LIFETECH SCI (01302): The IBS coronary stent has obtained EU CE MDR certification.

LIFETECH SCI (01302) announced that on October 29, 2026, the IBS absorbable drug-eluting coronary stent system (IBS coronary stent or the Product), independently developed by the Company's subsidiary Yuanxin Technology (Shenzhen) Co., Ltd. (Yuanxin), has obtained EU CE MDR certification, making it the world's first iron-based coronary stent system to receive marketing authorization. The IBS coronary stent has established patent coverage across multiple major global economies, with fully independent intellectual property rights, and is the world's first fully biodegradable iron-based absorbable coronary stent. Its matrix is an iron-nitrogen alloy, a material with strength, plasticity, and elasticity comparable to cobalt-chromium alloy, enabling the IBS coronary stent to have thin struts (5565 m) and stronger radial support force. The ultra-thin stent struts give it significant advantages in rapid endothelialization and reducing the risk of early thrombosis. In both animal studies and clinical research, the IBS coronary stent has been observed to achieve extremely rapid endothelial coverage, with no late acquired malapposition and an extremely low incidence of stent thrombosis. Innovative material research and a unique technical pathway enable the IBS coronary stent to have the same size range (2.254.0 mm, length 838 mm) and indications as permanent metal stents, with simple operation (no PSP/4P maneuvers required). Meanwhile, a PDLLA/Zn layer is used to precisely regulate the degradation cycle, ensuring that the iron scaffold basically does not degrade in the first three months, disintegrates at six months, and is completely absorbed in three years, effectively avoiding a series of long-term prognostic problems that may be brought by implantation of permanent metal stents. The iron content of one IBS coronary stent is only equivalent to 12 weeks of iron intake for an adult, less than that of a stainless steel stent of the same specification. Therefore, the Product is also MRI conditional safe, with early artifacts between those of stainless steel and cobalt-chromium stents of the same specification, and the artifacts disappear after absorption. The IBS coronary stent launched its pre-market clinical research in China (three phases in total) in March 2018, with Academician Gao Runlin serving as Principal Investigator (PI), and Academicians Ge Junbo and Han Yaling, as well as nearly 40 clinical research centers and experts nationwide, invited to participate. The Phase I clinical study of the IBS coronary stent was a prospective, single-center clinical study. The five-year follow-up results of 45 cases demonstrated the excellent safety of IBS, particularly the continuous expansion of stent and lumen area after six months, truly realizing the design concept of "positive vascular remodeling" for absorbable stents. The Phase II clinical study of the IBS coronary stent (Phase II clinical study) was a prospective, multicenter, single-blind, randomized controlled clinical study, with the primary endpoint being in-segment late lumen loss (In-Seg. LLL) at two years after coronary stent implantation. The clinical study was officially launched in March 2022 and completed enrollment of all 518 subjects at 36 centers in China in only nine months, with 1:1 randomization to the experimental group (IBS coronary stent) and the control group (XienceTM everolimus-eluting coronary stent). Two-year follow-up results showed that in-segment late lumen loss (In-Seg. LLL) was 0.280.52 mm in the experimental group and 0.230.43 mm in the control group, with no significant difference, meeting the pre-specified non-inferiority criteria and achieving the primary endpoint. Meanwhile, two-year follow-up results observed that no trial stent thrombosis events occurred in the experimental group, while 1 trial stent thrombosis event occurred in the control group. The Phase III clinical study of the IBS coronary stent (Phase III clinical study) was a prospective, multicenter, single-arm objective performance criteria clinical study, with the primary endpoint being target lesion failure rate (TLF) at one year after IBS coronary stent implantation. The clinical study was officially launched in February 2023 and enrolled a total of 1,060 patients, including 259 subjects from the experimental group of the Phase II clinical study of the IBS coronary stent and 801 subjects newly enrolled in the Phase III clinical study, in only five months. The one-year TLF rate for the primary endpoint was 2.7%. The non-inferiority objective value was met. As the inclusion/exclusion criteria and operational requirements of the Phase II and Phase III clinical studies were highly consistent, a post-hoc analysis compared all cases implanted with the IBS coronary stent in the Phase II and Phase III clinical studies with the control group of the Phase II clinical study (Xience everolimus-eluting coronary stent) in terms of TLF incidence at one and two years after stent implantation, and also reached non-inferior conclusions: one year 2.7% vs 2.7%; two years 5.5% vs 5.4%. In addition, the IBS coronary stent demonstrated extremely excellent safety: among 1,060 patients, the incidence of cardiac death at two years post-procedure was 0.1% (control group 1.2%, with a significant difference in post-hoc analysis), and the incidence of target vessel myocardial infarction was 1.3% (control group 1.6%); within two years, only 5 cases of trial stent thrombosis occurred, with a thrombosis event rate of 0.5%, of which 4 cases occurred within 1 month and 3 cases were clearly caused by non-device-related reasons; only 1 case of "possible" late thrombosis occurred. The Phase II and Phase III clinical studies also showed that the IBS coronary stent has an extremely high procedural device success rate, good deliverability, and a broad range of applicability. The patient enrollment criteria were highly consistent with the real-world patient situation, and the proportion of complex lesions in coronary artery lesion classification (i.e., ACC/AHA B2/C lesions) was as high as 74.9%, comparable to mainstream permanent stents and significantly higher than the proportion of ACC/AHA B2/C lesions included in large-scale clinical trials of polylactic acid absorbable coronary stents and magnesium alloy absorbable coronary stents already marketed domestically and abroad (5.7%58.9%). Meanwhile, in the Phase III clinical study, the proportion of IBS coronary stents of 33 mm and 38 mm lengths used was 24.4% (other absorbable coronary stents all have lengths 30 mm); according to post-hoc QCA analysis by the core laboratory, the vessel diameter range of implants in this clinical study was 1.395.58 mm, and vessels smaller than 2.5 mm accounted for 18.9%. Under such circumstances, implantation of the IBS coronary stent in all 1,110 lesions of 1,060 patients was successful, with simple surgical operation and convenience of use comparable to permanent stents. Compared with all clinical studies of absorbable stents domestically and abroad, the patient enrollment criteria of this study were highly challenging, yet excellent clinical results were similarly achieved. This proves that the IBS coronary stent is comparable in all aspects to the current mainstream drug-eluting metal stents in the market, while its absorbable properties also provide more long-term benefits. The IBS coronary stent has demonstrated mid- to long-term safety and efficacy in more than 1,100 samples, and has received official EU recognition and high attention from the European market and physicians. It has currently obtained clear cooperation intentions from distributors in 60 overseas countries or regions. The fully biodegradable metal coronary stent using iron as the material has demonstrated tremendous clinical application potential and bright prospects in current clinical research. The series of clinical studies of the IBS coronary stent provide solid evidence-based support for the success of its global commercialization. After obtaining CE approval, the Product will commence a large randomized controlled post-market study in Europe with TLF as the primary endpoint, further enriching the clinical evidence for the Product.