MicroPort® Urocare Obtains NMPA Marketing Approval for Ruyi Clip

Shanghai, China, 5 March 2022 — MicroPort Urocare Medical Technology (Jiaxing) Co., Ltd. (MicroPort® Urocare) has received marketing approval from China’s National Medical Products Administration (NMPA) for its independently-developed single-use hemostatic clip device, the Ruyi Clip. This is MicroPort® Urocare’s first Class III medical device approved for use in the Gastronintestinal (GI) tract and is also the world’s first hemostatic clip for large wound closure used in the GI tract.

Endoscopic submucosal dissection (ESD) is a common, minimally invasive endoscopic procedure for treating gastrointestinal diseases and a widely known treatment for early gastrointestinal cancers. However, there are some clinical drawbacks associated with ESD, such as incomplete exposure of the submucosal field of view and difficulties with postoperative wound closure. Ruyi Clip is a three-pronged clip with independent left and right movement and a standard opening width of 11mm. It can be used flexibly for wound retraction, closure, and hemostasis during ESD surgery. Compared with the traditional two-pronged hemostatic clips, Ruyi Clip not only ensures a clearer surgical field of view through precise retraction, but also reduces the difficulty of closing the large postoperative wound, allowing for simultaneous and firm clipping. It can be used for polyp removal, assisted positioning, perforation repairing, and other gastrointestinal procedures in addition to ESD surgery. Within 1 to 3 weeks after the surgery, it will detach automatically and be excreted from the body without causing damage to the intestine. The launch of the Ruyi Clip enables local medical institutions to perform ESD surgeries, benefitting more patients at a community level.

According to 2020 cancer data published by the World Health Organization's International Agency for Research on Cancer (IARC), among the 4.57 million newly diagnosed cases of cancer in China, 1.36 million cases are stomach, esophageal or colorectal cancer, accounting for nearly 30% of the total. The number of ESD surgeries in China is expected to reach 600,000 by 2022. However, due to the difficulty of ESD, only China's provincial first-class tertiary hospitals are capable of performing the procedure. Ruyi Clip facilitates the closure of large and complex wounds during ESD, helping reduce the difficulty of the procedure.

Mr. Yiyun Que, Senior Vice President of Intelligent Manufacturing and Global Supply Chain at MicroPort®, and Chairman of MicroPort® Urocare, stated, “The Ruyi Clip is a device developed independently by MicroPort® Urocare in close collaboration with clinicians. It comes from clinical practice and serves clinical needs and marks a significant achievement in the field of gastrointestinal endoscopic therapy. Since its establishment, MicroPort® Urocare has been powered by R&D innovation and driven by clinical needs. By adhering to a diversified strategy, it dedicates itself to the field of non-vascular intervention and surgeries, covering various areas such as urology, respiratory, gastroenterology and gynecology. MicroPort® Urocare will continue to improve communication and collaboration with clinicians, innovate and develop around clinical pain points and challenges, deliver more high-quality products to meet clinical needs, and provide inclusive and total medical solutions for non-vascular interventional treatment.”

About MicroPort Urocare

MicroPort Urocare Medical Technology (Jiaxing) Co., Ltd. (MicroPort® Urocare) is a subsidiary of MicroPort Scientific Corporation (Stock code: 00853.HK, MicroPort®). MicroPort® Urocare is dedicated to the development, production and sales of diagnostic and treatment devices in the field of non-vascular intervention, covering various areas such as urology and gynecology, gastrointestinal interventions, and respiratory interventions.