What You Should Know
- Craif Inc., a bio-AI company developing a non-invasive urine analysis platform for early cancer detection, closed an approximately $33M Series D round (¥5.28 billion), bringing its total capital raised to roughly $88M (¥14.2 billion).
- The financing was co-led by Granite-Integral (a joint venture between Granite Asia and Integral Corporation) and TAUNS Laboratories, Inc. (one of Japan’s largest rapid diagnostic test manufacturers), with participation from U.S.-based Unreasonable, existing backer X&KSK, and global institutional investors.
- Proceeds will fund U.S. clinical R&D at Craif’s newly established San Diego bio-AI laboratory, support a prospective clinical study in pancreatic cancer, prepare for a U.S. reimbursement-driven commercial launch, and advance Japanese regulatory filing for a Software-as-a-Medical-Device (SaMD) diagnostic tool.
- Craif’s platform applies artificial intelligence to analyze microRNA (miRNA) regulatory molecules in urine; its flagship test, miSignal, is deployed across 2,500+ medical institutions and 4,500+ pharmacies in Japan, with over 110,000 patient tests performed.
Overcoming Invasive Oncology Screening Friction
The capital infusion brings Craif’s cumulative funding to roughly $88 million (¥14.2 billion) and will support U.S. clinical trials, regulatory filings, and reimbursement strategy for its non-invasive, urine-based microRNA (miRNA) cancer diagnostic platform.
Early-stage detection for lethal malignancies—particularly pancreatic cancer—remains constrained by asymptomatic progression, invasive tissue biopsies, and costly diagnostic imaging. While liquid biopsies have advanced through circulating tumor DNA (ctDNA) blood draws, plasma collection still requires clinical appointments, specialized phlebotomy labor, and cold-chain logistics.
Craif addresses this diagnostic bottleneck through urinary biomarker isolation and bio-AI pattern recognition:
- Urinary MicroRNA (miRNA) Analysis: Captures small, non-coding regulatory RNA molecules that are excreted stably into bodily fluids, offering early cellular oncogenesis signals without requiring a blood draw or clinic visit.
- Commercial Validation at Scale: Built on data from Craif’s commercial miSignal assay in Japan, which has screened over 110,000 patients across 2,500 clinical institutions and 4,500 pharmacies, backed by more than 90 peer-reviewed publications and conference abstracts.
- Prospective Pancreatic Cancer Study: Focuses U.S. clinical development on pancreatic cancer triage to help clinicians distinguish high-risk patients who require immediate advanced imaging (such as MRI or endoscopic ultrasound) from those who can safely avoid invasive procedures.
- U.S. Laboratory & Clinical Governance: Expands operations at Craif’s bio-AI laboratory in San Diego, CA, led by newly appointed Chief Medical Officer Dr. Nicholas Bevins, MD, PhD (a board-certified clinical pathologist and experienced CLIA laboratory director), alongside CEO Ryuichi Onose’s relocation to lead U.S. operations.
- Software as a Medical Device (SaMD): Advances regulatory filings in Japan for an AI-powered SaMD diagnostic program while establishing the evidentiary framework required for U.S. FDA engagement and third-party payer reimbursement.
“We started Craif in 2018 to solve cancer, a problem the whole world shares, with technology built in Japan. We have brought our test to more than 2,500 clinics at home, and we are approaching a regulatory filing in pancreatic cancer. I moved to San Diego to build our U.S. business myself, because the United States is the hardest and most important market to prove this technology. What we are building goes beyond a single cancer test. The earliest signals of many diseases show up in urine, and reading them is what Craif is really about.”
— Ryuichi Onose, CEO, Craif Inc.
