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
NIQ Publishes 2026 ESG Progress Report, Highlighting Action Across Climate, People, Communities, and Responsible AI2.11.2026 13:45:00 EET | Press release
NIQ (NYSE: NIQ), a leading consumer intelligence company, today released its 2026 Environmental, Social and Governance (ESG) Progress Report, detailing the company’s progress on key ESG priorities throughout 2025. The report covers NIQ’s efforts across environmental responsibility, its people and communities, data integrity, and responsible AI. Key highlights from 2025 include: Strengthened its approach to climate risk and environmental measurement: NIQ conducted its first climate risk assessment aligned with Task Force on Climate-related Financial Disclosures (TCFD) recommendations, tracked Scope 1, 2 and 3 emissions under the GHG Protocol, and externally verified its carbon footprint. Invested in associate development, engagement and well-being: Internal mobility increased to 35%, up from 30%, while performance review completion reached 99% and the employee survey response rate reached 89%. NIQ also introduced three new leadership development tracks, while Employee Assistance Program
Agenus Announces Nature Medicine Publication of Multicenter UNICORN Phase 2 Trial Demonstrating Deep Responses with Neoadjuvant BOT+BAL in Resectable Colon Cancer2.11.2026 13:42:00 EET | Press release
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced the peer-reviewed publication of results from the investigator-sponsored, multicenter Phase 2 UNICORN trial evaluating short-course preoperative, or neoadjuvant, botensilimab (BOT), Agenus’ multifunctional, Fc-enhanced anti-CTLA-4 antibody, alone or in combination with balstilimab (BAL), Agenus’ anti-PD-1 antibody, in patients with resectable, locally advanced colon cancer. The manuscript, titled “Preoperative botensilimab with or without balstilimab for patients with resectable, locally advanced pMMR or dMMR colon cancer: the UNICORN trial by GONO,” was published in Nature Medicine and is available at DOI 10.1038/s41591-026-04710-1. The UNICORN trial enrolled 56 patients in four non-randomized cohorts of 14, evaluating BOT alone or BOT+BAL in mismatch repair proficient/microsatellite stable (pMMR/MSS) and mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) colon cancer. The study ass
New Joint Survey from Compass Pathways and the Depression and Bipolar Support Alliance Reveals the Lived Burden of Treatment-Resistant Depression on Patients and Caregivers2.11.2026 13:30:00 EET | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, in partnership with the Depression and Bipolar Support Alliance (DBSA), today released a new report summarizing findings from a national survey of people living with TRD (n=261) and caregivers (n=73) on the self-reported realities of living with a condition that can profoundly affect daily life, revealing the burden of prolonged depressive episodes without meaningful relief. The survey findings demonstrate the impact of TRD across various aspects of everyday life, with many patients reporting years spent cycling through treatments without significant improvement while the condition takes a toll on their hope, identity, relationships and ability to fully engage in life.1 They also underscore the impact on caregivers and families, including substantial personal, emotional and financial sacrifices. “These results give voice to the realities faced
Qorium Becomes Reyva as Cultivated Leather Company Moves Towards Commercial Scale2.11.2026 12:00:00 EET | Press release
Qorium, the company that develops cultivated real leather, today announces that it is becoming Reyva. The new name and identity mark its next stage: moving from a pioneering technology business towards a global material brand built for the exacting standards of the luxury leather sector. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261102661351/en/ Reyva creates beautiful, high-performing real leather. By cultivating leather in uniform sheets, we can move beyond the natural limits of traditional hides, with greater control over its shape, size, thickness and structure. Reyva sample photography by Laurent Stevens Reyva grows collagen directly from animal cells and cultivates it through a proprietary process to create uniform sheets. The resulting material is then tanned to become real leather, made from the same natural material that gives conventional leather its strength, breathability and durability. It does so without t
Ant International Research Highlights How Readable AI Memories Can Unlock More Personalised, Privacy-conscious Consumer Experiences2.11.2026 10:52:00 EET | Press release
Human sales and customer representatives have institutional memories to serve clients: their preferences and choices. How can we build a memory mechanism for AI services to create similarly personalised experiences? Ant International’s research on this subject recently received the Senior Area Chair (SAC) Highlight Award from the Best Paper Committee at EMNLP 2026, a leading global AI conference. Why do we need “readable AI memory”? In this paper titled 'Text as a universal interface for transferable personalisation', we look into one fact: until now, AI memory of a user has usually been generated and stored as dense numerical code only the original system can interpret. Two long-standing problems with that: First, today's user profiles are "black boxes" — opaque code locked inside a single app, so activity in one service teaches nothing to another, and every product has to re-learn you from scratch. Second, profiles are welded to the model that created them, so they don't transfer whe
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