赛诺医疗科学技术股份有限公司关于公司 冠脉球囊产品在海外获得注册证的自愿性披露公告

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].