TOKYO, Emeryville, California and Columbia, Maryland, July 18, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Eko Health Inc. (Co-Founder and CEO: Connor Landgraf, “Eko”) announced today that they have entered into a License & Supply Agreement for the global supply and license of Eko’s latest digital stethoscope, the CORE 500™, and a custom suite of Eko’s AI-powered cardiovascular disease detection software. Working collaboratively with Welldoc, Inc. (President, CEO: Kevin McRaith, “Welldoc”), Astellas intends to integrate Eko’s technology with Welldoc’s cardiometabolic digital therapeutic (DTx) capabilities to create a proprietary, non-invasive device-DTx solution for patients with heart failure, currently known as Z1608. Astellas intends to seek U.S. Food and Drug Administration (FDA) clearance for Z1608.
Through future studies, Astellas intends to evaluate if using Z1608 for remote monitoring of key physiological biomarkers associated with heart failure, in addition to providing automated coaching based on other health data points such as diet, activity, and medication adherence, can reduce the frequency of acute decompensation events in patients living with heart failure. Z1608 is being designed to place users at the center of their care, allowing them to take a more active role in managing their health while working in partnership with their care team.
The recently FDA-cleared Eko CORE 500™ device is a cardiac assessment tool that uses a three-lead ECG and electronic stethoscope to capture physiological data which can be processed by Eko’s proprietary algorithms to identify specific elements of cardiovascular function and dysfunction. To create Z1608, Astellas is combining Eko’s technology with Welldoc’s established cardiometabolic DTx capabilities. In addition, educational content specifically focused on heart failure will be provided by the American Heart Association (AHA) and included in Z1608.
AHA educational content helps individuals, families and caregivers develop lifestyle plans that focus on key factors that impact heart health. These factors include key concerns for people living with heart failure: like physical activity, nutrition, weight management, stress management, and smoking cessation.
Image of Eko CORE 500™ Digital Stethoscope (left) and Z1608 Smartphone App
There is a high unmet medical need for a noninvasive, connected, portable, and user-friendly digital solution for supporting patients living with heart failure. Heart failure is a global health issue affecting more than 64 million people worldwide1. In the US, the prevalence of heart failure is 6.9 million (2020 estimate) and is expected to increase by 24% to nearly 8.5 million by 2030 due to the aging and growth of the US population2,3.
"Under our Corporate Strategic Plan 2021, we are committed to “Advance the Rx+® business" as one of our strategic goals," said Adam Pearson, Chief Strategy Officer of Astellas. “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”.
“Caring for heart failure patients at home requires the ability to precisely measure patient data,” said Connor Landgraf, Co-founder and CEO of Eko Health. “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.”
“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,” said Kevin McRaith, President and CEO of Welldoc. “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.”
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