Craif is significantly strengthening its U.S. operations as part of its global commercialization strategy. The company has established an R&D lab in Irvine, California, and plans to open a business office in San Diego. It has already begun collecting pancreatic cancer samples in collaboration with 30 medical institutions across 15 U.S. states. Craif is now accelerating local research and development, as well as commercialization efforts in the U.S., with the goal of obtaining FDA approval and insurance reimbursement.

　Founded in 2018 as a spinout from Nagoya University, Craif’s mission is to help people live out their natural lifespan by enabling early detection and personalized treatment of disease. Utilizing proprietary AI-driven technology to analyze urinary microRNA (miRNA), Craif launched its early cancer detection test, miSignal, in 2022. The test is designed to identify risk of hard-to-detect cancers, such as pancreatic and lung cancer, at extremely early stages.
Since its Series B funding in 2021, Craif has rapidly scaled operations in Japan. miSignal is now available at over 1,000 medical institutions and 500 pharmacies nationwide, as well as via corporate wellness programs and online platforms. Craif has accumulated over 42,000 biospecimens, with research results published in approximately 60 papers and conference presentations. A recent study validating early detection of pancreatic cancer was featured in eClinicalMedicine, a journal in The Lancet family.

In addition, the company has doubled the size of its certified clinical laboratory and increased testing throughput by over 15 times. In April 2024, Craif initiated clinical trials in Japan to obtain regulatory approval for its software-based diagnostic program targeting pancreatic cancer.

“At Craif, our vision is to build a world where no one fears cancer and everyone can live a long, fulfilling life. This funding enables us to expand our testing solutions across Japan and work toward establishing a new model for cancer prevention and early detection. We are committed to scaling our science-driven innovation globally, bringing 'Made in Japan' healthcare technology to the world,” said Ryuichi Onose, CEO and Co-Founder of Craif.

・Series C(2nd close) Funding:
　- US＄14 million (Series C Funding:US＄22 million/Cumulative total: US＄57 million)
　　　- Equity: US＄12 million
　　　- Debt: US＄2 million
・New investors:
　- Aozora Corporate Investment Co., Ltd.,
　- Unreasonable Group
　- Daiwa House Industry Co., Ltd.
　- MR Co., Ltd.
　- TAUNS Laboratories, Inc.
　- individual investors

・New lenders:
　- Aozora Corporate Investment Co., Ltd.,

・Existing investors (Series C 1st close):
　- X&KSK
　- Toyoda Gosei Co., Ltd.
　- TOYOTA BOSHOKU CORPORATION

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　Craif is harnessing the power of miRNA in an easy to collect urine sample to detect diseases earlier than the standard of care in order to optimize treatment and improve outcomes.  We have launched a MultiCancer Early Detection test in Japan (miSignal), that tests for seven cancers.   The company has brought this technology to the US to develop an early pancreatic cancer detection assay for high risk patients.