LIFETECH SCI (01302) announced that its self-developed IBS® bioabsorbable drug-eluting coronary stent system has successfully completed Phase II clinical studies and two-year follow-up for Phase III clinical studies. The results were presented globally at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 conference in the U.S. on October 26-27, 2025, by Professor Song Lei from Fuwai Hospital, Chinese Academy of Medical Sciences, representing Academician Gao Runlin and the research team.

The two-year follow-up results of the Phase II clinical study for the IBS® coronary stent showed late lumen loss in the target lesion segment (test group: 0.28±0.52mm, control group: 0.23±0.43mm), meeting the non-inferiority primary endpoint. No stent thrombosis events occurred in the test group, while one such event was reported in the control group.

For the Phase III clinical study, the two-year follow-up results demonstrated a target lesion failure (TLF) rate of 5.5% post-implantation. Only five cases of stent thrombosis were reported within two years, with an event rate of just 0.5%. Four of these cases occurred within one month, with three confirmed as unrelated to the device.

To the company's knowledge, the IBS® coronary stent is the world's first fully degradable iron-based bioabsorbable coronary stent. Its framework is made from high-strength, high-plasticity pure nitrided iron tubing, ensuring thin walls and strong support. Innovative material research and unique technical approaches allow the product to retain the advantages of permanent metal stents—such as comprehensive specifications, superior physical performance, excellent biocompatibility, and ease of use—while also being fully absorbable. This helps mitigate long-term complications associated with permanent metal stents.

The release of the two-year follow-up results for both Phase II and Phase III clinical studies further strengthens the evidence-based medical support for this innovative product. The clinical follow-up data has been submitted to China's National Medical Products Administration (NMPA) and the European CE certification process. If approved, the IBS® coronary stent could soon provide a groundbreaking, safe, and effective treatment option for coronary artery disease patients worldwide, while also laying a solid foundation for the global development of other core products in LIFETECH SCI's iron-based bioabsorbable material platform.