Clinical research and clinical trials for elastic cartilage devices and development of a total system
First written in FY2018. 6 of 7 entries say "Advanced", first in FY2019. Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026AdvancedAnnual report
「Under this R&D project, the investigator-initiated clinical trial is progressing smoothly as originally planned with the University of Tokyo and other institutions, and the culture equipment and containers provided by our company are contributing to the cell manufacturing used in the trial.」
For the elastic cartilage device, the investigator-initiated clinical trial is progressing as planned, and the company's culture equipment and containers have reached the stage of being used in the trial. - 2026-08-10AdvancedFinancial Results Presentation
「Facial reconstruction regenerative medicine using elastic cartilage tissue manufactured with the proprietary culture technology “CELLFLOAT®” is aimed at commercialization, and investigator-initiated Phase I/IIa clinical trials are currently under way with the University of Tokyo and others.」
The company stated that it is pursuing investigator-initiated clinical trials aimed at commercializing elastic cartilage tissue. - FY2024AdvancedAnnual report
「We are currently working to obtain the clinical-trial application data for elastic cartilage tissue manufactured using our culture equipment, with the aim of starting the investigator-initiated clinical trial next fiscal year as originally planned.」
For the elastic cartilage device, the project progressed to the stage of obtaining clinical-trial application data, under the FY2023–FY2027 research program, with the aim of starting an investigator-initiated clinical trial in the following fiscal year. - FY2022AdvancedAnnual report
「Under a project commissioned by AMED (Japan Agency for Medical Research and Development), preparations are now substantially complete for clinical trials of regenerative medicine using an elastic cartilage device to treat velopharyngeal insufficiency, a project we have long pursued with Yokohama City University and the Kanagawa Children's Medical Center.」
The company stated that preparations for an investigator-initiated clinical trial of the elastic cartilage device had reached the stage of completion. - FY2020AdvancedAnnual report
「"Development of a Novel Treatment for Craniofacial Morphological Disorders Using a Human Elastic Cartilage Device" (FY2020 Bridging Research Strategic Promotion Program, Japan Agency for Medical Research and Development (AMED): FY2020–FY2021)」
The elastic cartilage device was selected for AMED's FY2020–FY2021 step-up research program, advancing the research toward clinical application. - FY2019AdvancedAnnual report
「Tissue constructs measuring 30 mm can now be cultured, and the company expects future expansion into indications such as the knee, ear and nose, which have substantially larger market potential.」
For the elastic cartilage device, 30 mm tissue constructs can now be cultured. Preparations for an investigator-initiated clinical trial targeting velopharyngeal insufficiency are continuing. The company also aims to sell a total system incorporating know-how including consultations with the PMDA. - FY2018First statedAnnual report
「We have developed and established a path toward commercialization of a 3D cell culture system capable of culturing large elastic cartilage tissue constructs measuring several tens of millimeters or more for use in regenerative medicine and other applications, and are preparing to pursue investigator-initiated clinical trials from the following year onward.」
The company established a path toward commercialization of a system for culturing elastic cartilage tissue measuring several tens of millimeters or more and explicitly stated plans to pursue investigator-initiated clinical trials from the following year onward.