FDA okays ResApp’s (ASX:RAP) SleepCheckRx; how are shares faring?

ResApp Health Limited (ASX: RAP), a digital health company, has received the US Food and Drug Administration (FDA) clearance for its at-home sleep test SleepCheckRx. This clearance opens a substantial market prospect for ResApp as over 20 million adults in America suffer from sleep apnoea. The company can now commercially sell the test in the United States.

SleepCheckRx is a sleep test (mobile application) that can be used at home. It analyses the risk of moderate to severe obstructive sleep apnoea in adults by probing breathing and snore sounds recorded on an Apple iPhone. It does not require any other accessories.

SleepCheckRx has got 510(k) clearance from FDA as a prescription-only software-as-a-medical device. ResApp plans to seek 510(k) clearance for Android devices in the future.

What is sleep apnoea?

© Tommaso79 | Megapixl.com

Sleep apnoea is a very common sleep breathing disorder, and its prevalence is growing due to the increasing ageing population and increasing rates of obesity. The condition affects over three out of ten men and almost two out of ten women. Studies indicate that almost 80% of people with sleep apnoea are unaware of the condition and are untreated.

Obstructive sleep apnoea is a condition when the air stops flowing to the lungs during sleep.

Patients can avail SleepCheckRx through a prescription from their healthcare providers. A specific code will be given to them for downloading the application from mobile Appstore. Their results will be uploaded to the portal of the healthcare provider.

SleepCheckRx was assessed in 220 patients in an at-home clinical trial, compared to simultaneous polysomnography, which is a study designed to identify sleep disorders. The app’s algorithm correctly identified 89.3% of patients with moderate to severe sleep apnoea with a 77.6% specificity.

Australian and Japanese patents

Yesterday (05 July), the company bagged a patent entitled “Methods and apparatus for cough detection in background noise environments”. The patent was granted in Australia and Japan. It covers the use of machine learning audio processing techniques for detecting cough sounds in settings with considerable background noise.

Stock information

At the time of writing this article (as on WED 06 JUL at 11:51 AM AEST), shares of RAP were trading at AU$0.132.