Korea Biomedical Reviewㅣ 2024-09-04
For 25 years, Choi Tae-geun, CEO of the Korean medical AI company Mediwhale, lived under the illusion of perfect health. But just before turning 26, a routine eye exam with Professor Rim Hyung-taek, who currently serves as the Chief Medical Officer at Mediwhale, shattered that illusion.
Choi was diagnosed with glaucoma—a condition insidiously dubbed the “sneak thief of sight” because it robs individuals of their vision without warning until irreversible nerve damage occurs.
Choi Tae-geun, CEO of Mediwhale, presents his right eye’s visual field test results—black areas indicate complete blindness and gray zones represent partial visibility—during a press conference on Wednesday at LW Convention in Seoul.
At a press conference hosted by Mediwhale on Wednesday, Choi revealed the results of his visual field test: “With my right eye alone, I see barely half of what is considered normal,” he said.
How could someone like Choi, who prided himself on knowing his body inside and out, be losing his sight without any prior sign?
Determined to prevent others from falling victim to such invisible threats, Choi founded Mediwhale in 2016 and developed Reti-CVD for cardiovascular disease, an AI tool that predicts cardiovascular disease within a minute using retinal imaging.
It is currently being adopted by 57 medical institutions in Korea and has been used in over 7,200 cases since its first use in June last year through August of this year, primarily for patients with metabolic conditions such as diabetes and hypertension.
Reti-CVD reveals hidden health risks by identifying cardiovascular issues
Diseases like diabetes and hypertension that gradually damage blood vessels will manifest signs in the eye long before they become critical.
Changes in these blood vessels—be they minor hemorrhages or tiny ischemic areas—can be early indicators of serious conditions like retinal diseases or diabetic retinopathy, which are closely linked to cardiovascular and cerebrovascular diseases.
“When diabetes is diagnosed, one of the primary complications to assess is retinal damage,” Professor Lee Yong-ho of Endocrinology at Severance Hospital and Secretary-General of the Korean Diabetes Association said during the press conference on Wednesday.
The 2023 guidelines from the Korean Diabetes Association now recommend retinal screening for all newly diagnosed patients. For the six million Koreans with diabetes—one in three of whom are over 65—annual eye exams are strongly advised.
Mediwhale’s Reti-CVD is a retinal-based AI diagnostic tool that autonomously assesses future cardiovascular disease risk, categorizing it into low, moderate, or high groups, with results comparable to heart CT scans.
At Severance Hospital, a 67-year-old diabetic woman, grappling with a decade of uncontrolled blood sugar, faced a critical situation. Despite her condition, which had been managed without a history of smoking, heart disease, or high LDL cholesterol, her retinal scan revealed severe cardiovascular risks.
“Reti-CVD’s system classifies risk from low to high, and this patient’s score was alarmingly high for her age,” said Lee. Her risk score of 51 thrust her into the high-risk category, underscoring the importance of early detection.
Currently, around 16 percent of diabetic patients suffer from diabetic retinopathy.
In another case, a patient at Incheon Naeun Hospital, who reported no heart symptoms but had dry eyes, underwent a comprehensive eye examination. The retinal imaging provided by Reti-CVD highlighted a high-risk cardiovascular profile, leading to an urgent referral to a cardiologist.
Subsequent tests revealed significant narrowing in three major coronary arteries, requiring immediate stent placement, which Lee said highlighted the “life-saving potential of early detection.”
Research underscores the gravity of coronary artery calcification, which increases the likelihood of cardiovascular disease. Notably, patients with high levels of coronary artery calcium are four times more likely to suffer cardiovascular events. Over five years, this translates to a 5 percent increased risk, escalating to 10 percent over a decade.
Coronary artery calcium (CAC) tests are currently the most reliable test for assessing cardiovascular risk, revealing calcium deposits in the arteries. However, Rim said its “significant radiation exposure limits its use to diagnostic rather than preventive purposes,” with U.S. guidelines recommending coronary calcium score tests every three to five years due to these concerns.
“Prevention demands more frequent monitoring than CT can provide,” Rim said. While carotid ultrasounds are a common, non-invasive tool in Korea, Rim added that they lack the accuracy of CT scans and are sometimes excluded from guidelines due to this limitation.
Reti-CVD offers a preventive approach combining the precision of CT scans with the safety of radiation-free technology, Rim said, adding that this non-invasive system allows for frequent monitoring—every three to four months—making it a “game-changer in preventive care.”
Rim Hyung-taek, Chief Medical Officer of Mediwhale, discusses the limitations of coronary artery calcium tests and highlights how Reti-CVD’s radiation-free, non-invasive technology enables frequent, preventive cardiovascular monitoring during a press conference on Wednesday.
The technology works by analyzing retinal images through its AI system, which is trained to identify subtle signs of silent diseases. “Our AI doesn’t just look for visible anomalies,” Choi explained. “It integrates a comprehensive range of data, including CAC scans, cholesterol levels, kidney function tests, and metabolic indicators like blood sugar and blood pressure.”
In addition, the AI considers a broad array of physiological metrics—such as body mass index, obesity, age, and gender—alongside factors related to aging and vascular damage. “By training our AI on this extensive data set, we avoid reliance on biased indicators, ensuring balanced precision in assessing overall cardiovascular risk,” Choi added. “This holistic approach maintains accuracy even when some data points are absent.”
Reti-CVD is underpinned by a database of 1.6 million images, drawn from diverse populations across multiple countries and spanning five to 20 years, including real disease events and aligned with crucial tests such as retinal scans and heart CTs.
Mediwhale eyes US market with Reti-CVD
Mediwhale is currently on a global expansion spree, with Korea at the forefront.
Reti-CVD has already received medical device approval from the Korean Ministry of Food and Drug Safety (MFDS) and has secured clearance in eight other regions worldwide, including Europe, the U.K., Australia, and Singapore.
“Our next big leap is breaking into the U.S. market,” Choi said, revealing the company’s goal of securing the FDA’s De Novo designation. No Korean medical AI company has achieved this yet, though Samsung Electronics earned it for the sleep apnea feature on its Samsung Health Monitor app. “We’re optimistic about our chances, as the De Novo track demands rigorous clinical standards that we are meeting.”
Mediwhale plans to submit its De Novo application next year, setting its sights on FDA approval. Reti-CVD is already operational at prominent institutions like Yonsei Severance Hospital and Seoul St. Vincent’s Hospital.
Currently, Reti-CVD is an optional, non-covered service. However, if a physician identifies cardiovascular risk, it may be covered. “Although coverage is determined by hospital discretion and not directly controlled by us or the government, our technology costs about half as much as a heart CT,” said Choi. “This reduces the patient’s financial burden while improving safety and effectiveness.”
출처 : KBR(https://www.koreabiomed.com)