Xianjian Technology (01302): SureCham™ Aortic Arch Single Branch Laminating Stent System Enters Special Review Process for Innovative Medical Devices

Zhitong Finance App News, Xianjian Technology (01302) issued an announcement. On September 24, 2026, the company received an official written notice from the State Drug Administration confirming that the SureCham™ aortic arch single-branch laminating stent system (sureCham™ single-branch stent or “this product”), which was jointly developed by the Company and Professor Shu Chang's team from Fuwai Hospital of the Chinese Academy of Medical Sciences of the National Cardiovascular Center, has entered the China Drug Administration's special review procedure for innovative medical devices (this procedure). This product is suitable for treating aortic dissection involving the active arch. It is the company's 19th product to enter this procedure by the State Drug Administration.

In recent years, thoracic aortic intravenous repair (TEVAR) has become the main treatment for aortic arch lesions. Traditional TEVARs often face a contradiction between insufficient proximal anchoring and left subclavian artery (LSA) coverage. As a result, SureCham™ single-branch stent came into being. The product is designed with a unique adjustable branch structure and a single path for the entire transfemoral artery. It only requires a single puncture of the femoral artery to complete the overall reconstruction of the main body and branch stent. While simplifying surgical operation and reducing the risk of path-related complications, it provides a simpler and safer choice for intracavitary treatment of complex arch lesions.

The Group owns independent intellectual property rights for this product. Currently, SureCham™ single-branch stents have been used clinically in some countries and regions in Europe and Asia, and their excellent performance and clinical value have been highly recognized and paid widespread attention by international clinical experts. The product will combine the aortic arch branch reconstruction chimney technology innovation product matrix, the aortic arch branch reconstruction in-situ window opening technology innovation product matrix, and the CS™ integrated arch branch reconstruction system to form the company's unique overall solution for intracavitary treatment of aortic arch lesions. The solution helps interventional vascular surgeons around the world respond more calmly, flexibly, and efficiently to the challenge of full lumen reconstruction of the aortic arch branch.

The board believes that the entry of this product into this process not only means that the innovative design and clinical value of SureCham™ single-branch stents have been recognized by authorities, but also marks that the company has further explored a more simplified, more efficient, and more standardized aortic arch branch reconstruction solution based on the existing single-branch technology path. At the same time, it will also accelerate the clinical transformation and commercialization of this product, and provide better treatment options for patients with dissection involving the aortic arch as soon as possible.