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CureApp: Digital Therapeutic App for Hypertension Receives Insurance Coverage, Sales of the Service to Medical Institutions Across Japan Launch on September 1

CureApp, Inc. (Head Office: Chuo-ku, Tokyo; CEO: Kohta Satake) announces the start of insurance coverage for its CureApp HT Hypertension Adjunctive Treatment App (hereafter, CureApp HT), a DTx*1 solution treating hypertension, in Japan from September 1, 2022. Looking ahead, the app will be prescribed and provided to patients with hypertension as a health insurance treatment at medical institutions.

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Assisting Lifestyle Changes as a Treatment for Hypertension (Graphic: Business Wire)

After confirming the efficacy and safety of CureApp HT through clinical trials, the results of a Japanese Phase III domestic multicenter randomized controlled trial were published in EHJ, one of the most well-respected peer reviewed journals in the world in 2021. In April 2022, CureApp HT was the first digital therapeutics app for hypertension to receive government approval in the world, and the app has been covered by insurance since September 1. This marks the first case of a DTx treatment solution being covered by insurance in the field of hypertension in the world. Looking ahead, CureApp looks to pursue further commercialization efforts of this Japanese-led medical innovation. The impact of hypertension is seen beyond Japan’s borders, and efforts to correct patient lifestyle habits is a common theme across the globe. Therefore, CureApp also plans to proactively expand CureApp HT’s reach all over the world, beginning with the U.S.

Importance of lifestyle changes, current challenges, and the potential of CureAppHT

The Guidelines for the Management of Hypertension 2019 describes that “lifestyle changes are important because not only are they expected to produce a hypotensive effect, but also they prevent hypertension”. The guidelines also say that “lifestyle guidance should be provided to all patients with hypertension, because they could increase the hypotensive effect and reduce the dosage of antihypertensive drugs”. Despite this recommendation, there has been little uptake in such behavioral therapy due to the challenges presented in having patients implement lifestyle changes on a continual basis and limited time of doctor consultation sessions. It is also said that a certain period of guided intervention*2 is needed for lifestyle changes to take hold.
CureApp HT helps to connect doctors and patients, and promotes lifestyle changes that were previously difficult to maintain while ensuring to sustain modified behavior in patients.

*1 An abbreviation of Digital Therapeutics. Products with pharmaceutical approval for use as medical devices.
*2 Kamioka H, Nakamura Y, Yazaki T, Uebaba K, Mutoh Y, Okada S, Takahashi M. Comprehensive health education combining hot spa bathing and lifestyle education in middle-aged and elderly women: one-year follow-up on randomized controlled trial of three- and six-month interventions. J Epidemiol. 2006 Jan;16(1):35-44. doi: 10.2188/jea.16.35. PMID: 16369107; PMCID: PMC7560544.

Summary of clinical trials for this product
https://doi.org/10.1093/eurheartj/ehab559

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

(Nonalcoholic steato-hepatitis)

Under joint development with Sawai Group Holdings Co. /

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 /

Clinical trials underway at the Okayama City General Medical Center, Okayama City Hospital

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/

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