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.
Eko CORE 500™ Digital Stethoscope (left) and Z1608 Smartphone App
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.
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.”
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.
About Eko Health
Eko Health is a leading digital health company advancing how healthcare professionals detect and monitor heart and lung disease with its portfolio of digital stethoscopes, patient and provider software, and AI-powered analysis. Its FDA-cleared platform is used by hundreds of thousands of healthcare professionals worldwide, allowing them to detect earlier and with higher accuracy, diagnose with more confidence, manage treatment effectively, and ultimately give their patients the best care possible. Eko Health is headquartered in Emeryville, California, with over $125 million in funding from Highland Capital Partners, Questa Capital, Artis Ventures, DigiTx Partners, NTTVC, Morningside Technology Ventures Limited, Mayo Clinic, Sutter Health, and others. For more information visit www.ekohealth.com.
Welldoc®, a digital health leader revolutionizing chronic care, is integrating personalized, real-time and actionable insights into the daily lives of individuals living with chronic conditions, enabling improved health and outcomes. Welldoc’s comprehensive chronic care platform provides multi-condition support across prediabetes, diabetes, hypertension, heart failure and weight management, with integrated mental wellbeing. Welldoc’s clinical rigor and regulatory expertise is backed by 9 FDA-clearances for type 1 and type 2 diabetes, 39 patents for our first-in-class technology and AI and over 65 publications focused on digital health engagement and outcomes. Welldoc partners with health plans, health systems, life sciences and employers with the goal of extending care, improving health and reducing costs. For more information, visit www.welldoc.com. Follow us on LinkedIn and Twitter.
Cautionary Notes (Astellas)
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.
Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
Contacts for inquiries or additional information:
Astellas Pharma Inc.
Eko Health Media Contact
Welldoc Media Contact
Megan Prock McGrath
1: GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1789-858.
2: Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, et al. Heart disease and stroke statistics-2018 update: a report from the American Heart Association. Circulation. 2018;137:e67-e492.
3: Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, et al. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19.