ASX-listed ResApp Health SleepCheckRx has received 510 (k) clearance from the US Food and Drug Administration for its mobile sleep apnea screening app.
Introduced Two years ago, SleepCheck was a home test for adults who are at risk of moderate to severe obstructive sleep apnea. It screens for conditions by analyzing the breath and snoring sounds recorded over the phone.
It has been approved in the United States as a prescription-only software-a-medical device on Apple smartphones. To download the app from the Apple App Store, patients need to secure a specific code from their care providers.
Raceup plans to ask for a further 510 (k) clearance for slipcheck on Android phones “in the future”, according to a media release.
Why it matters
According to a study published in the American Journal of Epidemiology, in the United States, sleep apnea is the most common sleep disorder affecting more than three out of 10 people and about two out of every 10 women. Aging population and increasing rates of obesity are increasing the cases. Among people with this condition, up to 80% are unaware of having sleep apnea, a Frost & Sullivan report found.
“More than 20 million American adults suffer from sleep apnea and most don’t know they have it. This release opens up a significant market opportunity for ResApp. Using SleepCheckRx, physicians will be able to conveniently test their patients and quickly Helps patients take the first step in their treatment, ”said Tony Keating, CEO and managing director of Raceup.
ResApp applied for a 510 (k) clearance for slipcheck in October last year. In a home clinical trial involving 220 patients, Slipcheck was found to correctly identify 89% of patients with moderate to severe obstructive sleep apnea with 77.6% specificity. In addition to the United States, the app is also commercially available in Europe and Australia.
In other news, ResApp announced Tuesday that patents for cough detection technology have been approved in Australia and Japan. The mentioned technology enables its respiratory diagnostic test ResAppDx and its cough counting software ResAppCC.
Last month, ResApp revealed that Pfizer had revised its offer to buy the company in its entirety. From A $ 0.207 per share to a company valued at around A $ 180 million ($ 122 million), the pharma giant is now offering A $ 0.146 per share, which represents an equity value of A $ 127 million ($ 86 million) – still a higher takeover valuation than the initial one. A $ 100 million ($ 68 million).