ProSomnus, Inc. announced plans to design a head-to-head clinical trial comparing its precision oral appliance therapy (OAT) and hypoglossal nerve stimulation (HGNS) in treating patients with severe OSA.
The clinical trial plans follow updated results from the First Line Obstructive Sleep Apnea Treatment Study (FLOSAT), a prospective, independent, head-to-head, crossover study comparing the effectiveness of precision OAT and CPAP among patients with moderate to severe OSA. The updated, preliminary data demonstrated that precision OAT was highly effective and non-inferior to CPAP as a first-line therapy for patients with moderate and severe OSA, even without the benefit of additional future titrations. The data were recently presented at the Royal Society of Medicine’s Sleep Symposium in London.
An additional and potentially important observation from the preliminary FLOSAT data is the performance of precision OAT devices for severe OSA patients relative to the results published for HGNS. Using the same criteria for efficacy – an AHI < 20 and a 50% improvement – 79% of exclusively severe OSA patients were successfully treated with non-invasive precision OAT devices, while the STAR trial reported 66% of patients with moderate to severe OSA were successfully treated using a surgically implanted HGNS device, even with the exclusion of concentric collapse patients. Further, secondary analysis indicates that precision oral devices are associated with lower rates of adverse events and lower total treatment costs than HGNS. Based on these findings, ProSomnus intends to design a head-to-head clinical trial comparing precision OAT and HGNS. More information will be available on ProSomnus’s previously announced second quarter 2023 investor call, scheduled for Thursday, August 3 at 5:30 am PT / 8:30 am ET.
What is FLOSAT?
Designed and conducted by The Antwerp University Hospital (UZA), the primary endpoints of FLOSAT are to evaluate the overall effectiveness of OAT as a first-line treatment for OSA, compare the overall effectiveness of OAT with that of CPAP and evaluate patients’ preference. ProSomnus devices are being used exclusively for the precision OAT arm of the study. A total of 136 patients enrolled in FLOSAT, all with moderate to severe OSA, body mass index less than 35 kg/m2, and central AHI less than 30% of total AHI, and all of whom had not received any previous OSA therapy and were eligible for OAT. After completing three months of first-line treatment with OAT followed by three months of CPAP, participants are asked which therapy they prefer. More information can be found at www.ClinicalTrials.gov