MedBot® Announces Completion of R-One® Registrational Clinical Trial

Shanghai, China, 26 May 2022 – Cathbot (Shanghai) Robot Co., Ltd. (“Cathbot”) announced today that all surgeries under the registration clinical trial for the R-ONE® Vascular Interventional Surgical Robot (“R-ONE®”) have been completed, making it the first vascular interventional robotic system to complete a large-scale clinical trial in China.

Cathbot is a joint venture company between Shanghai MicroPort MedBot (Group) Co., Ltd. (“MicroPort® MedBot®”) and Robocath S.A.S in France. Founded in 2009, Robocath S.A.S develops, manufactures, and sells surgical robotic solutions to treat vascular diseases. As one of the key innovative solutions for the pan-vascular segment of MicroPort® MedBot®, R-ONE® owns core patented technologies including bionic technology for guidewire translation and rotation and sub-millimeter stepwise movements, which could perfectly reproduce the doctor's hand movements, and enhance the continuity and stability of the guidewires, catheter and other instruments in the delivery process.

During the trial, R-ONE® completed surgeries on complex medical conditions such as the two crimunal blood vessels, a highly tortuous vessel with poor co-axiality, long diffuse lesion, calcified lesions, ectopic opening as well as subtotal occlusion, and completed three surgeries in a row, demonstrating its stability and reliability. The completion of the trial marks a new phase of robot-assisted vascular interventional surgery in China, and lays an important foundation for more precise and intelligent and less-invasive vascular interventional surgery.

The R-ONE® clinical trial project was initiated by the 301 Hospital in collaboration with Shanxi Cardiovascular Hospital, Meizhou People's Hospital and People's Hospital of Xinjiang Uygur Autonomous Region. In November 2021, Prof. Yundai Chen, Director of the Department of Cardiology, 301 Hospital, led his team to complete the first procedure under the confirmatory clinical trial in China. Prof. Jian An and his team from Shanxi Cardiovascular Hospital; Prof. Zhixiong Zhong, President of Meizhou People's Hospital; and Prof. Yining Yang, President of People's Hospital of Xinjiang Uygur Autonomous Region carried out the first procedures under the under the clinical trial in Central China, South China, and Northwest China, respectively, which were completed in May 2022.

The complexity of coronary arteries places great demands on the doctor's precision during vascular interventions. A conventional vascular intervention procedure requires the positioning of a guidewire and catheter under X-ray fluoroscopy and manual manipulation by the operator. Meanwhile, X-ray exposure and wearing heavy lead aprons for prolonged periods can cause a variety of occupational diseases.

The unique design of R-ONE® reduces the cost of consumables, and achieves 3 seconds of rapid installation and disassembly with simple and convenient operation. During the procedure, the automatic cartridge mechanism allows the operator to install guidewires with a single click, thus improving the effectiveness and shortens procedure time to as little as 11 minutes. The fully covered asepsis barrier ensures complete aseptic isolation of the guidewires, catheter, and mechanical arm during surgery, and ensures the safety of patients. It also reduces unnecessary X-ray imaging through close visual contrast and high precision instrument control resulting in a reduced radiation and contrast agent doses for patients. The large-angle, protective screen can reduce the radiation dose of the surgeon by more than 90%, and significantly reduce the occupational radiation exposure risk for doctors. R-ONE® features a standardized operation system and simple joystick control, which significantly flattens the operator's learning curve, resulting in a far more efficient procedure and post-training performance.

As a pioneering medical technology, R-ONE® represents an important advancement for future vascular intervention procedures. All clinical experts involved in the project were impressed by the ability of R-ONE® to work with precision and considerably reduce occupational injuries, among other benefits.

According to Prof. Yundai Chen of the 301 Hospital: "R-ONE® impressed me with its precision and rapid operation, especially for its balloon catheter’s precise positioning, and the double guidewire synchronization, benefit to dealing with complex cases such as the tortuous tortuous vessel with poor co-axiality, calcified lesions, and ectopic ureter. It reduces the risk of intraoperative and postoperative complications and benefits both the patients and the surgeons.”

Prof. Jian An of the Department of Cardiovascular Medicine, Shanxi Cardiovascular Hospital said: “The simple joystick design facilitates the operation of the doctor, who sits in front of the console and operates the joystick to complete the operation easily. It can be used after simple training, greatly shortening the learning curve. We look forward to the early launch of R-ONE® to benefit more patients and doctors.”

Prof. Zhixiong Zhong of Meizhou People's Hospital commented, “R-ONE®’s intuitive guidewire cartridge design significantly reduces the time required for preoperative preparation, resulting in a far more efficient procedure; the mobile radioprotection control station can shield operators from X-ray radiation throughout the procedure.”

Prof. Yining Yang of the People's Hospital of Xinjiang Uygur Autonomous Region commented: “R-ONE® also performed reliably in coronary procedures in a row during clinical enrollment trials. We trust it will benefit more patients with cardiovascular disease across the country.”

Dr. Chao He, President of MicroPort® MedBot®, said: "The completion of the multicenter clinical trial for the R-ONE® Vascular Interventional Surgical Robot is a major milestone for MicroPort® MedBot® in the pan-vascular intervention field. It is of great significance in driving the development of more precise and intelligent vascular interventions. In the future, robots for vascular interventions will be equipped with 5G and AI technologies. They will accomplish more breakthroughs when combined with angiography and hemodynamic monitoring and other technologies. Meanwhile, with the advantage of group-based operation, MicroPort® MedBot® will partner with more academic experts nationwide to promote high-quality medical resources to primary hospitals, and will provide more patients with precise, intelligent, and inclusive robotic surgical solutions.”

About MicroPort® MedBot®

By addressing the need for cutting-edge, minimally invasive surgeries, Shanghai MicroPort MedBot (Group) Co., Ltd. (Stock code: 02252.HK) has been dedicated to driving research and industrial integration in the fields of robotics, intelligent control, sensing and information, to provide intelligent total surgical solutions that innovatively prolong and reshape life. Currently, MicroPort® MedBot® is the only surgical robot company in the world with businesses covering five promising subsectors of surgical robots, including endoscopy, orthopedics, vascular intervention, natural cavity, and percutaneous punctures.