- ResApp Health’s (RAP) wearable device has been granted CE Mark certification as a Class I medical device accessory
- The clip-on device constantly monitors the wearer’s cough and doesn’t require an analyst to manually review the cough sounds — making it less labour intensive and more efficient
- ResApp will initially focus on introducing the device into clinical trials to measure cough frequency but it will also be used to monitor patients that may have chronic obstructive pulmonary disease or asthma
- Achieving CE Mark certification means ResApp can now manufacture and distribute the device in Europe
- Company shares are up 3.51 per cent and are trading at 5.9 cents
ResApp Health’s (RAP) wearable device has been granted CE Mark certification as a Class I medical device accessory.
Development of the wearable device began in May 2019 following an agreement with U.K.-based medical device consultancy Avanti Med to design and develop the hardware.
The wearable device is an easy-to-wear, clip-on platform, which monitors the wearer’s cough sounds 24 hours a day.
Importantly, the device can identify over 93 per cent of coughs, with less than one per cent of identified events being false positives. What sets this device apart is the fact it doesn’t require an analyst to manually review the cough sounds, which makes this a less labour-intensive and more rapid approach to monitoring coughing habits.
The respiratory health company will initially focus on introducing the device into clinical trials to measure cough frequency. Cough frequency is a key factor when assessing and managing the progression of respiratory disease. It may also be an important outcome measure in clinical trials.
ResApp will also utilise the device to monitor chronic disease patients that may have chronic obstructive pulmonary disease or asthma.
Achieving CE Mark certification is a significant step, as it allows the company to manufacture, sale and distribution of the device in Europe.
ResApp’s partner, OSI Electronics, will manufacture the device for its facilities in the U.K. and South East Asia.
“Discussions with potential partners, including global pharmaceutical companies, to introduce the wearable device into clinical trial settings have already commenced,” CEO and Managing Director Tony Keating said.
Significantly, CE Mark approval marks the third and final part of the agreement with Avanti Med and will see ResApp issue Avanti 6.25 million new shares under its 15 per cent placement capacity.
In addition to this development, ResApp is looking to secure CE Mark certification of a handheld device which will use its ResAppDx acute respiratory diagnostic test in face-to-face clinical environments.
Company shares are up 3.51 per cent and are trading at 5.9 cents at 10:17 am AEDT.