The ResApp Health Ltd (ASX: RAP) share price ticked up a notch towards the end of Monday's market session. This followed the digital health company's announcement that it has secured regulatory approval for its cough counter smartphone application.
At the closing bell, ResApp shares ended the day 5.36% higher to 5.9 cents apiece.
ResApp receives TGA clearance for cough counter smartphone application
Investors appeared to be excited by the company's latest news, sending the ResApp share price into positive territory.
In the release, ResApp advised that its cough counter smartphone application has been approved by the Australian Therapeutics Good Administration (TGA). In addition, the medical software has also achieved a CE Mark certification.
The significant milestone enables ResApp to sell its cough counter smartphone application in Europe as a class 1 medical device. The software is also listed on the Australian Register of Therapeutic Goods (ARTG).
Notably, ResApp now holds the title of being the world's first regulatory-approved standalone cough counter smartphone application.
Developed over the last 12 months, the cough counting application is designed to identify coughs and background noises in everyday settings. The software records the number of coughs from the user and uploads the data in a form of time and date stamps. This is then accessible to medical and healthcare professionals to monitor in real-time.
The company noted that cough frequency is a key factor in respiratory disease progression and management. Traditional methods such as self-reporting or listening to audio recordings are said to be costly that are inaccurate and labour-intensive.
The software is already being used by AstraZeneca in a clinical study to monitor patients who suffer from lung cancer. The program is set to run for a period of two years.
Management commentary
ResApp CEO and managing director, Dr Tony Keating said:
We are pleased to have secured regulatory clearance in Australia and Europe for our cough counting technology. The ability to measure cough frequency using only a smartphone is a highly scalable solution that has a number of broad clinical applications. After our success in partnering with AstraZeneca, we are particularly excited about the opportunity in supporting clinical trials, where cough can provide important insight into the progression of disease and efficacy of treatment.
ResApp share price summary
In July, ResApp shares were trading at multi-year lows before shooting up in the following months. While the company's shares are down 30% year to date, the past week alone has netted a gain of almost 10%.
ResApp commands a market capitalisation of about $50.69 million and has 859.2 million shares on its books.
