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
Dompé Doses First Patient in Phase 3 Study of Cenegermin-bkbj in NAION14.7.2026 15:00:00 EEST | Press release
Dompé, a biopharmaceutical company with operations in Italy and the US, announced the first patient has been enrolled in a Phase 3 study of cenegermin-bkbj for the treatment of non-arteritic anterior ischemic neuropathy (NAION). Involving more than 130 centers globally, the Phase 3 trial, “Galassia-NAION-301” is a multicenter, double-blind study comparing cenegermin-bkbj against placebo in improving vision loss caused by NAION. “Our NGF R&D program continues to accelerate with our third clinical study of 2026,” said Marcello Allegretti, Chief Scientific Officer at Dompé. “Dosing the first patient in our NAION trial marks a critical step in our mission to unlock the full potential of NGF. By advancing our proprietary intranasal NGF in clinical investigation, we are taking a bold, non-invasive approach that bypasses the blood-brain barrier and has the potential to redefine the standard of care.” NAION refers to a loss of blood flow to the optic nerve which causes rapid vision loss that u
Esri to Debut the Power of Where Collection at 2026 Esri User Conference14.7.2026 15:00:00 EEST | Press release
Esri, the global leader in location intelligence, will debut the Power of Where Collection at the 2026 Esri User Conference in July. The collection builds on the ideas introduced in The Power of Where: A Geographic Approach to the World's Greatest Challenges, by Esri president Jack Dangermond, published in 2024. The new collection expands these foundational concepts into focused, real-world applications that demonstrate the growing impact of geographic information system (GIS) technology. The first two other books starting the collection are Geowater: A Geographic Approach to Water Data and Forecasting and Parcels: How Property Shapes Geography. Together, these titles illustrate how spatial thinking and GIS are transforming how organizations understand systems, manage resources, and plan for the future. The Power of Where Collection reflects Esri’s ongoing commitment to helping organizations make smarter, more informed decisions across industries—on topics ranging from water sustainabi
Esri Helps Bring Up-to-Date Road Closure Information to Google Maps and Waze14.7.2026 15:00:00 EEST | Press release
Esri has expanded its Community Maps Program, enabling road closure data to be shared with Google Maps and Waze. The Road Closures solution, in Esri's ArcGIS platform, was introduced last year as a way for users to easily share road closure updates directly with popular consumer mapping providers so they can update their maps with this important information. The solution aimed to bridge the gap between government agencies managing timely road updates and the public, who rely on mapping apps for real-time navigation. Over 100 communities around the United States and other countries are actively sharing their road closure information. ArcGIS users can now easily share that same authoritative data with Google Maps and Waze via the Waze for Cities program. "For over a year, we've been working with dozens of our local government users to share their road closure information with our initial consumer mapping partners, Apple Maps and TomTom," said Deane Kensok, chief technology officer for Ar
CE-IVDR Mark for Hologic’s Aptima ® HPV Test Expanded to Include Self-Collected Sample Claim in Cervical Cancer Screening14.7.2026 15:00:00 EEST | Press release
Hologic, Inc. announced today that its Aptima® HPV Assay received an expanded CE-IVDR marking in the European Union and the UK and is now approved for self-collected vaginal samples using the Aptima Multitest Specimen Collection Kit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260714358586/en/ Hologic’s Aptima® HPV Assay and Aptima Multitest Specimen Collection Kit Cervical cancer is the fourth most common cancer in women but is largely preventable through HPV vaccination and regular screening.1 Evidence shows that organized screening and early detection reduces deaths from cervical cancer, with mortality reduction rates in Europe ranging from 41% to 92%.2 However, even in countries with an established cervical screening program, screening participation rates vary widely, from 25% to 80%, with some showing stagnation or decline in recent years.3 “Despite the benefits of cervical cancer screening, there are still barriers
ExaGrid Recognized in the Prestigious 2026 MES Midmarket 100 List14.7.2026 15:00:00 EEST | Press release
ExaGrid®, the industry’s only Tiered Backup Storage solution with AI-Powered Retention Time-Lock (RTL) that includes a non-network-facing tier (creating a tiered air gap), delayed deletes and immutability for ransomware recovery, announced today that MES Computing, a brand of The Channel Company, has highlighted ExaGrid in its 2026 MES Midmarket 100 list. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260714261987/en/ The annual MES Midmarket 100 recognizes technology vendors with deep knowledge of the unique IT needs of midmarket organizations. These vendors are committed to delivering future-focused products and services that support growth, innovation, and success for their midsize customers. MES Computing defines midmarket organizations as those with an annual revenue of $50 million to $2 billion and/or 100 to 2,500 total supported users/seats. Vendors were selected for the MES Midmarket 100 for their go-to-market strate
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