Michael Barbella, Managing Editor09.25.23
Astellas Pharma Inc. and Eko Health Inc. are joining forces to better detect heart failure amongst the world's aging population.
The two companies have drafted a license and supply agreement for 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., 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 will eventually seek U.S. Food and Drug Administration (FDA) clearance for Z1608.
Through future studies, Astellas will evaluate Z1608's efficacy for remotely monitoring key physiological biomarkers associated with heart failure. The trials also will determine whether Z1608 and 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.
"Under our Corporate Strategic Plan 2021, we are committed to 'Advance the Rx+® business' as one of our strategic goals," Astellas Chief Strategy Officer Adam Pearson said. “We hope 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.”
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.
“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 President/CEO Kevin McRaith stated. “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.”
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 worldwide.1 The prevalence of heart failure in the United States is 6.9 million (2020 estimate) and is expected to increase by 24% to nearly 8.5 million by 2030 due to the nation's growing aging population.2,3
“Caring for heart failure patients at home requires the ability to precisely measure patient data,” Eko Health Co-Founder/CEO Connor Landgraf said. “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.”
Astellas Pharma Inc. conducts business in more than 70 countries. It employs the Focus Area Approach to create new drugs to address diseases by focusing on biology and modality. The company is also looking beyond its foundational Rx focus to create Rx+® healthcare solutions that combine its expertise and knowledge with cutting-edge technology in different fields of external partners.
Eko Health is a digital health company advancing the way 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 healthcare professionals worldwide to detect earlier and with higher accuracy, diagnose with more confidence, manage treatment effectively, and ultimately give patients the best care possible. Eko Health is headquartered in Emeryville, Calif., with more than $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.
Welldoc is a digital health firm integrating personalized, real-time and actionable insights into the daily lives of individuals living with chronic conditions, enabling improved health and outcomes. Welldoc’s 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 nine FDA-clearances for type 1 and type 2 diabetes, 39 patents for its first-in-class technology and AI and more than 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.
References
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.
The two companies have drafted a license and supply agreement for 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., 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 will eventually seek U.S. Food and Drug Administration (FDA) clearance for Z1608.
Through future studies, Astellas will evaluate Z1608's efficacy for remotely monitoring key physiological biomarkers associated with heart failure. The trials also will determine whether Z1608 and 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.
"Under our Corporate Strategic Plan 2021, we are committed to 'Advance the Rx+® business' as one of our strategic goals," Astellas Chief Strategy Officer Adam Pearson said. “We hope 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.”
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.
“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 President/CEO Kevin McRaith stated. “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.”
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 worldwide.1 The prevalence of heart failure in the United States is 6.9 million (2020 estimate) and is expected to increase by 24% to nearly 8.5 million by 2030 due to the nation's growing aging population.2,3
“Caring for heart failure patients at home requires the ability to precisely measure patient data,” Eko Health Co-Founder/CEO Connor Landgraf said. “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.”
Astellas Pharma Inc. conducts business in more than 70 countries. It employs the Focus Area Approach to create new drugs to address diseases by focusing on biology and modality. The company is also looking beyond its foundational Rx focus to create Rx+® healthcare solutions that combine its expertise and knowledge with cutting-edge technology in different fields of external partners.
Eko Health is a digital health company advancing the way 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 healthcare professionals worldwide to detect earlier and with higher accuracy, diagnose with more confidence, manage treatment effectively, and ultimately give patients the best care possible. Eko Health is headquartered in Emeryville, Calif., with more than $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.
Welldoc is a digital health firm integrating personalized, real-time and actionable insights into the daily lives of individuals living with chronic conditions, enabling improved health and outcomes. Welldoc’s 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 nine FDA-clearances for type 1 and type 2 diabetes, 39 patents for its first-in-class technology and AI and more than 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.
References
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.