[Chosun Biz] AMCG Begins Clinical Trial to Evaluate Heart Disease Diagnostic Accuracy

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Start of clinical trial to evaluate magnetocardiography scan equipment accuracy

Comparing scan results and angiography test results with 600 patients

Medical device company AMCG announced on the 19th that it has begun clinical trials to evaluate the diagnostic accuracy of its Magnetocardiography (MCG) Scan for patients suspected of coronary artery disease.

This clinical trial, which will be completed by the end of next year, will be conducted by comparing MCG Scan results with angiography test results for about 600 patients. If the effectiveness and stability of MCG Scan tests are verified, the company plans to use these results as a foundation for new medical device certification from the Korea Health Technology Assessment Agency (NECA) under the Ministry of Health and Welfare and for medical insurance registration with the Health Insurance Review and Assessment Service.

Coronary artery disease occurs when the three vessels that deliver blood to the heart muscle, known as coronary arteries, become blocked. It is ranked as the second leading cause of death in Korea after cancer, with cardiovascular diseases such as acute myocardial infarction being typical examples.

The MCG Scan equipment owned by AMCG is a system that diagnoses cardiovascular diseases without drugs or radiation by measuring tiny magnetic fields generated by the human body. The Superconducting Quantum Interference Device (SQUID) sensor used here can measure magnetic field changes as small as one ten-billionth of the Earth's magnetic field.

The company believes that it can replace existing electrocardiogram tests for the diagnosis of ischemic heart disease with just one MCG Scan test. This equipment 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.

Clinical researchers unanimously said that coronary artery disease patients are often diagnosed as normal even when the degree of vascular stenosis is serious, and they will effectively verify the diagnostic accuracy of MCG Scan tests through clinical trials.

Professor Lee Kyung-hoon of the Department of Cardiology at Gachon University Gil Hospital, who is participating in this clinical trial, said, "I expect that MCG Scan tests will provide highly accurate diagnostic readings in a short time without side effects for patients. We will lead successful clinical trials to verify the diagnostic accuracy of MCG Scan tests."

Seo Yong-sung, CEO of AMCG, said, "Through this clinical trial, we will accumulate sufficient clinical data for the diagnosis of heart disease. Based on this, we will secure the diagnostic excellence of MCG Scan and do our best to establish it as a global heart disease diagnostic device."

[Chosun Biz Reporter Yeom Hyun-ah]