CureApp Inc., developing “Digital Therapeutics ”, starts joint-development and clinical research of Digital Therapeutics for hypertension with Jichi Medical University.

CureApp Inc. (head office: Chuo-ku, Tokyo, President and CEO: Kota Satake) announced it starts joint-development and clinical research of "Digital Therapeutics" for hypertension with Professor Kazuomi Kario of Cardiovascular Medicine, Jichi Medical University. The clinical research explores the anti-hypertensive effects of the "Digital Therapeutics" and aims to create a novel treatment strategy for hypertension other than medication.

Background

CureApp Inc. aims to create a brand new treatment that is individually optimized (personalized) to achieve a higher therapeutic effect in light of mobile technology evolution. In particular, the scope of treatment encompasses patient awareness, habits and time out in the reach of conventional intervention, such as outside of hospital/clinic, at home, or out of workplace, overarching a wide variety of patients’ life. CureApp acknowledges uniqueness of patient’s individual status and aims to establish a mechanism of’ timely follow ups in optimization of treatment.


Hypertension is the biggest risk factor for cardiovascular disease (stroke or heart disease), and the number of deaths due to hypertension in Japan is estimated to be roughly 100,000 people each year. The estimated patient population in Japan is roughly 43 million (* 1); of which patients receiving continuous therapy are considered to be as many as 10.1 million (* 2). The annual medical expense associated with hypertension is roughly 1.8 trillion YEN in recent years which is higher than 1.2 trillion YEN expense of diabetes. As the aging of population continues, medical expenses of cardiovascular diseases increase (* 3)

To address these epidemics and socioeconomic burden of the illness, CureApp Inc. develops "Digital Therapeutics" as a new form of treatment with the use of mobile technology. “Digital Therapeutics" provides individually optimized treatment guidance in patients' daily life, outside of hospital/clinic or at home, based upon clinical evidence. It promotes patient awareness and behavioral changes and supports the development of new habits. CureApp Inc. aims to achieve high therapeutic effects for lifestyle-related diseases. Therefore, in collaboration with the research group of Professor Kario, Jichi Medical University, CureApp Inc. initiates development of "Digital Therapeutics" designated for the treatment of hypertension and has begun clinical research targeting regulatory approval as a novel software as medical device.

About the High Blood Pressure "Digital Therapeutics"

Approximately 60% of Japanese men and 45% of Japanese women over 30 years old are diagnosed as hypertension (* 4). However, little evidence of intervention or guidance method for life-style modification has been established to the date, it is still difficult to expect optimum outcome in general practice. Moving forward, by using data from automated blood pressure monitor with IoT technology, individual patient data of blood pressure and lifestyle are automatically analyzed in optimization of treatment guidance (knowledge of impact that can be made through meals, exercise, sleep habits etc. and information to encourage behavioral changes). We have initiated a multicenter clinical research (140 patients to be enrolled) as of June 2018 to verify the effectiveness of the Digital Therapeutics with evaluation of anti-hypertensive effect and the relationship between improvement of blood pressure and that of lifestyle. Through this clinical research, we aim to build evidence of lifestyle improvements and behavioral changes in treatment of hypertension.

Forward looking statements

We envision an extensive use of "Digital Therapeutics" should prevent exacerbation (worsening) of hypertension and future occurrence of cardiovascular events. We accumulate data to improve treatment in practice targeting regulatory approval of our "Digital Therapeutics" that provide clinically appropriate guidance, even when a patient is outside of hospital/clinic or at home. With this application it is possible to provide high-quality personalized treatment to those at work and/or in remote areas who have difficulty receiving treatment at an adequate frequency. Physicians in primary care can access patient data through the application and utilize it for appropriate pressure management with fewer office visits. In addition, accumulation of chronological data facilitate improvement in accuracy of guidance, as more patients use the application. In conclusion, wider use of the new Digital Therapeutics using digital technology could contribute to the continuous reduction of medication and frequent visits to hospitals/clinicsresulting in reduction of medical costs in future.


About CureApp Inc.

CureApp., Inc. is a MedTech venture company that conducts research, development and manufacturing of Digital Therapeutics as medical devices using advanced software technology based upon clinical evidence. We create a brand new medical services in Japan, envisioning “the future of treatment with an application”.

The aim of a “Digital Therapeutics” is to create a new effective treatment through analysis and guidance provided by an application that uses clinical knowledge and evidence based upon daily progress of treatment of each patient. It also has the possibility to contribute to the improvement of conditions by transforming patient awareness and behavior. What clearly differentiates our Digital Therapeutics from other health care applications is we target regulatory approval as medical device with effectiveness demonstrated through clinical evaluation. We have begun the very first clinical trial of Digital Therapeutics in Japan which evaluates Digital Therapeutics for “nicotine dependence”. The trial is currently ongoing, as we develop other Digital Therapeutics for different diseases. In addition, based upon our development methodology deployed in Japan, we plan to expand globally our “Digital Health Solutions from Japan”.

The current development status of our "Digital Therapeutics" is as follows.

The Nicotine Dependence Digital Therapeutics: Joint development with Department of Internal Medicine (Respiratory) at Keio University School of Medicine. Multicenter clinical trials began in February 2015. Clinical trial began in October 2017. 

The Nonalcoholic Steatohepatitis (NASH) Digital Therapeutics: Collaborative research with the University of Tokyo, School of Medicine. A clinical research started y started in October, 2016 and a multi-center clinical study started in April, 2018.

The Hypertension Digital Therapeutics: Joint development with Department of Cardiovascular Medicine, Jichi Medical University. Clinical studies began in 2018. 

About Jichi Medical University

Name: Jichi Medical University
Location: 3311-1 Yakushiji, Shimotsuke, Tochigi Representative: Toshio Oishi,
Chairman of the Board Established: February 1972

CureApp Inc. Company Profile

Company name: CureApp (CureApp, Inc.)
CEO: Kota Satake
Head Office: Kodenmacho YS Building 4th Floor, 12-5, Kodenmacho, Nihonbashi, Chuo, Tokyo.
Capital and Capital Reserve: 100,000,000 YEN

Inquiries about the Digital Therapeutics ︎
CureApp, Inc. Public Relations, Nanako Daime
E-mail:support@cureapp.jp


<Source> 
* 1: Guidelines of Hypertension Treatment 2014 [JSH 2014]
 Japan Society of Hypertension (2014)

* 2: H.20 (2014) "Outline of Patient Survey" Ministry of Health, Labor and Welfare (2015)

* 3 (Reference): 2012~2017 "An Overview of National Medical Expenses" 
Ministry of Health, Labor and Welfare (2012 - 2017)

* 4 (Reference): 2016 "National Health and Nutrition Survey" 
Ministry of Health, Labor and Welfare (2016)

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