FDA Clears Vivos CARE Appliance for Severe Obstructive Sleep Apnea

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With the approval, the appliances represent an alternative treatment to CPAP or surgical neurostimulation implants for patients with severe OSA.

Kirk Huntsman, chairman and chief executive officer at Vivos

Kirk Huntsman

Recently, the FDA granted 510(k) clearance to Vivos Therapeutics for its removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances as a treatment option for patients with severe cases of obstructive sleep apnea (OSA). The newly approved devices, which include the flagship DNA (Daytime-Nighttime Appliance) oral appliance, the mRNA oral appliance, and the mmRNA oral appliance, give patients a new alternative to continuous positive airway pressure (CPAP) or surgical neurostimulation.1

The latest clearance comes less than a year after the FDA granted Vivos 510(k) clearance for the DNA oral appliance to treat mild to moderate OSA. In addition, it represented the first marketed oral appliance to treat moderate and severe OSA in adults, 18 years of age and older along with PAP and/or myofunctional therapy, as needed.

"This achievement is a pivotal milestone for Vivos, and elevates our proven treatment options right into the mainstream of sleep medicine," Kirk Huntsman, chairman and chief executive officer at Vivos, said in a statement.1 "It is even more important for the millions of severe OSA patients who are desperate for an effective alternative treatment. Before this, severe OSA patients’ only realistic treatment options were CPAP, neurostimulation implants or other invasive surgeries. Today, they have what we believe is a far more desirable option that is very affordable and doesn’t require surgery or a lifetime of nightly use and intervention."

The approval was based on clinical trial data from a cohort of 73 patients with severe OSA who were treated with the Vivos appliances over a median treatment duration of 9.7 months. According to the company, 80% of patients in the study experienced an improvement of at least 1 classification or at least a 50% improvement in the Apnea Hypopnea Index (AHI). Of note, 97% of patients reported improvements or sustained status.

An additional study, published in the Journal of Sleep Medicine in 2022, continued to demonstrate the effectiveness of Vivos treatment. The analysis featured 74 adult patients treated by 30 independent Vivos-trained dentists over an average treatment time of 14 months, with inclusion criteria review and statistical analysis performed by The EyeDeas Company, an independent research company.2

All told, results from the study showed that 28% of the cohort reported no remaining OSA symptoms, defined as AHI score of less than 5, after undergoing treatment with a Vivos appliance. Notably, these real-world findings were recorded with no oral appliance in place during the sleep tests. In addition, 82% of the cohort showed improvement in AHI scores, with 64% improving by at least 1 full category. AHI scores worsening in 15% of the cohort and 4% of patients showed no change. Average treatment time with the company’s class 1 DNA appliance for certain orofacial anomalies was 14 months.

Clinical Takeaways

  1. Clinical Efficacy: Clinical trial data involving 73 severe OSA patients demonstrated significant improvement, with 80% experiencing at least a 50% improvement in the Apnea Hypopnea Index (AHI).
  2. Broad Treatment Impact: The FDA approval positions Vivos as a mainstream option in sleep medicine, potentially increasing patient referrals and collaborations with medical professionals, with anticipated positive effects on reimbursement and revenue growth.
  3. Real-World Effectiveness: A separate study, with 74 adult patients treated by Vivos-trained dentists, showcased promising outcomes, including 28% reporting no remaining OSA symptoms after 14 months of treatment.

"Vivos trained providers can now treat patients with OSA and conditions associated with OSA comprehensively using our suite of FDA cleared devices, without regard to the severity of their OSA condition and across a range of price point options,” Huntsman added.1 "We believe this unprecedented decision by the FDA will generate broader acceptance throughout the medical community for Vivos treatment options, leading to the potential for higher patient referrals and case starts as well as collaboration with medical professionals.”

He continued, "We also believe it will enhance our value proposition to third-party distribution partners such as durable medical equipment (DME) companies. This approval could also clear the way for greater reimbursement levels from medical insurance payors and Medicare. We believe that all these factors should favorably impact our ability to grow our revenues in 2024 and beyond."

At the 2022 SLEEP Annual Meeting, a joint venture of the American Academy of Sleep Medicine and Sleep Research Society, researchers presented a retrospective review of the Vivos database, with the intention of understanding whether airway and OSA parameters change after treatment with such biomimetic oral appliance therapy (BOAT). In total, the analysis comprised of 786 patients who underwent treatment with Visos’ customized, proprietary oral appliances to treat dentofacial abnormalities and/or mild to moderate OSA and snoring in adults.3

Following treatment, both the median transpalatal width (TPW) of 33.5 (range, 31.0-35.3) mm and median 3D volume of 19,752 (range, 15,965-25,042) mm3 increased, to 35.0 (range, 33.0-37.5) mm and 21,919 (range, 17,484-27,711) mm3, respectively. These increases were significantly different (P <.001). Among a subset of patients with 18 months of study data on the therapy, the TPW increased by a median of 2.50 (range, 1.00-3.50) mm and the 3D volume by a median of 3092 (range, 1006-6480) mm3. Overall, the number of patients with no OSA went from 4 to 13 and the number of patients with severe OSA went from 10 to 3.

REFERENCES
1. Vivos Therapeutics receives first ever FDA 510(k) clearance for oral device treatment of severe obstructive sleep apnea. News release. Vivos Therapeutics. November 29, 2023. Accessed December 4, 2023. https://vivos.com/vivos-therapeutics-receives-first-ever-fda-510k-clearance-for-oral-device-treatment-of-severe-obstructive-sleep-apnea/
2. One in four patients in latest clinical study show no symptoms of obstructive sleep apnea after Vivos treatment. News release. Vivos Therapeutics. July 13, 2023. Accessed December 4, 2023. https://vivos.com/one-in-four-patients-in-latest-clinical-study-show-no-symptoms-of-obstructive-sleep-apnea-after-vivos-treatment/
3. Heckman S, Katz D, Kushida C. Non-surgical maxillary expansion using a novel oral appliance system. Presented at: 2022 SLEEP Annual Meeting; Abstract 0340.
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