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World’s First Medical Device Regulatory Approval of Digital Therapeutic App for Hypertension

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World’s First Medical Device Regulatory Approval of Digital Therapeutic App for Hypertension Mental and Behavioral Approaches to Lifestyle Modification  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 the medical device regulatory approval of an 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 reimbursement and launch the app in 2022. Hypertension     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

CureApp Hypertension Therapeutics App Clinical trial results announced at ESC Congress 2021 and published in the European Heart Journal, a leading cardiovascular journal

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  CureApp Hypertension Therapeutics App Clinical trial results announced at ESC Congress 2021 and published in the European Heart Journal, a leading cardiovascular journal Japan’s first major leap toward digital therapeutics in the field of hypertension The results of a Japanese Phase III domestic multicenter randomized controlled trial of a digital therapeutic app for hypertension (DTx) jointly developed by CureApp, Inc. (CEO Kohta Satake; hereafter “the Company”) and Jichi Medical University were presented by Professor Kazuomi Kario of Jichi University’s Department of Cardiovascular Medicine at the European Society of Cardiology Congress held at the end of August 2021 (ESC Congress 2021 - The Digital Experience: Late Breaking Trials in Hypertension). The results of this trial were also published in the European Heart Journal, one of the world’s leading journals on cardiovascular disease. Summary of the clinical trial  This clinical trial* 1 ran from January 2020 to December 2020 ev

CureApp and Jichi Medical University collaborate on a hypertension therapeutics app Primary endpoint met in Phase III clinical trial in Japan

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A major step toward realizing a groundbreaking new treatment method for hypertension — the first of its kind in Japan CureApp, Inc. (Head Office: Chuo-ku, Tokyo; CEO: Kohta Satake; hereafter “the Company”) has completed a Japanese Phase III multicenter randomized controlled trial of their digital therapeutics (“DTx”) app to treat hypertension, which was jointly researched by a team led by Professor Kazuomi Kario at Jichi Medical University. Results of this study showed a statistically significant difference in average systolic blood pressure*1 over a 24-hour period – the primary endpoint of this study, demonstrating a hypotensive effect. Moving forward, the Company will seek regulatory approval based on the results of this study. Summary of the clinical trial and efficacy of the hypertension therapeutics app  Commencing in December 2019, this trial*2 evaluated the efficacy and safety of the DTx app when used with patients with essential hypertension who had not received oral treatments

CureApp SC, Digital Therapeutic for Nicotine Addiction: Introducing a New Form of App-based Prescription Treatment Reimbursed in Japan’s Public Healthcare Insurance System

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CureApp SC, Digital Therapeutic for Nicotine Addiction: Introducing a New Form of App-based Prescription Treatment Reimbursed in Japan’s Public Healthcare Insurance System -  The Firs t Digital Therapeutic  to Be Covered by Japan’s Public Healthcare Insurance System CureApp, Inc. (Headquarters: Chuo-ku, Tokyo; CEO: Kohta Satake) has announced that CureApp SC Nicotine Addiction Treatment App and CO Checker (hereafter, CureApp SC) – a treatment app(digital therapeutic) targeting nicotine addiction – is now covered by Japan’s public healthcare insurance system as of December 1, 2020, following a period of clinical trials and regulatory approval. This marks the first case of a digital therapeutics application being covered by the insurance, as well as the first time that a digital therapeutic in the field of smoking cessation treatments has been covered by a country’s national health insurance system in the world. Patients diagnosed with nicotine addiction at a medical institution are elig

【Publication information】 Nicotine Addiction Treatment App With CO Checker Receives Regulatory Approval - CureApp, Inc.

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We are pleased to inform you that the article has been published with the approval of our Nicotine Addiction Treatment App With CO Checker.   Bio Space Asia’s First Prescription “Digital Therapeutic” Approved in Japan; Nicotine Addiction Treatment App With CO Checker Receives Regulatory Approval - CureApp, Inc.   https://www.biospace.com/article/releases/asia-s-first-prescription-digital-therapeutic-approved-in-japan-nicotine-addiction-treatment-app-with-co-checker-receives-regulatory-approval-cureapp-inc-/?s=85&utm_source=dlvr.it&utm_medium=twitter

Asia’s First Prescription “Digital Therapeutic” Approved in Japan ; Nicotine Addiction Treatment App with CO Checker Receives Regulatory Approval

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  Entering a New Age Where Innovative Treatments Are Provided With an App Asia’s First Prescription “Digital Therapeutic” Approved in Japan Nicotine Addiction Treatment App with CO Checker Receives Regulatory Approval The World’s First App-based Nicotine Addiction Treatment     CureApp, Inc. (Headquarter: Chuo-ku, Tokyo; CEO: Kohta Satake) received regulatory authorization for the manufacturing and sale of Asia’s first therapeutics app, the “CureApp SC Nicotine Addiction Treatment App and CO Checker” (hereafter, CureApp SC), from the Ministry of Health, Labour and Welfare (MHLW) on August 21st, 2020. The Company is currently proceeding with plans to receive insurance reimbursement and release CureApp SC in FY2020. CureApp SC  CureApp SC is a prescription medical device designed to aid patients who are receiving outpatient smoking cessation treatment. The device supports patients in their attempt to quit smoking in a home setting.  The product consists of three components - a patient ap