CUREAPP
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/
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/ |
View source version on businesswire.com: https://www.businesswire.com/news/home/20220502005371/en/
Link:
About Business Wire
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
Global EV Alliance Releases EV Driver Survey Results: Myths Are Slowing EV Market17.11.2025 19:19:00 CET | Press release
In a groundbreaking survey of more than 26,000 EV drivers across 30 countries, an overwhelming 77% say persistent myths about electric cars are the single biggest obstacle to EV adoption in their nations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251118388193/en/ There are still significant differences in the EV market across countries, and not everyone has a wide range of car brands to choose from. Photo: Markus Rotevatn/Norwegian EV Association. 83% say they believe policy measures are needed to increase EV sales in their country. “Misinformation about EVs is a serious challenge. It can make policymakers less confident that electric vehicles are a viable solution to climate change and local air pollution,” says Joel Levin, chair of GEVA and Director of Plug in America. One common myth in many countries is that electric cars are a fire hazard. 88% of the EV drivers in the survey say they aren’t worried about their EV b
Dilawer Farazi Returns to Loomis Sayles as Co-Head and Portfolio Manager on the Emerging Markets Debt Team17.11.2025 16:59:00 CET | Press release
Loomis, Sayles & Company is pleased to announce that Dilawer Farazi, ACA, has rejoined the firm as Co-Head and Portfolio Manager of the Emerging Markets Debt (EMD) Team. Dilawer becomes the firm’s first London-based portfolio manager. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117681347/en/ Dilawer Farazi, ACA, has rejoined Loomis Sayles as Co-Head and Portfolio Manager of the Emerging Markets Debt Team Dilawer brings over two decades of experience in emerging markets credit, having previously served as a Senior Credit Research Analyst at Loomis Sayles from 2018 to 2020. He rejoins the firm from Royal London Asset Management (RLAM), where he led the Emerging Markets Credit team and managed approximately USD $1 billion in assets across EM credit. At RLAM, he launched the firm’s first dedicated emerging markets funds, including an emerging markets corporate bond fund and an emerging markets short duration credit fund. I
Duravant Announces Retirement of CEO Mike Kachmer, Names Jill Evanko Successor17.11.2025 16:13:00 CET | Press release
Mike Kachmer to retire following a distinguished 43-year career, including nearly 12 years as Chairman & CEO of Duravant Jill Evanko to succeed Mr. Kachmer as Duravant’s Chief Executive Officer Duravant LLC (“Duravant”), a global leader in advanced automation solutions, announced today that Mike Kachmer will retire from his role as Chief Executive Officer after a highly successful tenure with the company. Duravant’s Board of Directors has named Jill Evanko as CEO, joining the company on January 5, 2026. To ensure a seamless transition, Mr. Kachmer will continue to serve as Chairman of Duravant. Mr. Kachmer will also continue to serve on the Board of Directors for Northwestern Memorial Healthcare and The London Clinic. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117036720/en/ Mike Kachmer “It has been a true honor and a humbling experience to lead this incredible company,” said Mr. Kachmer. “I am profoundly grateful to
Wolters Kluwer Enablon Control of Work Solution Now Available as Private Offer in AWS Marketplace17.11.2025 15:00:00 CET | Press release
Wolters Kluwer today announced that its Enablon Control of Work solution is now available in AWS Marketplace as a private offer. This purchasing model empowers customers to negotiate and receive tailored pricing, terms, and licensing agreements, while streamlining procurement and leveraging existing Amazon Web Services (AWS) billing workflows to accelerate deployment and optimize cloud budgets. Wolters Kluwer’s Enablon Control of Work solution consolidates permit-to-work, isolation management and risk assessments into an integrated system. Trusted by frontline workers and contractors in high-risk environments including oil & gas, pharmaceuticals, data center and manufacturing industries, the software helps streamline operations, minimize unplanned downtime and prevent serious injuries and fatalities. Richard Pulliam, SVP & General Manager of EHS & ESG for Wolters Kluwer, said: “Making Enablon's Control of Work solution available in AWS Marketplace is another step in our mission to help
Morningstar's 2026 Outlook Report Delivers Global and Regional Insights for Durable Portfolios17.11.2025 15:00:00 CET | Press release
Morningstar, Inc. (Nasdaq: MORN), a leading provider of independent investment insights, today published its 2026 Outlook, offering an overview of key challenges and opportunities for the year ahead. In a market defined by uncertainty, this year’s report emphasizes the value of preparation over prediction, equipping investors with strategies to focus on fundamentals and help build resilient portfolios that withstand both booms and busts. Drawing on insights from Equity, Manager, and Behavioral research analysts worldwide, this Outlook distills Morningstar’s thinking on how to navigate opportunity and risk across every major asset class in 2026. "Markets are unpredictable, and the geopolitical and tariff uncertainty of 2025 showed just how quickly forecasts can shift. That’s why Morningstar is redefining the Outlook, focusing on durable portfolios rather than short-term predictions,” said Dan Kemp, chief research and investment officer. “No matter what market conditions the year ahead m
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