Adherium Gains Clearance for Smart Inhaler Attachment

Adherium, a digital health company that improves medication adherence and patient outcomes, has announced U.S. Food and Drug Administration (FDA) 510(K) clearance for its new SmartTouch for Symbicort inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler.
 
The SmartTouch for Symbicort is a device installed onto a patient’s inhaler to monitor and encourage medication adherence as part of a self-management plan. It is the latest product to be added to Adherium’s product portfolio to assist patients, who suffer from respiratory conditions such as asthma and COPD, with adherence.
 
Adherence to medication is crucial for the successful management of many chronic diseases, but it is common for patients with respiratory conditions to only take between one third and one half of their prescribed medications.
 
Arik Anderson, CEO of Adherium, said, “The SmartTouch for Symbicort is the most advanced Smartinhaler product to date for Adherium and a key product in our strategic collaboration with AstraZeneca by bringing the benefits of digital monitoring to patients and their physicians. With each new generation, our Smartinhalers get smaller, easier to use, and incorporate more sensors that generate higher quality data, and higher levels of medication adherence. This is Adherium’s third U.S. 510(k) clearance to market. In addition, the company has secured clearances in Europe, Canada, Australia, China, Singapore, and New Zealand.”
 
The next generation device records the date and time the inhaler is used and automatically transmits this information to an app on the patient’s phone or tablet. The SmartTouch stores the history of patient medication usage patterns, allowing physicians to also review the information and help make evidence-based decisions on how best to meet the patient’s needs. The SmartTouch can be used in home monitoring programs, such as hospital re-admission prevention programs, where maintaining medication adherence after hospital discharge is a key objective. 
 
SmartTouch for Symbicort is designed to make inhaler installation and removal easy for all patients, especially older patients with COPD. The SmartTouch design includes three buttons that help patients easily access the audio visual-reminders, battery monitoring, and Bluetooth low-energy (BLE) pairing features.
 
The company recently announced the sale of its 100,000th Smartinhaler.
 
Adherium’s innovative Smartinhaler platform integrates a Bluetooth-enabled sensor and smartphone application to detect and record actual usage of inhaled medications. The Smartinhaler provides patients and physicians with critical data that can increase adherence to inhaled medication regimens, resulting in improved management of chronic respiratory conditions. Used in more than 60 projects and referenced in 65 peer reviewed journal articles, the Smartinhaler’s clinical outcomes data have proven that it can improve adherence by up to 59% in adults and 180% in children. These improvements were associated with a 60% reduction in severe respiratory episodes in adults, leading to improved quality-of-life and demonstrating a substantial gain over current best practice treatment. The Smartinhaler has received FDA 510(k) clearance to market and CE marks for its sensors and software.
 
Adherium has a variety of Smartinhaler sensor configurations that are compatible with multiple medications, and the Company is strongly positioned to realize the clinical and commercial value of its technology among key customers, including caregivers, insurers and hospitals.