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
KATE Launches "KABUKE: Break Convention" Kabuki-Inspired International Campaign17.7.2026 10:00:00 EEST | Press release
Global cosmetics brand KATE launched “KABUKE: Break Convention,” a new international campaign drawing on elements of Kabuki, the traditional Japanese performing art. The campaign debuted on Wednesday, July 8, 2026. In this campaign, KATE’s shadow enhancing makeup—rooted in Japanese aesthetics—was paired with the Kabuki spirit inherited from traditional Kabuki theater to communicate the value of individuality and self‑expression through makeup on a global scale. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708829427/en/ KATE international campaign “KABUKE: Break Convention” key visual. Dedicated website: https://www.kate-global.net/my/special/kate_kabuki/ Since its founding, KATE has championed the slogan “NO MORE RULES.,” offering makeup that defies convention and empowers individuals to express their identity and bring out confidence. At the heart of this vision is the brand’s signature shadow enhancing makeup approach
Yoshihiro Shimamura Joins the Marché du Film’s “Investors Circle 2026” as an Invited Investor, Backing a New Feature Film17.7.2026 04:00:00 EEST | Press release
Shimamura Yoshihiro Film Production Co., Ltd. (Head office: Osaka, Japan; Representative Director: Yoshihiro Shimamura), a company active in film production and investment, today announced that Representative Director Yoshihiro Shimamura has decided to invest in an international feature film after being invited to the “Investors Circle 2026” — a distinction that reflects his standing as one of the field’s most highly regarded producers and investors. Hosted by the Marché du Film, the business arm of the Festival de Cannes and one of the world’s largest film markets, the Investors Circle is an invitation-only summit that connects a select group of private investors with high-end feature films during early-stage financing. Held in Cannes, France, May 16-17, 2026, it brings internationally acclaimed directors and producers together with investors around a curated slate of projects in development. During the summit, Shimamura attended private pitching sessions and, after individual meeting
Meiji Seika Pharma: Results from the Global Phase III Trial (Integral-2) of Nacubactam, a Novel β-Lactamase Inhibitor, Highlighted in The Lancet Microbe ’s Coverage of ESCMID Global Congress 202617.7.2026 04:00:00 EEST | Press release
Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, President and Representative Director: Toshiaki Nagasato) today announced that results from the global Phase III trial (Integral-2) of nacubactam (Development Code: OP0595), a novel β-lactamase inhibitor, were highlighted in The Lancet Microbe’s coverage of ESCMID Global Congress 2026 (held in Munich, Germany). As highlighted in The Lancet Microbe’s coverage, the key findings presented by Meiji Seika Pharma at ESCMID Global Congress 2026 are as follows: The Integral-2 study (jRCT2031230076) is a global Phase III clinical trial that enrolled patients with complicated urinary tract infections, acute uncomplicated pyelonephritis, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, or complicated intra-abdominal infections caused by carbapenem-resistant Gram-negative bacteria (excluding Acinetobacter species). The study has achieved the prespecified study objectives. For the primary endpoint of overall treatme
Takeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis Studies17.7.2026 01:00:00 EEST | Press release
Takeda (TSE:4502/NYSE:TAK) announced new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented at the 2026 American Academy of Dermatology (AAD) Innovation Academy, these secondary endpoint data show that zasocitinib demonstrated consistent and high rates of skin clearance across hard-to-treat, high-impact sites, including the scalp, nails, palms and soles, compared with placebo.1-5 These data build on the topline results from the Phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled LATITUDE PsO 3001 and 3002 studies.2,6 In those studies, about 70% of patients treated with zasocitinib achieved static Physician Global Assessment (sPGA) 0/1 (clear or almost clear skin) at week 16, with a significantly greater Psoriasis Area and Severity Index (PASI) 75 response rate seen as early as w
Merz Completes Inaugural €450 Million Schuldschein Loan Issuance17.7.2026 00:36:00 EEST | Press release
The Merz Group has successfully completed its first-ever Schuldschein loan issuance, placing a total volume of €450 million in the debt capital market – a multiple of three relating to the launch volume. The debut transaction was significantly oversubscribed and attracted strong interest from all investor groups. The proceeds were settled and paid out today. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260716926041/en/ Dr. Almuth Steinkühler, Chief Financial Officer Merz Group The transaction comprises both fixed- and floating-rate tranches with maturities of three, five, seven, and ten years. Around 50 German and international investors participated, representing a broad range of institutions, including private banks, German federal state-owned banks, public savings banks, cooperative banks, pension funds and occupational pension institutions. With the successful placement, Merz has further diversified its funding base by
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