SINOMED(SH:688108) Zheng Quan Zhi Xing·2025-05-09 09:35Core Viewpoint - Sino Medical Science and Technology Co., Ltd. has received registration certificates for its SC HONKYTONK™ coronary balloon dilation catheter and NC ROCKSTAR™ non-compliant balloon dilation catheter from COFEPRIS and ARCSA, marking a significant step in the company's overseas business expansion [1][2][3] Product Registration Details - The SC HONKYTONK™ coronary balloon dilation catheter is designed for rapid exchange and is composed of multiple components including a tip, balloon protective sheath, and a platinum-iridium alloy radiopaque marker. It is sterilized with ethylene oxide and has a shelf life of 3 years [1][2] - The NC ROCKSTAR™ non-compliant balloon dilation catheter features a dual-layer balloon design that balances high burst pressure and low compliance, ensuring better tracking performance and resistance to kinking during procedures. It is also sterilized with ethylene oxide and has a shelf life of 3 years [2][3] Market and Regulatory Approvals - Both products have received various international certifications, including the China National Medical Products Administration (NMPA) registration in December 2022, and are expected to receive FDA approval and other international registrations from 2022 to 2025 [2][3] - The SC HONKYTONK™ catheter has been approved in multiple countries including the USA, Thailand, Taiwan, India, Uzbekistan, Pakistan, South Korea, Hong Kong, Belarus, Kyrgyzstan, Morocco, Peru, Malaysia, Mexico, and Ecuador [2][3] Impact on Company - The acquisition of these registration certificates is expected to enhance the sales of the company's products in international markets, contributing positively to the company's overseas business growth [3]