Asia’s First Prescription “Digital Therapeutic” Approved in Japan ; Nicotine Addiction Treatment App with CO Checker Receives Regulatory Approval
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 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 app, a doctor app, and a portable CO Checker. The patient app leverages the fact that a smartphone is always by the patient’s side, enabling personalized guidance based on a patient’s therapy status and condition. The patient app is used in tandem with the portable CO Checker, allowing patients to accurately measure the concentration of carbon monoxide in their breath at home. Before the app, the home and work settings were seen as “blank” periods in a treatment program, where a medical professional could not provide an intervention. Assisting patients in such settings improves the success rate of smoking cessation. Details on the patient’s condition obtained from the patient app and the CO Checker will be shared with doctors via the doctor app. The doctor app provides doctors with greater insight into the patient’s response to treatments between checkups, allowing them to provide higher quality smoking cessation treatments and achieve greater efficiency.
“Therapeutics apps'' prescribed by doctors for medical conditions represent a new form of treatment that is attracting keen interest both in Japan and abroad. In Europe and the U.S., there exist therapeutic apps that have already obtained regulatory approval and have been prescribed to patients under national and private insurance systems. The safety and efficacy of CureApp SC has been demonstrated through clinical trials and, following preliminary approval from the Medical Devices and In-Vitro Diagnostics Working Group, Pharmaceutical Affairs and Food Sanitation Council of MHLW on June 19, CureApp SC received official regulatory approval by MHLW on August 21st. This is the world’s first therapeutics app to receive national regulatory approval for effectively treating nicotine addiction.
For inquiries from medical professionals regarding this product (CureApp SC teaser site)
Summary of clinical trials for this product (CureApp blog)
About Nicotine AddictionNicotine addiction involves both “physical addiction” and “mental addiction.” While smoking-cessation drugs are effective at treating the physical addiction and associated withdrawal symptoms, doctors struggled to tackle mental addiction with conventional approaches. The difficulty is due to physical and time restrictions that healthcare professionals have in providing therapeutic intervention outside the doctor’s office. The restrictions lead many patients to struggle against the addiction by themselves. In Japan, the success rate of conventional smoking cessation outpatient treatment at the one year mark remain under 30% (*1); there is great need for a more effective method of treatment.
The soaring rise in medical expenses in Japan has also come under the spotlight as a pressing social issue. Economic losses from excessive medical spending and labor losses caused by smoking are estimated at around 4.3 trillion yen (*2). This therapeutic app is expected to effectively reduce the smoking population, thereby reining in future medical spending.
*1: Report on a Fact-finding Survey into Smoking Cessation Success Rates at Authorized Insurance Medical Institutions that Measure Nicotine Dependency Rates (2009 Survey)
*2: Smoking and Health - Ministry of Health, Labour and Welfare (https://www.mhlw.go.jp/content/000550455.pdf)
Message from Kohta Satake, CEO of CureApp, Inc. and Practicing DoctorWe were able to succsessfully develop Japan’s first therapeutic app within six years of our founding. Therapeutic apps are already being prescribed in some countries, and many companies from across the globe are aggressively pursuing new research and development. However, cases such as ours where regulatory approval has been granted following a strict series of clinical trials remain few and far between. I have seen countless patients over the years as a pulmonologist, and I have unwavering confidence that this nicotine addiction therapeutic app receiving the regulatory approval will bring Japanese smokers a new approach to smoking cessation. Looking ahead, we will focus our efforts on promoting “app-based therapeutics” as a new method of treatment while continuing to push forward research and development into treatments for various other ailments besides nicotine addiction.
About CureApp, Inc.CureApp, Inc. is a software-as-a-medical-device (SaMD) startup. CureApp manufactures and distributes SaMDs (“therapeutic apps*”) backed by advanced software technology and medical evidence and rigorous research and development. The Company has been working to establish a new healthcare service in Japan offering app-based therapeutics.
Therapeutic apps currently in research and development include a nicotine addiction treatment app jointly developed with the Division of Pulmonary Medicine, Department of Medicine, Keio University, School of Medicine; a nonalcoholic steato-hepatitis (NASH) treatment app jointly developed and currently undergoing clinical trials with the University of Tokyo Hospital; and a hypertension treatment app jointly developed and undergoing clinical trials with the Department of Cardiovascular Medicine, Jichi Medical University.
In addition to designing apps for medical institutions, CureApp draws upon the knowledge accumulated over the course of development to provide lifestyle improvement apps to corporations. This mobile health program, the “ascure Smoking Cessation Program,” has been introduced to over 180 corporations, health insurance associations, and local municipalities.
CureApp plans to sequentially roll out this “digital health solution from Japan” worldwide, based on the model established in Japan.