Guichuang Tongqiao-B (02190) announced that the ZYLOX Unicorn vascular suture device, developed independently by the group, recently received NMPA (National Medical Products Administration) approval for listing. As the first domestically developed vascular suture device product, the approval for listing of ZYLOX Unicorn vascular suture device marks the breakthrough of domestic brands in the market monopoly status of import brands in vascular puncture point closure solutions. With the launch of ZYLOX Unicorn vascular suture device, it will help popularize domestic alternative vascular suture technology, reduce patients' idling time, and lower the risk of puncture complications, allowing more patients to enjoy high-quality and affordable innovative medical technology. As of the date of this announcement, the company has obtained NMPA approval for a total of 44 products in China, and CE certification for 8 products in the European Union. The products have covered European, South American, and Middle Eastern countries such as Germany, Italy, Argentina, Brazil, and the United Arab Emirates.

Vascular suture device is a widely used medical device product designed to quickly, accurately and effectively suture vascular incisions or puncture points during surgery. Especially in vascular surgery and interventional surgery, vascular suture devices can be used for vascular angioplasty, bypass surgery, aneurysm resection, closure after vascular puncture, effectively simplifying and accelerating the vascular closure process, reducing operation time, and improving the safety and success rate of the operation, and reducing the risk of postoperative complications. With the innovation and development of vascular intervention medical devices, the clinical demand for large-caliber suture of vascular suture devices is gradually increasing. Compared with vascular occluders, the suture range of ZYLOX Unicorn vascular suture device has been expanded to 5F-22F, which can be compatible with large-caliber suture of 8F and above, and is expected to achieve more application scenarios in clinical use, and meet the clinical needs that have not been met. The successful approval of ZYLOX Unicorn vascular suture device is not only a demonstration of the company's innovative research and development strength, but also another important milestone in the company's positive response to clinical needs and promotion of the improvement of the industry's independent innovation ability.

With the innovation and development of vascular intervention medical devices, the clinical demand for large-caliber suture of vascular suture devices is gradually increasing. Compared with vascular occluders, the suture range of ZYLOX Unicorn vascular suture device has been expanded to 5F-22F, which can be compatible with large-caliber suture of 8F and above, and is expected to achieve more application scenarios in clinical use, and meet the clinical needs that have not been met. The successful approval of ZYLOX Unicorn vascular suture device is not only a demonstration of the company's innovative research and development strength, but also another important milestone in the company's positive response to clinical needs and promotion of the improvement of the industry's independent innovation ability.