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].