Continued strengthening of core technologies centered on healthcare

「Obtained more than 30 510(k) clearances from the FDA over the past 12 months」

「The main achievements for the period included the launches in the United States and China of the EVIS X1 EDOF (Extended Depth of Field) upper gastrointestinal video scope and the EU-ME3 endoscopic ultrasound system; the U.S. launch of the EVIS X1 EDOF lower gastrointestinal video scope; the launches of OLYSENSE CAD/AI in the United States and Europe; the launches of the SecureFlex aspiration biopsy needle for endoscopic ultrasound-guided procedures in the United States, Europe, Japan and Asia-Pacific; and the launches of the Retentia hemostatic clip in Europe and Asia-Pacific.」

「Our Group believes that developing endoluminal robots will contribute to the adoption of minimally invasive endoscopic surgery and improved medical outcomes, leading to better health and well-being for more patients. We are therefore actively investing in endoluminal robotics through in-house research and development and investments in startups.」

「The main achievements for the period included obtaining U.S. FDA clearance for the EU-ME3 endoscopic ultrasound system and developing the VISERA ELITE III surgical endoscopy system ahead of its launch in the United States and China. In addition, with the aim of seamlessly integrating its broad portfolio of endoscopy systems, video scopes, gastroenterology accessories, reprocessing and services with cloud-based applications, the Company's first cloud-based AI-assisted endoscopic image interpretation support system obtained U.S. FDA clearance and European MDR certification.」

「The amount spent on R&D activities across the Group during the interim consolidated accounting period was ¥43,206 million. There were no material changes in the status of the Group's R&D activities during the interim consolidated accounting period.」

「The main achievements for the period included development ahead of the launch of the EVIS X1, the Company's flagship endoscopy system, in the United States and China, as well as development ahead of the U.S. launch of the GIF-1100 general-purpose upper gastrointestinal video scope and CF-HQ1100DL/I colon video scope.」

「There were no material changes in the status of the Group’s R&D activities during the nine months ended December 31, XXXX.」

「The main achievements for the period included the development of the VISERA ELITE III surgical endoscopy system and the EU-ME3 endoscopic ultrasound observation system. Development is also under way ahead of the launch of next-generation endoscopy systems and single-use duodenoscopes.」

「Odin was established by prominent clinicians and artificial intelligence specialists affiliated with the University College London (UCL) Wellcome / EPSRC Centre for Interventional and Surgical Sciences (WEISS) to develop next-generation cloud-based AI applications for endoscopy. By incorporating Odin's solutions, which use procedural and clinical data collected and analyzed in real time, the Company aims not only to reduce the administrative burden on healthcare professionals and support clinical decision-making, but also to help healthcare professionals provide better care to patients.」

「The main achievements for the period included the development of the Vivoly+ subscription service, a cloud-based endoscopic image and report management software platform for clinics with AI support. Development is also under way ahead of the launch of next-generation surgical endoscopy systems and single-use duodenoscopes.」

「The main achievements for the period included the development of the EVIS X1 next-generation gastrointestinal endoscopy system, the Company's flagship gastrointestinal endoscopy product; the GIF-EZ1500 general-purpose upper gastrointestinal video scope and CF-EZ1500DL/I colon video scope, both equipped with EDOF (Extended Depth of Field) technology for obtaining endoscopic images with a wider focal range; and ENDO-AID, an AI-enabled endoscopic CAD platform.」

「Although some development projects in the Imaging Components business were terminated during the cumulative first quarter, there were no material changes in the status of the Group's R&D activities.」

「The main achievements for the period included the development of optical technologies and image-processing technologies, including AI, to enable early diagnosis and improved observation; device technologies and precision-control technologies, including robotics, to enable minimally invasive treatment; efforts to enhance the functionality and reduce the cost of new medical products, including endoscopes and therapeutic devices, through simulation and materials technology; processing technologies for mass production of high-precision lenses; and production technologies, including the development of equipment linked to automated production lines.」

「There were no material changes in the status of the Group’s R&D activities during the nine months ended December 31, XXXX.」

「There were no material changes in the status of the Group’s R&D activities during the three months ended March 31, XXXX.」

「The main achievements for the period included the development of the ORBEYE surgical microscope system, equipped with 4K 3D video technology to support intricate surgery with high-definition digital images and a three-dimensional field of view; the ENDOEYE 3D rigid video scope for surgical procedures, designed to support faster and more accurate surgery; and Endocyto, an ultra-magnifying endoscope that enables real-time observation down to the cellular level, like a microscope.」

「There were no material changes in the status of the Group’s R&D activities during the three months ended March 31, XXXX.」

「Under the Medium-Term Management Plan (16CSP) announced in March 2016, the Company formulated its Technology Development Functional Strategy. Its R&D functions aim to support each business strategy centered on healthcare from a technological perspective in order to achieve its management objectives, while continuously strengthening its core technologies.」

「There were no material changes in the status of the Group’s R&D activities during the nine months ended December 31, XXXX.」

「There were no material changes in the status of the Group’s R&D activities during the six months ended June 30, XXXX.」

「The Company formulated its Technology Development Functional Strategy, with the aim of supporting each business strategy centered on healthcare from a technological perspective in order to achieve its management objectives, while continuously strengthening its core technologies.」