ProSomnus, Inc. announced that its ProSomnus EVO(R) [PH] Sleep and Snore Device now qualifies for Medicare reimbursement. The Pricing, Data Analysis, and Coding (PDAC) Contractor has reviewed and verified the device for the Healthcare Common Procedure Coding System (HCPCS) code E0486. Medicare beneficiaries account for an estimated 20% of people in the United States with OSA.

The ProSomnus EVO [PH] is a precision OAT medical device specifically engineered to meet Centers for Medicare Services coding guidelines, offering Medicare beneficiaries a non-invasive, comfortable, easy-to-use, and effective alternative to CPAP machines, surgical procedures, and legacy dental products. Per Medicare coding guidelines, the ProSomnus EVO [PH] device repositions and stabilizes the patient's jaw during sleep, increasing pharyngeal space and reducing the risk of upper airway collapse. The device is approximately 32% smaller than predicate devices and features unique comfort bumps around key components.

The device has unique advancement markings and visual indicators to make it easier for beneficiaries to use the device and to communicate with their healthcare providers throughout treatment. Every ProSomnus EVO [PH] device is personalized and digitally manufactured based upon the patient's unique anatomy and healthcare provider's treatment plan for each patient. The ProSomnus EVO [PH] is the only Medicare coding verified device for OSA made from engineered, Medical Grade Class VI-rated material, the highest material quality grade offered by US Pharmacopeia.

In November, ProSomnus announced that it had received 510(k) clearance from the United States Food and Drug Administration (FDA) for the ProSomnus EVO [PH]. In a multi-center IRB-controlled preference study, 91% of patients strongly preferred ProSomnus EVO [PH] to their prior dental products therapy. 94% of patients reported that EVO [PH] felt smaller, more natural, and more comfortable than their prior therapy.

100% of providers who participated in the study said they would prescribe the device again, and 100% said that they would recommend it to their colleagues.