Selected as a global market development support business for medical devices by KHIDI and consulting contract with IDD, a Japanese CRO company, for ACPi Japanese market research and PMDA certification.

We have been selected as a business operator in the global market development support project for medical devices, which is a support project of KHIDI.

Until 2020, the project was divided into an emerging market development support project and a global cooperation support project.

Anyfusion pump and Anyfusion ACPi, which are advanced medical devices developed by us, are necessary products in advanced markets such as the United States, Japan, and Germany, which have a market share of more than 80% of the global market.

It is necessary to raise the status of the Korean medical device industry as an innovative product centered on advanced countries, which has not been successful due to the emergence of emerging countries such as China, which have been focused on copy and modify.

Products that were recognized in advanced markets were easy to advance into emerging or underdeveloped countries, but the existing support projects were not suitable at the time when they had to enter advanced markets such as the United States, Japan, and Germany as the next-generation innovative products comparable to the economic level of Korea.

We suggested that it is necessary to move away from the market entry business centered on emerging or underdeveloped countries, and that innovative technology products focused on advanced market targets will not be given an opportunity.

Since this year, the size and purpose of the project have been changed and announced so that it can enter advanced countries, and we have been selected by supporting them.

Through this support project, we have made a contract with IDD, a global CRO, which is building a global clinical network for the 2022 global clinical trials of Anyfusion Pump and Anyfusion ACPi to enter the Japanese market with PMDA certification, and advanced markets such as the United States, Japan, and Germany.

The consulting contract period is from May 1st to September 30th, 2021, and we will apply for PMDA certification for Anyfusion pump and Anyfusion ACPi V100, Pro and Anyfusion cartridge set and kit set at the time of the end of consulting.

The global market development support project for medical devices for the purpose of consulting for PMDA certification will be invested as 15 million won and we will invest 5 million won in this consultation project.

Based on IDD's global network, it includes consulting (CRO role) for joint clinical trials of Anyfusion pump, Anyfusion ACPi V100, Pro, Anyfusion cartridge set and kit set in the United States, Germany, and Japan.

We are also introducing Anyfusion pump, ACPi V100, Pro, cartridge set, kit set, etc. to major companies such as Japan's global medical device company T, which is affiliated with Japanese IDD.

Through this support project, we will supply Anyfusion platform products that combine ACPi-centered ICT (HIS linkage) and IoT with force majeure and lack of alternatives in developed countries, such as the German and Japanese markets, where the ICT and IoT smart system penetration rates are 20-30% from the beginning, and the US market, which is 50-60%.

With the Anyfusion smart system platform item, we will do our best to become a bridgehead to advance into the advanced markets, starting with the Japanese market.

Thank you to KHIDI and the judges who selected as the support providers.