CureApp Hypertension Therapeutics App: Clinical Trial Results Announced at ESC Congress 2021 and Published in the European Heart Journal, a Leading Cardiovascular Journal
13.9.2021 11:49:00 EEST | Business Wire | Press release
The results of a Japanese Phase III domestic multicenter randomized controlled trial of a digital therapeutic app for hypertension (DTx) jointly developed by CureApp, Inc. (CEO Kohta Satake; hereafter “the Company”) and Jichi Medical University were presented by Professor Kazuomi Kario of Jichi University’s Department of Cardiovascular Medicine at the European Society of Cardiology Congress held at the end of August 2021 (ESC Congress 2021 - The Digital Experience: Late Breaking Trials in Hypertension). The results of this trial were also published in the European Heart Journal, one of the world’s leading journals on cardiovascular disease.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210913005308/en/
Overview of the digital therapeutic intervention (HERB system) for essential hypertension. (Graphic: Business Wire)
Summary of the clinical trial
This clinical trial*1 ran from January 2020 to December 2020 evaluating the efficacy and safety of the therapeutic app for patients with essential hypertension. This trial was performed as a comparative study of two groups, a control group who received guidance on lifestyle changes based on the Guidelines for the Management of Hypertension 2019 (hereafter, the “Guidelines”)*2, and an intervention group who used this therapeutic app in addition to applying lifestyle changes in accordance with said Guidelines.
This represented the world’s first trial of a therapeutic app for the purpose of regulatory approval in the field of hypertension.
Efficacy and clinical significance of the hypertension therapeutic app
The difference in the 24-hour systolic blood pressure between the groups (adjusted mean value) based on ABPM*3 at the study entry point of 12 weeks – the primary evaluation item – was -2.4 mmHg, indicating a significant hypotensive effect in the intervention group using the therapeutic app compared to the control group (Fig. 1).
The control group was provided guidance on lifestyle changes, and had their blood pressure monitored every day. A difference in the 24-hour systolic blood pressure between the groups based on ABPM of -2.4 mmHg represents a clinically significant change, reducing the risk of developing cardiovascular diseases and cerebrovascular diseases by 10.7%.*4
Further, the difference between the groups in terms of morning home SBP (systolic blood pressure) at the 12 week mark of the study was -4.3 mmHg (Fig. 1), an effect that was sustained until the 24 week mark. A J-HOP study*5 of patients at risk of cardiovascular disease in Japan found that morning home SBP is an independent risk factor for cerebral apoplexy, showing that an increase in systolic blood pressure of 10 mmHg increased the risk of a stroke by 36%. The 10 mmHg reduction of morning home SBP provided when using this therapeutic app demonstrates a clinically significant outcome in reducing cardiovascular diseases, while also demonstrating the effectiveness of the therapeutic app as an option for treating hypertension in the future.
ABPM: Ambulatory blood pressure monitoring,
Morning home SBP: Morning home systolic blood pressure
Evening home SBP: Evening home systolic blood pressure
Office SBP: Systolic blood pressure upon consultation
source：European Heart Journal, ehab559, https://doi.org/10.1093/eurheartj/ehab559
About hypertension
Hypertension is highly prevalent in Japan, with some 43 million*2 patients nationwide, and medical costs associated with hypertension upwards of around 1.8 trillion yen*6. Hypertension is the highest risk factor for cardiovascular and cerebrovascular diseases (stroke and heart disease), and an estimated 100,000 people*7 die of hypertension-induced cardiovascular and cerebrovascular diseases every year. Despite this, only 10 million people*8 are said to receive continuous treatment for hypertension, and mild stage medical intervention remains inadequate, with 70% of patients failing to meet their target blood pressure, or left untreated. While the importance of early adoption of sustainable lifestyle changes outside medical clinics and at home in order to maximize the benefit of treatments is being emphasized, there are large numbers of patients that are not receiving treatment at a medical clinic and, even for patients that are receiving treatment, there are limits to what doctors can achieve by providing individually-tailored lifestyle guidance within a limited consultation time frame.
The potential of a “therapeutic app” for hypertension
While lifestyle improvements are vital for treating hypertension, maintaining such changes is dependent on a patient’s values and motivation, their workplace and home environment, and other factors. This presents challenges for effective intervention by medical institutions.
In response to these issues, the DTx app automatically delivers personalized treatment guidance directly to the individual (optimal nutritional, exercise, and sleeping advice based on IoT blood pressure monitoring and lifestyle habit logs, and notifications prompting behavioral changes). This form of treatment encourages awareness and helps patients to adopt sustainable lifestyle changes, thereby providing a therapeutic effect that lowers blood pressure and alleviates hypertension. Doctors can also use the doctor’s app to check up on the lifestyle changes the patient has made, while the therapeutic app helps bring the patient and doctor closer together, improving the quality of medical care and facilitating the adoption of sustainable lifestyle changes.
*1 Kario K. Nomura A. Satake K. et al. A multicenter clinical trial to assess the efficacy of the digital therapeutics for essential hypertension: Rationale and design of the HERB-DH1 trial. J Clin Hypertens. (Greenwich) 2020;22(9):1713-1722 https://doi.org/10.1111/jch.13993
*2 Guidelines for the Management of Hypertension 2019 [JSH2019] The Japanese Society of Hypertension (2019) https://www.jpnsh.jp/guideline.html
*3 Ambulatory blood pressure monitoring (ABPM): Continuous blood pressure measurements taken at predetermined intervals over a 24 hour period during the course of one’s daily life. This helps determine variations in blood pressure (variation patterns over the course of a day). This is important due to the various factors which may alter one’s blood pressure.
*4 Is antihypertensive treatment based on home blood pressure recommended rather than that based on office blood pressure in adults with essential hypertension? Calculated based on the (meta-analysis) formula
Satoh M, Maeda T, Hoshide S, Ohkubo T. Is antihypertensive treatment based on home blood pressure recommended rather than that based on office blood pressure in adults with essential hypertension? (meta-analysis). Hypertens Res.2019;42:807-816.
*5 Hoshide S, Yano Y, Haimoto H, et al. Morning and Evening Home Blood Pressure and Risks of Incident Stroke and Coronary Artery Disease in the Japanese General Practice Population: The Japan Morning Surge-Home Blood Pressure Study. J-HOP Study Group.Hypertension. 2016;68:54-61.
https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.116.07201?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
*6 “Medical Care Expenditure Summary” 2018 Study (Ministry of Health, Labour and Welfare)
https://www.mhlw.go.jp/toukei/saikin/hw/k-iryohi/18/index.html
*7 “Vital Statistics Summary” 2019 Study (Ministry of Health, Labour and Welfare)
https://www.mhlw.go.jp/toukei/saikin/hw/jinkou/kakutei19/dl/15_all.pdf
*8 “Patient Study” 2017 Study (Ministry of Health, Labour and Welfare)
https://www.mhlw.go.jp/toukei/saikin/hw/kanja/17/dl/05.pdf
Details on the presentation and paper releasing the results of this clinical trial
[European Society of Cardiology (ESC Congress 2021 - The Digital Experience)]
Late Breaking Trials in Hypertension
Speaker: Kazuomi Kario Jichi Medical University - Tochigi, Japan
https://digital-congress.escardio.org/ESC-Congress?_ga=2.248172036.2087792987.1628038424-1168805000.1620870041
[European Heart Journal]
Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial
European Heart Journal, ehab559, https://doi.org/10.1093/eurheartj/ehab559
About CureApp, Inc.
CureApp, Inc. is a medtech startup that conducts research and development and manufactures and distributes software medical devices. They focus on the development of Therapeutic Apps that realize the new medical concept of applying advanced software technology and medical evidence to treat diseases. In August 2020, CureApp obtained regulatory approval for "CureApp SC," the first nicotine addiction treatment application and CO checker in Japan, and in December of the same year, it received approval for national insurance reimbursement.
The following digital therapeutics are also currently undergoing research and development
- NASH (nonalcoholic steato-hepatitis) therapeutic app (jointly developed with the University of Tokyo Hospital, clinical trial ongoing)
- Alcohol dependency therapeutic app（jointly researched with the National Hospital Organization KURIHAMA Medical and Addiction Center, clinical trial started at the Okayama City Hospital, Okayama City General Medical Center）
- Cancer patient support therapeutic app (jointly developed with the DAIICHI SANKYO COMPANY, LIMITED)
CureApp also draws upon the knowledge accumulated through the development of these therapeutic apps for medical institutions to provide the “ascure Smoking Cessation Program” and “Specific Health Guidance-based ascure Smoking Cessation Program,” a mobile health program for corporations that has been taken up at over 200 corporations and health insurance associations. CureApp leverages their knowledge in servicing both medical and corporate clients in providing an online smoking cessation program, “ascureDr. Smoking Cessation Program,” to health insurance associations, corporations, and municipalities to facilitate CureApp SC® prescriptions.
Moving forward, CureApp will look to sequentially roll out their digital therapeutics solutions worldwide.
* “CureApp SC” is a registered trademark of CureApp.
[CureApp, Inc. Company Profile]
Representative Director and CEO: Kohta Satake
Head office: Kodenma-Cho YS building 4F, 12-5, Nihonbashi Kodenma-Cho, Chuo-ku, Tokyo, Japan
Business description: Development of medical device programs, mobile health-related services
URL: http://cureapp.co.jp/
[Jichi Medical University Overview]
Name: Jichi Medical University
Representative: Director, Toshio Oishi
Address: 3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan
URL: http://www.jichi.ac.jp/
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/20210913005308/en/
Contact information
[Contact Details]
For research inquiries
Department of Cardiovascular Medicine, Jichi Medical University
Professor Kazuomi Kario
E-mail: kkario@jichi.ac.jp
For inquiries regarding therapeutics apps
CureApp, Inc.
PR Representative, Yuuki Mishima
E-mail: pr-team@cureapp.jp
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
Day One Strategy Founders Recognised in The LDC Top 50 Most Ambitious Business Leaders for 20267.10.2026 20:00:00 EEST | Press release
Hannah Mann and Abigail Stuart, Co-Founders of Day One Strategy have been recognised as one of The LDC Top 50 Most Ambitious Business Leaders for 2026. The programme was created by private equity investor LDC, part of Lloyds Banking Group, in partnership with The Times. Since 2018, it has celebrated the ambition and achievements of hundreds of exceptional entrepreneurs. This year The LDC Top 50 attracted more than 620 nominations from across the UK, highlighting the depth of ambition among leaders building successful businesses in every region and sector. The leaders featured are driven by an appetite for growth that is helping to build stronger, more sustainable businesses and a more competitive UK economy. They are expanding internationally, developing new products and services, challenging established markets and investing in their people. Together, their businesses generate £1.4bn in annual revenues and employ almost 8,500 people. Headquartered in 55 towns and cities, they demonstr
TestMu AI Adds Evidence Packs to Kane CLI, Turning Every AI Test Run into One Portable, Shareable File7.10.2026 17:29:00 EEST | Press release
TestMu AI (formerly LambdaTest), the Full Stack Agentic AI Quality Engineering platform, announced evidence packs for Kane CLI, its terminal-first tool for natural language browser and mobile app testing. Every Kane CLI run now produces one sealed .evidence file that holds the complete record of what the AI agent was asked to do, what it did at each step, and what happened. Kane CLI launched in April 2026, giving developers and AI coding agents a way to run tests on real browsers and mobile apps from the terminal, in plain English, with a clear pass-or-fail verdict. Since launch, it has added AI-powered test case generation and the Assurance Lifecycle, which ties tests back to requirement documents. Evidence packs are the next step: a full record of every run. As AI agents write and run more tests, engineering teams need a clear answer to a simple question: what exactly did the agent do, and why did the run pass or fail? That proof is often spread across screenshots, log folders, and d
Medisca and EUROAPI Form Strategic Partnership to Strengthen API Access for Pharmaceutical Compounding7.10.2026 17:07:00 EEST | Press release
Medisca and EUROAPI have formed a strategic partnership focused on expanding API access for pharmaceutical compounding, creating differentiated access in North America and establishing a broader framework for international growth and peptide collaboration. For more than three decades, Medisca has built its business around the evolving needs of pharmaceutical compounders. That starts with the products it chooses to bring to market but extends much further to the manufacturers behind them, the documentation and technical information supporting them, and the quality systems that carry those products through to the customer. The partnership with EUROAPI advances that approach. Under the new strategic partnership, Medisca becomes EUROAPI’s first strategic distribution partner focused on bringing its European-manufactured APIs to the North American compounding market. The collaboration includes exclusive supply arrangements for selected APIs and creates a framework to expand the offering ove
iQmetrix Launches Vendor Managed Inventory Integration with Valor Communication7.10.2026 17:00:00 EEST | Press release
iQmetrix, the global provider of Intelligent Commerce Operating Systems for telecom, is launching a Vendor Managed Inventory integration with Valor Communication, a factory-direct wireless accessory manufacturer and distributor serving carriers, retailers, and dealers since 1997. Built into the iQmetrix Intelligent Commerce Operating System, the integration connects Valor's assortment directly to the platform telecom retailers already run their business on – so replenishment runs on real sell-through data instead of guesswork, and approved accessories move from Valor's floor to the peg without manual reordering. The integration will be available to retailers across the iQmetrix client base. The addition of Valor Communication marks another step in the rapid expansion of the iQmetrix Partner Ecosystem, bringing clients a growing network of integrated partners that work natively inside the platform they already run their business on. This press release features multimedia. View the full
Hightouch Names Matthew Lubeck General Manager, EMEA7.10.2026 16:40:00 EEST | Press release
Hightouch, the leader in data and AI for marketing, has named Matthew Lubeck General Manager, EMEA. Based in London, Lubeck will lead all of Hightouch's go-to-market functions across EMEA as the company helps brands in the region move to agentic marketing. Hightouch already has a strong foundation in Europe, with offices in London and Paris, and native-speaking teams in France, the German-speaking markets, Italy, the Nordics, Benelux, and the Middle East. It supports EU data residency and runs inside each customer's own data warehouse, so customer data never has to be copied into another platform. Brands across the region use Hightouch, including Accor, HelloFresh, Currys, Telenor, Salomon, Bolt, Nando's, and Depop. The company is also growing its Middle East presence, with a new team in Dubai focused on the UAE and Saudi Arabia. Lubeck's appointment follows more than 100 percent growth for Hightouch in each of the past two years, and its $150 million Series D earlier this year. Lubeck
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