Results of Pre-Market Clinical Trial “CATCH” for MicroPort NeuroTech™ NUMEN® Coil Embolization System Published in World Neurosurgery

Shanghai, China, 31 December 2021 —The results of MicroPort NeuroTech Limited (MicroPort NeuroTech™)’s Coil Application Trial in China (CATCH) for the Numen® Coil Embolization System (NUMEN®) have been published in Word Neurosurgery, a leading journal in the field of neurology. The paper, entitled “Endovascular aneurysm treatment with the Numen coil embolization system: A prospective, randomized, controlled, open-label, multi-center, non-inferiority trial in China”, was published on 11 December 2021.

The NUMEN® CATCH pre-market study is the first prospective, randomized, controlled, open-label, non-inferiority trial conducted in ten centers across China, that follows international standards to investigate the treatment of intracranial aneurysms using coil embolization. The study was initiated by Prof. Jianmin Liu of the Cerebrovascular Disease Center of Shanghai Changhai Hospital, in collaboration with nine nationally renowned neurointerventional centers.

A total of 350 patients were enrolled in the randomized controlled study. The 174 subjects in the test group were treated with NUMEN® and the 176 subjects in the control group were treated with the most widely-used product in global clinical practice. The CATCH study reported both the angiographic outcomes and results at six-month and one-year follow-ups. The primary endpoints were the successful aneurysm occlusion rate at six months and the complete aneurysm occlusion rate at 12 months. The successful aneurysm occlusion rate at six months was 91.18% for the test group, compared with 91.85% in the control group, showing no significant difference between the test group that used NUMEN® and the control group. The complete aneurysm occlusion rate at 12 months postoperatively was 70.94% in the test group compared with 65.60% in the control group. The results of the CATCH study showed that the clinical efficacy of NUMEN® has reached an internationally advanced level comparable to that of top-tier products.

Commenting on the results, Prof. Jianmin Liu said, “When treating intracranial aneurysms the most challenging task for doctors is to choose the right combination of coils to improve the embolism density. We are pleased to see similar results in both the test and control groups in terms of effectiveness and safety in the CATCH study. We are also glad to note that nearly 70% of the procedures relied on an all-NUMEN® combination. This reflects surgeons’ approval of the design and performance of NUMEN® and their confidence in quickly mastering its use.”

Cerebral aneurysms are usually abnormal bulges in the walls of intracranial arteries. The possibility of aneurysm rupture increases over time, and intracranial aneurysms are known as ‘a ticking time bomb in the head’ due to their high mortality and morbidity rate upon rupture. Coil embolization is one of the most important methods of intracranial aneurysm treatment. With an ultra-fine platinum-tungsten coil and a unique three-dimensional structure, NUMEN® offers a combination of flexibility and support, minimizing pressure on the aneurysm wall and ensuring safe embolization. NUMEN® is available in 177 lengths, allowing doctors to select the most appropriate coil for precision embolization based on each patient’s condition.

About Numen® Coil Embolization System (NUMEN®)

NUMEN® is a coil embolization system independently developed and designed by MicroPort NeuroTech™. Since its launch in China in September 2020, NUMEN® has also obtained marketing approval by the MFDS (South Korea), CE marking (EU) and FDA certification (USA), leading to the first overseas implantation in August 2021. Since its launch, NUMEN® has also been recognized by surgeons for its pushability, traceability, and detachability. In keeping with the trends of academic frontiers and technological development, MicroPort NeuroTech™ is dedicated to undertaking innovative and quality-driven R&D, promoting continuous product optimization based on clinical needs and feedback, and is committed to providing accessible and high quality medical solutions for the treatment of stroke.

About MicroPort NeuroTech Limited

MicroPort NeuroTech Limited is a subsidiary of MicroPort Scientific Corporation (00853.HK). Founded in 2012, MicroPort NeuroTech is a high-end medical device company focused on neuro-intervention, that provides a range of neuro-interventional products to treat a variety of brain conditions. In the future, MicroPort NeuroTech will invest more resources in innovation and development to provide more quality and innovative solutions for cerebrovascular and neuro interventions for doctors and patients at home and abroad.