Recently, Selethru® PTCA Balloon Dilatation Catheter, independently developed by Kossel Medtech, has obtained official marketing approval from Singapore’s Health Sciences Authority (HSA). This milestone further optimizes the Company’s strategic layout across Southeast Asia and accelerates its global expansion drive.

As a hub for medical innovation in Southeast Asia, Singapore boasts world-leading medical regulatory frameworks and stringent market access criteria. The approval stands as high recognition by HSA of Selethru® PTCA Balloon Dilatation Catheter in terms of its safety, clinical efficacy and quality control system. It also diversifies the range of coronary interventional devices available in Singapore and the broader Southeast Asian region, bringing clinical benefits to local patients.

To date, Selethru® PTCA Balloon Dilatation Catheter has achieved large-scale commercialization across Asia, the Middle East, South America and North America. It has obtained multiple authoritative international certifications, including EU MDR, US FDA clearance, South Korea KFDA approval and India CDSCO certification, with its presence covering major medical device markets worldwide.

The successful Singapore registration marks another vital breakthrough in Kossel Metech globalization strategy. Moving forward, the Company will continue to deepen its expertise in panvascular intervention, uphold technological innovation and rigorous quality refinement, and steadily advance its global market deployment. We aim to bring domestically developed innovative medical devices to the world, deliver care to patients globally, and contribute Chinese expertise to the diagnosis and treatment of panvascular diseases worldwide.