Japan's Ministry of Health, Labour and Welfare has awarded the Japanese medtech startup CureApp a medical device regulatory approval for its digital therapeutic app for hypertension.

WHAT IT DOES

CureApp's latest DTx app assists patients in maintaining lifestyle improvements as part of their treatment for hypertension. It automatically delivers personalised guidance to users, including advice on diet, exercise, and sleep, which are captured via blood pressure monitoring, as well as lifestyle habit logs and notifications about behavioural changes.

As it helps patients adopt sustainable lifestyle changes, the app is said to bring a therapeutic effect that lowers their blood pressure.

The app also has a doctor-facing version that enables physicians to remotely check on their patients.

WHY IT MATTERS

According to CureApp, the Ministry of Health's approval represents what could be the world's first regulatory approval for a hypertension DTx app.

In Japan, hypertension affects some 43 million and is considered the top risk factor for stroke and heart diseases. Based on recent government data, only 10 million Japanese patients have received treatment for the condition with 70% failing to meet their target BPs or being left untreated.

Following its device clearance, CureApp is set to receive government reimbursement and roll out its app within the year.

THE LARGER TREND

Last year, CureApp published the findings of its clinical trial for the hypertension DTx app. Its study with Jichi Medical University found that the app brought down the risk of developing cardiovascular and cerebrovascular diseases by 10.7%. Using the app could also reduce morning home systolic BP for users by 10 mmHg.

The medtech startup is also developing other DTx apps, one of which is a NASH (nonalcoholic steatohepatitis) therapeutic app which is undergoing clinical trials at the University of Tokyo Hospital. It is also trying out its DTx for alcohol dependency with the National Hospital Organization Kurihama Medical and Addiction Center at the Okayama City General Medical Center. 

CureApp is creating a DTx for breast cancer with Daiichi Sankyo Co. while it is developing a chronic heart failure app with its partners from the Yumino Medical Corp.

ON THE RECORD

"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 behavioural change needed to address the underlying causes of the disease," said CureApp CEO Dr Kohta Satake.

He noted that their new DTx app for hypertension "acts as adjunctive therapy in providing guidance during physicians consultations". It also "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," Dr Satake added.