Source – Astellas Pharma
Astellas has obtained the licensing rights to a smart stethoscope device developed by Eko Health, with plans to integrate it into a digital therapeutic (DTx) approach for heart failure management.
The strategy involves combining the CORE 500 digital stethoscope, equipped with artificial intelligence algorithms to detect and diagnose cardiovascular disease, with a digital health platform developed by Welldoc. This platform facilitates connectivity among patients, care teams, and healthcare systems.
The resulting DTx product, codenamed Z1608, aims to enable remote monitoring of physiological biomarkers associated with heart failure in patients. It will also provide coaching on diet, physical activity, and medication adherence, featuring content endorsed by the American Heart Association (AHA).
The ultimate goal is to demonstrate that Z1608 can reduce the frequency of acute decompensation events in patients living with heart failure, and subsequently seek FDA approval for this application.
Eko previously received FDA approval for its CORE 500 device, which combines a stethoscope with a three-lead electrocardiogram (ECG), capable of detecting cardiovascular abnormalities such as heart murmurs, atrial fibrillation (AF), and low left ventricular ejection fraction (LVEF) during routine physical examinations within seconds.
“Under our Corporate Strategic Plan 2021, we are committed to “Advance the Rx+® business” as one of our strategic goals. We hope that we can deliver new VALUE to patients with heart failure by combining Eko and Welldoc’s products to create and commercialize an innovative solution, Z1608”.
– Adam Pearson, Chief Strategy Officer of Astellas
The accompanying AI algorithm is also FDA-cleared to detect murmurs and AF, and a study conducted by investigators last year showed that a simpler Eko device, equipped with a single-lead ECG, achieved an accuracy of 80% to 90% in detecting LVEF. This condition is observed in approximately half of all heart failure patients.
Astellas and Welldoc have been collaborating on digital health projects since their strategic alliance began in 2019, initially focusing on diabetes but later extending to other therapeutic categories, including heart failure, hypertension, and pre-diabetes.
“Caring for heart failure patients at home requires the ability to precisely measure patient data. Through our partnership with Astellas to integrate our best-in-class CORE 500™ Digital Stethoscope and AI with Welldoc’s proven DTx capabilities, we’re closer to a future where heart failure is proactively managed rather than reactively treated. We’re making significant steps towards transforming heart health by working with partners to bridge the home-clinic care gap.”
– Connor Landgraf, Co-founder and CEO of Eko Health
Although currently, only the diabetes functions of the app have received FDA approval, Astellas expressed confidence in Welldoc’s “established cardiometabolic DTx capabilities.”
Both companies emphasized the significant unmet medical need for a non-invasive, connected, portable, and user-friendly digital solution to support patients living with heart failure.
“Patients diagnosed with heart failure and their providers are in need of connected solutions which seamlessly integrate into daily life, support better self-management and drive more data-driven clinical decisions. Welldoc is excited to partner with Astellas to create a first-in-class digitally enabled solution that provides novel data-driven insights and personalized coaching, leveraging cardiometabolic components of our comprehensive chronic care platform.”
– Kevin McRaith, President and CEO of Welldoc
