MicroPort NeuroTech Limited announced that NUMEN Coil Embolization System has been approved by the Japanese Ministry of Health, Labour and Welfare (the "MHLW") for final marketing authorisation. NUMEN is independently developed by the Group as the new-generation electrolytic detachment coil and represents the first product of the Group approved for commercialization in Japan. Japan is the world's third large neuro-interventional market.

Intracranial coil is classified as class IV high-risk special control medical device in Japan, and is subject to strict regulatory approval requirements. Leveraging on its design which fully addresses clinical needs and its outstanding performance demonstrated in verification tests, NUMEN, as a neuro-interventional product independently developed, designed and manufactured by the Group, has been successfully recognized by relevant regulatory authorities in Japan. According to the World Health Organization, stroke is currently the second leading cause of death worldwide.

The intracranial aneurysm, the fatality rate and disability rate of which are extremely high once ruptured, is called an intracranial "untimed bomb". As a new- generation electrolytic detachment coil, NUMEN is characterized by stable framing and dense packing. With its special microcircuit design of the pusher, electrolytic detachment of coils is made possible, shortening the operation time.

The extremely-thin platinum and tungsten alloy wire and unique three-dimensional structure enable NUMEN to be both flexible and supportive, minimizing pressure on the intracranial aneurysm wall and ensuring the safety of embolization, and allows NUMEN to be applied to the treatment of intracranial aneurysms of different shapes and provides physicians with a full range of solutions for the treatment of intracranial aneurysms. NUMEN and NUMEN FR coil detachment system, after being approved for commercialization in China in 2020, have successively obtained CE Marking in the European Union, the Food and Drug Administration (FDA) approval in the United States, the Ministry of Food and Drug Safety (MFDS) approval in South Korea, and the Brazillian Health Surveillance Agency (ANVISA) approval in Brazil. Since its first overseas implantation completed in August 2021 in Chile, NUMEN has been successfully commercialized in a number of countries in the Asia Pacific, North America and Europe. Its stable characteristic and excellent clinical performance have been fully recognized by physicians.

The commercialization of NUMEN in Japan is one of the Group's global strategic initiatives to continuously explore emerging markets. Moving forward, the Group will continue to devote itself to expanding the overseas market of neuro-interventional products, and providing more top-quality and comprehensive medical solutions of cerebral vessel diseases for patients and physicians worldwide.