MicroPort® MedBot® SkyWalker™ Orthopedic Surgical Robot Obtains CE Marking in EU

Shanghai, China, 31 December 2022 - MicroPort® OrthoBot, a fully-owned subsidiary of MicroPort® MedBot® (2252.HK) has recently obtained CE marking in the European Union (EU) for its independently developed SkyWalker™ Orthopedic Surgical Robot (SkyWalker™), becoming the first orthopedic surgical robot in China to receive this certification. SkyWalker™ obtained marketing approval from the Chinese National Medical Products Administration (NMPA) and was certified by the U.S. Food and Drug Administration (FDA) in April and July 2022, respectively. It is the first and only surgical robot developed by a Chinese company to obtain marketing approval and certification from the NMPA, FDA and CE.

Research has shown that there are more than 350 million patients with arthritis worldwide, with the prevalence rate increasing each year. Total knee arthroplasty is the primary treatment option for intermediate to advanced arthritic disease. In recent years, there has been an increase in demand for implant retention during total knee arthroplasty, and orthopedic surgical robots have received widespread attention for their high accuracy in implant positioning and reduction of post-operative pain. As a result, the market size for orthopedic surgical robots has been growing rapidly.

As the pioneer of surgical robots domestically, MicroPort® MedBot® has spent years developing the SkyWalker™ to assist surgeons in joint replacement surgery. The SkyWalker™’s robotic arm is guided by CT images and its first approved indication is for total knee arthroplasty. With customized preoperative planning, precise positioning compensation, multiple safety protections, and flexible scalability, the SkyWalker™ can shorten the learning curve of total knee arthroplasty, increase surgical precision, and improve prognosis.

The SkyWalker™ is gradually maturing in clinical application and has demonstrated highly stable performance. So far, it has completed over 300 robot-assisted surgeries for clinical validation purposes in 27 hospitals, 7 provinces and 18 cities across China, spanning orthopedics, joint surgery, and sports medicine departments. Cumulatively, over 140 doctors have received training and mastered the essentials of robotic surgical operation. On 22 November 2022, the first total knee joint replacement surgery in the U.S. was completed using the SkyWalker™.

The CE marking represents recognition from the EU medical device regulators and confirms that the effectiveness and safety of SkyWalker™ are comparable to its international counterparts . It also signifies that MicroPort® OrthoBot has completed its preliminary preparation to enter key markets around the world, which is of great significance for MicroPort® MedBot® in realizing its vision of “building a medical robotics total solution innovation platform with global presence”.

According to Dr. Yangbin Chen, General Manager of MicroPort® OrthoBot: “For MicroPort® SkyWalker™ Orthopedic Surgical Robot, the CE marking is a manifestation of MicroPort® OrthoBot's core technology and its rapid product iteration capability. It is another important breakthrough after obtaining FDA certification. SkyWalker™ can provide global patients with professional, safe and efficient digital and integrated orthopedic surgical solutions.”

Mr. Yu Liu, Executive Vice President and Chief Commercial Officer of MicroPort® MedBot®, stated: “SkyWalker™ Orthopedic Surgical Robot has been approved and certified in China, the United States and the European Union one after another within one year, which demonstrates the strong technical strength and product performance of Chinese orthopedic surgical robots. The certification in overseas markets and smooth market entry will help MicroPort® MedBot® accelerate its globalization strategy, help more patients globally, and realize our aspiration from day one to eliminate difficult surgeries in the world.”

About MicroPort® MedBot®

Founded in Shanghai in 2015, Shanghai MicroPort MedBot (Group) Co., Ltd. (“MicroPort® MedBot®”, stock code: 02252.HK), a subsidiary of MicroPort Scientific Corporation (“MicroPort®”, stock code: 00853.HK), is currently the only surgical robot company in the world with businesses covering five promising subsectors of surgical robots, including endoscopy, orthopedics, vascular intervention, natural orifice surgery, and percutaneous puncture. At MicroPort® MedBot®, we are committed to meeting the growing demand for cutting-edge robotic surgery. By integrating advanced research on robotics, control algorithms, electrical engineering, image-based navigation and precision imaging, we provide comprehensive intelligent surgical solutions to prolong and reshape the lives of patients, lead the advancement of robotic surgery, and shape the era of super intelligent surgery.

More information is available at www.medbotsurgical.com.