On Monday, ATsens announced the initiation of prescriptions for its long-term continuous electrocardiogram (ECG) monitoring device, AT-Patch, in Japan. This announcement follows just one week after Huinno, another domestic ECG patch manufacturer, revealed a partnership to jointly promote its ECG patch alongside industry giants such as Johnson & Johnson and Yuhan Corp.

Atrial fibrillation (AF), a common type of arrhythmia, increases the risk of stroke, heart failure, and in severe cases, cardiac arrest, and requires early diagnosis and appropriate treatment. In 2019, the estimated number of AF patients in Japan was around 1 million, and this figure is anticipated to rise with the aging population. Japan is one of the few countries in the world where health insurance covers ECGs.

AT-Patch received licensing from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in August 2022 and was subsequently approved for reimbursement in October of the same year. Since June 2023, the product was introduced in selected Japanese hospitals through local distributor Japan Lifeline.

It is the first long-term continuous ECG monitoring device in Korea, which is used in tests to measure, analyze, and monitor heart signals (ECG) to diagnose arrhythmias and other heart diseases. AT-Patch can measure ECG for up to 14 days without charging or changing batteries, and it is dust and water-resistant allowing constant testing even during showers and exercise. Its ECG analysis software, AT-Report is equipped with artificial intelligence (AI) algorithms to quickly analyze patient ECG data.

Huinno’s device also offers similar properties with the ability to monitor patients’ ECG for up to 14 days and analyze the data to provide a report to medical staff also using AI-based software. Accordingly, Huinno stated its intention to take its device global with the network of Johnson and Johnson MedTech. 

However, AT-Sens is the first domestic wearable ECG manufacturer to strike an official supply partnership with the National Health Service (NHS) in the UK and has already won FDA approval last year October. Additionally, the company has already completed supply contracts with 17 countries including Japan, Germany, Switzerland, Greece, Italy, UAE, and Kuwait, and is expanding its global influence by conducting export discussions with 10 countries including the U.S., Spain, and Saudi Arabia. 

"AT-Patch can be used for patients who are at high risk of developing atrial fibrillation after an unexplained stroke or atrial fibrillation ablation, or for patients who experience symptoms of suspected arrhythmia, such as palpitations or dizziness, only once or twice a week," explained Dr. Yoshihide Takahashi of Cardiology at Shin-Yurigaoka General Hospital in Japan.

"We are proud to be the first company to enter the Japanese medical device market, where even the No. 1 global wearable ECG company has not entered," said ATsens CEO Peter Jeong. "We plan to quickly expand our share in Japan and subsequently secure market competitiveness through active overseas expansion."