ENVALITH
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Cyfuse Biomedical K.K.

4892・Growth Market・Pharmaceuticals

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Cyfuse Biomedical K.K.4892

Business

Cyfuse Biomedical K.K. was founded in 2010. It is a regenerative medicine venture that possesses a proprietary "three-dimensional cell layering technology (bio 3D printing)" as its core technology, enabling the fabrication of three-dimensional tissues and organs using only human cells without any artificial materials. Its business domains consist of three areas: (1) the regenerative medicine field (development of the Regenerative Medicine Product Pipeline (Peripheral Nerve Regeneration, Bone/Cartilage Regeneration, Vascular Regeneration)), (2) the drug discovery support field (development and sales of functional cell devices such as the Human 3D Mini Liver® (FCD® Series)), and (3) the device field (development and sales of the Bio 3D Printer such as "Regenova®" and "S-PIKE®"). Its main customers include pharmaceutical companies, nonclinical contract research organizations, universities, and research institutions. The company listed on the Tokyo Stock Exchange Growth Market in December 2022 (securities code: 4892) and additionally listed on the Fukuoka Stock Exchange Q-Board Market in December 2025.

Business Model

In the short to medium term, the company aims to build up base revenue through sales of the Bio 3D Printer and related consumables (device domain) and sales/contract services of 3D cell products such as Human 3D Mini Liver® (drug discovery support domain). In parallel, it applies grants from public institutions such as AMED (¥101 million in FY2025) to R&D expenses to curb losses. Over the medium to long term, the company targets large-scale monetization through regulatory approval and commercialization of regenerative medicine products such as peripheral nerve, bone/cartilage, and vascular regeneration. For its manufacturing and sales structure, it adopts a distinctive alliance strategy built through joint development consortia with partner companies (Taiyo Holdings, Kuraray, etc.).

Company Strengths

The company's three-dimensional cell layering technology, which creates three-dimensional tissues and organs using only cells, is protected by fundamental patents based on an exclusive license agreement with Kyushu University. It succeeded in the world's first transplantation into an actual patient of a three-dimensional nerve conduit manufactured from the patient's own cells, and has also obtained a U.S. patent (Human 3D Mini Liver®).

The company is advancing parallel development with support from AMED across multiple national universities, including peripheral nerve regeneration (Kyoto University, University of Tokyo), bone/cartilage regeneration (Keio University, Fujita Health University), vascular regeneration (Saga University), and periodontal regeneration (Hiroshima University), among others. It has also concluded comprehensive partnerships with business corporations such as Taiyo Holdings, Kuraray, PHC, and Medipal Holdings, jointly building manufacturing and sales systems.

The company has continuously secured R&D grants from AMED, NEDO, JST, the Ministry of Economy, Trade and Industry, and others. In FY2025, grant income reached ¥101 million (up 132.1% year on year), contributing to a narrower loss as non-operating income. Since its founding, the company has continued to be selected for multiple AMED commissioned projects, establishing recognition and trust from public institutions.

ENVALITH's Perspective

Revenue for Q1 FY2026 (ending March 2026) was ¥28 million (versus ¥24 million in the same period last year), maintaining a growth trend, but progress against the full-year forecast of ¥278 million remains at just about 10.1%. The structure of an operating loss of ¥215 million against revenue of ¥28 million remains unchanged, and a fundamental improvement in profitability is unlikely to be expected without regulatory approval and commercialization of regenerative medicine products. The full-year earnings forecast (revenue of ¥278 million, operating loss of ¥1,081 million) remains unchanged, and losses are expected to continue expanding.

The operating loss for Q1 FY2026 (ending March 2026) was ¥215 million, an improvement from ¥240 million in the same period last year, but the ordinary loss worsened significantly to ¥223 million from ¥162 million in the same period last year. The main causes were an 87.9% decline in subsidy income, from ¥81,596 thousand in the same period last year to ¥6,821 thousand, and an increase in non-operating expenses including ¥8,080 thousand in share issuance costs and ¥5,637 thousand in interest expenses. This was a quarter that exposed the vulnerability of an earnings structure dependent on subsidies, and attention should be paid to how future trends in obtaining public funding will directly affect profit and loss.

Cash and deposits at the end of Q1 FY2026 (ending March 2026) stood at ¥3,533 million (down ¥193 million from ¥3,727 million at the end of the previous fiscal year). The company carries interest-bearing debt totaling ¥1,238 million, consisting of ¥415 million in short-term borrowings, ¥310 million in long-term borrowings due within one year, and ¥513 million in long-term borrowings. If the quarterly net loss pace of ¥224 million continues, funds would be calculated to decrease by roughly ¥900 million on an annualized basis. There is no note regarding going concern assumptions, but improved transparency in the medium-term funding plan would help reassure investors.

Growth Strategy

Aiming for regulatory approval and market launch of regenerative medicine products as a medium-to-long-term goal, the company is advancing both base revenue expansion and industry-academia-government collaborative development as twin pillars

Safety and efficacy data have been obtained for all patients in the physician-initiated clinical trial at Kyoto University Hospital. Preparations for the initiation of a company-sponsored clinical trial are underway together with Kyoto University, Taiyo Holdings, and Taiyo Pharma Tech.

With support from AMED, the clinical trial notification was accepted together with Kyoto University and the University of Tokyo, and the physician-initiated clinical trial was launched in Q1 FY2026 (ending March 2026). Research findings have also been published in the international academic journals PLOS One and Cell Transplant.

Under the AMED Bridging Research Program, manufacturing systems have been established together with Keio University Hospital and Fujita Health University Hospital, and manufacturing trials are being conducted. A foundation for social implementation is also being built through the launch of the CReM TONOHANE consortium.

The lineup has been expanded through the addition of new products including the Human 3D Mini Liver® disease model and Human 3D Mini Intestine. Through participation in the AMED Drug Discovery Infrastructure Promotion Research Program, the company aims to establish the Human 3D Mini Liver® as a standard evaluation tool.

A business and capital alliance has been concluded with Kuraray, and a four-company joint development effort with Kuraray, ZACROS, and Chiyoda Corporation (establishing a mass culture process and platform) is strengthening the manufacturing foundation toward the industrialization and social implementation of regenerative medicine.

The company is promoting the adoption of its devices and technology in Asian markets through collaboration in Taiwan with Hitachi Global Life Solutions, MetaTech, and Taiwan Hitachi Asia Pacific, as well as ongoing strategic collaboration negotiations with C2iTech (Hong Kong).

Last updated: July 17, 2026