- ResApp Health (RAP) has received the final design files, reports and documents for its handheld wearable devices
- These Android-based devices are easy-to-wear platforms that can continuously monitor patients with a chronic respiratory disease for up to three days
- Clinical, electrical and usability evaluations are now underway for these products
- The results from the evaluations will be combined with the design files to form a CE Mark technical file
- Following this, ResApp is aiming to receive CE Mark approval for the wearable devices by the first half of this year
- Company shares are up a slight 3.03 per cent on the market today and are trading for 17 cents each
ResApp Health (RAP) has received the final design files, reports and documents for its handheld and wearable devices.
In mid-February, the digital health company announced that Avanti Med and OSI Electronics had successfully completed testing of the wearable prototypes.
These Android-based devices are easy-to-wear platforms that can continuously monitor patients with a chronic respiratory disease for up to three days.
According to ResApp, this is a low-cost option to pair with its respiratory disease diagnosis apps, such as ResAppDx-EU.
ResAppDx-EU is the company’s mobile software app, which is used by clinicians for the diagnosis of multiple respiratory problems.
It uses machine learning algorithms to analyse a patient’s cough sounds to diagnose diseases and provide quick and accurate information.
Clinical, electrical and usability evaluations are now underway for these wearable devices.
The results from these evaluations will be combined with the design files to form a CE Mark technical file. Following this, ResApp is aiming to receive CE Mark approval by the first half of this year.
By receiving the final design files for the wearable devices, ResApp has satisfied two-thirds of the milestones under the device development agreement that was announced in May 2019.
The company has already achieved the milestones for delivery of functional prototypes and delivery of functional designs — now, it is just waiting on CE Mark approval.
When the device development agreement was first announced, ResApp said it would pay $500,000 to a U.K.-based medical device consultancy when each milestone is reached, either in cash or shares.
The company today stated that it will pay this milestone in shares.
Approximately 9,090,909 shares will be issued to the device developer at a price of 11 cents, which is 80 per cent of the volume-weighted average price from the 30-days before this milestone was reached.
ResApp is up a slight 3.03 per cent on the market today and shares are trading for 17 cents each at 11:13 am AEST.