Experts estimate that sleep apnoea affects nearly 1 billion people worldwide. Every year, 4 million people die prematurely from chronic respiratory diseases such as COPD, asthma, acute respiratory tract infections, tuberculosis and lung cancer. 

The global impact of respiratory based ailments is expansive, prompting The World Health Organisation to launch the Global Alliance Against Respiratory diseases in 2006 to bring together various organisations and expertise to improve the lives of those living with respiratory illness. 

Understanding the scope of the issue, digital health company ResApp (ASX: RAP) develops smartphone apps for both the diagnosis and management of respiratory disease.

The Company already has two regulatory- approved and clinically validated products. ResAppDx is a smartphone based diagnostic test for acute respiratory disease, designed for use in primary care, emergency and telehealth settings. SleepCheck is another ResApp platform, allowing consumers to self-assess their risk of sleep apnoea. 

Taking their suite of diagnostic tools further, ResApp has developed another app named SleepCheckRx. The app functions as a prescription-only, software-as-a-medical-device smartphone app for at-home sleep apnoea screening. The app requires no extra equipment to make an assessment, just a smartphone. 

After achieving success in a prospective clinical study of 308 patients, the Company has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA). 

In the aforementioned study, the algorithms for the SleepCheckRx app were tested against an American Academy of Sleep Medicine Type II sleep study. The app and algorithms performed to both high sensitivity and specificity. 

Once unlocked, FDA clearance could expand ResApp’s total addressable market rapidly. In America, there are an estimated 42 million people living with sleep disordered breathing. 3 in 10 men and almost 1 in 5 women have sleep apnoea. 

Tony Keating, CEO and Managing Director of ResApp commented on the news, saying: “This marks another important milestone for our sleep apnoea product line. Last year, we obtained TGA approval and CE Mark certification for our direct-to-consumer SaleepCheck app which is now available in over 36 countries. This SleepCheckRx 510(k) submission is the first step in the review process with the FDA and we look forward to working with the FDA through the review to obtain clearance for SleepCheckRx. 

“Sleep apnoea is a serious sleep disorder and research tells us that most people in the US with sleep apnoea don’t know they have it. With SleepCheckRx, physicians will have the opportunity to screen their patients conveniently and quickly for sleep apnoea, helping their patients conveniently and quickly care for sleep apnoea, helping their patients take the first step in getting treatment.”