The adjustable intracranial stent retriever product (“Luci”), which is jointly developed by the Group and its associated company Nanjing Kainite Medical Technology Company Limited* (南京凱尼特醫療技術有限公司), has been granted registration certificate for medical device by the National Medical Products Administration of the People’s Republic of China (“NMPA”) recently. This is another milestone for the Group in the direction of neurointervention in the field of cerebro-cardiovascular precision interventional diagnosis and treatment.
Luci is the first adjustable intracranial stent retriever product that produced in China. The stent is designed with a round wire braided structure, and can be manually adjusted in vitro to the ideal diameter to match the target blood vessel.
According to the results of the registration clinical study, the successful recanalization rates of the experimental group Luci and the control group Medtronic’s Solitaire FR were 98.3% and 95.8%, respectively; the successful recanalization rates of the vessels after the first thrombectomy were 68.9% and 68.0%, respectively; the incidence of symptomatic intracranial hemorrhage within 24 hours after surgery was 2.7% and 3.4%, respectively; and the incidence of serious adverse events within 90 days after surgery was 32.8% and 35.3%, respectively.
According to Frost & Sullivan data, the disability rate of AIS in China exceeds 30%, and the one-year mortality rate exceeds 15%. From 2017 to 2021, the number of cases of acute ischemic stroke in China increased from 3.232 million to 3.766 million, with a compound annual growth rate of 3.9%. By 2026 and 2032, the number of cases of acute ischemic stroke in China is expected to increase to approximately 4.795 million and 5.972 million. At present, the main clinical methods for treating AIS are intravenous thrombolysis and interventional therapy. Intravenous thrombolysis is first used to treat AIS patients with onset within 4.5 hours.
The field of cerebro-cardiovascular precision interventional diagnosis and treatment is one of the core strategic areas of the Group. The Group adheres to the treatment concept of “interventional without implantation” and conducts comprehensive strategic plan in three directions, namely channel management, structural heart disease, electrophysiology and heart failure, to build a high-end medical device product cluster. At present, the segment has reserved 14 products, of which 9 products in channel management have been approved for commercialization in China.
The Group always puts focus on the R&D of innovative products and advanced technologies. Adhering to a patient-centered and innovation-driven approach, the Group will continue to increase its investment in world-class innovative products and advanced technologies to meet unmet clinical needs and enrich its product pipeline and improve supply chain. The Group adopts the strategy of “global expansion and dual-cycle operation”, forming a new pattern of domestic and international cycles that synergize with each other. In this way, the Group can make full use of its industrial advantages and R&D capabilities, to accelerate the commercialization process for innovative products and provide patients with more advanced and diverse treatment options globally.
