By Healthcare Edge Editorial Staff
ProSomnus, Inc. (NASDAQ: OSA), a provider of an alternative treatment for Obstructive Sleep Apnea, released new clinical trial data showing that the First Line Obstructive Sleep Apnea Treatment study (FLOSAT) is on track to achieve all endpoints.
“The updated data and analysis from FLOSAT is validation that precision oral appliance therapy with ProSomnus devices is an effective front-line treatment for moderate to severe OSA,” said Len Liptak, Co-Founder and Chief Executive Officer of ProSomnus. “This is an important finding. Each year millions of people worldwide are diagnosed with moderate to severe OSA. An estimated 40% of them refuse CPAP. Over two and a half million people have been impacted by the recent CPAP recall and seek alternatives. The results of this study indicate that precision OAT with ProSomnus devices is an effective, and preferred, option for these patients.”
Findings include that ProSomnus’s precision oral appliance therapy is effective, and non-inferior to CPAP, as a first-line treatment for moderate to severe OSA. ProSomnus’s 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.
“The FLOSAT study was designed to evaluate whether precision Oral Appliance Therapy could be utilized for the very practical and emergent issue of patients with OSA who could not access CPAP due to the recall,” commented Prof. Dr. Olivier Vanderveken, Antwerp University Hospital. “The preliminary results of this study indicate that precision oral appliances are an effective and patient preferred treatment option, which is particularly relevant for the growing number of sleep clinicians practicing the P4 approach to making medicine more predictive, preventive, personalized and participatory.”