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Zylox-Tonbridge: PTA Balloon Catheter — Large Diameter Obtains Marketing Approval from NMPA

On April12, Zylox-Tonbridge (2190.HK, “the Company”) announced its PTA Balloon Catheter-Large Diameter, a product independently developed by the Company, has been granted the marketing approval by the National Medical Products Administration of the People’s Republic of China (the “NMPA”) for the Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, marking an important step forward in the Company’s product portfolio of peripheral vascular interventional total solutions.


This product is the first domestically developed PTA Balloon Catheter — Large Diameter product that has ever been approved by NMPA, which is breaking the monopoly condition of imported products and improving the innovation capability and manufacturing quality of domestic manufacturers in this field.


This product has several outstanding features: 1) The unique tapered head end and short shoulder design which can maximize the protection of normal blood vessels even for tortuous lesions; 2) The braided delivery rod demonstrates excellent crossing capability; 3) The fluoroscopic visualization ensures accurate positioning of the balloon during procedures. Additionally, the product is expected to deliver outstanding filling performance and it has wide-ranging specifications for different clinical demand. The peripheral vascular companies expect this product will better fulfill the needs of clinicians and provide them with more comprehensive products, so as to bring better treatment for patients.


The Company also expects this newly launched product to show advantages in the treatment of various vascular disease, such as iliac vein compression syndrome and other peripheral vascular occlusion. When this product is properly used in combination with mechanical thrombectomy devices, drug-coated balloons and peripheral stents, the Company expect to see better treatment efficacy.


With the improvement of “early diagnosis, early treatment” awareness, peripheral vascular interventional technology has developed rapidly. According to incomplete statistics, the domestic market capability of PTA Balloon Catheter-Large Diameter is expected to reach 30,000 every year, while nearly half of the market was occupied by alternatives because of supply shortage. The Company believes this newly launched product will better meet the clinical needs of domestic patients, so as to help establishing more standardized treatment and applications of medical device.


As the Company’s peripheral intervention business division, Zylox-Medical has developed a full product portfolio covering both arterial and venous diseases treatments, including the peripheral stent system, balloon, drug-coated balloon catheter, filter and so on. Zylox-Medical has launched 6 products in China and 5 products in CE market by April 2022.


This product also marks the second NMPA approval that the Company has obtained in 2022, demonstrating its strong R&D capability and efficient management. The Company will adhere to its original missions, which is “Innovation for Quality Life”, to provide patients and physicians with full and affordable medical devices and service, so that everyone has access to the high-quality life brought by advanced medical technology.


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