World’s First Medical Device Regulatory Approval of Digital Therapeutic App for Hypertension

Mental and Behavioral Approaches to Lifestyle Modification

　CureApp, Inc. (Head Office: Chuo-ku, Tokyo; CEO: Kohta Satake) was notified by the Ministry of Health, Labour and Welfare on April 26, 2022 that the company had received the medical device regulatory approval of an digital therapeutic app for Hypertension. This marks the first time a standalone software app supporting doctors and patients has received medical device regulatory approval in Japan, and is the first app addressing hypertension to be approved in the world. Preparations are now underway to receive reimbursement and launch the app in 2022.

Hypertension

 　
　Lifestyle modification is a vitally important part of treating essential hypertension, regardless of blood pressure classification. However, lifestyle modifications are dependent on the patient’s mindset and motivation, and workplace and home environment, and are difficult to maintain. Even with the involvement of a medical institution, successfully implementing such changes requires a significant amount of effort, and there are many limitations to what busy doctors can achieve.

　Large numbers of patients suffer from hypertension in Japan, some 70% of these patients have either not achieved their anti-hypertensive goals, or have gone untreated. In addition, essential hypertension presents the single greatest risk factor of cerebrovascular diseases and heart diseases*1, and medical expenses related to hypertension continues to increase year after year*2.

*1: Source: Guidelines for the Management of Hypertension 2019

*2: FY2019 Ordinance of the Ministry of Health, Labour and Welfare General Overview of National Medical Expenditure

About this app

　This app provides direct treatment guidance that has been tailored to each individual patient, including advice on diet, exercise, sleep, and other aspects of their lifestyle, and information intended to encourage behavioral improvements based on information entered by the patient, via their smartphone. Encouraging lifestyle changes and aiding patients acquire correct lifestyle habits helps patients make sustainable lifestyle changes, and is intended to bring about therapeutic efficacy in the form of lowering blood pressure by reducing salt intake and weight loss. The version of the app available to physicians allows physicians to check a patient’s daily progress toward implementing lifestyle changes, and is intended to contribute in a meaningful way toward improving the quality of medical care provided within a limited time frame.

　The FY2022 revision of the national medical payment system added the “Addition of Medical Management of Software as a Medical Device, etc.”, and this marks the first case of a standalone software application acting as a doctor and patient aid receiving pharmaceutical approval. This is also the first time in the world medical device regulatory approval has been granted for DTx*3 in the field of hypertension.

*3: Abbreviation of Digital Therapeutics. Software-based treatments.

Overview

Official name	CureApp HT Hypertension Adjunctive Treatment  App
General name	Hypertension Adjunctive Treatment  Program
Approval number	30400BZX00100000
Intended use or effect	Adjunctive treatments of essential hypertension in adults
Date of approval	April 26, 2022
Manufacture and sales	CureApp, Inc.

Summary of clinical trials for this product

Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial 

Kario et al. European Heart Journal, Volume 42, Issue 40, 21 October 2021, Pages 4111–4122,https://doi.org/10.1093/eurheartj/ehab559

Report on clinical trial results from the Company（CureApp）

https://cureapp-en.blogspot.com/2021/09/cureapp-hypertension-therapeutics-app.html

Message from Kohta Satake, M.D. and Representative Director and CEO of CureApp, Inc. 

　We are proud to announce a new digital therapeutics solution for hypertension, following on from our digital therapeutics app for nicotine addiction. Hypertension is a disease that many suffer from in silence. It is a notoriously difficult disease to manage and treat, and one that requires fundamental lifestyle changes. Patients tend to have a low sense of urgency toward treating this disease while they still have few subjective symptoms of the disease, and it is difficult to maintain the level of behavioral change needed to address the underlying causes of the disease. The app acts as an adjunctive therapy in providing guidance during physicians consultations, and assists patients outside of consultations in approaching lifestyle changes in the correct way to get to the root cause. The app also provides physicians with a way to catch up on measures implemented during gaps in the patient’s treatment and their lifestyle habits, and makes it possible to provide better quality healthcare that is better tailored to the needs of the individual patient.

　Digital therapeutics is set to become a standard form of treatment in Japan for both physicians and patients, and we will continue to look to develop DTx applications that treat other diseases.

About CureApp, Inc.

　CureApp, Inc. is a MedTech venture that conducts research and development into the creation of medical device programs, which apply advanced software technology and medical evidence to treat illnesses, with the intent of manufacturing and distributing them. The Company is hard at work developing “therapeutic apps” - apps used to treat illnesses - in order to become the first in Japan to establish a new healthcare service centered on “producing a therapeutic effect to treat illnesses using an app”. In August 2020, CureApp was the first to receive medical device regulatory approval for a disease treatment app in Japan in the form of a nicotine addiction treatment app, which was later reimbursed under national health insurance in December of the same year.

Businesses CureApp is involved in

Nicotine addiction	Received Medical Device Regulatory Approval in August 2020; reimbursed by National Healthcare insurance and prescriptions begin in December of the same year
Hypertension	Received Medical Device Regulatory Approval  in April 2022
NASH (Nonalcoholic steato-hepatitis)	App currently in development and undergoing clinical trials with the University of Tokyo Hospital
Alcohol addiction	App currently in development with the National Hospital Organization Kurihama Medical and Addiction Center Clinical trials underway at the Okayama City General Medical Center, Okayama City Hospital
Oncology	Treatment app for breast cancer patients currently in development with DAIICHI SANKYO COMPANY, LIMITED.
Chronic heart failure	App under development with our partners at the YUMINO Medical Corporation

　In addition to the above, we provide mobile health programs for private companies through our “ascure Smoking Cessation Program” and “Specific Health Guidance ascure Smoking Cessation Program”, which leverages the knowledge garnered in the development of these digital therapeutics for medical institutions. These programs have been implemented at over 230 companies and health insurance societies. Looking ahead, we will look to sequentially rolling out this “Japanese-developed digital health solution” worldwide based on the model established in Japan.