EXCLUSIVE: ProSomnus' Device Therapy Better Than Philip's Device(s) For Sleep-Related Breathing Disorder, Study Shows

ProSomnus Inc OSA, a provider of CPAP alternatives for Obstructive Sleep Apnea, announced updated data presented at the ProSleep Conference earlier this month. 

The updated data indicate the FLOSAT study is on track to achieve all endpoints.

The company completed enrollment in the FLOSAT study in December last year. 

OSA is the frequent airway collapse during sleep, resulting in oxygen shortages and abrupt awakenings accompanied by gasping or choking.

What Happened: FLOSAT is a head-to-head study comparing precision oral appliance therapy (OAT) as first-line treatment versus continuous positive airway pressure (CPAP) therapy from Koninklijke Philips NV PHG. 

ProSomnus EVO devices are being used exclusively for the precision OAT arm of the study. 136 patients with moderate and severe OSA were included in the study.

Why It Matters: Data shows that select Precision oral appliance therapy is effective and non-inferior to CPAP as a first-line treatment for moderate to severe Obstructive Sleep Apnea.

Precision OAT was effective among 90% of moderate and 85% of severe OSA patients.

Precision OAT was preferred by patients, with 98% continuing therapy at three months versus 22% discontinuing CPAP therapy over the same time.

ProSomnus' precision OAT demonstrated twice the mean disease alleviation as CPAP.

"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 Dr. Olivier Vanderveken, Antwerp University Hospital. 

Price Action: OSA shares closed 3.06% higher at $1.01 on Tuesday.