EXCLUSIVE: ProSomnus Concludes Enrollment In Head To Head Study Comparing Its Sleep Device With Philips'

ProSomnus Inc OSA has completed enrollment in the FLOSAT study, a head-to-head, crossover study comparing the effectiveness of precision oral appliance therapy (OAT) as first-line treatment versus continuous positive airway pressure (CPAP) therapy. 

What Happened: ProSomnus precision intraoral medical devices are being used exclusively for the precision OAT arm of the study.

Treatment effectiveness is calculated as the product of therapeutic efficacy and nightly compliance. 

Efficacy is the reduction in Obstructive Sleep Apnea (OSA) severity. Secondary endpoints include patient preference. 

The study will use Koninklijke Philips NV's PHG active CPAP therapy device.

The Antwerp University Hospital (UZA), Belgium, designed and conducted the study.

The enrollment target is 121 patients with moderate and severe OSA.

 All 121 patients have already completed the OAT arm of the study. The researchers expect to have the study's full results in early 2023.

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

It is estimated that more than one billion people worldwide and over 74 million people in North America suffer from OSA. 

Approximately 56 million of those 74 million people in North America are undiagnosed.

Price Action: OSA shares closed at $5.91 on Tuesday.