ProSomnus to Design Head-to-Head Clinical Trial vs. Hypoglossal Nerve Stimulation
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
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. 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 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. 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’s previously announced second quarter 2023 investor call, scheduled for
Designed and conducted by
ProSomnus (NASDAQ: OSA) is a leading CPAP alternative 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.
This press release contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the
Source: ProSomnus Sleep Technologies, Inc.