ProSomnus Inc announced plans to design a head-to-head clinical trial comparing its precision oral appliance therapy (OAT) and hypoglossal nerve stimulation (HNS) in treating patients with severe obstructive sleep apnea.
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 HNS, according to a release from ProSomnus. Using the same criteria for efficacy—an AHI of less than 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 HNS 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 HNS, according to a release from ProSomnus. Based on these findings, ProSomnus intends to design a head-to-head clinical trial comparing precision OAT and HNS.
More information will be available on ProSomnus’ previously announced second quarter 2023 investor call, scheduled for Thursday, Aug. 3, at 8:30 am ET.