Skywalker™ Total Knee Robot System Completes Multicenter Clinical Trial Enrollment Before Market Launch

Shanghai, China, 22 January 2021 – Skywalker™, a total knee robot system (“Skywalker™”), recently performed the 100th surgery in its multicenter clinical trial before its commercial launch, marking the successful completion of the project’s case enrollment task. Skywalker™, independently developed by Suzhou MicroPort OrthoBot Co., Ltd. (“MicroPort® OrthoBot”), a subsidiary of Shanghai Microport Medbot(Group)Co., Ltd. ("MicroPort® MedBot"), is the first total knee replacement robot designed and developed in China with complete case enrollment for its pre-marketing multicenter clinical trial.

In 2017, in collaboration with selected Chinese universities, MicroPort® registered its “compatible, safe, efficient and minimally traumatic joint surgery robotic system for hips and knees” with the Ministry of Science and Technology of China as the first national-level major project in the field of joint surgery robotics with government support. After years of in-depth research efforts, the project team has developed a robotic arm and navigation system with proprietary technology that can meet actual clinical application needs. On May 21, 2020, Skywalker™ passed the special review by the National Medical Products Administration (NMPA) on innovative medical device application and entered the fast track of the special review process, and later performed the first surgical operation on human on June 30, 2020.

Yu Haiying, General Manager of MicroPort® OrthoBot, said, "Aiming at meeting the clinical needs of orthopedic surgery, we have always focused on R&D in the field of orthopedic surgery robotics and the commercialization of high-end medical devices. By gaining access to first-in-class medical resources in China and leveraging our strengths on the orthopedic technology market, we have been continuously iterating our technology with a lean R&D model. We remain committed to developing minimally traumatic, precise, and efficient robotic products for orthopedic surgery to fill the gaps in China's orthopedic surgery robot industry."

Dr. He Chao, President of MicroPort® MedBot, added, "The successful completion of 100 clinical trial surgeries by Skywalker™ Total Knee Robot System has demonstrated the technical strength and core competitiveness of MicroPort® MedBot. We will continue to strengthen our cooperation with clinical centers of various disciplines nationwide, explore and devote ourselves to product design and development as well as application expansion, and provide more patients and doctors with versatile and intelligent total surgical solutions."

About Skywalker™ Total Knee Robot System

Skywalker™ is a surgical robot to assist in total knee replacements. Its preoperative planning software generates a personalized prosthesis implantation surgical plan based on the patient's preoperative CT scan data, prosthesis model data, and the anatomical characteristics of the patient's lower limb bones. During operations, with the help of the alignment technology, the highly dexterous and lightweight robotic arm can perform precise positioning according to the surgical plan for quick and accurate osteotomy. The system can do without the medullary cavity positioning required by traditional surgery, which reduces surgical injury, improves the postoperative lower limb alignment, reduces surgical complications, and helps patients achieve rapid postoperative recovery.