Recently, it was reported that a patient at a clinic in Tokyo (hereinafter referred to as "the Clinic") that provided Regenerative medicine in accordance with the Act on Ensuring the Safety of Regenerative medicine, etc., experienced a sudden deterioration in their condition on the day of administration of treatment with autologous adipose-derived stem cells for chronic pain, and subsequently died (hereinafter referred to as "the Incident"). We offer our deepest condolences to the deceased patient and their family.
On March 13, 2026, the Ministry of Health, Labour and Welfare issued an emergency order to the clinic and related specific cell processing facilities in response to this incident, including a temporary suspension of operations related to the provision of Regenerative medicine and cell processing.
Neither our company nor our group's cell processing facilities are involved in this matter in any way, and our group's specific cell processing product manufacturing facilities have not received any administrative penalties or other actions. Furthermore, we have not received any reports of serious illnesses or other conditions that may be suspected to be causally related to cells processed by our company.
Meanwhile, following reports of this incident, we have re-evaluated the risks related to quality and safety within our company and have confirmed that there are no issues with continuing the mesenchymal stem cell culture contract services that we provide. Our group processes cells at a specific cell processing facility authorized by the Ministry of Health, Labour and Welfare in accordance with the Act on Ensuring the Safety Regenerative medicine, etc.
Furthermore, on March 12, 2026, the Ministry of Health, Labour and Welfare issued a "Warning Regarding Matters to be Noted by Medical Institutions When Providing Regenerative medicine, etc.," which reiterated the importance of legal compliance, system development, and safety assurance in the provision of Regenerative medicine, etc. We take these warnings very seriously and will continue to prioritize safety, striving to thoroughly implement appropriate procedures and safety management in accordance with the law.
Furthermore, we ask that all medical institutions providing Regenerative medicine and related treatments review the "Important Notice Regarding Matters to be Noted by Medical Institutions When Providing Regenerative medicine and Related Treatments" issued by the Ministry of Health, Labour and Welfare, and continue to strive to establish appropriate systems and comply with laws and regulations.
Our company will continue to strictly comply with various regulations, including the Act on Ensuring the Safety of Regenerative medicine, and will thoroughly implement quality control and safety information collection in cooperation with our partner medical institutions. We will strive to develop highly reliable Regenerative medicine, prioritizing safety above all else so that patients can receive treatment with peace of mind.