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Zylox-Tonbridge Receives Approval to Launch ZYLOX Octoplus™ IVC Filter from NMPA
On December 2nd, 2022, Zylox-Tonbridge (2190.HK, “the Company”) announced that the company was granted marketing approval by China’s National Medical Products Administration (NMPA) for its self-developed ZYLOX Octoplus™ Retrievable Inferior Vena Cava (IVC) Filter which is expected to provide a more comprehensive, safe treatment solution for patients with high-risk deep vein thrombosis (DVT).
The ZYLOX Octoplus™ IVC Filter retrieval kit is an innovative next-generation medical device developed in-house for the prevention and treatment of DVT and pulmonary embolism (PE). With an innovative structure that delivers outstanding performance in terms of instant adherence to the IVC wall alongside excellent self-balancing capabilities, the device enables precise release and efficient interception of thrombus. The solution also reduces the risk of PE and provides a longer window for thrombolytic therapy while increasing the cure rate of DVT, helping patients to reduce medical costs and improve their quality of life. The name of ZYLOX Octoplus™ is a combination of "Octopus" and "Plus", reflecting the safety and innovation of the product.
DVT is a common vascular disease. Dislodged blood clots can cause a pulmonary embolism (PE), which can be fatal. According to industry research, the number of DVT cases in China is expected to grow from 1.5 million in 2019 to 3.3 million in 2030, with a compound annual growth rate (CAGR) of 7.3%. Interventional procedures have become the first choice for DVT thanks to their advantages. In particular, the number of IVC filter interventional procedures is anticipated to increase from 85,700 in 2019 to 673,700 in 2030, with a CAGR of 20.6%.
Led by principal investigator Prof. Liu Jianlong from Beijing Jishuitan Hospital, the clinical trial of the ZYLOX Octoplus™ IVC Filter was conducted and completed at nine well-known peripheral vascular intervention centers in China, including Nanjing First Hospital, Beijing Friendship Hospital, Capital Medical University, the First Affiliated Hospital of Chongqing Medical University, the First Affiliated Hospital of Xi'an Jiaotong University, the Affiliated Hospital of Qingdao University, the Second Affiliated Hospital of Soochow University, Wenzhou People's Hospital, and Xi'an Red Cross Hospital. The results of the trial fully demonstrated the clinical safety and efficacy of the product.
Zylox-Tonbridge has obtained NMPA approval for 19 products in China as well as CE certification from the EU for eight products. The Company, based on its mission of “Innovation for Quality Life”, continues to provide patients and physicians with full and affordable medical devices and solutions, so that everyone has access to the high-quality life brought by advanced medical technologies.