-Jointly Developed by Astellas and M. Heart- 
-Implementing MYHOLTER II  into M.Heart’s cloud-type 
Holter ECG Analysis service-

TOKYO and Iwate, July 16, 2021  - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and M. Heart Co., Ltd. (Headquarters: Iwate, President and CEO: Yoshimi Mizunuma,  "M. Heart") launched "MYHOLTER II", a software for the holter analyzer that the two company jointly developed, on July 15. MYHOLTER II is a program that uses artificial intelligence (AI) to analyze data obtained from Holter electrocardiography and provided to healthcare professionals through M.Heart’s cloud-type Holter ECG*1 analysis service.

Astellas enterd into an exclusive license agreement for MYHOLTER II in Japan with M. Heart in May. Based on the license agreement, Astellas will receive a portion of the sales of the cloud-type Holter ECG analysis service using MYHOLTER II by M. Heart. This collaboration, which has been pursued as part of the Rx+® program*2, is one of the ways Astellas is striving to prevent chronic diseases from becoming severe*3.This is the first full-scale commercialized program in Rx+® program.

Astellas and M. Heart have jointly developed MYHOLTER II since December 2019 for the purpose of early detection of atrial fibrillation, which is estimated to affect approximately 700,000 patients in Japan1. In March 2021, M. Heart obtained certification for MYHOLTER II as a medical device (Class II) software from a certifying body registered by the Minister of Health, Labour and Welfare.

Medical costs for heart diseases and other cardiovascular diseases in Japan exceed 6 trillion yen per year—the highest of any disease category2. Of particular concern is cardiogenic cerebral embolism, which occurs when a thrombus that formed in the heart blocks an artery in the brain or neck. This has a high mortality rate (20%) and often results in severe sequelae such as a bedridden state (40%)1. Atrial fibrillation is said to be the cause of cardiogenic cerebral embolism in 3 out of 4 cases1. Early detection of atrial fibrillation is an important social issue.

The number of heart beats that are analysed by the Holter ECG amount to 100,000. This is a significant labour burden for healthcare professionals who have to analyze this large amount of data. In addition, there was also the issue of the accuracy of automatic ECG analysis that had to be addrssed. To resolve these issues, Astellas and M. Heart have succeeded in developing an efficient and accurate process for the automatic analysis of ECG data with MYHOLTER II by using an AI-assisted algorithm. This web-based cloud service allows healthcare professionals to conduct ECG data analysis from anywhere. Furthermore, by adopting the international standard, i.e., Medical waveform Format Encoding Rule (MFER*4) compliant data format for the system, an open environment in which many electrocardiograph device manufactures are able to adopt the program is provided. By making ECG examinations "more familiar and easier", we are hoping that this will contribute to the prolongation of healthy life expectancy by promoting early detection and appropriate treatment of atrial fibrillation. Both companies will continue to enhance its AI to improve its diagnostic accuracy using more ECG data obtained from clinical research.


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