[Money Today] AMCG Begins Clinical Trial to Evaluate MCG Scan Accuracy

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AMCG announced on the 19th 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 World in Songpa-gu, Seoul on the 7th. About 30 people attended, including Dr. Park Hyun-min, Director of the Korea Research Institute of Standards and Science (KRISS), CEO Yoo Jung-hee of CRO Dream CIS, and 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.

The clinical participating research physicians who participated in the event unanimously said that many coronary artery disease patients are diagnosed as normal despite multiple tests until the degree of vascular stenosis becomes serious. They expressed their determination to smoothly lead the clinical trial to effectively verify the diagnostic accuracy of MCG Scan.

Dr. Lee Yong-ho of the Korea Research Institute of Standards and Science said, "There have been many ups and downs in developing next-generation quantum sensors used in MCG Scan equipment over the past 30 years, and I am deeply moved to take the first step in commercialization through AMCG. I hope this clinical trial will be an opportunity for MCG Scan to take deep root in the domestic and overseas medical device markets."

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. 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. Starting from this day, it will enter multi-center clinical trials with the goal of completing clinical trials for early diagnosis of coronary artery disease by the end of next year.

This clinical trial is being conducted to evaluate the diagnostic accuracy of MCG Scan for early diagnosis of coronary artery disease with approximately 600 patients. In particular, it will verify the effectiveness and stability of MCG Scan tests by identifying the presence of coronary artery disease, the degree of vascular stenosis, and the location of stenosis through 1:1 comparison with angiography test results. It also 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."

He continued, "Based on this, we will do our best to secure diagnostic excellence and establish MCG Scan as a global heart disease diagnostic device. We hope that the early detection of various heart diseases through MCG Scan will significantly reduce the number of deaths from heart disease, which is the leading cause of death worldwide."

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

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

AMCG explained that it can complement and replace the step-by-step screening cardiac diagnostic tests currently used for the diagnosis of ischemic heart disease, such as electrocardiogram, exercise stress test, echocardiography, cardiac nuclear medicine test, and cardiac CT, with just one MCG Scan test. This enables precise diagnosis with a sensitivity of more than 90%, they explained.

[Money Today Reporter Park Soo-hyun]