Current status after the designation of FDA STeP

1. Domestic hospital doctors and nurses trusted the stability and effectiveness of existing drug injection pumps developed in the U.S. and supplied worldwide through global major, but they correctly recognized through STeP that the source technology of the device itself causes medical accidents due to safety and effectiveness issues, and increased the reliability of Anyfusion.

2. The Ministry of Food and Drug Safety and the Ministry of Health and Welfare's guidelines for innovative medical devices agreed on the need to improve the system by including technology products classified as FDA innovative medical devices, and are considering reflecting it as soon as possible.

3. As a partner in the North American market, (1) we provide a guide line description and headquarters review data suitable for the world-class D company's Korean representative and meeting company. (2) Personal consultant, (3) Specialist consultant, and then select partners in North America and Europe through consulting.

4. We are developing optimal products for the global market, ICU, and anti-cancer (injection) preparation, and attracting investments for strategic and active large-scale academic and exhibition marketing from at least 2 to 3 billion won in the first half of 2023.

5. We are discussing with the Jeonju Medical Device Development Project Group of the Ministry about the upgrade Anyfusion cylinder pump and Anyfusion ACPi model development support project suitable for the global market.

6. I submitted an application for adjustment from Anyfusion cartridge screening (conditional) benefits to medical care (full) benefits, and an application for a separate calculation of Anyfusion ACPi system activity fees and ACPikitset to the Health Insurance Review and Assessment Service

7. Company A is negotiating over investment, joint development, and consignment production.

Thank you.