Source: Heart Future; Editor: Bai Xiaofei
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Recently,Enlight Medical Limited(abbreviation: "Enlight Medical")Wholly-owned subsidiaryBeijing Youzhuozhenglian Medical Technology Co., Ltd.(hereinafter referred to as "Youzhuo Medical") independently developedNovoTaper® Thoracic Aortic Stent Graft SystemApproved for registration by the National Medical Products Administration (NMPA)。NovoTaper® is developed by Beijing Youzhuozhenglian Medical Technology Co., Ltd.The All-New Thoracic Aortic Stent Graft System, used forEndovascular Intervention for Aortic Dissection。▲Source: Company official websiteApproval of NovoTaper® Thoracic Aortic Stent Graft SystemFurther enriches the company's existing aortic and peripheral vascular intervention product pipeline., providing better options for clinicians and patientsEndovascular Intervention Solutions for AortaIn the future, the company will continue to focus on unmet clinical needs, accelerate the research and development and market launch of new products, benefiting more patients.#Aortic Stent GraftMarket OverviewAortic Stent Graft, also known as Great Artery Stent Graft, is mainly used in endovascular interventional surgeries for the treatment of aortic diseases such as aortic dissection, abdominal aortic aneurysm, and thoracic aortic aneurysm.。 Aortic dissection commonly occurs in people aged 50-70, while aortic aneurysms are more prevalent in individuals over 60. According to estimates by the National Health Commission,Around 2035, the population aged 60 and above will exceed 400 million, accounting for over 30% of the total population.China's aging trend is intensifying, and aortic diseases are common among middle-aged and elderly people.Increase in IncidenceIs a major important factor driving the increase in demand for aortic stent grafts.Element.According to the treatment technology of aortic stent grafts, they can be classified into thoracic aortic stent grafts and abdominal aortic stent grafts.Thoracic aortic stent grafts are mainly used in thoracic endovascular aortic repair (TEVAR) procedures., used to treat diseases such as thoracic aortic aneurysms, Stanford Type B dissections, and acute Stanford Type A dissections. TEVAR is widely applied in the treatment of thoracic aortic aneurysms and Stanford Type B dissections. Due to the complex vascular structure of Stanford Type A dissections and the high difficulty in developing interventional devices, surgical treatment is often adopted.The main type of thoracic aortic stent graft is straight-tube.，Representative ProductIncluding: Talos Straight-Tube Thoracic Aortic Stent Graft System, Castor Branched Aortic Stent Graft (the world's first approved branched aortic stent), etc.。 Abdominal aortic stent grafts are mainly used in endovascular aneurysm repair (EVAR) procedures., used to treat abdominal aortic aneurysms and Stanford Type B dissections involving the abdominal aorta. The main type of abdominal aortic stent grafts are bifurcated, and can be divided into one-piece, two-piece, and three-piece types, etc.Representative ProductIncluding: Aegis Ⅱ Abdominal Aortic Stent Graft System, Ankura Abdominal Aortic Stent Graft System, etc.。 In China, the industry of aortic stent graft systems started relatively late and has long been dominated by foreign companies such as Medtronic and Gore.In recent years, with the rise of local enterprises, the competitive landscape of China's aortic stent graft system industry has changed significantly. Overall, the localization of the aortic stent graft system industry in China is accelerating.In addition, due to factors such as the high cost of aortic stent graft systems, the complexity of aortic stent graft surgeries, and the fact that most hospitals capable of performing aortic stent graft surgeries are provincial-level hospitals,The market size of the aortic stent graft system industry in China is still not very large.。According to calculations by relevant research institutions, the market size of aortic stent grafts in China increased from RMB 6.5 billion in 2017 to RMB 15.0 billion in 2022.It is predicted that by 2027, the market size will reach 3.43 billion RMB., with a compound annual growth rate (CAGR) of 18.0% from 2023 to 2027。▲Scale of the Aortic Stent Graft IndustryThe market for aortic stent grafts is a细分赛道 of the aortic interventional device market and also its primary track.The aortic interventional device market in China is mainly dominated by multinational companies such as Medtronic, Gore, and Cook, with Medtronic holding the leading position in the industry and a market share of over 30%.。Multinational enterprises occupy a larger market share by leveraging their strong financial strength, R&D capabilities, brand reputation, and other advantages.Chinese companies started locally relatively late, but have gained certain competitive advantages by developing innovative products.。
▲Market Status of Thoracic Aortic Stent Grafts
# NovoTaper® Thoracic Aortic Stent Graft System▲NovoTaper®Stent Features(From the official website)The NovoTaper® Thoracic Aortic Stent Graft System, based on the previous generation of products,Significantly optimized the performance of the covered stent and delivery system. The stent specifications cover diameters from 18mm to 42mm, with covered segment lengths ranging from 40mm to 220mm; available in straight and tapered designs with tapers from 0mm to 14mm.Fully adaptable to aortic morphology, effectively avoiding stent-induced vascular injury caused by excessive expansion at the distal end of the stent.。The stent coating material adopts a denserMultifilament braided polyester membrane, less permeable, better sealing performance。Post-release design at the head endEnsure that the stent does not shift during deployment, achieving precise release.▲NovoTaper® Delivery SystemFeatures(From the official website)NovoTaper®The outer diameter of the delivery system is further reduced, with a minimum of 17F., with an ultra-soft core, can easily pass through the arch to reach the target position,Reduce vascular injury and access requirementsStent deployment adopts"Rotational Fine Release" Combined with "Direct Pull Quick Release" Dual-Mode Operation, ensuring precise, quick, and controllable stent deployment. The outer sheath features a composite reinforcement layer with spiral metal wire and braided metal mesh, offering superior resistance to bending, twisting, and deformation.
Enlight Medical was founded in April 2020.with R&D centers in Shanghai, Beijing, and Boston, USA,Committed to the product development, production, and sales of innovative medical devices,Focus on structural heart disease, peripheral vascular intervention, and neuro-modulation/brain-computer interface.Cutting-edge technologies in fields such as, itsProduct pipeline covers structural heart disease and pan-vascular disease treatmentA variety of innovative products.
Currently, there isIncluding the Thoracic Aortic Stent Graft System, four Class III medical device products have obtained NMPA registration certificates., and other includingMultiple products, including the mitral valve repair system, are in the research and development and clinical process.。
Beijing Youzhuozhenglian Medical Technology Co., Ltd. was officially merged into Enlight Medical in 2021, becoming its wholly owned subsidiary.The company is located in the Changping District Science Park in Beijing. It is a national high-tech enterprise engaged in the research, development, and production of Class III cardiovascular medical devices.Holds 5 Class III medical device registration certificates, including thoracic aortic stent graft systems and non-vascular stents (esophageal, biliary, prostatic urethral).。
As of the date of publication, the financing history of Enlight Medical is as follows:
