Adherium receives Australian TGA approval for Next Generation Sensors

Melbourne, Australia – Link Here: Adherium Limited (“Adherium”; ASX: ADR), a leader in respiratory eHealth, remote monitoring and data management solutions, is pleased to announce receiving Australian Therapeutic Goods Administration (TGA) approval to commercially distribute its new, next generation Hailie® sensors with physiological parameters. These latest additions to the Hailie sensor product family connect patients with GlaxoSmithKline (GSK) pMDIs (Ventolin®, Advair®, Flovent®), GSK Ellipta® DPI’s (Breo®, Anoro®, Incruse®, Trelegy® and Arnuity®), and AstraZeneca’s Symbicort® pMDI inhaler medications.

Mr Rick Legleiter, Adherium Chief Executive Officer, commented, “Receiving TGA approval for our new, next generation Hailie digital sensors opens the door in our home market for this latest remote patient monitoring technology to be made available for Australians suffering from Asthma and COPD. These latest devices provide superior data and insights into patient inhaler technique and usage giving healthcare providers immediate, real-time feedback and enabling physicians to enhance patient care by capturing clinical data supporting patient management and treatment.”

Hailie sensors are intended for single-patient multiple use as an electronic data capture accessory for monitoring and recording actuation and other parameters, including inspiratory flow of prescribed inhaler usage and inhaler technique. As the sensor may be used in clinical trials, in patient self-management and by doctors and healthcare providers for patient care, these applications will be the focus of commercial opportunities in the Australian market.

Tara Creaven-Capasso, Adherium’s Vice President of Quality, Regulatory and Clinical Affairs, commented, “Our objective with each generation of Hailie sensors is the pursuit of our mission – to be the leading digital solution for remote patient monitoring; integrating devices and data to optimise outcomes for patients, healthcare professionals and payors. As part of the Australian government’s response to the COVID-19 pandemic, expanded access to healthcare services has been achieved through MBS telehealth items. With this greater offering of new and expanded reimbursement options for virtual care management programs, more reimbursement opportunities for doctors have become available, which gives access to comprehensive patient data for more effective care delivery, better care coordination, and improved health outcomes.”

Adherium is a provider of integrated digital health solutions and a worldwide leader in connected respiratory medical devices, with more than 180,000 sold globally. Adherium’s Hailie platform solution provides clinicians, healthcare providers and patients access to remotely monitor medication usage parameters and adherence, supporting reimbursement for qualifying patient management. The Hailie solution includes a suite of integration tools to enable the capture and sharing of health data via mobile and desktop apps, Software Development Kit (SDK) and Application Programming Interface (API) integration tools, and Adherium’s own broad range of sensors connected to respiratory medications. Adherium’s Hailie solution is designed to provide visibility to healthcare providers of medication use history to better understand patterns in patient respiratory disease.

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This ASX announcement was approved and authorised for release by the Board of Adherium.