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We sincerely appreciate your continued support.
In 2022, although economic activity gradually began to recover to the level prior to COVID-19, many changes occurred such as the price increases for daily commodities and food items due to the sharp decline in the yen and soring raw material prices, as well as instability overseas.
As the development of allogeneic chondrocyte sheets is being carried out with the aim of acquiring marketing approval under the Act on Pharmaceuticals and Medical Devices (the “PMD Act”), we continued to consult with the Pharmaceuticals and Medical Devices Agency (PMDA) with the aim of submitting the clinical trial application. Unfortunately, we were not able to submit the application by the end of December 2022, which was our initial target date. However, we are preparing for the start of the clinical trial in 2023. The provision of cartilage tissues collected from patients with polydactyly which are approved for commercial use started in 2021 from the National Center for Child Health and Development, and in 2022, we constructed a system for constantly receiving the tissues suited to a wider industrial use. We established the master cell bank for clinical trials of which the safety and efficacy were confirmed. In December 2022, we held a public symposium jointly with Tokai University on allogeneic chondrocyte sheets titled “Letʼs learn and talk about the future of cartilage regenerative medicine ‒ The frontline of clinical research for the treatment of knee osteoarthritis using cell sheets ‒.” During the symposium, patients who received a transplant of allogeneic chondrocyte sheets in the clinical research conducted at Tokai University shared their valuable experience. We realized that allogeneic chondrocyte sheets are a beneficial treatment for patients, and we reconfirmed our determination to accelerate the development process to enable the use of allogeneic chondrocyte sheets by patients as soon as possible.
To deliver treatments based on Japan-originated cell sheet engineering worldwide, we will make persistent efforts to commercialize products of cell sheet regenerative medicine. At the 22nd Congress of the Japanese Society for Regenerative Medicine held in March 2023, which was held face-to-face for the first time in four years, we made an oral presentation about the development of allogeneic chondrocytes sheets, as well as a poster presentation on cultureware that uses a temperature-responsive polymer. At the exhibition booth, we introduced our new UpCell® series products and our contract manufacturing services. We will continue to actively promote our research and development activities. We sincerely ask the readers for your continued support.