CureApp: World’s First Medical Device Regulatory Approval of Digital Therapeutic App for Hypertension
6.5.2022 03:32:00 EEST | Business Wire | Press release
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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220502005371/en/
World’s First Medical Device Regulatory Approval of Digital Therapeutic App for Hypertension (Graphic: Business Wire)
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
|
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
|
|
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.
CureApp, Inc. Company Profile
|
Representative Director and President |
Kohta Satake |
|
Head Office Address |
Kodenma-Cho YS building 4th floor 12-5, Nihonbashi Kodenma-Cho, Chuo-ku, Tokyo, Japan, 103-0001 |
|
U.S. Branch |
CureApp North America, Inc. |
|
Business activities |
Development of Software as a Medical Device (SaMD), mobile health-related services |
|
URL |
https://cureapp.co.jp/en/ |
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220502005371/en/
Contact information
[ Inquiries ]
CureApp, Inc.
PR Representative, Yuuki Mishima
pr-team@cureapp.jp
Phone: +81 3-6231-0183
Please send any questions or inquiries to the CureApp PR team, and leave a note when you need a response by.
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
The Expensify Visa® Commercial Card Brings New Proactive Spend Controls to 14 Countries17.8.2026 16:00:00 EEST | Press release
Expensify, Inc. (Nasdaq: EXFY), the easiest way to manage expenses, travel, and corporate cards, today expanded the reach of Expensify Card spend rules, the market-leading way for businesses to control corporate card spend before it happens. Available to businesses in 14 countries, spend rules let admins decide exactly how, where, and when each Expensify Card can be used, so only compliant transactions go through. Unlike traditional corporate cards that rely on after-the-fact expense review, the Expensify Card enforces policy at the point of purchase. Admins set the rules once, and the card handles the rest. With Expensify Card spend rules, admins can: Lock a card to a subscription. Give each recurring SaaS tool its own virtual card, so a vendor can only ever charge what it should. If the card owner changes teams or leaves, the subscription keeps running, with no swapping cards and no missed payments. Cover a one-time purchase. Issue a virtual card for a single transaction like event r
Riskified Analysis Finds Travel Fraudsters Are Adapting Faster Than Traditional Signals Can Keep Up, With May Flight Risk Up 32%17.8.2026 15:30:00 EEST | Press release
Riskified (NYSE: RSKD), a global leader in ecommerce fraud and risk intelligence, today released new findings from its Travel Industry Insights report, revealing how sophisticated fraud rings and AI-enabled fraudsters are evolving their tactics across airlines, hotels, and online travel platforms. Riskified’s analysis shows that fraudsters are increasingly adapting their behavior to resemble legitimate travelers, making traditional fraud indicators less reliable and creating new challenges for travel merchants. Riskified’s analysis of hundreds of millions of travel transactions across flights, hotels, and land transportation found that flight fraud risk increased through the first five months of 2026, with May 2026 marking the sharpest year-over-year increase at 32% compared to May 2025. The findings show that sophisticated fraud activity is not limited to predictable travel peaks, with organized fraud rings continuously adjusting their methods throughout the year. Riskified's travel n
PIF Delivers Strong Revenue and Profit Growth in 202517.8.2026 14:54:00 EEST | Press release
PIF today published its 2025 Annual Report demonstrating strong financial performance and continued progress against its long-term objectives. As a long-term investor with a unique mandate to drive the economic transformation of Saudi Arabia and deliver sustainable financial returns, PIF maintained a diversified portfolio in 2025, balancing returns with national impact and long-term resilience. Maintaining Financial Discipline In 2025, revenue rose 9% year on year to $120 billion, while net profit more than doubled to $17 billion, supported by stronger contributions from maturing portfolio companies. PIF retained over $900 billion in assets under management and achieved an annualized total shareholder return of 5.8% since 2017. Total shareholder return in 2025 was positively driven by increased dividends from portfolio companies and returns from financial investments. It was also impacted by downward movements in the valuations of some assets, as a result of wider market conditions, an
Foundever Successfully Closes a Holistic Recapitalization, Reducing its Debt by Nearly $900 Million and Strengthening its Financial Position for Long-Term Growth17.8.2026 14:30:00 EEST | Press release
Foundever Group S.A.® (“Foundever” or the “Company”) – a global leader in integrated customer experience, digital operations and analytics services, today announced that it has successfully closed a holistic recapitalization (the “Transaction”) in coordination with 95.4% of the lenders under its term loan facility (“Term Loan Lenders”), 100% of its revolving credit facility lenders (“RCF Lenders”), and the Company’s existing majority shareholders. The Transaction meaningfully strengthens Foundever’s financial foundation and positions the Company to invest in its growth strategy. Key terms of the Transaction include: Company's existing majority shareholders invest $225 million into common equity. Term loan facility exchange reduces the Company's total debt by nearly $900 million. Revolving credit facility maturity date is extended by more than four years to December 2030, and term loan maturity date is extended by more than 2.5 years to March 2031. Certain of the Company's RCF Lenders p
Uniphore Launches Marketing AI as Marketing Moves Beyond the CDP17.8.2026 14:30:00 EEST | Press release
Uniphore, the Business AI company, today launched Marketing AI, ushering in a new era of enterprise marketing built on customer intelligence rather than customer data management. Uniphore Marketing AI gives marketers the ability to know every customer better than ever before, predict what each customer is likely to do next and simulate marketing outcomes before committing budget. The system continuously learns from every customer interaction, making its predictions more accurate with every cycle. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260817325069/en/ The Uniphore Marketing AI Flywheel: A Self-Learning System Named a Leader in the 2026 Gartner® Magic Quadrant™ for Customer Data Platforms, Uniphore has helped enterprises bring customer data together while providing sovereign control over where that data lives. Marketing AI builds on that foundation, extending Uniphore’s composable approach from the data layer into the
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom