Adherium submits new Hailie sensor for US FDA clerance

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Respiratory eHealth company Adherium (ASX:ADR) has submitted to the US FDA for 510(k) clearance to connect Ellipta inhaler users with its new Hailie sensor.

The new sensor, which is designed for use with GSK's Ellipta dry powder inhaler, has physiological parameters for monitoring Asthma and COPD medication use.

The company said this additional information and reporting adherence provides a new and a 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 empower the patient-physician relationship with remote, automated and objective data to guide patient care and support patient management.

Adherium said Ellipta’s addition to the Hailie range of products will broaden the pathway for its 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.”