The Respiri Ltd (ASX: RSH) share price is on watch today after the company advised it has received United States Food and Drug Administration (FDA) clearance for its Wheezo app.
Respiri is a software-as-a-service (SaaS) company supporting asthma patients to monitor and manage their asthma. The company views that asthma is often under-diagnosed and under-treated, creating a substantial burden to sufferers and their families.
Respiri has created an eHealth SaaS platform, ‘Wheezo’, that uses a device and app to measure, record and monitor asthma symptoms. The device records breath sounds over 30 seconds to be analysed in the app. The app has features that allow users to log symptoms, triggers, medication and local environment factors, which can then be used to build a personalised asthma profile to be shared with healthcare professionals.
The company believes the sub-optimally managed asthma market represents a significant opportunity, with over 340 million people affected globally.
Respiri share price in focus
The Respiri share price will be on the radar this morning after the company announced it has received clearance from the US FDA for Wheezo, thus permitting the company to market and sell its product in the US as a class II medical device alongside the Wheezo app.
Respiri CEO and Managing Director Mr Marjan Mikel commented on clearance:
The regulatory clearance of Wheezo and our App in the United States represents a highly significant and major milestone for the Company as we continue to expand our regulatory footprint for Wheezo and enter substantial new markets. The FDA is one of the most stringent regulatory bodies in the world and this clearance further validates the efficacy and utility of our Wheezo device and algorithm. To our knowledge [this is] the first time the FDA has cleared a device/mobile application for the detection, recording and changes of wheeze rates. This represents a step-change in technology for patients with respiratory wheeze seeking an effective, replicable and rapid device measurement and associated App that monitors this important measurement of lung function.
Respiri plans to launch in the US market in Q3 2022 with an initial focus on the 60% of children with persistent and severe asthma, representing 3.3 million patients. According to the company, the Wheezo device and app will play a role in providing significant analytical information for patients and their caregivers.
Respiri highlights the reimbursement codes available from the Centers for Medicare and Medicaid Services (CMS) in the US as a key tailwind for Wheezo. These enable clinicians and qualified medical professionals advising patients on the purchase of the device and associated SaaS fees to receive financial compensation for the time spent and equipment used for patient care delivered remotely.