NextBiomedical Secures Exclusive Japan Distribution Deal for NexSphere-F Embolization Device
核心洞察
NextBiomedical (搜索) signed an exclusive distribution agreement with Asahi Intecc (搜索) for its NexSphere-F (搜索) fast-resorbable microsphere device in Japan, targeting chronic pain (搜索) patients.
The partnership leverages Asahi Intecc (搜索)'s extensive physician network and distribution capabilities across 120 countries, with the Japanese company reporting JPY 120 billion in revenue.
NexSphere-F (搜索) has already received regulatory approvals in Korea, Europe, and Canada, with U.S. FDA approval targeted for 2027-2028.
NextBiomedical (搜索) shares surged 10.53% to 67,200 won in early trading following the announcement of an exclusive distribution agreement with Japanese medical device giant Asahi Intecc (搜索) for its flagship embolization device NexSphere-F (搜索) in Japan.
The South Korean medical device company announced the partnership on April 9, 2026, marking a significant milestone in its global expansion strategy. Under the agreement, Asahi Intecc (搜索) will conduct clinical trials for NexSphere-F (搜索) targeting chronic pain (搜索) patients to obtain approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
Strategic Partnership with Global Leader
Asahi Intecc (搜索) specializes in medical microcatheters and guidewires, maintaining a strong global presence across Japan, the United States, Europe, China, and India. The company supplies 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.
As of the end of fiscal year 2025, Asahi Intecc (搜索) 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.
The Japanese company has strengthened its market influence through its extensive physician network in Japan, including Dr. Yuji Okuno, a pioneer in genicular artery embolization for osteoarthritis (搜索), as well as its strong distribution capabilities.
NexSphere-F Technology and Market Position
NexSphere-F (搜索) is a fast-resorbable microsphere designed for musculoskeletal pain embolization. The device has received regulatory approvals from Korea's Ministry of Food and Drug Safety (搜索) (MFDS), CE-MDD certification in Europe, and approval from Health Canada. Post-market clinical studies are actively underway both domestically and internationally.
Unlike many biotechnology companies that generate revenue through technology transfer and royalties, NextBiomedical (搜索) 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.
Global Expansion Timeline
NextBiomedical (搜索) is currently conducting clinical trials for U.S. Food and Drug Administration (FDA) approval of NexSphere-F (搜索), with the company targeting approval between 2027 and 2028. The PMDA approval and reimbursement approval processes in Japan are expected to be pursued in collaboration with Asahi Intecc (搜索).
A NextBiomedical (搜索) representative 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 (搜索)'s local sales network."
The representative added, "This exclusive agreement in Japan will serve as a significant milestone in NexSphere-F (搜索)'s global expansion strategy. We aim to achieve meaningful outcomes in the Japanese market through close collaboration with local physicians and partners."
NextBiomedical (搜索) expects that Asahi Intecc (搜索)'s robust physician network and distribution capabilities will play a key role in facilitating NexSphere-F (搜索)'s entry into the Japanese market, particularly given the partner's expertise in vascular interventional procedures including musculoskeletal embolization (MSKE) and transcatheter arterial chemo-embolization (TACE).