Shanghai, China - Recently, the second-generation valve balloon catheter independently developed by MicroPort^® CardioFlow Medtech Corporation (02160.HK, hereinafter referred to as "MicroPort^® CardioFlow"), the Alwide^® Plus Valve Balloon Catheter (hereinafter referred to as "Alwide^® Plus"), has obtained market approval from the Mexican National Health Supervision Bureau (COFEPRIS, full name Comisión Federal para la Protección contra Riesgos Sanitarios) (SANITARY REGISTRY NO. 2556C2024 SSA).

As an upgraded product of Alwide^® valve balloon catheter, Alwide^® Plus was approved by the China National Drug Administration (NMPA) on July 29, 2021 (Registration Certificate No.:20213030586) and successfully launched in Argentina, Colombia, Brazil, Thailand, Russia, Indonesia, Saudi Arabia, and Hong Kong, China, with its excellent performance widely recognized by the physicians: Its ultra-low compliance can realize more precise balloon expansion to avoid vascular damage; high burst pressure performance can effectively expand the site of severe calcification, which can better cope with the characteristics of Chinese patients with high calcification; fast filling and pumping performance can minimize the impact of prolonged blood flow blockage on cardiac function, reduce the pacing time, and lower the risk of surgery; significantly improved anti-puncture performance can further increase the safety of balloon dilatation while bring the surgeons a better experience.

Currently, MicroPort^® CardioFlow's two generations of balloon dilation catheters, Alwide^® and Alwide^® Plus, have been fully adopted in over 700 core hospitals worldwide. Its third-generation valvuloplasty balloon catheter—the AccuSniper™ dual-layer balloon dilation catheter—has successfully achieved commercial clinical application after receiving NMPA approval, offering patients more high-quality and accessible treatment options.

Mexico, a major economic power in Latin America and one of the world's most open economies, has seen rapid growth in the demand for medical devices in recent years, with significant market development potential. The approval of Alwide^® Plus in Mexico will further enhance the international influence of "Made in China with Intelligence." In the future, MicroPort^® CardioFlow will accelerate its global expansion, bringing hope to more patients with structural heart disease worldwide.

Notes:

[1] CardioFlow's laboratory test data (compared with Alwide^® valve balloon catheter)