SBI Investment Portfolio Company Mediwhale Bets on U.S. FDA Clearance Ahead of IPO… Triples R&D Investment

• Ahead of its IPO, Mediwhale, an SBI Investment portfolio company developing AI-based retinal image analysis medical devices, has made obtaining U.S. FDA clearance the core of its strategy to enhance enterprise value, roughly tripling its R&D investment to KRW 2.89 billion last year from KRW 960 million the year before.
• Its flagship product, ‘Dr. Noon CVD,’ a solution that predicts cardiovascular disease risk from retinal images, has been supplied to about 250 institutions in Korea and abroad, 54 of which, including in the UK, are overseas. The company applied to the FDA for De Novo authorization last December and is currently preparing additional clinical studies.
• It has already obtained CE MDR certification in Europe and plans to keep expanding its AI medical device portfolio while developing follow-on pipelines, including prediction solutions for chronic kidney disease, fatty liver disease and Alzheimer's disease.

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