Core Points - The company has received approval from ANVISA for its SC HONKYTONKTM coronary balloon dilation catheter, marking a significant milestone in its overseas business expansion [1][2]. Group 1: Product Registration Details - The SC HONKYTONKTM coronary balloon dilation catheter is designed for the dilation of narrowed segments of coronary arteries and can be used for pre-dilation before PCI stent implantation [2]. - The product has a rapid exchange design and is composed of multiple components, including a tip, balloon protective sheath, and a platinum-iridium alloy radiopaque ring [2]. - The product has previously received various international certifications, including from the National Medical Products Administration of China and the FDA in the United States, among others [2]. Group 2: Impact on the Company - The approval of the product in Brazil is expected to enhance the company's sales in international markets, contributing positively to its overseas business growth [3]. - The company acknowledges that international market sales may be influenced by regulatory policies, market environment changes, and exchange rate fluctuations, which could impact future performance [3].

Core Viewpoint - Sino Medical (688108.SH) has received approval from Brazil's National Health Surveillance Agency (ANVISA) for its SC HONKYTONKTM coronary balloon dilation catheter, which is designed to improve myocardial perfusion by dilating narrowed segments of coronary arteries or bypass grafts [1]. Group 1 - The company submitted the registration application for the SC HONKYTONKTM product to ANVISA in November 2024 [1]. - The approval from ANVISA indicates a significant milestone for the company's expansion into international markets [1]. - The SC HONKYTONKTM product is specifically intended for use in coronary artery interventions [1].

Core Viewpoint - Sino Medical (688108) has successfully received approval from Brazil's National Health Surveillance Agency (ANVISA) for its SC HONKYTONK™ coronary balloon dilation catheter registration application submitted in November 2024 [1] Group 1 - The company submitted the registration application for the SC HONKYTONK™ coronary balloon dilation catheter to ANVISA on November 18, 2024 [1] - The approval from ANVISA was recently communicated to the company, indicating a positive regulatory outcome for the product [1]

Core Viewpoint - The company has received regulatory approval for its SC HONKYTONKTM coronary balloon dilation catheter and NC ROCKSTARTM non-compliant balloon dilation catheter from the national health authorities of Mexico and Ecuador [1] Group 1 - The SC HONKYTONKTM and NC ROCKSTARTM products have successfully obtained registration certificates from the Mexican and Ecuadorian health regulatory agencies [1]