Hongneung Small Giant Special Zone Achieves Major Successes with Research-Based Companies

Endorobotics Becomes First in Korea to Obtain FDA 'NAY' Code

Endorobotics, a company specializing in the development of endoscopic surgical robots, has become the first in Korea to receive the 'NAY' medical device classification code from the U.S. Food and Drug Administration (FDA).

The Ministry of Science and ICT announced on November 13 that this achievement demonstrates the Hongneung Small Giant Special Zone’s technology startup ecosystem is now producing visible global results.

Hongneung Small Giant Special Zone. Hongneung Small Giant Special Zone Website

The FDA's 'NAY' code is assigned to robot-controlled surgical systems, such as the da Vinci robot. Endorobotics has developed a surgical robot system that can be attached and detached from an endoscope, significantly improving precision and safety. With this approval, the company has secured the legal and technological foundation for entering the global market and is in the final stages of raising approximately 30 billion won in Series C investment. The total accumulated investment is expected to reach 50 billion won.

The Hongneung Small Giant Special Zone is a digital healthcare-focused cluster designated in 2020, centered around KIST, Korea University, and Kyung Hee University. Over the past four years, it has achieved tangible results, including 65.9 billion won in investment attraction, 110 technology transfers, 76 new startups, the establishment of 39 research-based companies, and 18.3 billion won in sales. This year, it received the highest grade in its annual evaluation.

Global achievements are also continuing. Curebus, a research-based company in the special zone, succeeded in exporting technology worth 500 billion won to Angelini Pharma in Italy last year. In June this year, it received FDA Phase 1 clinical trial approval in the United States and is now pursuing global joint research.

The Ministry of Science and ICT plans to expand public technology-based startup programs such as the 'Startup School,' strengthening a virtuous cycle from technology discovery to follow-up investment and global expansion. First Vice Minister Koo Hyukchae stated, "Through the Small Giant Special Zone, we will establish an ecosystem where research outcomes lead to startups, and startups achieve results in the global market."

This content was produced with the assistance of AI translation services.