The board of directors of LifeTech Scientific Corporation announced that the three-year follow-up of the feasibility of FIM clinical study (the"Study") on the Group's self-developed IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System ("IBS Coronary Scaffold" or the "Product") has been successfully completed, and the results were published online by Professor Gao Runlin's team at Fuwai Hospital, Chinese Academy of Medical Sciences, on the authoritative international medical journal EuroIntervention on 10 April, 2023. The Study was conducted in Fuwai Hospital, Chinese Academy of Medical Sciences in 2018, with Professor Gao Runlin as the principal investigator (PI). In the Study, participants were randomly assigned to two cohorts, with cohort 1 completing six months and two years of imaging follow-up, and cohort 2 completing one year and three years of imaging follow-up, with preliminary positive results.

The completion of three-year follow-up of the Study indicates that the commercialization process of this innovative product is continuously and steadily advancing. The IBS Coronary Scaffold operates in the same way as the metal permanent stents, without compulsory PSP and slow dilatation. All stents in the Study were successfully implanted in the patients, without surgical complications, and the device, lesion and clinical success rates were all 100%.

Clinical data shows that the target lesion failure rate ("TLF") after six months of stent implantation is only 2.2%, while the TLF after one, two, and three years of implantation remains stable at 6.7%, with no deaths, myocardial infarction, or thrombotic events occurring throughout the follow-up period. Meanwhile, the OCT analysis results showed that the neointimal coverage rate after six months of stent implantation was as high as 99.8%, and reached 100% one year later. Preliminary results suggest that IBS CoronaryScaffold has a good interim safety profile in simple primary coronary lesions.

At the same time, there were no stenotic changes in the lumen during the three-year follow-up period and no long-term acquired malapposition during the degradation of the Product. In-segment late luminal loss (LLL) 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. In addition, the lumen area of IBS Coronary Scaffold continued to expand after six months of implantation, steadily increasing from 7.22mm to 8.03mm after three years of implantation, which was significantly different from the lumen area of other stents that continued to decrease with increasing stent implantation time.

This is the expected development trend of absorbable stents and reflects the unique clinical advantages of IBS Coronary Scaffold. In addition, the rate of absorption of IBS Coronary Scaffold was observed to be 82%±10% after two years of implantation and 95%±4% after three years of implantation from the Study, providing sufficient evidence that iron-based stents can be safely absorbed in humans. Iron-based fully degradable metal coronary stents show its great potential and bright prospects.