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4 Clinical Research in Humans and the Path to Commercialization — From Research to Real-World Implementation —
4 Clinical Research in Humans and the Path to Commercialization — From Research to Real-World Implementation —
Last updated: August 24, 2026
Yoshio Shimo Representative Director, CEO
Graduated from Waseda University School of Science and Engineering and earned a master's degree from Chuo University Graduate School of Policy Studies. He was appointed Managing Officer at Toyota Motor Corporation in 2016, President of Hino Motors in 2017, and Chairman of Hino Motors in 2021. He has served as Representative Director and CEO of OrganTech since September 2024. View full profile >
Graduated from Waseda University School of Science and Engineering and earned a master's degree from Chuo University Graduate School of Policy Studies. He was appointed Managing Officer at Toyota Motor Corporation in 2016, President of Hino Motors in 2017, and Chairman of Hino Motors in 2021. He has served as Representative Director and CEO of OrganTech since September 2024. View full profile >
Hello everyone. This is Shimo from OrganTech, Inc.
In the previous chapters, we introduced the challenges associated with conventional dental implants and our ongoing development of the Bio-hybrid Tooth. In this chapter, we will explain how this technology is progressing from the research stage toward real-world implementation, and provide an overview of our current initiatives.
OrganTech, Inc. has been developing periodontal ligament-integrated implants based on many years of research into organ regeneration. In preclinical studies using dogs, which have an oral environment similar to that of humans, we have obtained favorable results, including the formation of periodontal ligament-like tissue. Building on these research achievements, we are now advancing development toward specified clinical research in humans.
In 2025, we initiated specified clinical research on periodontal ligament-integrated implants in collaboration with a research group led by the Maxillofacial Implant Center at Minami-Tohoku Medical Clinic, affiliated with the Southern Tohoku Research Institute for Neuroscience. (Video) This study is evaluating the safety and efficacy of a novel implant treatment designed to connect with the alveolar bone through the periodontal ligament, in a manner similar to a natural tooth.
In the previous chapters, we introduced the challenges associated with conventional dental implants and our ongoing development of the Bio-hybrid Tooth. In this chapter, we will explain how this technology is progressing from the research stage toward real-world implementation, and provide an overview of our current initiatives.
OrganTech, Inc. has been developing periodontal ligament-integrated implants based on many years of research into organ regeneration. In preclinical studies using dogs, which have an oral environment similar to that of humans, we have obtained favorable results, including the formation of periodontal ligament-like tissue. Building on these research achievements, we are now advancing development toward specified clinical research in humans.
In 2025, we initiated specified clinical research on periodontal ligament-integrated implants in collaboration with a research group led by the Maxillofacial Implant Center at Minami-Tohoku Medical Clinic, affiliated with the Southern Tohoku Research Institute for Neuroscience. (Video) This study is evaluating the safety and efficacy of a novel implant treatment designed to connect with the alveolar bone through the periodontal ligament, in a manner similar to a natural tooth.
Video: Press Conference Announcing the Start of the Specified Clinical Research
In March 2026, the research group published an interim progress report. At the time of the report, successful engraftment had been confirmed in all cases that had undergone the procedure. As of August 2026, follow-up and evaluation are continuing. The specified clinical research remains ongoing, and we plan to accumulate further scientific evidence by increasing the number of cases and continuing rigorous clinical evaluation. (The specified clinical research is scheduled to be completed in February 2027.)
In parallel with our research and development activities in Japan, we are also looking ahead to global expansion. In the United States, the world's largest dental care market, we have begun collaborating with local companies with a view to future submission to the U.S. Food and Drug Administration (FDA). Through continued dialogue with regulatory authorities, we are working to establish an international framework for development and commercialization.
Bringing regenerative medicine technologies into actual clinical practice requires more than outstanding research results. It requires the steady advancement of multiple processes, including objective evaluation through clinical research, the establishment of robust quality control and manufacturing systems, consultations with regulatory authorities, and collaboration with medical institutions and companies both in Japan and overseas.
By steadily advancing each step of the development process, we aim to realize a new treatment option that patients can choose with confidence.
Ultimately, we seek to bring regenerative medicine technologies originating in Japan to the global market and contribute broadly to society by establishing them as a new treatment option in dental care.
In parallel with our research and development activities in Japan, we are also looking ahead to global expansion. In the United States, the world's largest dental care market, we have begun collaborating with local companies with a view to future submission to the U.S. Food and Drug Administration (FDA). Through continued dialogue with regulatory authorities, we are working to establish an international framework for development and commercialization.
Bringing regenerative medicine technologies into actual clinical practice requires more than outstanding research results. It requires the steady advancement of multiple processes, including objective evaluation through clinical research, the establishment of robust quality control and manufacturing systems, consultations with regulatory authorities, and collaboration with medical institutions and companies both in Japan and overseas.
By steadily advancing each step of the development process, we aim to realize a new treatment option that patients can choose with confidence.
Ultimately, we seek to bring regenerative medicine technologies originating in Japan to the global market and contribute broadly to society by establishing them as a new treatment option in dental care.
Related Information
Launch of Specified Clinical Research — Announced January 29, 2025
Interim Progress Report on the Specified Clinical Research — March 2026
Partnership with a U.S. Company Toward FDA Submission
Interim Progress Report on the Specified Clinical Research — March 2026
Partnership with a U.S. Company Toward FDA Submission
＊ This article reflects research and development-stage information as of August 24, 2026, and does not represent finalized medical procedures or products.