Adherium submits US FDA 510(k) application for Ellipta® inhaler users to connect to Hailie platform with physiological parameters

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Melbourne, Australia – 7 March 2022: Adherium (ASX: ADR), a leader in respiratory eHealth, remote monitoring, and data management solutions, announces the submission to the US Food and Drug Administration (FDA) of a 510(k) clearance to market application to connect Ellipta® inhaler users with its new, next generation Hailie® sensor with physiological parameters for monitoring Asthma and COPD medication use.

Adherium’s latest Hailie sensor, designed for use with the GlaxoSmithKline (GSK) Ellipta® dry powder inhaler (DPI), is the second in Adherium’s series of new sensors, following AstraZeneca’s Symbicort® pMDI inhaler, specifically designed to capture physiological parameters such as respiratory flow rate in litres per minute. This additional information and reporting adherence provides a new, never before available window into inhaler usage and technique giving patients immediate feedback and promoting greater engagement with the Hailie phone app. Recording inhaler adherence and physiological parameters also empowers the patient-physician relationship with remote, automated and objective data to guide patient care and support patient management.

Interest in telehealth and remote patient monitoring continues growing to new heights driven by expanded reimbursement and from the necessity to protect patients and healthcare systems during the COVID-19 pandemic. Ellipta’s addition to the Hailie range of products will broaden the pathway for Adherium’s customers in the US to access reimbursement for remote monitoring of patients prescribed Asthma and COPD medications.

“Submitting the market application with the FDA is another key step in the extension of our digital respiratory management ecosystem. Adherium is focused on delivering technology leading respiratory solutions including our next generation of sensors that capture physiological parameters” said Geoff Feakes, Adherium’s Chief Technology Officer. “Physiological parameters were consistently identified as a valuable data set to improve patient management. Clinicians globally have told us of the importance to build on our core adherence capability, extend the range of the clinical respiratory data we capture, and expand our market coverage of inhaled medications. As part of Adherium’s market expansion we intend to rollout additional new sensors with physiological parameters taking our Asthma and COPD medication coverage in the US to over 80% of the addressable market volume supporting 18 medications”.