April 10, 2026 | Friday | News
NEXTBIOMEDICAL, an innovative medical device company based in South Korea, has entered into an exclusive distribution agreement in Japan with Asahi Intecc Co, 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 specialises 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 embolisation procedures, including musculoskeletal embolisation (MSKE) and transcatheter arterial chemo-embolisation (TACE).
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.