HIROTSU Bio Science Enters the World’s Largest Cancer Screening Market with the Establishment of U.S. Subsidiary “Hirotsu Global Inc.” in Delaware Positioning its proprietary Japanese technology to become the new global standard from its base in the San Francisco Bay Area.

2026.03.06

TOKYO, JAPAN – March 6, 2026 – HIROTSU Bio Science Inc. announced the establishment of a new U.S. subsidiary, Hirotsu Global Inc., effectively completing its corporate registration in the State of Delaware on March 6, 2026 (JST). This strategic move establishes a robust foundation for full-scale business operations and research partnerships in the United States, aiming to introduce our innovative cancer screening technology to the world.

Concurrently, the company has opened a new operational hub in the San Francisco Bay Area, California—a global epicenter for innovation—marking its first major step toward rapid expansion in the global market.

Bringing Proprietary Japanese Technology to the U.S. Market The United States represents the world’s largest cancer screening market, characterized by unparalleled awareness and investment in preventive medicine. Leveraging the robust track record and technological capabilities cultivated in Japan, HIROTSU Bio Science is embarking on a full-scale challenge in this massive market.

Funded by the Japanese parent company, Hirotsu Global Inc. is designed to be more than a conventional overseas branch. It will serve as the company’s “second engine,” leading large-scale fundraising efforts in the U.S. market, spearheading independent clinical trials, and building a testing infrastructure intended to become a global standard.

Roadmap to Accelerate Corporate Value in the U.S. Achieving explosive adoption in the U.S. market requires strict compliance with rigorous regulatory standards and the accumulation of solid clinical data. To meet the expectations of our global investors, we have outlined a clear, three-phase roadmap to expand our business steadily and rapidly:

• Phase 1: Expedited Market Entry via CLIA-Compliant LDT Initially, we will establish an environment compliant with the Clinical Laboratory Improvement Amendments (CLIA), the strict U.S. quality standards for laboratory testing. We will promptly launch our service as a Laboratory Developed Test (LDT) to accumulate real-world clinical data in one of the world’s most advanced healthcare landscapes.
• Phase 2: Establishing “Trust” through FDA Approval and Insurance Coverage Armed with robust evidence, we will advance procedures to obtain clearance from the U.S. Food and Drug Administration (FDA) and secure medical insurance coverage, effectively embedding our technology into the core of the U.S. healthcare system.
• Phase 3: Nationwide Expansion of our Delivery Network While clearing regulatory requirements, we will expand our network of alliances with medical institutions and local governments across the United States. This phase will dramatically accelerate the scaling of our business and the creation of new social value.

Integrating with the World’s Premier Ecosystem Our new base in the San Francisco Bay Area positions us alongside world-class medical research institutions, top-tier universities, and pioneering deep-tech companies. By forging strong partnerships with key local players, we will drive the accumulation of clinical evidence and social implementation at an unprecedented speed.

Statement from Takaaki Hirotsu, Representative Director and CEO “Our technology is not meant to be confined to Japan. Through extensive discussions with various stakeholders in the U.S., we have received exceptionally high praise for our technology, concepts, and the R&D and business development we have achieved in Japan. By taking on the world’s largest market, I am confident we will become a ‘game changer’ that fundamentally overturns conventional wisdom in cancer screening. Integrating with Silicon Valley’s cutting-edge ecosystem will solidify our path toward clinical implementation and FDA approval with a profound sense of speed. We are determined to save lives globally with our proprietary technology while realizing explosive growth in corporate value. Together with our shareholders and investors in both Japan and the U.S., we are ready to write a new chapter in medical history.”

Overview of the New Subsidiary

Primary Business Activities: General operations related to fundraising, development of clinical trial and testing infrastructure, and business development in the United States.

Company Name: Hirotsu Global Inc.

Place of Registration: Delaware, USA

Business Hub: San Francisco Bay Area, California, USA

Date of Registration: March 6, 2026 (JST)

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