Core Viewpoint - Xianjian Technology (01302) has seen a stock price increase of nearly 5%, currently trading at 1.7 HKD, following the announcement of its product entering a special review process by the National Medical Products Administration (NMPA) [1] Group 1: Product Development - The company received formal notification from the NMPA confirming that the Concave Supra integrated arch three-branch reconstruction system (CSTM stent system) has entered the NMPA's special review procedure for innovative medical devices [1] - This product is designed for minimally invasive treatment of complex aortic arch aneurysms and penetrating ulcers, representing a global first in providing a no-brain ischemia integrated solution for arch reconstruction [1] - The company holds independent intellectual property rights for this product, which has successfully completed multiple clinical implants in Germany, Switzerland, Greece, and Hong Kong, receiving high recognition from international clinical experts [1] Group 2: Market Impact and Future Prospects - The board believes that entering the special review procedure will shorten the registration process for the product, thereby accelerating its market launch [1] - The company anticipates that further evidence from clinical studies will confirm the safety and effectiveness of the product [1]

Core Viewpoint - Xianjian Technology (01302) has seen a nearly 5% increase in stock price following the announcement of its innovative medical device entering a special review process by the National Medical Products Administration of China [1] Group 1: Product Development - The company announced that its Concave Supra integrated arch three-branch reconstruction system (CSTM stent system) has entered the special review process for innovative medical devices by the National Medical Products Administration [1] - This product is designed for minimally invasive treatment of complex aortic arch aneurysms and penetrating ulcers, representing a global first in providing a no-brain ischemia integrated solution for arch three-branch reconstruction [1] - The company holds independent intellectual property rights for this product, which has successfully completed multiple clinical implants in Germany, Switzerland, Greece, and Hong Kong, receiving high recognition from international clinical experts [1] Group 2: Market Impact - The entry of the product into the special review process is expected to shorten the registration timeline, thereby accelerating its market launch [1] - The company anticipates that further evidence from clinical studies will confirm the safety and effectiveness of the product [1]

Core Viewpoint - The company has received formal notification from the National Medical Products Administration confirming that its Concave Supra integrated arch branch reconstruction system (CSTM stent system) has entered the special review procedure for innovative medical devices, marking a significant advancement in minimally invasive treatment for complex aortic arch aneurysms and penetrating ulcers [1][3]. Group 1: Product Development and Innovation - The CSTM stent system is the world's first integrated arch branch reconstruction solution designed for complex aortic arch pathologies, addressing the challenges of traditional endovascular techniques [1][2]. - The product features a unique groove design that fits the anatomy of the arch, significantly reducing the risk of cerebral ischemia, and employs an integrated structure to prevent endoleaks while ensuring high branch patency rates [2][3]. - The company holds independent intellectual property rights for the product, which has already been successfully implanted in multiple clinical cases across Germany, Switzerland, Greece, and Hong Kong, receiving high recognition from international clinical experts [3]. Group 2: Clinical Research and Results - The feasibility study (FIM study) led by Professor Shu Chang completed enrollment of 10 patients in June 2023, showing no endoleaks and high patency rates at 12-month follow-up, validating the safety and effectiveness of the CSTM stent system [2]. - A subsequent prospective, multi-center clinical trial aims to enroll 103 patients across 25 authoritative centers, with 52 patients enrolled as of August 31, 2025, demonstrating a 100% technical success rate and a 1.92% all-cause mortality rate at 30 days post-operation [2]. - The absence of severe complications such as permanent paralysis or retrograde type A aortic dissection further supports the clinical value and application prospects of the CSTM stent system in aortic arch reconstruction [2]. Group 3: Market Impact and Future Outlook - The entry of the CSTM stent system into the special review procedure is expected to shorten the registration process and accelerate its market launch, benefiting patients with aortic arch aneurysms and ulcers [3]. - The anticipated market introduction will expand the company's product offerings and establish a comprehensive minimally invasive treatment solution for aortic diseases, covering key technical areas such as endovascular reconstruction of the arch branches, visceral branch, and iliac arteries [3].

Core Viewpoint - The company has received formal notification from the National Medical Products Administration confirming that its Concave Supra integrated arch branch reconstruction system (CSTM stent system) has entered the special review procedure for innovative medical devices, marking a significant advancement in minimally invasive treatment for complex aortic arch aneurysms and penetrating ulcers [1][3]. Group 1: Product Development and Innovation - The CSTM stent system is the world's first integrated solution for aortic arch branch reconstruction without brain ischemia, designed specifically for the complex anatomy of the aortic arch [1][2]. - The product has been developed in collaboration with Professor Shu Chang from the National Cardiovascular Center and has become the company's 17th product to enter the special review procedure [1][3]. Group 2: Clinical Research and Results - A feasibility study (FIM study) led by Professor Shu Chang included 10 patients and showed no internal leakage or adverse events after 12 months, validating the safety and effectiveness of the CSTM stent system [2]. - A subsequent prospective, multi-center clinical trial has enrolled 103 patients across 25 centers, with 52 patients enrolled as of August 31, 2025, demonstrating a 100% immediate technical success rate and a 1.92% all-cause mortality rate within 30 days [2]. Group 3: Market Potential and Strategic Outlook - The company holds independent intellectual property rights for the CSTM stent system, which has been successfully implanted in multiple cases in Germany, Switzerland, Greece, and Hong Kong, receiving high recognition from international clinical experts [3]. - The entry into the special review procedure is expected to shorten the registration process and accelerate the product's market launch, benefiting patients with aortic arch aneurysms and ulcers while expanding the company's product range [3].

Core Viewpoint - The company, Xianjian Technology (01302.HK), has received formal notification from the National Medical Products Administration confirming that its Concave Supra integrated arch branch reconstruction system (CSTM stent system) has entered the special review procedure for innovative medical devices. This product is designed for minimally invasive treatment of complex aortic arch aneurysms and penetrating ulcers, marking a significant advancement in the field [1]. Group 1 - The CSTM stent system is the world's first integrated arch branch reconstruction solution that does not require brain ischemia, addressing a critical need in vascular surgery and endovascular intervention [1]. - This product is the 17th to enter the special review procedure by the National Medical Products Administration, indicating the company's strong pipeline of innovative medical devices [1]. - The aortic arch region is known for its complex anatomy and unique hemodynamics, making it one of the most challenging areas in vascular surgery [1]. Group 2 - The CSTM stent system was developed in collaboration with Professor Shu Chang from the National Center for Cardiovascular Diseases and Fuwai Hospital, showcasing the company's commitment to partnerships in advancing medical technology [1]. - The system employs a unique groove and integrated structure, fundamentally addressing multiple technical challenges associated with traditional endovascular techniques in arch branch reconstruction [1]. - This innovation provides a systematic, minimally invasive, and safer solution for complex arch lesions, representing a significant leap forward in treatment options [1].