Japan Tissue Engineering Co., Ltd.

The company holds approvals for 5 of the 25 regenerative medicine products approved in Japan, and has Japan's first products in the skin, cartilage, and ophthalmology fields respectively. JACE (Autologous Cultured Epidermis) was Japan's first product in its category (approved 2007), JACC (Autologous Cultured Cartilage) was Japan's first in the orthopedics field (approved 2012), and Nepic (Autologous Cultured Corneal Epithelium) was Japan's first in the ophthalmology field (approved 2020). Over 25 years of accumulated regulatory response and manufacturing know-how since founding forms a barrier to entry.

Leveraging the GCTP (Good Gene, Cellular, and Tissue-based Products Manufacturing Practice) ordinance-compliant manufacturing and quality control systems and regulatory affairs development know-how cultivated through the development and manufacturing of its own products, the company has built a system capable of providing seamless support from the research stage through to commercial production, regardless of whether the product is derived from somatic cells, stem cells, or iPS cells. In FY2026 (ending March 2026), multiple projects with Actualize, VC Cell Therapy, Metcela, and AlliedCel are transitioning to higher-value-added phases, and this track record serves as a basis for acquiring new customers.

The LabCyte series of research-use cultured human tissue models has had 4 test methods adopted into OECD Test Guidelines—skin irritation (TG439), skin corrosion (TG431), eye irritation (TG492), and skin sensitization (EpiSensA, listed June 2024)—giving the company Japan's top domestic market share. Furthermore, in July 2025 it was also included in ISO10993-23, and this conformity with international standards serves as the foundation for overseas expansion into Europe, India, and other markets.

Effective January 1, 2026, insurance coverage was granted for the expanded indication for knee osteoarthritis, and the number of contracted facilities expanded to 125. In March 2026, a record-high monthly order volume of 30 cases was achieved, positioning the product as a core offering over the medium to long term. It is expected to serve as the primary driver of the earnings recovery in FY2027 (ending March 2027).

Indicated for skin defects including burns, an application for manufacturing and marketing approval was filed in March 2026. The product features proprietary drying technology enabling both long-term storage at room temperature and immediate use, aiming for rapid provision at emergency sites and expansion into overseas markets. Upon approval, it is expected to expand the product lineup and become a new revenue source.

Multiple projects with Actualize, VC Cell Therapy, Metcela, and AlliedCel have progressed to higher value-added phases, advancing the shift away from dependence on specific customers. Through the Kashiwa-no-ha "Regenerative Medicine Platform," collaboration with Teijin, National Cancer Center Hospital East, and Mitsui Fudosan is accelerating expansion into the oncology field.

In Europe, the number of regular customers reached 8, and preparations are underway to establish a subsidiary in Germany. In India, interest is growing not only in the epidermis model but also in the Corneal Model, and sales activities are being tailored to local needs. The technology transfer of the Research Intestinal Epithelial Model from Osaka University is also expected to enable new expansion into the drug discovery and food industries.

Efforts to improve patient access through collaboration with facilities focused on vitiligo treatment have progressed, expanding the number of base facilities to 42. Toward the fiscal year-end, orders were secured from newly added facilities, advancing the foundation for revenue growth. Accelerating adoption following the October 2024 inclusion in insurance coverage remains a future challenge.