CureApp: World’s First Medical Device Receives Regulatory Approval For Digital Therapeutic App For Hypertension.
Mental and behavioral approaches to lifestyle modification.
TOKYO – 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 medical device regulatory approval of a 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 a reimbursement and launch the app in 2022.
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 for cerebrovascular diseases and heart diseases*1, and medical expenses related to hypertension continues to increase year after year
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.
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 ( Abbreviation of Digital Therapeutics. Software-based treatments) in the field of hypertension
| 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. |
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.
Message from Kohta Satake, M.D. and Representative Director and CEO of CureApp, Inc.
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.
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.