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SEOUL, South Korea, April 9, 2026 /PRNewswire/ — NEXTBIOMEDICAL CO., LTD. (KOSDAQ: 389650), an innovative medical device company based in South Korea, announced today that it has entered into an exclusive distribution agreement in Japan with Asahi Intecc Co., Ltd., a global medical device company, for Nexsphere-F™, the company’s novel fast-resorbable microsphere for embolization.
Unlike many biotechnology companies that generate revenue through technology transfer and royalties, NEXTBIOMEDICAL differentiates itself by exporting finished medical devices directly. This agreement follows the same model, under which the Company will supply finished products to its Japanese partner.
Asahi Intecc specializes in medical microcatheters and guidewires and has established a strong global presence across Japan, the United States, Europe, China, and India. Guidewires are essential devices used in most vascular interventional procedures, while microcatheters play a critical role in various embolization procedures, including musculoskeletal embolization (MSKE) and transcatheter arterial chemo-embolization (TACE).
Asahi Intecc supplies its products to approximately 120 countries worldwide and continues to expand its business in the vascular intervention field, supported by a broad product portfolio aligned with the growing demand for minimally invasive treatments. In particular, Asahi Intecc has strengthened its market influence through its extensive physician network in Japan, including Dr. Yuji Okuno, a pioneer in genicular artery embolization for osteoarthritis, as well as its strong distribution capabilities. Its flagship products maintain a leading global market share and strong competitiveness.
As of the end of fiscal year 2025, Asahi Intecc reported revenue of approximately JPY 120 billion, representing a 12% year-over-year increase, with an operating profit margin of 25.1%. Approximately 90% of its revenue is generated from its medical device segment, and the company continues to expand beyond its domestic Japanese market into global regions, including the United States, Europe, and China. NEXTBIOMEDICAL expects that Asahi Intecc’s robust physician network and distribution capabilities will play a key role in facilitating Nexsphere-F’s entry into the Japanese market.
Nexsphere-F™, NEXTBIOMEDICAL’s flagship product, is a fast-resorbable microsphere designed for musculoskeletal pain embolization. The product has received regulatory approvals from the Ministry of Food and Drug Safety (MFDS) in Korea, CE-MDD certification in Europe, and approval from Health Canada. Post-market clinical studies are actively underway both domestically and internationally. In addition, clinical trial for U.S. FDA approval is currently in progress, with the Company targeting approval between 2027 and 2028.
Through this agreement, NEXTBIOMEDICAL aims to accelerate its entry into the Japanese market. The PMDA approval and reimbursement approval processes in Japan are expected to be pursued in collaboration with Asahi Intecc Co., Ltd.
A representative from NEXTBIOMEDICAL stated, "This agreement was made possible due to strong recognition of our product competitiveness and global market potential. We plan to accelerate our expansion into Japan by leveraging Asahi Intecc’s local sales network."
The representative added, "This exclusive agreement in Japan will serve as a significant milestone in Nexsphere-F™’s global expansion strategy. We aim to achieve meaningful outcomes in the Japanese market through close collaboration with local physicians and partners."
