The board of directors of LifeTech Scientific Corporation announced that on 7 July 2023, the enrollment of the self-developed IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System in the China Prospective Multicenter Single-arm Clinical Study was completed. The Phase III Clinical Study is a crucial component of the confirmatory clinical study of the Product in China. It was officially launched in February 2023 and it has completed the enrollment of more than 800 subjects in total only after five months.

The operation success rate is 100%. Up to now, no device-related serious adverse events (SAE) have occurred. At this point, the enrollment of the confirmatory clinical study the Product in China has completed, and it has fully entered the clinical follow-up stage.

After reaching the primary endpoint, the application for marketing approval will be submitted in China. The Chinese confirmatory clinical study of IBS Coronary Scaffold was approved in August 2021. According to the guidelines issued by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (the "NMPA"), it is divided into two parts: randomized controlled study (phase II clinical study) and single-arm objective performance criteria study (phase III clinical study), aiming to evaluate the safety and effectiveness of IBS Coronary Scaffold in patients with coronary heart disease.

The confirmatory clinical study of IBS ® Coronary Scaffold in China was conducted by Academician Gao Runlin as the principal investigator (PI), with Academicians Ge Junbo, Han Yaling and clinical experts from around 40 clinical research centers all over the country fully participating. Previously, the Phase II clinical study successfully completed all the enrollment of 518 subjects in nine months, with an operation success rate of 100%. All patients had completed six-month follow-up, and no device-related serious adverse events (SAE) occurred.