Craif raises USD $33 million & names Chief Medical Officer

Craif has raised USD $33 million in a Series D funding round and appointed Dr Nick Bevins as Chief Medical Officer, bringing total funding since its founding to USD $88 million.

The San Diego- and Tokyo-based cancer testing company will use the new money to support research and development in the United States, a prospective pancreatic cancer study, and preparations for a US launch of its urine-based cancer test.

The round was co-led by Granite-Integral and Tauns, with participation from Unreasonable, existing investor X&KSK, and other institutional and individual backers in Singapore, the United States, and Japan. It included about USD $30.7 million in equity and about USD $3.3 million in debt.

Founded in Japan in 2018, Craif is developing a urine analysis platform that uses artificial intelligence to assess microRNA for signs of cancer and other diseases. Its main test, miSignal, is already available at more than 2,500 medical institutions and 4,500 pharmacies in Japan, where more than 110,000 tests have been carried out.

The company has published more than 90 peer-reviewed papers and conference presentations, including two independent publications on the early detection of pancreatic cancer. It is also preparing a Japanese regulatory filing for a software-based medical device programme focused on pancreatic cancer diagnosis.

US expansion

A central part of Craif's next phase is expanding its San Diego laboratory, which opened this year. The site is expected to support a prospective clinical study of the urine-based pancreatic cancer test as the company builds evidence for reimbursement and regulatory requirements in the US market.

Bevins will lead the clinical development strategy. He is a physician, board-certified clinical pathologist, and CLIA laboratory director, qualifications that matter for companies seeking to offer laboratory-developed tests in the United States through a CLIA-certified laboratory.

His background includes a degree in biochemistry from Columbia University; an MD and a PhD in neuroscience from the University of California, San Diego; and residency training in clinical pathology and laboratory medicine. He has published more than 40 peer-reviewed papers and abstracts and has previously served as Chief Medical Officer and CLIA Labouratory Director at several biotechnology and diagnostics companies.

The appointment adds to a broader buildout of Craif's US business. The company set up its US subsidiary in 2022 and joined the JLABS incubator before opening its San Diego laboratory in April. Chief Executive Officer Ryuichi Onose has relocated to San Diego to lead the US operation, while Chief Financial Officer Takeo Mukai joined this year after finance and operating roles at Medtronic and other US healthcare companies.

Craif is now advancing partnerships with 30 medical institutions across 15 states as it seeks to establish a presence in the US diagnostics market.

Onose outlined the company's rationale for the fundraising and US expansion. "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. Cancer is the first step," said Onose.

Bevins also commented on his decision to join the company. "I joined Craif because the company has built a differentiated platform, generated an extraordinary body of clinical evidence in Japan, and is committed to advancing science through rigorous data rather than hype. Urine will play an increasingly important role in the future of early disease detection because it offers a non-invasive window into human biology. I look forward to collaborating with the team to make this accessible to patients," said Dr Bevins.

Investors backing the round pointed to the broader potential of less invasive testing. "Cancer screening should be as simple as a routine check-up, not a procedure patients avoid. Craif has proven in Japan that a non-invasive urine test can detect cancer early and at scale, and we believe the same approach can unlock massive unmet demand in the United States. We are proud to co-lead this round as Craif brings that vision to the world's largest healthcare market," said CK Chuon, Partner & Co-Head, Granite-Integral.

Tauns, which also distributes miSignal, said the new funding should support both research and clinical development. "Serving as a co-lead investor in Craif's Series D means a great deal to us. This round will accelerate Craif's R&D, its clinical development toward regulatory approval and its global expansion. As one of Craif's distribution partners for miSignal, we also expect the funding to move both miSignal and the pancreatic cancer SaMD program now in development closer to real-world clinical use. Craif's urine microRNA analysis technology opens new possibilities in early cancer detection and more precise diagnosis, and we want to see it reach as many patients and healthcare institutions as possible. TAUNS will continue to support Craif's growth over the long term. Through our partnership, we intend to help bring next-generation diagnostics into practice and contribute to solving healthcare challenges in Japan and around the world," said Masataka Nonaka, President & Representative Director, TAUNS Labouratories.