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On May 13, we received the long-awaited partial change approval for autologous cultured cartilage. This approval brings us closer to achieving our company's founding goal: treating knee cartilage using the patient's own cells. We have reached this milestone thanks to the support of many individuals. The conditions of the approval reflect the diseases we aimed to address, allowing us to deliver new medical treatments to more patients. We are deeply grateful.

Maintaining good conditions for a long term after treatment

Since the approval of autologous cultured cartilage in 2012, it has been used by over 1,900 patients. However, the indications have been quite limited until now. Many doctors have supported us in realizing this treatment. In the implementation of regenerative medicine in society, our company's products play only a part. The selection of appropriate disease conditions, in addition to the doctors' techniques, is extremely important. Last year, with the cooperation of doctors, a paper on the long-term results of autologous cultured cartilage was published in a prestigious journal. The essence of regenerative medicine lies in the potential to maintain good conditions for a long time after treatment. In this sense, the demonstration of long-term treatment results is highly significant. We are confident that this product can help treat more patients.

Treatment aiming for true "regeneration"

The clinical trial took about five years--longer than expected. It coincided with the COVID-19 pandemic and involved comparative trials with existing treatment methods. We received tremendous support and cooperation from patients and medical institutions. Thanks to this, we successfully met the primary evaluation criteria in the trial. Additionally, we demonstrated that many of the treated areas in patients healed with tissues similar to normal cartilage. The positive evaluation from doctors is the greatest joy in our activities. The value of this product has been further enhanced as a treatment aiming for true "regeneration."

We aim to widely promote autologous cultured cartilage and showcase this treatment from Japan to the world. As a leading country in regenerative medicine, we strive to gain high recognition both in name and reality from overseas. We believe this will be a way to repay those who have supported us. The platform for implementing medical treatments using patients' cells is becoming a reality. Efforts in mechanization, automation, and corresponding data science are also progressing. The original vision of our company is coming to fruition.

We will continue our efforts so that many patients can say, "I'm glad I was treated with autologous cultured cartilage."

May 13, 2025