Lifetech Scientific (01302) has announced that on September 24, 2026, the company received formal written notification from the National Medical Products Administration confirming that the SureCham Aortic Arch Single-Branch Stent Graft System (SureCham Single-Branch Stent or "the Product"), jointly developed by the company and Professor Shu Chang's team at the National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences, has entered the NMPA's Special Review Pathway for Innovative Medical Devices (the Pathway).
The Product is indicated for the treatment of aortic dissection involving the aortic arch, and represents the company's nineteenth product to enter this NMPA pathway.
In recent years, thoracic endovascular aortic repair (TEVAR) has become the primary treatment modality for lesions involving the aortic arch. Traditional TEVAR often faces the dilemma of insufficient proximal landing zone and coverage of the left subclavian artery (LSA).
Therefore, the SureCham Single-Branch Stent was developed to address this challenge. The Product features a unique adjustable branch structure and a fully transfemoral single-access design as its core innovations, requiring only a single puncture of the femoral artery to achieve complete reconstruction of both the main body and branch stent. This simplifies surgical procedures, reduces the risk of access-related complications, and provides a simpler and safer option for endovascular treatment of complex arch lesions.
The Group holds independent intellectual property rights over the Product. Currently, the SureCham Single-Branch Stent has been clinically applied in certain countries and regions across Europe and Asia, with its outstanding performance and clinical value receiving high recognition and widespread attention from international clinical experts.
The Product will join the company's aortic arch branch reconstruction chimney technique innovative product matrix, aortic arch branch reconstruction in-situ fenestration technique innovative product matrix, and the CS One-Piece Arch Three-Branch Reconstruction System to collectively form the company's unique comprehensive endovascular treatment solution for aortic arch lesions. This solution helps global vascular intervention physicians more confidently, flexibly, and efficiently address the challenges of total endovascular reconstruction of aortic arch branches.
The Board believes that the Product's entry into the Pathway not only signifies that the innovative design and clinical value of the SureCham Single-Branch Stent have received authoritative recognition, but also marks the company's further exploration of a more simplified, more efficient, and more easily standardized aortic arch branch reconstruction approach building upon its existing single-branch technology pathway. At the same time, it will accelerate the clinical translation and commercialization process of the Product, bringing superior treatment options to the many patients suffering from aortic dissection involving the aortic arch at an earlier date.