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Craif raises $33M to accelerate introduction of its urine-based cancer test to the U.S. * 4 hrs ago SAN DIEGO, Aug. 18, 2026 (GLOBE NEWSWIRE) - Craif Inc., a bio-AI company developing a urine analysis platform for early detection of cancer and other diseases, today announced the close of its approximately $33 million* Series D, bringing total capital raised since the company's founding to roughly $88 million**. Craif will use the proceeds to strengthen its U.S. R&D, prepare for a reimbursement-driven launch of its non-invasive cancer test in the United States and advance its Japanese regulatory filing for a software-based medical device program targeting pancreatic cancer diagnosis. The financing was co-led by Granite-Integral, a joint venture between Granite Asia and Integral Corporation, and by Tauns Co., Ltd., one of Japan's largest makers of rapid diagnostic tests. Granite Asia is a Singapore-based investment platform managing about $10 billion across the Asia-Pacific region. Integral Corporation manages approximately $3 billion and was the first Japanese private equity firm to list on the Tokyo Stock Exchange. U.S. based Unreasonable and existing investor X&KSK also participated, alongside institutional and individual investors across Singapore, the United States and Japan. The round comprised approximately $30.7 million in equity and approximately $3.3 million in debt. Founded in Japan in 2018, Craif developed a urine-based cancer detection platform that uses artificial intelligence to analyze microRNA, small regulatory molecules whose discovery and biological significance were recognized by the 2024 Nobel Prize in Physiology or Medicine. Its flagship test, miSignal, is offered at more than 2,500 medical institutions and 4,500 pharmacies across Japan, with over 110,000 tests performed to date. Craif has published more than 90 peer-reviewed papers and conference presentations, including two independent publications demonstrating the early and accurate detection of pancreatic cancer. A clinical team built for the American market A key component of Craif's plans is scaling R&D at its newly opened San Diego laboratory, including a prospective clinical study of its urine-based test in pancreatic cancer. This is an indication where the clinical utility and the path to reimbursement are clear. A simple, non-invasive urine test could help clinicians decide who needs further workup and who can safely wait. To spearhead that work, Craif has appointed Nicholas (Nick) Bevins, MD, PhD, as chief medical officer. Dr. Bevins will lead the company's clinical development strategy to build the body of evidence necessary to meet reimbursement and regulatory requirements. Dr. Bevins holds a bachelor's degree in biochemistry from Columbia University, an MD and a PhD in neuroscience from the University of California, San Diego, and completed a residency in clinical pathology and laboratory medicine. He has published more than 40 peer-reviewed papers and abstracts. He is a board-certified clinical pathologist and has served as both chief medical officer and CLIA laboratory director at several biotechnology and diagnostics companies. Because offering laboratory-developed tests in the United States requires a CLIA-certified laboratory under the oversight of a qualified laboratory director, Dr. Bevins brings a rare combination of that qualification and executive responsibility for clinical and regulatory strategy. His appointment further accelerates Craif's strategic expansion as it now advances partnerships with 30 medical institutions across 15 states. The company established a U.S. subsidiary in 2022 and joined the JLABS incubator. In April 2026, Craif opened its bio-AI laboratory in San Diego, and CEO Ryuichi Onose relocated there to lead the U.S. business. Chief Financial Officer Takeo Mukai, who previously held finance and operating leadership roles at Medtronic and several U.S. healthcare companies, also joined this year as a local hire. Quote from Ryuichi Onose, CEO and co-founder, Craif "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." Quote from Nick Bevins, Chief Medical Officer "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." Quote from CK Chuon, Partner & Co-Head, Granite-Integral "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." Quote from Masataka Nonaka, President & Representative Director, TAUNS Laboratories, Inc. "Serving as a co-lead investor in Craif's Series D means a great deal to Mycarrollcountynews. 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, Mycarrollcountynews 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 Mycarrollcountynews 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 its partnership, Mycarrollcountynews intend to help bring next-generation diagnostics into practice and contribute to solving healthcare challenges in Japan and around the world." *Total round amount, including equity investment, financing, and the secondary transaction. ¥5.28 billion at an exchange rate of ¥160.72 = $33 million. The exchange rate used is July TTM: ¥ 160.72 per USD. **Cumulative equity investment, financing, and grants since founding. Total funding raised to date: ¥14.2 billion (approximately $88 million). About Craif Craif is a bio-AI company founded in 2018 that develops non-invasive tests for the early detection of cancer. Its platform combines proprietary biomarker detection from urine and other bodily fluids with AI to assess disease risk. Building on one of the world's largest urine datasets, Craif aims to create a urine analysis platform that detects a wide range of diseases early, with cancer as the first step. The company is based in Tokyo and operates a wholly owned laboratory in San Diego, opened in 2026. Learn more at craif.com. Forward-looking statements This release contains forward-looking statements about Craif's plans, clinical development, regulatory timelines, and business prospects. Actual results may differ materially from those expressed or implied. Craif undertakes no obligation to update these statements except as required by law. Media inquiries Craif USA, Inc.

Medtronic faces contrasting developments after a federal jury ordered it to pay $88 million in compensatory damages over injuries linked to Covidien hernia mesh in August 2026. The verdict represents a record settlement in the ongoing litigation. Meanwhile, Medtronic Canada secured Health Canada approval for its Affera Integrated Mapping and Ablation System, designed to treat atrial fibrillation and atrial flutter. The approval gives Medtronic a second pulsed field ablation platform alongside its existing PulseSelect system. The company's investment narrative projects $41.5 billion in revenue and $6.6 billion in earnings by 2029, requiring 4.5% annual revenue growth. Analysts estimate a fair value of $98.00, representing a 7% upside from current levels. However, cautious analysts forecast lower revenue of around $38.6 billion and earnings of approximately $6.2 billion by 2029, citing concerns over legal exposure and execution risks.

Medtronic has received Health Canada approval for its Affera Integrated Mapping System and Sphere-9 Catheter to treat atrial fibrillation and atrial flutter. The licence permits commercial use of Medtronic's combined pulse field and radiofrequency ablation technologies across Canada. The Affera system offers physicians an all-in-one mapping and ablation platform designed to support procedural efficiency and patient care. The approval represents a milestone for Medtronic's Cardiac Ablation Solutions division in the global atrial fibrillation treatment market. Medtronic, a US-based medical equipment company with a market capitalisation of approximately $115.9 billion, develops and sells device-based therapies to healthcare systems and clinicians globally. The approval extends Medtronic's cardiac ablation offerings from Europe and the US into Canada, where it will compete with Abbott and Boston Scientific.