Notice of Medical Device Approval for Resorbable Bone Regeneration Material 'Verte'

Information for Press We provide information on Menicon Group companies and related information to domestic press. Please note that it is not intended to provide information to the general public. April 7, 2026 Nagoya University, Tokai National Higher Education and Research System Okayama University Menicon Co., Ltd. Nagoya University (Headquarters: Nagoya City, President: Nao Sugiyama), Okayama University (Headquarters: Okayama City, President: Yasutomo Nasu), and Menicon Co., Ltd. (Headquarters: Nagoya City, President and CEO: Koji Kawaura) announce that the resorbable bone regeneration material "Verte" has newly obtained medical device approval in Japan as of February 13, 2026. This medical device was developed using the results of joint research between the Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine (Professor Shiro Imagama and others) and Menicon Co., Ltd., and the Department of Systems Physiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences (Professor Keiji Naruse) and Menicon Co., Ltd. The approved medical device, which utilizes self-assembling peptide gel technology, is expected to contribute to the provision of better medical care by assisting bone regeneration in bone defect areas as a bone graft substitute. In the reconstruction of bone defects (*1), autologous bone grafting is a golden standard treatment with excellent osteogenic ability. However, in cases with extensive bone defects or fragile bone quality, it is difficult to harvest a necessary and sufficient amount of autologous bone, and the invasiveness of the harvest site is also a major issue. Therefore, a "combined procedure" in which harvested autologous bone is mixed with artificial bone (bone graft substitute) to secure the filling volume is widely performed. In the current combined procedure, chip-like autologous bone and granular bone graft substitute are mixed and used during surgery, but they are difficult to blend with each other, and the material scatters when filling the defect area, which poses the problem of limited operability and shape retention. In addition, physical gaps generated between autologous bone and bone graft substitute due to their respective shapes become a factor that impairs continuity and becomes a bottleneck that hinders good bone regeneration (bone fusion). These issues not only cause stress to physicians, but also increase physical burdens on patients, such as extending surgical time and causing instability in treatment outcomes. The Department of Systems Physiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Menicon Co., Ltd. have developed a self-assembling peptide (SPG-178 *2). SPG-178 forms a hydrogel with a 3D network when dissolved in water. This hydrogel is highly stable and transparent at neutral pH, and has high biocompatibility, so its application to the medical field has been anticipated. The Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine and Menicon Co., Ltd. have been working on the application of this self-assembling peptide (SPG-178) gel to the orthopedic field. As a result of accumulating non-clinical research for about 10 years at the Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, the optimal composition and application method of the peptide gel for assisting bone regeneration, utilizing the characteristic of functioning as a cell scaffold, were discovered. In the process, under the framework of the Medical-Engineering Collaboration Promotion Project by the Japan Agency for Medical Research and Development (AMED), a system was established in which the Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine and Menicon Co., Ltd. jointly promoted research and development. Through this, along with further deepening of non-clinical studies and consultations with the Pharmaceuticals and Medical Devices Agency (PMDA), clinical