[Edaily Reporter Kim Hyung-il ] Finemedix Co., Ltd., a provider of gastrointestinal endoscopy solutions, announced on the 21st that it has signed an Original Design Manufacturing (ODM) agreement with Creo Medical, a UK-based medical device company, for two types of endoscopic instruments.

The two companies signed the agreement on the 19th (local time) at the Union of European Gastroenterology Week (UEGW) in Barcelona, Spain. The contract spans three years, from this year through 2028, and targets the U.S. and Latin American markets. The total contract value is $2,109,910 (approximately 2.973 billion won). The agreement is structured so that the supply volume will expand in stages following the initial shipment, and Finemedix Co., Ltd. expects to secure additional revenue opportunities through follow-up orders.

This agreement is significant in that it marks an expansion of Finemedix Co., Ltd.’s business scope beyond the direct sale of its in-house developed and manufactured medical devices to serving as a manufacturing partner supplying products to the product portfolio of a global medical device company. By entering the U.S. and Latin American markets through Creo Medical’s global sales network, Finemedix Co., Ltd. can reduce the time and costs required to establish local distribution channels and build brand awareness, allowing the company to focus on expanding product sales.

The products covered by the agreement are the “ClearTip EUS-FNA/B,” a tissue-sampling device used for endoscopic ultrasound-guided fine-needle aspiration and biopsy (EUS-FNA/B), and the “ClearCap Distal Attachment,” which is mounted on the distal end of an endoscope to improve visibility and procedural convenience.

ClearTip is used to identify lesions and collect tissue samples using endoscopic ultrasound. Finemedix Co., Ltd. explained that, compared to global competitors’ products, it facilitates lesion identification and allows for flexible control of the needle’s movement, thereby enhancing procedural convenience. ClearCap is a product attached to the tip of an endoscope to improve visibility and procedural convenience. Building on the product competitiveness it has accumulated in the gastrointestinal field, Finemedix Co., Ltd. is expanding its portfolio to include respiratory endoscopy products.

Finemedix Co., Ltd. cited its in-house capabilities—spanning product development, regulatory approval, and production—as the foundation for this contract. The company has been developing and manufacturing endoscopic instruments in-house and has supplied its products to a total of 48 countries to date. ClearTip received marketing authorization from the U.S. Food and Drug Administration (FDA) last year, while ClearCap was approved in 2021. In June of this year, the company also completed the transition to certification under the European Medical Device Regulation (CE MDR) for both products. The company explained that securing the safety and quality standards required for medical devices in the global market led to this contract.

This contract is expected to further bolster the company’s recent trend of improved performance and expansion of overseas operations. Finemedix Co., Ltd.’s revenue for the first half of this year reached 6.26 billion won, a 43.7% increase compared to the same period last year, and the company returned to profitability. Overseas revenue rose by approximately 51% year-over-year. Finemedix Co., Ltd. is expanding its overseas business by leveraging local partnerships in key markets such as the U.S. and Japan.

Finemedix Co., Ltd. plans to use this contract as an opportunity to strengthen its global business structure, which combines sales of its own brand with ODM supply. The company intends to enhance the stability of its overseas sales by ensuring that product approvals and supply contracts lead not only to initial sales but also to follow-up orders and cumulative revenue, while simultaneously expanding its ODM product lineup and supply regions in phases.

Jeon Seong-woo, CEO of Finemedix Co., Ltd., stated, “This contract is highly significant as it signifies that Finemedix Co., Ltd.’s capabilities in product development, regulatory approval, and production have been recognized by a global medical device company.” He added, “Following improved first-half performance and increased overseas sales, we will build on this ODM contract to secure follow-up orders and sales results in the U.S. and Latin American markets.”

He added, “By simultaneously expanding sales centered on our own brand and ODM supply through global partners, we will enhance the quality of our product portfolio and overseas sales and build a foundation for sustained growth.”