CellSeed Inc.
7776・Growth Market・Precision Instruments
Business
CellSeed Inc. is a Tokyo Stock Exchange Growth Market-listed company established in 2001. Based on "cell sheet engineering," a foundational technology originating in Japan, the company operates two businesses: (1) the Regenerative Medicine Support Business, which manufactures and sells Temperature-Responsive Cell Culture Devices and provides Regenerative Medicine Contract Development and Manufacturing (CDMO) Services, and (2) the Cell Sheet Regenerative Medicine Business, which promotes the development of regenerative medicine products such as the Allogeneic Chondrocyte Sheet (CLS2901C). Its main customers are research institutions, pharmaceutical companies, and medical institutions both in Japan and overseas. In October 2025, the company initiated a Phase 3 trial (enrollment of the first patient) for its flagship pipeline product, and is now at the stage of preparing for commercialization.
Business Model
In the Regenerative Medicine Support Business, revenue is recorded through sales of Temperature-Responsive Cell Culture Devices via domestic distributors such as Funakoshi and overseas distributors such as Thermo Fisher Scientific (Nunc A/S), as well as through Regenerative Medicine CDMO contract services utilizing the Cell Processing Center (CPC). The Cell Sheet Regenerative Medicine Business is currently in the research and development stage, and the company positions upfront payment income from product sales and business alliances following manufacturing and marketing approval as its future primary revenue source.
Company Strengths
Developed based on joint research with Tokyo Women's Medical University, Cell Sheet Engineering is a proprietary technology that enables non-invasive recovery of cell sheets through temperature change alone. Domestic sales began in 2007 under products such as UpCell and RepCell, and the technology has also been deployed in Europe and elsewhere through an international distribution agreement with Thermo Fisher Scientific (Nunc A/S).
The Cell Processing Center (CPC), established in 2016, holds both a specified cell processed product manufacturing license (obtained in 2017) under the Act on the Safety of Regenerative Medicine and a regenerative medicine product manufacturing business license (obtained in 2018) under the Pharmaceuticals and Medical Devices Act. It is a rare piece of infrastructure capable of contract manufacturing of clinical-use cell sheets and serves as the foundation of the CDMO business.
The Allogeneic Chondrocyte Sheet (CLS2901C), for which a clinical trial notification was submitted to the PMDA in September 2023, completed enrollment of its first case on October 9, 2025, following an agreement with Tokai University, and the Phase III trial is proceeding as planned. A stable supply system for raw materials has also been established through a specimen supply agreement with the National Center for Child Health and Development (through June 2026).
ENVALITH's Perspective
Performance Trend
Over the past five fiscal periods, revenue trended as follows: ¥162 million (FY2021) → ¥126 million (FY2022) → ¥190 million (FY2023) → ¥193 million (FY2024) → ¥84 million (FY2025), with a sharp decline in FY2025. In the first quarter of FY2026 (ending December 2026), revenue remained at a low level of ¥13 million (down 49.1% year on year). The cumulative operating loss for Q1 FY2026 was ¥250 million, an improvement from ¥393 million in the same period last year; however, this was due to a substantial reduction in R&D expenses (down ¥165 million year on year), not a structural improvement accompanied by a recovery in revenue. In terms of the external environment, uncertainty over US trade policy and geopolitical risks are hindering the recovery of overseas equipment sales. Also notable is the recording of an extraordinary loss in the form of an impairment loss of ¥20 million (versus ¥0.5 million in the same period last year).
Growth Strategy
Advancing completion of the Phase III trial for the Allogeneic Chondrocyte Sheet and early filing for approval, while pursuing business alliances and strengthening the revenue base of the support business in parallel
Enrollment of the first case was completed in October 2025, and as of the end of March 2026, the trial is progressing according to plan. The jRCT information has been updated to reflect the addition of clinical trial sites. The trial is being advanced based on the milestone agreement with Tokai University, and obtaining approval is a prerequisite for monetization.
Negotiations are ongoing with multiple companies aimed at concluding alliance and joint research agreements to accelerate the commercialization of the Allogeneic Chondrocyte Sheet and build a future sales structure. Once alliances are established, cost-sharing for development and securing sales channels are expected.
In Japan, the company is promoting increased brand recognition of its device products and expanded sales through distributors, including via academic activities such as a poster presentation at the 25th Annual Meeting of the Japanese Society for Regenerative Medicine. Overseas, in order to recover from a sales slump caused by geopolitical turmoil, the company is preparing to implement new promotional measures to replace conventional advertising and direct mail methods. For CDMO Services, the company has renewed its website to strengthen the acquisition of new contract projects.
For the 25th Series Stock Acquisition Rights issued on December 8, 2025, the exercise rate as of March 31, 2026 was 48.92%, raising ¥1,213 million. Cash on hand at the end of Q1 increased to ¥2,012 million, securing an equity ratio of 84.1%. Additional exercises (114,000 shares, ¥32 million) were also carried out in April 2026, and continuous fundraising is progressing.
Last updated: July 17, 2026