Lifetech's IBS® Iron-Based Bioresorbable Drug-Eluting Coronary Stent System Receives Approval for Pivotal Clinical Trial in China

SHENZHEN, August 27, 2021 /PR Newswire/ --On August 25, 2021, the independently developed innovative product—IBS, by Biotyx Medical (Shenzhen) Co., Ltd., a holding subsidiary of Lifetech Scientific^®Bioresorbable Drug-Eluting Coronary Stent System (hereinafter referred to as IBS^®Coronary stent) has received implicit approval for clinical trials from the National Medical Products Administration (NMPA), which marks the IBS^®The pivotal clinical trial for the coronary stent has officially commenced in China, marking a comprehensive transition of stent therapy for coronary artery disease into the era of iron-based bioresorbable scaffolds. This pivotal trial is designed to conduct a prospective, multicenter evaluation of the IBS^®Clinical validation of the safety and efficacy of coronary stents for the treatment of coronary artery disease is planned to be conducted at over 40 centers across China.

Recently, IBS^®The First Investigator Meeting for the Confirmatory Clinical Trial of Coronary Stents in China was successfully held. Academician Gao Runlin, Academician Ge Junbo, Academician Han Yaling, and over 130 other experts attended the meeting and discussed IBS^®In-depth discussions and exchanges were conducted on topics including the clinical trial protocols, clinical application experience, imaging acquisition requirements, data management, and statistical analysis of coronary stents.

Coronary heart disease is one of the most common cardiovascular diseases, characterized by high incidence and mortality rates, posing a severe threat to human health. In recent years, the number of coronary heart disease patients in China and globally has grown rapidly. Currently, the number of coronary heart disease patients in China has reached 11 million, and the number of myocardial infarction patients is approximately 4 to 5 million.^[1]Percutaneous coronary intervention (PCI) has developed rapidly due to its advantages of being minimally invasive, time-saving, safe, and highly effective, and has become the mainstream treatment modality for coronary artery disease.

However, due to their non-biodegradable nature, current mainstream permanent metallic coronary stents remain in the patient's body for life after implantation, resulting in a series of issues including the need for lifelong medication, long-term risks of stent fatigue and fracture, vascular restenosis, and restricted secondary interventions due to the progression of atherosclerosis. In recent years, with the continuous advancement of medical science, vascular reconstruction under the "intervention without implantation" concept has become a developmental trend in the field. Currently, bioresorbable metallic and polylactic acid polymer-based...Absorbable MaterialCoronary stent.

IBS^®The bioresorbable drug-eluting coronary stent system was independently developed by Lifetech Scientific over 15 years and isWorld's FirstFully degradable iron-based bioresorbable coronary stent. Its scaffold is fabricated from a high-purity nitrided iron tube with high strength and high ductility, resulting in thin struts and strong radial support. It features the thinnest strut thickness and the smallest cross-sectional area, with a total strut thickness of only 70–80.um, thinner than current mainstream permanent metallic coronary stents. IBS^®After providing effective vascular support (i.e., 3–6 months post-implantation), the coronary stent begins to degrade. It safely enters the final stage of degradation at approximately 2 years and is ultimately completely resorbed by human tissues without adverse effects, thereby effectively avoiding a series of long-term prognostic complications associated with permanent stent implantation. Innovative material research and unique technological pathways enable the IBS^®The coronary stent retains the advantages of permanent metallic coronary stents, including a complete range of specifications, superior mechanical properties, excellent biocompatibility, and ease of operation, while also featuring the characteristic of being fully bioabsorbable. It isOnlyA bioresorbable coronary stent product with the potential to completely replace permanent metallic coronary stents.

Meanwhile, at this investigator meeting, Academician Gao Runlin, based on IBS^®The 2-year follow-up results of the FIM (first-in-man) clinical trial (feasibility study) for the coronary stent indicate that IBS^®The coronary stent undergoes rapid endothelialization, with no malapposition or struts protruding into the lumen observed. No major adverse events such as thrombosis, death, or myocardial infarction occurred. Two years post-vascular implantation, the stent has safely entered the final stage of degradation, fully demonstrating the IBS^®Characteristics of the coronary stent. Its FIM clinical data preliminarily demonstrated IBS^®Coronary stents are safe and effective.

IBS^®The approval of the bioresorbable drug-eluting coronary stent system for a confirmatory clinical trial in China marks a highly encouraging major milestone in Lifetech Scientific's R&D journey for iron-based bioresorbable materials. It is the third globally pioneering product on this innovative material technology platform to officially initiate a confirmatory clinical trial in China. With the steady advancement of subsequent clinical trials, accumulating evidence-based clinical data will further validate the safety and efficacy of this product. Upon successful commercialization, it will provide an unprecedented treatment option for patients with coronary heart disease in China, while laying a solid foundation for its entry into the global market.

【1】Data Source: CCIF 2021