Fine Medix Secures MHLW Approval in Japan for "ClearCut Knife"

First Approval for Korean ESD Knife in Japan
Targeting the Market with Up to 20% Price Competitiveness

Fine Medix announced on the 10th that its endoscopic submucosal dissection (ESD) incision knife, the "ClearCut Knife," has obtained medical device approval from Japan's Ministry of Health, Labour and Welfare (MHLW).

Exterior view of PineMedics located in Yulam-dong, Dong-gu, Daegu Metropolitan City. PineMedics.

Painmedikseu's seven 'Clearcut Knife' models for ESD incisions. Painmedikseu.

The ClearCut Knife from Fine Medix is an incision knife used in ESD procedures to remove early-stage cancer lesions. It consists of seven different types, allowing it to be selected according to the procedure environment and lesion characteristics. In addition, its enhanced insulation function ensures both procedural efficiency and safety.

The company explained that this approval is the first case of a Korean-made ESD device obtaining medical device approval in the Japanese market, which demonstrates its strong competitiveness in terms of quality, safety, and precision control technology. Japan has a market structure centered on domestic companies and a strict product evaluation system, resulting in a high entry barrier for foreign companies.

Fine Medix stated that, starting from this approval, it will designate Japan as a strategic core market alongside Germany, Russia, and the United States, and will begin expanding its global business from this year. The company plans to secure market share by leveraging price competitiveness that is 15% to 20% lower than existing products distributed in Japan. It is also expanding its product portfolio beyond the ClearCut Knife into high value-added product lines. In this regard, it has already completed regulatory approval applications for products such as the endoscopic hemostatic device "Clear Hemograsper" and is awaiting the results.

In particular, the company plans to establish a sales base in Japan in the second half of this year and then set up a local subsidiary next year to solidify its influence in the market. It will also embark on full-scale marketing activities in cooperation with local distribution partners such as Medical Leaders and Gadelius Medical, which have networks with major university hospitals and endoscopy societies. The company intends to expand training programs such as local hands-on workshops to increase contact points with medical staff, while simultaneously improving products by reflecting on-site feedback.

Fine Medix CEO Jeon Sungwoo said, "Obtaining the first approval for a Korean-made ESD knife in Japan, which has led the global standard for ESD procedures, is a remarkable achievement that proves the clinical value and technological excellence of our product to the world," adding, "We will make every effort to expand our global market share so that Korean medical devices can become leading brands in the global market."

Fine Medix is a global endoscopic device specialist that was listed on the KOSDAQ market in December 2024. It was founded in 2009 by gastroenterology specialist CEO Jeon, with the goal of breaking the monopoly structure held by overseas companies in the endoscopic device market. The company currently develops and manufactures six product groups, 27 products, and 549 models in-house, and supplies them to 45 companies in 51 countries across the United States, Europe, Asia, and other regions.

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