Cyfuse Biomedical K.K.

Business Details

Based on its proprietary "Bio 3D Printing" technology, the company operates in a multifaceted manner across three areas: (1) the regenerative medicine field (pipeline development for peripheral nerve, bone/cartilage, and vascular regeneration, etc.), (2) the drug discovery support field (sales of FCD products including Human 3D Mini Liver®), and (3) the device field (sales of Bio 3D Printers and consumables). For the first quarter of FY2026 (ending December 2026), revenue was ¥28 million (up 17.6% year-on-year), a modest increase, but the company recorded an operating loss of ¥215 million due to continued R&D investment. Operated as a single segment.

Recent Overview

Progress in pipeline and partnerships, including the start of a physician-initiated clinical trial for peripheral nerve regeneration and a business/capital alliance with Kuraray.

In the first quarter of 2026, revenue was ¥28 million (up 17.6% year-on-year), a modest increase. Operating loss improved to ¥215 million from ¥240 million in the same period of the prior year, but subsidy income sharply declined 87.9% year-on-year to ¥6 million, causing ordinary loss to expand to ¥223 million (compared to ¥162 million in the same period of the prior year). On the business front, key topics included the start of a physician-initiated clinical trial for peripheral nerve regeneration (second generation), the conclusion of a business and capital alliance with Kuraray Co., Ltd., the announcement of joint development of a new-model Bio 3D Printer with NSK Ltd., and progress in negotiations for expansion into Asia in Taiwan and Hong Kong. As a subsequent event, payment for restricted stock (a total of 120,000 shares, issue price of ¥605) for directors and executive officers was completed on April 24, 2026. There is no change to the full-year earnings forecast.

Key Products

Growth Drivers

• Progress in the peripheral nerve regeneration pipeline: preparing for a company-sponsored clinical trial of the first generation (autologous cells), and started a physician-initiated clinical trial of the second generation (allogeneic umbilical cord-derived mesenchymal cells) in the first quarter of 2026
• Completion of preparations for the start of clinical trials for bone/cartilage regeneration: establishing a manufacturing system with Keio University Hospital and Fujita Health University Hospital, and building a foundation for societal implementation through the launch of the CReM TONOHANE consortium
• Acceleration of new business creation in the regenerative medicine and life sciences fields through the conclusion of a business and capital alliance with Kuraray Co., Ltd.
• Strengthening of the manufacturing base through joint development among four companies—Kuraray, ZACROS, and Chiyoda Corporation—to establish a mass culture process
• Expansion of the FCD product lineup (addition of the Human 3D Mini Liver® disease model and 3D Mini Intestine Model) and revenue accumulation in the drug discovery support field
• Establishment of a position for Human 3D Mini Liver® as a standard evaluation tool through participation in AMED's Drug Discovery Infrastructure Promotion Research Program
• Strengthening competitiveness in the device field through joint development of a new-model Bio 3D Printer (supporting scale-up and automation) with NSK Ltd.
• Progress in Asian expansion through collaboration with Taiwan (Hitachi Global Life Solutions, MetaTech, Taiwan Hitachi Asia Pacific) and Hong Kong (C2iTech)
• Expansion of the mid-to-long-term business domain by cultivating next-generation pipelines such as dental and facial nerve regeneration

Risks

• Risk of prolonged and uncertain clinical development toward obtaining approval and launching regenerative medicine products
• Continued increase in R&D expenses leading to an expanding operating loss (full-year forecast for FY2026, ending December 2026: operating loss of ¥1,081 million)
• Risk of fluctuation in subsidy income: an 87.9% year-on-year decline (from ¥81 million to ¥6 million) was the main factor behind the expansion of ordinary loss in the actual results
• Risk of revenue dependence on specific customers and contract projects (in the prior period, contract work for Arktus Therapeutics accounted for 70.4% of revenue)
• Ongoing need for fundraising (risk of dilution and financial burden from new share issuances and borrowings)
• Cumulative expansion of accumulated losses (△¥3,846 million) and continued decline in cash and deposits (down ¥193 million during the quarter)
• Regulatory compliance risk related to the manufacturing and quality control of regenerative medicine products (Pharmaceuticals and Medical Devices Act, etc.)
• Collaboration risk in a business model dependent on joint development frameworks with partner companies and universities
• Geopolitical risk and regulatory environment uncertainty in Asian expansion and global commercialization