Xianjian Technology (01302): The LantValTM aortic valve replacement system has entered a special review process for innovative medical devices

^{Zhitong Finance App News, Xianjian Technology (01302) issued an announcement. On September 9, 2026, the company received an official written notice from the China Drug Administration (China Drug Administration) confirming that the Lantval TM aortic valve replacement system jointly developed by the Company's subsidiary Shenzhen Jianxin Medical Technology Co., Ltd. (Jianxin Medical) and Fuwai Hospital of the Chinese Academy of Medical Sciences of the National Cardiovascular Center has entered the special review procedure for innovative medical devices by the State Drug Administration.} This product is suitable for surgical treatment of patients with aortic stenosis or stenosis with incomplete closure. It is the world's first fully preinstalled dry valve design (no stitching) aortic valve replacement product. It is the company's 18th product to enter the National Drug Administration's procedure.

Aortic stenosis (AS) is one of the most common diseases in valvular heart disease. As the Chinese population ages, the number of patients with aortic valve disease continues to increase, especially those with severe aortic stenosis. Failure to receive timely and effective treatment will often lead to poor prognosis and lower survival rate.

This product combines the advantages of traditional surgical aortic valve replacement (SAVR) to remove primary calcified valves, reliable hemodynamic performance, and long-term durability with the self-expanding no-stitch anchoring design mechanism of transcatheter aortic valve replacement (TAVR). In valve treatment, innovative dry film treatment technology developed by the project team is used to improve the storage and use of biological valves and further enhance the long-term durability of valves. The fully pre-assembled and ready-to-use design supports rapid implantation under minimally invasive incisions, reduces suture operations, significantly shortens operation time, and reduces operation difficulty, and provides a new solution that balances minimally invasiveness and excellent performance for surgical treatment of aortic valve disease.

The product completed its first human (FIM) clinical trial in 2025. Research data showed that valve implantation time was significantly shorter than conventional surgical valve replacement surgery. All participants completed follow-up at major endpoints, and recovered and had a good quality of life after surgery. The FIM study results initially verified the engineering and clinical feasibility of the first “dry valve+full preinstallation+no stitching” integrated surgical valve replacement product, showing the clinical value of this product in simplifying surgical operation, shortening valve implantation time, reducing the risk of perivalvular leakage, improving hemodynamics, and improving valve durability.

The Group owns independent intellectual property rights for this product. Currently, pre-marketing registration clinical studies for this product are about to commence. As subsequent clinical trials progress steadily, there will be more high-quality evidence-based medical evidence to further confirm the safety and efficacy of this product.