Three-Year Follow-Up Results of First-in-Man Clinical Study on IBS® Absorbable Drug-Eluting Coronary Stent System Published by Academician Gao Runlin’s Team

ShenzhenApril 13, 2023PR Newswire -- Biotyx Medical (Shenzhen) Co., Ltd., a wholly-owned subsidiary of Lifetech Scientific, independently developedWorld's FirstProduct -- IBS^®Absorbable Drug-Eluting Coronary Stent System (hereinafter referred to as: IBS)^®Coronary stent) has successfully completed the three-year follow-up of the feasibility (FIM) clinical study.April 10, 2023, the research findings were published by a team led by Academician Runlin Gao from Fuwai Hospital, Chinese Academy of Medical Sciences, in an internationally authoritative medical journal.EuroInterventionPublished online. This not only represents the international industry's high attention to this research and unanimous affirmation of the product's innovation, but also marks another perfect debut of China's medical innovation technology on the global academic stage.

Global Leader, Positive Data

IBS^®The FIM clinical study of the coronary stent began in 2018 at Fuwai Hospital, Chinese Academy of Medical Sciences, with Academician Runlin Gao serving as the Principal Investigator (PI). In this clinical study, subjects were randomly assigned to two cohorts. Cohort 1 has completed six-month and two-year imaging follow-ups, while Cohort 2 has completed one-year and three-year imaging follow-ups, with preliminary results being positive. The completion of the three-year FIM clinical follow-up marks that the commercialization process of this innovative product is proceeding steadily.

IBS^®The operation method of coronary stents is the same as that of metal permanent stents, withoutMandatoryPSPAnd Slow Expansion, All stents in the clinical study were successfully implanted into patients without surgical complications. The device, lesion, and clinical success rates were all 100%. Clinical data showed that the target lesion failure rate (TLF) six months after stent implantation was only 2.2%, stabilizing at 6.7% one, two, and three years post-implantation. Throughout the follow-up period, there were no occurrences of death, myocardial infarction, or thrombotic events. Additionally, OCT analysis results indicated a high neointimal coverage rate of99.8％, and reached 100% one year later. Preliminary results indicated IBS^®Coronary stents have good mid-term safety and effectiveness in simple primary coronary artery lesions.

Meanwhile, no stenotic changes occurred in the lumen during the three-year follow-up period, and no late-acquired malapposition was observed during the stent degradation process. The late lumen loss (LLL) within the segment was 0.25 ± 0.26 mm at six months, 0.27 ± 0.45 mm at one year, 0.27 ± 0.35 mm at two years, and 0.21 ± 0.38 mm at three years.Rather thanThe lumen area of its stent continues to decrease significantly with the increase of stent implantation time, IBS^®The lumen area continued to expand six months after coronary stent implantation, from 7.22Square millimeterStably increased to 8.03 three years after implantation.Square millimeter. This is precisely the anticipated development trend for absorbable stents, and it also reflects IBS^®The Unique Clinical Advantages of Coronary Stents.

FromIBS Observed in FIM Clinical Study^®The absorption rate of the coronary stent reached 82% ± 10% two years after implantation and 95% ± 4% three years after implantation, fully demonstrating that the iron-based stent can be safely absorbed in the human body. The fully degradable metal coronary stent made of iron shows great application potential and a bright future.

Figure 1. In-stent and in-segment late lumen loss (LLL)

Figure 2. OCT Follow-up Results

Crafting Dreams, Leading the Future

IBS^®Coronary stent isThe World's FirstFully Degradable Iron-Based Absorbable Coronary Stent. Its substrate is made from high-strength and high-ductility high-purity nitrided iron tubing, with a thin stent wall (total strut thickness of only 70μm) and strong support. Innovative material research and a unique technical approach have enabled IBS.^®Coronary stents not only retain the advantages of permanent metal coronary stents, such as a complete range of specifications, superior physical performance, good biocompatibility, and simple operation, but also possess the characteristic of being fully absorbable, effectively avoiding a series of long-term prognostic issues that may arise from the implantation of permanent metal stents.

The announcement of the three-year follow-up results of the IBS® Coronary Stent FIM clinical study further strengthens the evidence-based medical proof for this innovative product. It will also lay a solid foundation for the global development of this product and other core products on Lifetech Scientific's iron-based bioresorbable materials platform. The IBS® Coronary Stent completed the enrollment of all subjects in its Phase II randomized controlled clinical study in December 2022, and its prospective, multi-center, single-group objective performance criterion study (i.e., Phase III clinical study) is currently in the process of patient enrollment.

Lifetech Scientific's iron-based bioabsorbable materials platform has undergone sixteen years of steady development, positioning itself as an innovator and leader in the global bioabsorbable stent field.PreviouslyIn the concluded final of the 2022 China Disruptive Technology Innovation Competition, it stood out among more than 2,800 technology projects after rounds of selection to enter the finals. Ultimately, it excelled among 157 high-quality projects with disruptive potential, receiving a unanimous vote to win the highest award in the finals—the Excellence Award—and entered the Ministry of Science and Technology's Disruptive Technology Candidate Pool. It is believed that with the continuous improvement of subsequent clinical and evidence-based medicine, this revolutionary technology will bring unprecedented benefits to patients worldwide.Treatment ofTherapeutic methods, and will actively promote the comprehensive entry of the treatment of related diseases into the era of iron-based absorbable materials.。

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, it is a national high-tech enterprise and recognized as a specialized, refined, distinctive, and innovative "little giant" enterprise by China’s Ministry of Industry and Information Technology. The company’s research and product portfolio includes 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 December 31, 2022, the company has achieved a high-quality patent layout.1,800In addition, a total of 15 products have been approved by the National Medical Products Administration (NMPA) to enter the "Special Review Procedure for Innovative Medical Devices." Adhering to the development strategies of "innovation" and "internationalization," the company's main products currently on sale have long held leading market shares in China. The company has subsidiaries and offices in six countries worldwide, with a sales network covering over 100 countries and regions globally. It is one of the few Chinese Class III interventional medical device enterprises with a highly internationalized business.