Zylox-Tonbridge Medical Technology Co., Ltd. updated information in relation to the latest business and new product development of the Group. The Company announced that the ZYLOX® Phoenix Peripheral Detachable Fibrous Coil Embolization System, self-developed by the Group, has recently been granted marketing approval by the National Medical Products Administration (the "NMPA"). This is the Company's first product launched for peripheral vascular embolization interventional procedures. As of the date of this announcement, the Company has obtained approvals from the NMPA for a total of 34 products in the People's Republic of China (the "PRC"). ZYLOX ® Phoenix Peripheral Detachable Fibrous Coil Embolization System is a domestically developed medical device for minimally invasive interventional treatment of peripheral arterial embolism. The clinical application of coils for vascular embolization has been prevalent in the field of peripheral vascular intervention. For instance, endoleak management of abdominal aortic aneurysms, embolization treatment of visceral aneurysms, hemoptysis and arteriovenous fistula are important clinical applications, and their safety and efficacy have been internationally recognized. At present, in China's peripheral vascular intervention device market, fibrous coils are still dominated by imported brands. The launch of the ZYLOX® Phoenix Peripheral Detachable Fibrous Coil Embolization System can effectively fill the gap in the field of domestically developed arterial embolization devices and provides doctors and patients with high-quality and affordable products and solutions. Based on the existing embolization coil products, the ZYLOX ® Phoenix Peripheral Detachable Fibrous Coil Embolization System optimizes and upgrades the interlocking arm detaching structure, which will enhance the cornering ability of the embolization coils and reduce the risk of premature detaching. Moreover, this product specifically adds polypropylene anti-untwisting wire, which further solves the technical challenge of premature untwisting of embolization coils. Compared with similar products currently available in the market, the ZYLOX ® Phoenix Peripheral Detachable Fibrous Coil Embolization System is available in a wider range of length and diameter specifications,
providing more options to meet the needs of various vascular embolization scenarios. The pre-marketing clinical registration trial of the ZYLOX® Phoenix Peripheral Detachable
Fibrous Coil Embolization System was led by Professor Zhao Jichun from West China Hospital of Sichuan University. A total of 101 patients from 14 top clinical trial centers
across the PRC were enrolled, and the immediate postoperative target vessel subtotal occlusion rate reached 100%. During the follow-up visits with all 101 subjects, no patient
needed further interventional treatment or surgery in the target vessel embolization segment or aneurysm. Such excellent clinical trial results strongly demonstrate the safety and efficacy of this product.