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Eko CORE 500™ digital stethoscope will be incorporated into Z1608 solution under development for heart failure patients built on Welldoc's digital therapeutic platform.
Astellas Pharma and Eko Health have entered into an 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, 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 Z1608.1
Astellas intends to seek FDA clearance for Z1608 and will evaluate in studies 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.
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 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.
Heart failure is a global health issue affecting more than 64 million people worldwide.2 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 population.3,4
"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, in a press release. "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."
Kevin McRaith, president and CEO of Welldoc, said, "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."
1. Astellas and Eko Health Announce Agreement to Incorporate Next Generation Eko CORE 500™ Digital Stethoscope into Z1608, an Innovative Solution Under Development for Heart Failure Patients Built on Welldoc's Proven Digital Therapeutic Platform. TOKYO, EMERYVILLE, Calif. and COLUMBIA, Md., July 18, 2023. PRNewswire.
2. 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.
3. 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.
4. 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.