for OSA include obesity, aging, hypertension, smoking, narrowed airways, diabetes, chronic nasal congestion, and asthma.

Sleep Apnea

Achieve Exceptional OSA Treatment Results, Open New Horizons with FDA Clearance

Vivos presented data to the FDA from 73 severe OSA patients, demonstrating that 80% experienced at least one classification improvement or a 50% improvement in the Apnea Hypopnea Index (AHI). Over an average treatment duration of 9.7 months, 97% of patients showed improvement or maintained their condition. Remarkably, patients with severe OSA demonstrated superior treatment outcomes compared to those with mild or moderate OSA.

The FDA’s decision now allows Vivos-trained providers to comprehensively treat patients with OSA across various severity levels using their suite of FDA-cleared devices. This development is expected to foster greater acceptance within the medical community, potentially increasing patient referrals, collaborations with medical professionals, and partnerships with third-party distribution companies like durable medical equipment (DME) providers. Additionally, it may lead to enhanced reimbursement levels from medical insurance providers and Medicare. All these factors are anticipated to positively impact revenue growth for Vivos in 2024 and beyond.

 

Resource: PharmExec, November 29, 2023

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