Craif Raises $33M to Advance US Cancer Testing Platform

Craif, a company developing artificial intelligence tools to analyze microRNA from urine samples for early cancer detection, has raised approximately $33 million in Series D financing. The round, led by Granite-Integral and Tauns Co., includes $30.7 million in equity and $3.3 million in debt. Other investors such as Unreasonable and X&KSK also took part. This funding brings Craif's total capital raised since its 2018 founding to around $88 million.

The company's flagship miSignal platform uses artificial intelligence to analyze urine-based microRNA signals with the aim of identifying cancer before symptoms become severe. Craif's technology has already been deployed in over 2,500 medical institutions and 4,500 pharmacies across Japan, with more than 110,000 tests performed. The company has also published more than 90 peer-reviewed papers and conference presentations.

Craif plans to use the new funding to strengthen its research and development in the US, prepare for reimbursement-driven launch of its cancer test, and file for regulatory approval in Japan. The US launch will target pancreatic cancer diagnosis, with the miSignal platform currently available in more than 30 medical institutions across 15 US states. Craif recently opened a bio-AI laboratory in San Diego to support a prospective clinical study for pancreatic cancer.

The company is also bolstering its clinical development capabilities by appointing Nicholas Bevins as chief medical officer. Bevins has extensive experience in biotechnology and diagnostics companies and will help Craif establish its technology within the US healthcare system. Craif's longer-term strategy involves developing a urine analysis platform for multiple diseases, with cancer as the first step.

The company aims to build one of the world's largest urine datasets for disease analysis, providing additional resources for regulatory preparation and US market expansion.