FineMedix, a gastrointestinal endoscopic device company, is entering the Japanese market after becoming the first Korean company to obtain Japanese regulatory approval for an endoscopic submucosal dissection (ESD) knife.
FineMedix announced on the 10th that its ESD knife "ClearCut Knife" has received medical device approval from Japan's Ministry of Health, Labour and Welfare (MHLW). The ClearCut Knife is used in ESD procedures to remove early-stage cancer lesions. The product line consists of seven types, allowing physicians to select various tip configurations based on procedural requirements and lesion characteristics. The device features enhanced insulation technology that ensures both procedural efficiency and safety.
This approval is significant as it marks the first time a Korean-made ESD surgical device has received regulatory clearance in Japan. Japan is known for its domestic company-dominated market structure and stringent product evaluation system, creating high barriers to entry for foreign firms. The approval demonstrates that FineMedix products have proven competitive excellence in quality, safety, and precision control technology.
FineMedix plans to accelerate its Japanese market expansion following this approval. The company's strategy is to capture market share through pricing that is 15-20% lower than existing products. The company is also expanding its product portfolio. It has completed regulatory applications for high-value products including the endoscopic hemostatic device "ClearHemograsper," with results expected in the first half of this year.
The company plans to establish a local presence in Japan within this year and will conduct marketing in partnership with local distributors Medical Leaders and Gadelius Medical, which have networks with major university hospitals and endoscopy societies. FineMedix also plans to strengthen its key opinion leader (KOL) network and expand educational programs including local hands-on workshops to increase engagement with medical professionals.
The company aims to build its Japan sales infrastructure in the second half of this year, followed by establishing a local subsidiary in 2027 to solidify its market presence.
"Obtaining the first approval for a Korean-made ESD knife in Japan, which has led global standards for ESD procedures, is a significant achievement that proves our products' clinical value and technological capabilities to the world," said Jeon Sung-woo, CEO of FineMedix. "We will dedicate all our efforts to expanding market share so that Korean medical devices can become a leading global brand."
