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
Compass Pathways Appoints Kelley Boucher as Chief People Officer30.9.2026 13:30:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced the appointment of Kelley Boucher as Chief People Officer, effective today. This appointment strengthens the Compass executive team as the company continues to scale in support of its mission to bring the first classic psychedelic treatment to the field of psychiatry. In this role, Ms. Boucher will oversee the Company’s people strategy, with an initial focus on guiding its planned evolution towards the launch of COMP360 psilocybin, subject to FDA approval, in the first half of 2027. "We are thrilled to welcome Kelley to our executive team at this pivotal moment in Compass’ journey. As we prepare for our NDA submission in the fourth quarter of this year, we are closer than ever to achieving our goal of introducing an entirely new treatment model in mental health care with COMP360 psilocybin," said Kabir Nath, Chief Executive Officer a
NIQ Expands Google Relationship with Meridian Integration into NIQ Cadence™30.9.2026 13:30:00 EEST | Press release
NIQ (NYSE: NIQ), a leading consumer intelligence company, today announced the expansion of its relationship with Google through the integration of Meridian, Google's open-source MMM framework, into NIQ Cadence™, NIQ's AI-native marketing effectiveness operating system. The strategic partnership gives marketers a single place to measure marketing performance and act on it, shortening the distance between insights and optimization. Marketing leaders are under growing pressure to prove the return on every media dollar, and traditional measurement has struggled to keep pace. In NIQ’s latest CMO Report, 74% of CMOs said they were under more scrutiny to prove marketing ROI, while just 9% felt they had adequate access to real-time insights. NIQ Cadence™ was built to help close the 65-point actionability gap between accountability and timeliness. Rather than treating measurement as a one-time event, the integration brings Meridian into NIQ Cadence™, a unified platform which brings data, models
EUMETSAT: Media Invitation30.9.2026 13:17:00 EEST | Press release
For the first time, weather forecasters will have access to near-real-time, four-dimensional observations of the atmosphere over Europe every 30 minutes from Europe’s first meteorological infrared sounder in geostationary orbit. EUMETSAT invites media to mark this milestone as the Infrared Sounder (IRS) on board MTG-S1 enters operational service. To mark the occasion, MTG-S1 will also take the name Meteosat-13. The event will showcase the first operational IRS data and EUMETSAT’s 4D weather cube, which combines observations of atmospheric profiles, winds, convection and lightning from three key MTG instruments. Before MTG, only weather models could provide this complete view; now it can be built from real observations and updated every 30 minutes. Journalists will have the opportunity to discover the new data and hear how they can support weather forecasting and the monitoring of rapidly developing and potentially severe weather. Media representatives are invited to register by contact
Sitetracker Selected by BNZ to Support Scalable Multitechnology Renewable Energy Growth Across Southern Europe30.9.2026 13:07:00 EEST | Press release
Sitetracker, the global leader in complete Asset Lifecycle Management for critical infrastructure, today announced that BNZ, an independent power producer (IPP) focused on renewable energy across Southern Europe, has selected Sitetracker to streamline and scale the management of its growing multitechnology portfolio. BNZ develops, builds, and operates utility-scale renewable energy assets across Spain, Italy, and Portugal. Its portfolio exceeds 2.7 GW across development, construction, and operation, including 530 MW connected and 222 MW under construction. To support its continued growth, BNZ sought a centralized platform to improve visibility, standardize workflows, and strengthen operational efficiency across the full asset lifecycle. “The next generation of renewable energy leaders will be defined by how efficiently they can scale,” said Giuseppe Incitti, CEO of Sitetracker. “BNZ is taking a proactive approach to building the operational infrastructure needed to support long-term gr
Linesight Appoints John Butler as CEO30.9.2026 13:00:00 EEST | Press release
Linesight, the global construction consultancy, today announced the appointment of John Butler as Chief Executive Officer, effective 1 January 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260930482486/en/ John Butler, incoming CEO of Linesight (left), and Paul Boylan, Group CEO of IPS-Integrated Project Services, LLC (right). Butler will become CEO of Linesight effective 1 January 2027, succeeding Boylan, who will continue to lead the wider group. Butler will succeed Paul Boylan, who will remain closely involved with Linesight and its clients as Group CEO of IPS-Integrated Project Services, LLC (IPS). Boylan will continue to lead this wider group, encompassing IPS, Linesight and Springtide. Today, the group comprises of more than 4,500 people and generates approximately $2 billion in net revenue, providing multi-sector solutions through its specialist brands. Linesight is a global construction consultancy with over 5
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