Chinese VAD Developer Completes Safety Phase of Head-to-Head Trial Against Abbott, Receives FDA Clearance for Pivotal Study

China's Artificial Heart Enterprises Make Significant Progress in "Going Global" —— On August 6 local time, BrioHealth Solutions, a wholly-owned subsidiary of China-based CH Biomedical in the United States, announced the successful completion of the Safety Phase of its INNOVATE U.S. clinical trial, which directly compares its fully magnetically levitated artificial heart with Abbott’s. The company has also received approval from the U.S. Food and Drug Administration (FDA) to enter the Pivotal Phase of the confirmatory clinical stage. With this, BrioHealth Solutions' self-developed product, BrioVAD, has officially obtained the "pass" for large-scale confirmatory clinical trials in the United States. After entering the confirmatory phase, the number of cooperative research centers participating in the INNOVATE clinical trial will expand to 60, with a cumulative enrollment of 780 participants. (NBD)