Mediwale, a Korean medical artificial intelligence (Medical AI) company, announced today that it has secured 15.8 billion KRW (approximately 11.9 million USD) in Series B2 funding. This round of funding involved both existing and new shares, with participation from the Korea Development Bank(KDB), Woori Venture Partners, IMM Investment, and Mirae Asset Securities.

Following a 3.3 billion KRW Series A investment in 2021 and an 11.4 billion KRW Series B1 investment in 2023, Mediwale has successfully secured additional funding.

Founded in 2016, Mediwale is a medical AI company that developed the world’s first “Reti- CVD” solution, which can predict cardiovascular disease within a minute using a simple retinal scan. The company has proven through world-renowned medical journals that Reti- CVD can predict cardiovascular disease risk as accurately as a cardiac CT scan. In Korea, it was approved as a new medical technology with deferred evaluation last year and is being prescribed as uninsured service by insurance at many medical institutions, including Yonsei University’s Severance Hospital.

Mediwale plans to use the newly acquired funds for US Food and Drug Administration (FDA) approval of Reti-CVD; AI enhancement; global business expansion; and development of new products.

The Korea Development Bank, which led this investment, stated, “Mediwale is the world’s first company to develop and commercialize medical AI that can prevent cardiovascular disease with a simple eye exam. Both its business performance and technological capabilities are highly differentiated compared to existing global competitors. We have decided to actively invest with the expectation that Mediwale will write a new history in the field of AI for predicting cardiovascular and metabolic diseases not only in Korea but also in overseas markets.”

Tae-Geun Choi, CEO of Mediwale, said, “I believe that Mediwale’s success in securing investment even in a frozen capital market is due to our excellent technology. We will lead the global market for managing cardiovascular and metabolic diseases with our ‘original new medical technology’ that we have developed and commercialized for the first time in the world. We are preparing for the De Novo track, which is granted only to the first medical technology by the FDA. Our goal is to launch the product in the United States after receiving De Novo approval in 2025. We will also significantly improve AI performance to maintain an overwhelming technological gap over our competitors and expand our product pipeline to the area of chronic kidney disease prediction.”

Meanwhile, Mediwale is strengthening its product pipeline for predicting cardiovascular and metabolic diseases through retinal blood vessels. In the first half of next year, the company plans to launch a software called “Reti-CKD” that predicts the risk of chronic kidney disease and obtains approval and insurance coverage for domestic distribution.