Lifetech's IBS® Absorbable Drug-Eluting Coronary Stent Completes Enrollment in China's Pivotal Randomized Controlled Clinical Trial

ShenzhenDecember 13, 2022/PR Newswire/ --

IBS® Coronary Stent Randomized Controlled Clinical Study
Completion of Enrollment for All Subjects

December 13, 2022Lifetech Scientific's wholly-owned subsidiary, Biotyx Medical (Shenzhen) Co., Ltd., has successfully completed patient enrollment for the prospective, multicenter, randomized controlled clinical study (Phase II clinical study) in China for its self-developed innovative product—the IBS® Bioresorbable Drug-Eluting Coronary Stent System (hereinafter referred to as the "IBS® Coronary Stent"). This marks another significant step forward in the commercialization process of this globally pioneering product by Lifetech Scientific.

This randomized controlled clinical study aims to evaluate the safety and efficacy of the IBS® coronary stent in the treatment of coronary heart disease. The study is led by Academician Runlin Gao as the Principal Investigator (PI), with the honor of inviting Academician Junbo Ge and Academician Yaling Han, along with nearly 40 clinical research centers and experts across China, to participate. The study was completed in a time-efficient manner.9 MonthsThe enrollment of all 518 subjects (1:1 ratio of experimental group to control group) was successfully completed.The success rate of the device and surgery is 100%., currently no device-related Serious Adverse Events (SAE) have occurred. This not only reflects the strong academic research atmosphere brought about by the unparalleled innovation of this product but also demonstrates the experts' earnest expectations and high confidence in the revolutionary progress this product will bring to the global treatment of coronary heart disease.

Sixteen Years of Dedicated Research and Development
World's First Fully Degradable Iron-Based Absorbable Coronary Stent

Coronary heart disease is one of the most common cardiovascular diseases, with high incidence and mortality rates, posing a serious threat to human health. In recent years, the number of patients with coronary heart disease in China and globally has grown rapidly. Currently, the number of coronary heart disease patients in China has reached 11 million, with approximately 4 to 5 million myocardial infarction patients.^[1]Percutaneous coronary intervention has developed rapidly due to its advantages of being minimally invasive, time-saving, safe, and efficient, and has now become the mainstream method for treating coronary heart disease.

However, mainstream permanent metal coronary stents, due to their non-degradability, will remain in the patient’s body for life after implantation. This results in a series of issues such as lifelong medication, the risk of long-term stent fatigue and fracture, limitations in secondary interventions for restenosis and the progression of atherosclerosis. In recent years, with the continuous advancement of medicine, "intervention without implantation" in revascularization has become a developmental trend in the field.

IBS® Coronary Stent: Independently Developed by Lifetech Scientific Over 16 Years, the World’s First Fully Bioabsorbable Iron-Based Coronary Stent. Its substrate is made from high-strength and highly ductile high-purity nitrided iron tubing, with a thin stent wall (total strut thickness of only 70μm) and strong radial support. Innovative material research and unique technical pathways allow the IBS® Coronary Stent to retain the advantages of permanent metal coronary stents, such as comprehensive specifications, excellent physical properties, good biocompatibility, and ease of operation, while also featuring complete bioabsorption. It begins to degrade after providing effective vascular support (3-6 months post-implantation) and safely enters the final stages of degradation around two years later, ultimately being harmlessly absorbed by human tissue, effectively avoiding a series of long-term prognostic issues potentially caused by permanent metal stent implantation.

The FIM Feasibility Clinical Study (i.e., Phase I Clinical Study) of the IBS® Coronary Stent began enrolling participants in 2018 and has now completed three years of follow-up. Preliminary results indicate good mid-term safety and effectiveness in simple primary coronary lesions. Measurements from angiography (QCA) and intravascular optical coherence tomography (OCT) showed that the average lumen area of the target vessel continued to expand six months after the implantation of the IBS® Coronary Stent, demonstrating the unique clinical advantages of this innovative product.

Unprecedented, Leading the Future

Completion of Full Patient Enrollment in the IBS® Coronary Stent Randomized Controlled Clinical Trial Marks Another Significant and Joyful Milestone for This Innovative Product and for Lifetech Scientific's Iron-Based Bioresorbable Materials Platform. The clinical results will lay a solid foundation for the global development of the IBS® Coronary Stent and other core products on this platform. Following this, the prospective, multi-center, single-group objective performance criterion study (i.e., Phase III clinical trial) of the IBS® Coronary Stent is also about to initiate patient enrollment. As subsequent clinical trials progress steadily, more evidence-based medical data will further confirm the safety and efficacy of the product. Upon successful market entry, it will bring an unprecedented treatment option to patients with coronary heart disease worldwide, fully leading coronary stent therapy into the era of iron-based bioresorbability!

[1] Data source: CCIF 2021

About Lifetech Scientific:

Lifetech Scientific (Shenzhen) Co., LTD. (Stock Code: 1302.HK) is a leading enterprise in the field of cardiovascular, cerebrovascular, and peripheral vascular interventional medical devices. Established in Shenzhen, China in 1999, the company is a national high-tech enterprise and recognized as a specialized, refined, distinctive, and innovative "little giant" enterprise by the Ministry of Industry and Information Technology of China. The company’s research and commercial product portfolio covers structural heart disease, peripheral vascular disease, pacemaker electrophysiology, respiratory intervention, neurointervention, and oncology intervention. It also owns the world’s first iron-based bioresorbable materials platform and has achieved independent technological breakthroughs in multiple niche areas. As of June 30, 2022, the company has implemented a high-quality patent layout with over 1,500 patents and has had a total of 15 products approved by the National Medical Products Administration (NMPA) for entry into the "Innovative Medical Device Special Review Process." Adhering to an "innovation + internationalization" development strategy, the company's main products have consistently held leading market shares in China, while its global presence includes multiple subsidiaries and offices. Its sales network now extends to over 100 countries and regions worldwide, making it one of the few highly internationalized Class III interventional medical device enterprises in China.