CureApp Inc., a Tokyo, Japan-headquartered software-as-a-medical-device (SaMD) startup, has received regulatory authorization for the manufacturing and sale of Asia’s first therapeutics app, the “CureApp SC Nicotine Addiction Treatment App and CO Checker” (CureApp SC) from the Ministry of Health, Labour and Welfare (MHLW) on 21 August, 2020.

The startup is currently proceeding with plans to receive insurance reimbursement and release CureApp SC in FY2020.

WHAT IT DOES

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.

With a smartphone always by the user’s side, the patient app is able to provide 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.

Prior to the use of the app, the home and work settings were seen as “blank” periods in a treatment program, where a medical professional did not have visibility and thus could not provide appropriate recommendations. 

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.

THE LARGER TREND

Last month, the World Health Organization announced a new smoking cessation initiative that will combine free nicotine replacement therapies with an artificial intelligence-based “virtual health worker,” MobiHealthNews reported. The digital tool comes from virtual-avatar-maker Soul Machines, and aims to dispel misinformation about COVID-19 and tobacco use while helping develop personalized plans to quit smoking.

Back in 2016, Hayward, California-based Chrono Therapeutics, developer of a sensor-enabled nicotine patch with a connected app, raised $47.6 million in Series B financing. The product consists of a transdermal patch embedded with sensors that deliver nicotine when smokers have their strongest cravings.

ON THE RECORD

“We were able to successfully 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,” said Kohta Satake, CEO of CureApp, Inc., who is also a practicing doctor.

“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.”