Nagasaki Medical Center and Curvegen Launch Joint R&D for AMED's 'FY2026 Medical Device Development Promotion Research Project'

Nagasaki Medical Center (Location: Omura City, Nagasaki Prefecture; Director: Hayato Takayama; hereinafter 'Nagasaki Medical Center') and Curvegen Co., Ltd. (Headquarters: Shibuya-ku, Tokyo; Representative Director: Masakazu Nakajima; hereinafter 'the Company') are pleased to announce the commencement of joint research and development for the research project 'Gram Stain Deep Learning-based Rapid Identification Medical Device for Drug-Resistant Bacteria: Multi-institutional External Verification and Implementation Development' (Research Representative: Dr. Hideki Mori, Chief Physician), which Nagasaki Medical Center was selected for under the Japan Agency for Medical Research and Development (AMED)'s 'FY2026 Medical Device Development Promotion Research Project'. In this research and development project, Nagasaki Medical Center will serve as the primary research and development body, responsible for multi-institutional data collection and quality control, and overall research coordination. The Company will act as a joint research and development partner, providing support for the social implementation of research outcomes through its AI implementation platform 'CarbConnect® (CBC)' and offering expertise in pharmaceutical affairs and medical device development strategies. 1. Overview of the Research and Development Project Project Name FY2026 'Medical Device Development Promotion Research Project' (Japan Agency for Medical Research and Development: AMED) Category Clinical research/trials aimed at practical application of innovative medical devices / a) Preparation for clinical evaluation Research and Development Project Title Gram Stain Deep Learning-based Rapid Identification Medical Device for Drug-Resistant Bacteria: Multi-institutional External Verification and Implementation Development Research Representative Dr. Hideki Mori, Chief Physician (Department of General Internal Medicine, Nagasaki Medical Center, National Hospital Organization) Joint Research and Development Partner Curvegen Co., Ltd. (Support for social implementation through AI implementation platform 'CarbConnect®', and provision of expertise in pharmaceutical affairs and medical device development strategies) Research and Development Period April 1, 2026 - March 31, 2028 (2 years) AMED Selection Announcement Date March 5, 2026 Source: AMED Public Offering Information 'FY2026 Medical Device Development Promotion Research Project' List of Selected Projects https://www.amed.go.jp/koubo/03002/01/C_00002.html 2. Background: Drug-Resistant Bacteria (AMR) and Diagnostic Support Needs The spread of antimicrobial resistance (AMR) is recognized as a global challenge threatening the sustainability of healthcare. There is a significant need for rapid and appropriate diagnostic support in the early stages of infectious disease treatment, and the development of new diagnostic support methods utilizing AI technology is progressing in various locations. 3. Division of Roles between the Two Parties ■ Nagasaki Medical Center (Research and Development Representative Institution) ・Responsible for overall coordination, multi-institutional data collection, and quality control as the primary research and development body. ・Research Representative: Dr. Hideki Mori, Chief Physician (Department of General Internal Medicine) ■ Curvegen Co., Ltd. (Joint Research and Development Partner) ・Support for social implementation of research outcomes through the AI implementation platform 'CarbConnect® (CBC)' ・Provision of expertise in pharmaceutical affairs and medical device development strategies for the development of Software as a Medical Device (SaMD) 4. Future Outlook Through this research and development, both parties aim to contribute to the global challenge of antimicrobial resistance (AMR) by promoting the social implementation of excellent AI research outcomes from academia. Our company will continue to support the social implementation of excellent AI research outcomes from academia, leveraging the AI and pharmaceutical affairs expertise cultivated through the development of the bacterial infection species estimation support AI software 'BiTTE®-Urine' (SaMD), and utilizing the AI implementation platform CarbConnect® (CBC) as a platform for AI social implementation in the life science domain. The specific details and progress of this research and development will be communicated sequentially in accordance with the policies of both parties. 5. Representative Comments ■ Dr. Hideki Mori, Chief Physician, Department of General Internal Medicine, Nagasaki Medical Center, National Hospital Organization (Research Representative) "We are greatly honored to have this research and development project selected for AMED's 'FY2026 Medical Device Development Promotion Research Project'. We aim to develop diagnostic support technology that enables rapid determination of drug-resistant bacteria risk by combining Gram staining, a highly versatile examination method, with deep learning technology. Through joint research and development with Curvegen Co., Ltd., we will strive for social implementation as a technology that can be utilized in medical settings nationwide." ■ Masakazu Nakajima, Representative Director, Curvegen Co., Ltd. "We are deeply honored to be able to participate as a joint research and development partner in Nagasaki Medical Center's research project selected for AMED's 'FY2026 Medical Device Development Promotion Research Project'. Leveraging the AI and pharmaceutical affairs expertise cultivated through the development of the Software as a Medical Device BiTTE®-Urine, and utilizing the AI implementation platform CarbConnect®, we will fully commit to bridging excellent academic research outcomes to society. Through open innovation in industry-academia collaboration, we aim to contribute to solving the global challenge of antimicrobial resistance."