The board of directors of LifeTech Scientific Corporation announced that the one-year follow-up of the phase II clinical study (the "Phase II Clinical Study") on the Group's self-developed IBS ® Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System ("IBS ® Coronary Scaffold" or the "Product") has been successfully completed, and the results were announced globally for the first time by Dr. Lei Song, the director of Fuwai Hospital, Chinese Academy of Medical Sciences, on behalf of Academician Runlin Gao and entire research and development team, at the EuroPCR 2024 on 14 May 2024. The Phase II Clinical Study on IBS ® Coronary Scaffold is a prospective, multi-center, single-blinded, randomized trial. The primary endpoint of the study was in-segment late lumen loss two years after the implantation of the coronary scaffold.

The Phase II Clinical Study was officially launched in March 2022 and 518 subjects enrolled within nine months in 36 study sites, with a 1:1 random allocation to the experimental group (IBS ® Coronary Scaffold) and the control group (Xience ® Everolimus Eluting Coronary Stent). The one-year clinical follow-up results showed that there was no significant difference in the incidence of Target Lesion Failure (TLF) between the experimental and control groups (experimental group: 2.3%, control group: 2.7%, P=0.78). The incidence rates of cardiac death (experimental group: 0, control group: 1.2%, P=0.20) and target vessel-related myocardial infarction (experimental group: 0.4%, control group: 1.2%, P=0.37) were also similar in both groups with no device-related thrombosis occurred.

The current data preliminarily proves that the IBS ® Coronary Scaffold is not inferior to the current mainstream drug-eluting metal stent on the market and shows its remarkable performance in terms of safety and effectiveness. IBS ® Coronary Scaffold is the world's first fully degradable iron-based bioresorbable coronary scaffold, as far as the Company is aware. The backbone is processed from high-purity nitrided iron pipes with high strength and plasticity, and the strut is thin with a high radial strength.

The innovative material research and unique technological approach enable the Product to retain the advantages of permanent metal coronary stents, namely complete specifications, superior physical properties, good biocompatibility, simple operation and has fully absorbable characteristics, thereby effectively avoiding a series of long-term prognosis issues that may arise from the implantation of permanent metal stents. The announcement of the one-year follow-up results of the Phase II Clinical Study of IBS ® Coronary Scaffold further enhances the evidence-based medical evidences for this innovative product and will lay a solid foundation for the global development of the Product and other core products on the company's iron-based bioresorbable material platform. Currently, IBS ® Coronary Scaffold has been successfully submitted for CE registration approval and is expected to become the second successfully commercialized iron-based bioresorbable scaffold product in European Union, following the IBS Angel TM Iron Bioresorbable Scaffold System.

With the steady progress of follow-up clinical trials, more evidence-based medical evidences are expected to further confirm the safety and effectiveness of the Product. The Company believes that when it is launched to the market, IBS ® Coronary Scaffold will bring unprecedented treatment for patients with coronary heart disease all over the world.