Clinical Study involving new Hailie Sensor with Physiological Parameters Launched in U.S.

Melbourne, Australia – 20 September 2022 Link here : Adherium Limited (ASX: ADR), a leader in respiratory eHealth, remote monitoring and data management solutions is pleased to announce a two-part clinical study at Washington University School of Medicine in St. Louis in the United States to monitor the adherence of Asthma patients using Adherium’s US FDA 510(k) cleared current and new, next generation Hailie® digital sensors for AstraZeneca’s Symbicort® medication. Following the full market launch earlier this year for sensors which capture physiological parameters including inhalation flow rate along with adherence, this demonstrates Adherium as a global partner of choice for remote patient monitoring.

With funding from the National Institutes of Health (NIH), the trial will utilize Adherium’s Hailie platform and technology to assess inhaled corticosteroids (ICS) adherence in adults (Part I – 50 patients) and adolescents (Part II – 40 patients) while testing a novel inhaler approach that could mitigate the detrimental consequences of maintenance inhaler non-adherence.

The Hailie data generation and transmission will play a critical role in the study by measuring the use and adherence to maintenance medications while the patients are at home. The second phase of the study with adolescent patients will deploy the new, next generation Hailie for Symbicort® HFA, its first use in a clinical study in the United States. For this phase, the clinical team will not only be able to monitor inhaler usage, but also assess potential therapy effectiveness by analyzing inspiratory flows and other physiological parameters.

Principal investigator James G. Krings, MD, MSc, an Assistant Professor of Medicine in the Division of Pulmonary Critical Care Medicine at Washington University School of Medicine, commented, “In this pragmatic clinical trial, we are assessing different inhaler strategies in Asthma patients who are non-adherent to maintenance inhalers. The electronic sensors used in the trial will help to assess participants’ adherence to different inhaler regimens that we are trying, which is critical to the study. In addition, assessing inspiratory flows may provide valuable data on day-to-day inspiratory flow and the quality of a patient’s inhaler actuations, which we are excited to explore in this study.”

The Hailie platform and technology has been used at clinical sites throughout the past decade. Now the new, next generation devices create a new chapter for Adherium and for pulmonary care by empowering clinicians to review inhalation flows, assess inhaler technique, and determine the effectiveness of inhaler therapy for respiratory patients. The Hailie for AstraZeneca’s Symbicort® inhaler with physiological parameters was market launched in the US in February and Adherium recently submitted and received FDA 510(k) clearance for the inspiratory capable Hailie for GlaxoSmithKline Ellipta® medications. Hailie sensors have 510(k) clearances for 91% of the US top 20 branded inhalers for monitoring adherence usage.

About Adherium (ASX: ADR)
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.