Prosomnus, Inc. Announces Updated Clinical Trial Data
August 23, 2023 at 08:00 am
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ProSomnus, Inc. announced updated clinical trial data, presented at the ProSleep 2023 Users Conference earlier this month. The updated data indicate that the First Line Obstructive Sleep Apnea Treatment study (FLOSAT) is on track to achieve all endpoints. FLOSAT is an ongoing, prospective, independent, head-to-head study comparing the effectiveness of precision OAT as first-line treatment versus CPAP therapy. ProSomnus EVO® devices are being used exclusively for the precision OAT arm of the study. A total of 136 patients with moderate and severe OSA were included in the study. Key findings to date include: Precision oral appliance therapy is effective, and non-inferior to CPAP, as a first-line treatment for moderate to severe OSA, Precision OAT was effective among 90% of moderate and 85% of severe OSA patients, Precision oral appliance therapy was preferred by patients, with 98% continuing therapy at three months versus 22% discontinuing CPAP therapy over the same period of time. In an intention to treat analysis factoring efficacy and adherence, precision OAT (ProSomnus) demonstrated twice the mean disease alleviation as CPAP. An additional observation from FLOSAT is the performance of precision OAT among severe OSA patients, in the context of data reported for hypoglossal nerve stimulation (HNS). Using the same criteria for efficacy ? an AHI < 20 and a 50% improvement ? 85% of severe OSA patients were successfully treated with non-invasive precision OAT. Clinical studies for the surgically implanted HNS devices, such as the STAR trial, report success in the range of 66% even with patient selection and the exclusion of concentric collapse patients. In July, ProSomnus announced plans to design a head-to-head clinical trial comparing precision OAT and HNS in treating patients with severe OSA.
Patients are actively being enrolled in the Severe OSA Study, a multi-center, prospective, clinical trial designed to demonstrate the safety and effectiveness of ProSomnus devices for the treatment of severe OSA and apply for FDA label expansion.
ProSomnus, Inc. is a medical technology company. The Company is focused on the development, manufacturing and marketing of precision intraoral medical devices, a novel non-invasive option for treating and managing patients with obstructive sleep apnea (OSA). Its intraoral medical devices are engineered to precisely track the treatment plan and anatomy for each patient. The Company's devices have demonstrated efficacy, safety, adherence, and overall outcomes in a growing body of clinical investigations. Its 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. The Companyâs products include ProSomnus EVO Sleep and Snore Device, ProSomnus EVO SELECT Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus [CA] LP Sleep and Snore Device and ProSomnus [MOG] Morning Occlusal Guide.
PROSOMNUS, INC. 
