[E-Daily] AMCG Begins Multi-Center Clinical Trials for Ultra-Precise Heart Diagnostic Device

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AMCG announced on the 16th that it will begin clinical trials to evaluate the diagnostic accuracy of MCG Scan for patients suspected of coronary artery disease.

AMCG held a kick-off meeting for the multi-center clinical trial of MCG Scan at Lotte Hotel in Jamsil, Seoul. The meeting was attended by about 30 people, including clinical research physicians and clinical trial officials from Gachon University Gil Hospital, The Catholic University of Korea Eunpyeong St. Mary's Hospital, and Armed Forces Capital Hospital, as well as Dr. Park Hyun-min, Director of the Korea Research Institute of Standards and Science (KRISS), who developed the original technology for MCG Scan and transferred it to AMCG for commercialization, development manager Dr. Lee Yong-ho, and CEO Yoo Jung-hee of CRO Dream CIS.

Professor Lee Kyung-hoon of the Department of Cardiology at Gachon University Gil Hospital, who attended the event, said, "It is unfortunate that many coronary artery disease patients are diagnosed as normal despite many tests until the degree of vascular stenosis becomes serious. With MCG Scan, I expect to obtain accurate diagnostic readings in a short time without side effects for patients."

The MCG Scan equipment for this clinical trial received item approval from the Ministry of Food and Drug Safety for market sale in June last year, and in March, it passed the Clinical Ethics Committee (IRB) review at Gachon University Gil Hospital and The Catholic University of Korea Eunpyeong St. Mary's Hospital, completing all preparations for clinical entry. The multi-center clinical trial will begin on the 19th, with the goal of completing the clinical trial for early diagnosis of coronary artery disease by the end of 2024.

This clinical trial will involve approximately 600 patients to evaluate the diagnostic accuracy of MCG Scan for early diagnosis of coronary artery disease. In particular, it will verify the effectiveness (determination of coronary artery disease, degree of vascular stenosis, and location of stenosis) and stability of MCG Scan through 1:1 comparison with angiography test results. Through this, it plans to lay the groundwork for new medical device certification (NECA) and medical insurance registration (HIRA).

Seo Yong-sung, President of AMCG, said, "In addition to the verification clinical trial for early diagnosis of coronary artery disease, we will conduct clinical studies for the expansion of indications such as cardiomyopathy and paroxysmal atrial fibrillation (arrhythmia). Through this clinical trial, we will accumulate sufficient clinical data for the diagnosis of heart disease, secure the diagnostic excellence of MCG Scan based on this, and publish clinical trial papers to establish MCG Scan as a global heart disease diagnostic device."

This launch of clinical trials for heart diagnostic devices (MCG Scan) is the first case of domestic clinical trials for large medical devices developed with domestic technology.

The MCG Scan owned by AMCG is a system that can accurately diagnose heart disease without the injection of drugs such as contrast media or radiation by using SQUID (Superconducting Quantum Interference Device) sensors to detect tiny magnetic fields generated by the human body. It is particularly specialized for early diagnosis of atherosclerotic coronary artery disease (angina) patients and chemotherapy-induced cardiomyopathy, and in the future, it plans to expand the indications for diagnosis to cover the entire spectrum of heart diseases, including fetal heart disease (arrhythmia) and arrhythmia.

[E-Daily Reporter Na Eun-kyung]