The board (Board) of directors (Directors) of the Company announced that on 13 December 2022, the enrollment in the China Prospective Multicenter Randomized Controlled Clinical Study (the "Phase II" or the "Study") of the self-developed IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System ("IBS Coronary Scaffold" or the "Product") was completed and clinical enrollment in the China Prospective Multicenter Single-arm Target Study (the "Phase III") will be initiated. A total of 518 subjects were enrolled in Phase II and randomly assigned in a 1:1 ratio to the test and control groups, and the objective of the Study is to evaluate the safety and effectiveness of the IBS Coronary Scaffold in patients with coronary heart disease. The Study took nine months from the first enrollment in March 2022 to the completion of all enrollments.

Up to now, the device and surgery success rates are both 100% and no device-related serious adverse events (SAE) have occurred. As the world's first fully degraded iron-based bioresorbable coronary scaffold, the FIM for IBS Coronary Scaffold clinical implantation began in 2018, and it has completed the three-year follow-up, and the preliminary results demonstrate good intermediate-term safety and efficacy in simple primary coronary lesions. The completion of Phase II enrollment is another milestone for the Product, and with the advancement of follow-up clinical trials, there will be more clinical evidences to further confirm the safety and effectiveness of the Product.

Upon the successful launch of the Product, the IBS Coronary Scaffold is expected to be an unprecedented treatment for patients with coronary heart disease all over the world.