ProSomnus Comments on Insurance Coverage Policy Update for Obstructive and Central Sleep Apnea

ProSomnus, Inc. (NASDAQ: OSA) (the “Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy™, welcomes the adoption of UnitedHealthcare’s updated medical policy (#2024T0525NN) for Obstructive and Central Sleep Apnea, effective March 1, 2024. The updated policy will establish oral appliance therapy (OAT), such as ProSomnus’s Precision OAT devices, as prerequisite therapy for Implantable Hypoglossal Nerve Stimulation in adult patients with moderate to severe OSA. Specifically, the policy states, “Failure of adequate trial of Oral Appliance therapy,” as the new medical policy of UHC.

“I am pleased to see this policy update acknowledging the role of oral appliances in the continuum of care for Obstructive Sleep Apnea,” commented Edward T. Sall, MD, DDS, MBA. “Recent research has demonstrated that modern, precision oral appliances are effective and safe. It is good medical practice to exhaust the available, non-invasive, reversible treatment options before moving to surgical options.”

“Our review of patient chart data shows that recently 60% of all of our sleep apnea patients receive oral appliance therapy as a first line treatment for OSA of all severities,” stated Jordan C. Stern, MD, Founder and CEO of BlueSleep. “At BlueSleep we have treated over 5,500 patients with oral appliances over the years. Modern, precision oral appliances are different from the oral appliances of ten years ago. Modern oral appliances are safe, effective, comfortable, and easy for the patient to insert, remove and keep clean. Compared with the oral appliances of ten years ago, we can achieve consistent, predictable results and a high level of satisfaction for our patients.”

Data presented at the November 2023 World Sleep Congress reported that treatment with ProSomnus Precision OAT devices was at least non-inferior to CPAP in a prospective, cross over clinical trial, and data published in the medical journal Cureus, “Evaluating the Clinical Performance of a Novel, Precision Oral Appliance Therapy Medical Device Made Wholly From a Medical Grade Class VI Material for the Treatment of Obstructive Sleep Apnea,” reported that 89% of patients with OSA of all severities were successfully treated to an AHI of < 10 with ProSomnus devices. 96% of patients were confirmed to be in active treatment at a one-year follow up. No patients were excluded due to inadequate dental anatomy.

Link to UnitedHealthcare’s updated medical policy: https://www.uhcprovider.com/content/dam/provider/docs/public/policies/index/commercial/obstructive-sleep-apnea-treatment-03012024.pdf

About ProSomnusProSomnus (NASDAQ: OSA) is the leading non-CPAP therapy for the treatment of Obstructive Sleep Apnea, a serious medical disease affecting over 1 billion people worldwide, that is associated with comorbidities including heart failure, stroke, hypertension, morbid obesity, and type 2 diabetes. ProSomnus intraoral medical devices are engineered to precisely track the treatment plan and anatomy for each patient. Non-invasive, patient preferred and easy to use, ProSomnus devices have demonstrated excellent efficacy, safety, adherence, and overall outcomes in a growing body of clinical investigations. ProSomnus precision intraoral devices are FDA-cleared, patented, and covered by commercial medical insurance, Medicare, TRICARE and many Government sponsored healthcare plans around the world, representing over 200 million covered lives. To learn more, visit www.ProSomnus.com.

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