[Market Feature] FineMedix Surges on FDA Approval of Second-Generation 'ClearTip'

FineMedix is showing strong performance. This appears to be driven by the news that its second-generation ClearTip device, designed for tissue sampling during pancreaticobiliary endoscopic ultrasound procedures, has received approval from the U.S. Food and Drug Administration (FDA).

As of 9:09 a.m. on September 2, 2025, FineMedix is trading at 8,610 KRW, up 15.57% from the previous day.

On this day, FineMedix announced that its second-generation ClearTip (ClearTip EUS-FNA/B) device for tissue sampling during pancreaticobiliary endoscopic ultrasound procedures has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA).

ClearTip is a high value-added product that drives FineMedix's overseas sales. The first-generation ClearTip had already received FDA sales approval in 2018, and with this second-generation approval, FineMedix now has a total of 12 FDA-approved products. The company plans to leverage this to further increase overseas sales and expand its market share in the United States.

This FDA approval is particularly significant as it not only recognizes FineMedix's technology in a market long dominated by global companies, but also demonstrates the potential of its products. FineMedix is currently finalizing contracts with distribution partners to begin full-scale sales of ClearTip in the U.S. market.

ClearTip is a device used for fine-needle aspiration/biopsy (FNA/B) to collect tissue samples for diagnosis during endoscopic ultrasound (EUS) procedures. Its ergonomic design greatly improves visibility and sampling rates in the challenging pancreaticobiliary EUS procedures. In 2017, FineMedix became the first domestic company to localize such a device, launching the first-generation ClearTip based on innovative technology in a market previously dominated by global firms. In 2023, the company introduced the world's first button-type structure in the second generation to enhance procedural efficiency and convenience.

Jeon Sungwoo, CEO of FineMedix, stated, "This FDA approval goes beyond simple sales clearance; it serves as a catalyst to showcase the excellence and competitiveness of our products in the global market, accelerate partnerships, and speed up market expansion. We will continue to develop innovative products that meet the needs of medical professionals and prove our presence in the global endoscopic device market."

Meanwhile, FineMedix is a global endoscopic device specialist company that was listed on the KOSDAQ market in December 2024. It was founded in 2009 by CEO Jeon Sungwoo, a practicing gastroenterologist, to break the monopoly of foreign companies in the endoscopic device field. The company currently develops and manufactures six product lines, 23 products, and 234 models, supplying them to 45 companies in 51 countries, including the United States, Europe, and Asia.