The board of directors of MicroPort Scientific Corporation announced that on 30 July 2024, the new generation Firesorb Bioresorbable Scaffold System (?Firesorb Stent?), self- developed by the Group, obtained the approval for marketing from the National Medical Products Administration of China (the ?NMPA?), which will further improve the Group's integrated, precise and intelligent holistic solutions for the diagnosis and treatment of coronary artery-related diseases, in order to serve the comprehensive needs of patients worldwide. About Firesorb Stent: First Target Eluting Bioresorbable Scaffold System with Reduced Strut Thickness to Same Level as Metal Stents While Maintaining Equal Support The Group adopted thin strut design which made Firesorb Stent the first target eluting bioresorbable scaffold system with reduced strut thickness to same level as metal stents while maintaining equal support. The Rate of Thrombosis of All Patients in the FUTURE-I, II and III Three Trials was only 0.32% at 2-year Follow up, with a Four-year Thrombotic Event of 0% in the RCT Study Data from large preclinical studies have shown that Firesorb Stent is non-inferior to permanent drug-eluting stents in terms of major clinical parameters from publicly available clinical data.
Firesorb Stent has a target lesion failure (TLF) rate of only 4.3% at 4-year follow-up of RCT study. The rate of thrombosis of all patients in the FUTURE-I, II, and III Trials was only 0.32% at 2-year follow up, with four-year thrombotic event of 0% in the RCT study. The imaging results supports that Firesorb Stent is not inferior to other marketed permanent stents in terms of endothelial coverage rate and speed, and the numerical results of the clinical trial are superior compared to other biodegradable stents.
Target Eluting Technology to Reduce Effective Drug Load while Achieving Same Efficacy Adopting the unique ?target eluting? technology of MicroPort, Firesorb Stent achieves precisely targeted drug application, coating only one side of the stent facing the vessel wall and reducing the effective drug load to one-third of the universal drug load while achieving the same efficacy. Wider Lesion Size Coverage As a bioresorbable stent with wider lesion size coverage and applicable to the treatment of small- vessel lesions up to 2.5 millimeters in diameter, Firesorb Stent solves the problem of accessibility of bioresorbable stent in small-vessel lesion areas.
Meanwhile, the guidewire for rotational atherectomy, which is used in conjunction with the Group's first self-developed rotational atherectomy catheter system and coronary rotational atherectomy system, has recently obtained marketing approval from the NMPA, and the coronary rotational atherectomy system has entered the NMPA special review approval process for innovative medical devices (the ?Green Path?). Impact on the Company. Improve the Diagnosis Holistic Medical Solutions for the Treatment of Cardiovascular Diseases to Bring New Growth Momentum The marketing approval of Firesorb Stent and guidewire for rotational atherectomy by the NMPA will further improve the Group's integrated, precise and intelligent holistic solutions for the diagnosis and treatment of coronary artery-related diseases, in order to serve the comprehensive needs of patients worldwide.
Leveraging on the commercialisation capability of the Group's existing cardiovascular interventional product channels and overseas platforms, it is believed that new growth momentum will be brought to the Group. Strengthen the Leading Position in the Global Coronary Stent Field The incidence of coronary heart disease is trending younger. Bioresorbable stents, which can support diseased blood vessels in the short term and degrade completely in the body in the long term, are at the scientific and technological hub amid the global competition.
The approval of Firesorb Stent will further strengthen the Group's leading position in the global coronary stent field. Application of Technologies Derived from Platform The technologies derived from Firesorb Stent platform are expected to be applied in other areas such as cerebral infarction, peripheral vascular stenosis, and bone trauma in the future, allowing more patients to access internationally leading treatment solutions.