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Shanghai, China - On December 3, 2022, Honghu, independently developed by MicroPort NaviBot (Suzhou) Co., Ltd (hereinafter referred to as "MicroPort^® NaviBot^® (Suzhou)"), the holding subsidiary of Shanghai MicroPort MedBot (Group) Co., Ltd. (hereinafter referred to as "MicroPort^® MedBot^®"), has successfully passed the testing and certification by British Standards Institution (BSI), making it the first joint replacement robot in China to receive European CE certification. This is another major achievement created by Honghu after receiving the approval from the National Medical Products Administration (NMPA) of China in April and the approval from the U.S. Food and Drug Administration (FDA) in July this year. The success of the Chinese-developed orthopedic surgical robots in receiving approval in China, the United States and the European Union within one year marks a significant milestone in the rapid development of China’s medical surgical robot industry. It will boost the globalization of MicroPort^® MedBot^®, deliver the benefits of leading surgical robotic technology to more countries, and drive the cause of human health with high-quality and highly reliable robotic products.

CE (Conformite Europeenne) is a safety mark widely used in the European Common Market. It declares that a product complies with directives of the European Union, and is considered a manufacturer's passport to open and enter the European market. Products with the "CE" mark can be sold in all member states of the European Union, thus realizing free flow within the EU member states.

The CE certification of Honghu represents its first step to enter the EU market, which means that the product is qualified for commercial use in the European Union market, and also proves that Honghu has undergone strict clinical evaluation and will provide accurate, effective help for surgeons in surgical treatment. The rigorous R&D process, excellent product architecture and outstanding clinical performance have made it a benchmark and pioneer of orthopedic robot products in the world to lead the innovation and progress of the smart medical industry. The approval from the United States and the European Union marks the initial completion of market access of MicroPort^® NaviBot^® (Suzhou) in key global regions, which is of strategic significance for MicroPort^® MedBot^® to build a globalized medical robots total solution innovation platform. Such achievements will lay a solid foundation to provide advanced robot products for surgeons and patients around the world.

With more than 350 million people living with arthritis worldwide, the global market for joint replacement surgical robots has been growing rapidly in recent years, driven by the rising prevalence of arthritis and the increasing demand for implant viability. Orthopedic surgical robots have received widespread attention for their high accuracy in implant positioning and reduction of postoperative pain.

As a trailblazer of medical robotics in China, MicroPort^® MedBot^® has spent years developing the Honghu Orthopedic Surgical Robot, which is currently the first and only Chinese-developed orthopedic surgical robot that has passed NMPA, FDA, and CE certifications. It can assist the surgeon in arthroplasty with a robotic arm guided by CT images, and its first approved indication is total knee arthroplasty. Allowing for customized preoperative planning, precise positioning compensation, multiple safety protections and flexible scalability, Honghu will save the learning period of total knee arthroplasty, increase the operation precision, reduce intraoperative injuries and improve patient prognosis. Receiving the CE mark means that Honghu has reached the international level in effectiveness and safety and that it has been recognized by the EU medical device regulatory authorities.

To date, Honghu has completed over 300 robotic-assisted clinical validation surgeries in orthopedics, joint surgery, and sports medicine departments across 7 provinces, 18 cities and 27 hospitals in China, and more than 140 surgeons have been trained to master the operation of robotic surgery. On November 22, Honghu Orthopedic Surgical Robot performed its first total knee replacement at Lighthouse Surgical Suites in Hollis, N.H.. These events have demonstrated that MicroPort^® Honghu Orthopedic Surgical Robot has become increasingly sophisticated in clinical applications and showed highly stable performance. It is capable of fully meeting the clinical requirements of orthopedic surgical robots and help hospitals make continuous high-quality progress in scientific research.

Dr. Yangbin Chen, General Manager of MicroPort^® NaviBot^® (Suzhou), said that the CE certification acquired by Honghu Orthopedic Surgical Robot is a reflection of the core product technologies of MicroPort^® NaviBot^® (Suzhou) and its ability to rapidly iterate on products. It is also another important breakthrough since the product is approved by FDA in the U.S, marking that Honghu has not only been recognized by international authorities in terms of qualification, but has also become increasingly sophisticated in clinical application. Professional, safe and efficient digital orthopedic integrated surgery solutions will be available for surgeons and patients worldwide.

Mr. Yu Liu, Executive Vice President and Chief Commercial Officer of MicroPort^® MedBot^®, said that the approval for Honghu Orthopedic Surgical Robot in China, the United States and the European Union within one year shows the strong technical strength and product advantages of the  Chinese-developed orthopedic surgical robot; the successful launch and application of Honghu in the oversea market will boost the globalization progress of MicroPort^® MedBot^®, bring benefits to more patients in the world, and help realize its original intention of "Make Surgery Easier, Safer and Less Invasive".

①The registered trademark of Honghu is named “SkyWalker” in abroad , which is in the process of application in USA, completed registration in EU and other countries and regions.