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Japan Cancels CureApp’s DTx Hypertension App



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Japan Cancels CureApp’s DTx Hypertension App


Japan’s Ministry of Health, Labor and Welfare has granted Japanese medical technology startup CureApp a medical device regulatory approval for its digital hypertension therapy app.

WHAT DOES HE DO

CureApp’s latest DTx app helps patients maintain lifestyle improvements as part of their hypertension treatment. It automatically provides personalized guidance to users, including diet, exercise and sleep recommendations, captured through blood pressure monitoring, as well as lifestyle logs and behavioral change notifications.

Because it helps patients make sustainable lifestyle changes, it is said to have a therapeutic effect that lowers blood pressure.

The app also has a doctor-oriented version that allows doctors to remotely monitor their patients.

BECAUSE IT MATTER

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

In Japan, hypertension affects an estimated 43 million and is considered the leading risk factor for stroke and heart disease. According to recent government data, only 10 million Japanese patients have received treatment for the condition and 70% have not reached target blood pressure values ​​or have received no treatment.

Once the device is approved, CureApp will receive the reimbursement from the government and launch its app within the year.

THE BIGGEST TREND

Last year, CureApp published the results of its clinical trial for the DTx hypertension app. Their study with Jichi Medical University found that the app reduced the risk of developing cardiovascular and cerebrovascular diseases by 10.7%. Using the app could also lower users’ home morning systolic blood pressure by 10 mmHg.

The medtech startup is also developing other DTx apps, one of which is a NASH (non-alcoholic steatohepatitis) therapy app that is in clinical trials at Tokyo University Hospital. He is also testing his DTx for alcohol addiction with the Kurihama National Hospital Organization Addiction and Medical Center at Okayama City General Medical Center.

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

IN THE DOCUMENT

“Hypertension is a disease that many suffer from in silence. It is a notoriously difficult disease to manage and cure, requiring fundamental lifestyle changes. Patients tend to have a low sense of urgency to treat this disease while still having few subjective symptoms of the disease and it is difficult to maintain the level of behavior change needed to address the underlying causes of the disease,” said Kohta Satake, CEO by CureApp.

He noted that his new DTx hypertension app “acts as a complementary therapy by providing guidance during doctor visits.” He also “helps patients outside of the office address lifestyle changes the right way to get to the root cause.”

“The app also gives clinicians a way to catch up on measures put in place during gaps in patient treatment and lifestyle habits, and enables them to deliver better-quality healthcare, better tailored to the needs of patients.” individual patients,” Dr. Satake added.

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