Kossel Medical has recently achieved a string of overseas regulatory wins, securing market approvals for multiple products in Japan, the United States, Singapore, Vietnam and Hong Kong SAR. Spanning coronary, peripheral and neurointervention segments, several product lines have delivered simultaneous breakthroughs in key international markets, further accelerating the company’s global footprint.

IndustryClinical Codevelopment: SPEQTA® Microcatheter Receives Firstever Approval in Japan

SPEQTA® Microcatheter has recently obtained market approval in Japan. This marks Kossel’s firstever approval for a neurointerventional product in Japan and signals the substantive overseas launch of its neurointervention business.

Developed through joint collaboration between Kossel and Japanese clinicians, the product’s design concept originates from realworld frontline clinical demands in Japan. More than simply a product for export, it represents twoway innovation that translates clinical needs into product development. Building on this milestone, Kossel will continue to deepen such partnerships, convert frontline clinical insights into driving forces for product iteration, and deliver bettersuited medical devices for the Japanese market.

Sequential Market Authorizations Accelerate Global Footprint Expansion

• United States: Sabelly® NCPTA Balloon Dilatation Catheter obtains FDA clearance
• Singapore: Falexpand® HP PTA Balloon Dilatation Catheter obtains Singapore medical device registration
• Vietnam: Selestem® Singleuse Radial Artery Tourniquet obtains Vietnamese medical device registration
• Hong Kong SAR: Selethru® PTCA Balloon Dilatation Catheter and Selethru® NC PTCA Balloon Dilatation Catheter obtain Hong Kong SAR medical device registrations

These multimarket approvals further strengthen Kossel’s coronary and peripheral product portfolios across regional and major international markets. They lay a solid foundation for deepening presence in ASEAN and expanding into North America, speed up Kossel’s global outreach, and enable highquality Chinesemade vascular interventional devices to benefit more patients worldwide.

These successive market authorizations consolidate the overseas layout of Kossel’s core coronary and peripheral product lines, while delivering new progress in its neurointervention business. This achievement reflects Kossel’s integrated industrialchain capabilities and global operational expertise. Guided by its “Local Base, Global Reach” international strategy, Kossel will keep advancing overseas regulatory submissions and commercialization, steadily expanding key global markets, and bringing premium Chinesemanufactured medical devices to more healthcare institutions and patients.