The Korea Health Industry Development Institute's February 2025 Clinical Evaluation Project for Domestic Medical Devices to Expand Domestic Medical Device Usage has secured participation from S University's main hospital, Korea's top university hospital, and C University Seoul Hospital, one of the five major hospitals. K University's main hospital, Korea's top private university, and Wonju S University Hospital have also expressed their intention to participate. This project runs until the end of 2025. Through usability evaluations over a maximum of two years, it aims to assess the reliability, safety, and efficacy of domestic medical devices, targeting their continued use and expansion. S University will serve as the Principal Investigator (PI).

Feedback received thus far from CS, GG, E, and W Universities, Bucheon and Incheon S Hospitals, U University's Gangneung A Hospital, and other hospital users. After incorporating this feedback and upgrading the product, the Anyfusion Cylinder Pump demonstrated superior competitiveness in safety, efficacy, and convenience compared to any domestic or international product, leading to our application for this project. Being selected for this project means that these hospitals will achieve clinical evaluation results equal to or better than existing user hospitals. This will not only support continued or expanded use at these hospitals but also significantly aid in spreading adoption to other hospitals.

Furthermore, based on demo results from the Department of Anesthesiology at S University Seoul Hospital, one of the five major hospitals, we made several improvements and formally registered it for use. In 2025, we aim to expand usage in major hospitals through this project. We will also participate in a booth at the Korean Society of Critical Care Medicine conference on April 24-25 to exhibit and promote the completed Rack and the MRI shielding curtain equipment currently under development.

The safety, efficacy, and convenience of the Rack, MRI shielding membrane, and pump will secure unrivaled competitiveness in real clinical settings. Beyond resolving issues like free flow, air alarms, and real-time inaccuracies inherent in existing technologies, supplying Anyfusion-dedicated Racks and MRI shielding membranes will dramatically reduce user workload and human error, broadening choice options. Through this project, we aim to expand sales into overseas markets by presenting reliable clinical validation data from actual use at major hospitals with the highest number of critically ill patients in the second year. This will be achieved through international conference paper presentations and exhibition promotions, shifting the paradigm of drug infusion pumps to Anyfusion.

The head of the ICU at Cheonan Soonchunhyang University Hospital highly praised the newly developed rack and stated they would recommend Anyfusion for use in other departments as well.

Thank you.