Notice

Progress of the Asia-Pacific Medtech Innovation Forum(Singapore) and FDA STeP

- The Asia-Pacific Medtech Innovation Forum(Singapore, September)

We participated in the Asia-Pacific Medtech Innovation Forum event of Medtech, a global medical device consulting and accelerator company, at Suntec Convention & Exhibiton Centre in Singapore from September 26th to 27th.

Although we were not selected for this competition program, we are invited by Medtech and global major companies are members, participating in several major companies, and exhibiting innovative medical device products developed by start-up companies in the Asia-Pacific region.

The Medtech Forum presented the startup companies' No. 5 (1st stage: document screening, 2nd stage: 50 companies, 3rd stage: 20 companies, 4th stage: 4 companies, 5th stage: 1 company) to select the final one (more than 100 million won in prize money), and the forum on accelerating companies such as licensing, marketing, and production was displayed at the same time.

Many start-up companies participated to introduce innovative technology products developed by start-up companies to a number of major companies, but there was no opportunity to achieve their intended purpose by participating in major companies' Singapore offices for business purposes. The Singapore Institute of Technology (STUD), which highly evaluated our technology, was asked to give a lecture on Anyfusion innovation technology development design and experience to students in September 2023, and we decided to negotiate the exclusive supply of Singapore with the introduction of buyer who participated in the exhibition.

 

- FDA STeP progress

We officially submitted the application on August 26th, received the first supplement on September 25th after 30 days of intensive review, and were asked to submit proofs of the safety of many existing products by September 30th. Clinical trials were conducted at Seoul National University, Yonsei University, Japan, and Samsung Seoul, and reported to the academic community, and based on three SCi thesis data, we received consulting from consulting company and submitted it on September 30th.

With Anyfusion V100 and H100, clinical trial data that we faithfully prepared for the Korea Health Industry Development Institute (Ministry of Health and Welfare) support project, such as new product test support project and clinical trial support project, have become important data to efficiently use to prove FDA STeP's most important safety.

- We will attend the Medical Japan International Medical Device Exhibition in Tokyo, Japan, from October 11th to 14th. We are scheduled to consult with Company N, one of Japan's leading global medical device companies, and several other companies. Our low-cost, high-efficiency Anyfusion ACP system is the most suitable and only general-purpose product for advanced markets such as Japan and the United States, and we would like to negotiate an exclusive supply contract with N company.


Thank you.

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