Craif Inc

Craif is a molecular diagnostics company leveraging miRNA and machine learning for early cancer detection. Our proprietary platform, launched in Japan in 2022, powers the miSignal test, which screens for seven cancers (pancreatic, ovarian, esophageal, lung, breast, colorectal, and gastric) and has seen over 400% YoY revenue growth. In parallel with the commercialization of miSignal, we have started the clinical trial for the IVD test - pancreatic cancer diagnostic test for high risk population (e.g. diabetes, pancreatitis, etc.). This is a test seeking FDA/PMDA approval and planned to be reimbursed by insurance companies in the U.S. and reimbursed by the National Healthcare System in Japan. The clinical trial in Japan started in April 2024 and is planned to obtain approval in 2027H1. Craif USA was established in 2023 to bring this platform to the U.S. market, focusing on pancreatic cancer due to the high unmet need. We are currently enrolling cancers and high-risk controls to begin validation of the assay in a US population and are developing a US portfolio strategy that reflects the unmet clinical need and competitive landscape.