All confirmatory clinical enrollment trials were completed on April 29, 2022, for Mona Lisa Robotic Prostate Puncture Positioning System (“Mona Lisa”) of Shanghai IntBot Robotic Co., Ltd. (MicroPort^®IntBot), a joint venture established in China by Shanghai MicroPort MedBot (Group) Co., Ltd. (“MedBot®”) and Biobot Surgical Pte. Ltd. of Singapore. The clinical trials were led by Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School ("Nanjing Drum Tower Hospital") , with the First Affiliated Hospital of Xi 'an Jiaotong University and Northern Jiangsu People's Hospital participating in. With the completion of clinical trials, Mona Lisa has become the first prostate puncture robot in China to complete the multi-center clinical trial in urology, which marks a key leap forward in accurate diagnosis and treatment of prostate cancer, fills up the gap in the domestic market, and symbolizes a new breakthrough of MedBot® in the field of percutaneous puncture.

The incidence of prostate cancer ranks the second of most common malignant tumors in the world and the first among male tumors in the United States. However, the overall incidence rate is only 0.16% due to the lack of screening for prostate cancer in China. With the rapid development and popularization of detection technology in recent years, the detection rate of prostate cancer in China has ·increased year over year. As prostate cancer cells are distributed in multiple foci inside the prostate gland, they can be only detected by prostate biopsy rather than the traditional medical imaging methods such as CT and MRI. Manual biopsy operation tends to be completed through collaboration among two or more doctors, thus leading to some disadvantages, such as low positioning accuracy, uneven puncture, multiple punctures through the same point, and higher complication rate of puncture biopsy, etc. Furthermore, it highly depends on the operator's experience. It bears a rate of missed diagnosis and needs multiple punctures, resulting in more pain to patients. There is no robot-assisted puncture product ever approved in China, and the listing of Mona Lisa will fill up the gap in this technical field.

It took only 5 months after the start of confirmatory clinical trials of Mona Lisa that the rapid and significant progress has been made in the project of Mona Lisa, which benefits from the solid underlying technical system and innovative industrial incubation platform of MedBot® and MicroPort^®IntBot, and it is also an important achievement of close industry-university-research-medicine collaboration in the process of innovation and development of medical devices. Accurate, minimally invasive and intelligent are the inherent advantages of surgery robots. Depending on surgery robots and AI(artificial intelligence), surgical plans can be made on Mona Lisa through intelligent software to assist clinicians in completing operations better. It demonstrates the 3D visualization MRI- ultrasound fusion technology, and its motion compensation and needle offset position compensation technology further improves the accuracy of puncture procedure, which helps doctors to perform biopsy sampling more safely, accurately, intelligently and efficiently, decreases the misdiagnosis rate and the operative trauma, and alleviates the patients’ pain.

Mona Lisa, an innovative product of MedBot® laid out on the percutaneous puncture racetrack, completed the first clinical trial operation of robot-assisted prostate biopsy in China in November 2021. Professor Hongqian Guo of Nanjing Drum Tower Hospital led his team in completing all clinical trials of robot-assisted prostate biopsy of the center in January 2022. Director Xuefei Ding of Northern Jiangsu People’s Hospital and Professor Lei Li of the First Affiliated Hospital of Xi 'an Jiaotong University led their team to overcome the impact of epidemic lockdown and successfully completed all clinical trial surgeries of robot-assisted prostate biopsy with Mona Lisa respectively on April 27 and 29. The surgeries have tested the underlying technical system and cutting-edge innovation ability of Mona Lisa system. So far, the clinical trial enrollment in three centers of Mona Lisa have all been completed. The clinical center researchers reflected that Mona Lisa, the surgical robot system adopted in the clinical trials, featured stable and safe operation and smooth process during the procedure. The system has obvious advantages over the traditional manual biopsy in terms of surgical safety, learning curve and puncture detection rate, and implies great clinical values.

Professor Hongqian Guo of Nanjing Drum Tower Hospital said: "Nanjing Drum Tower Hospital has been paying close attention to the emerging research directions in the field of medical robot. We hope it will provide more accurate diagnosis and treatment to patients. This clinical study project has fully verified the advantages of MicroPort^®IntBot Mona Lisa in improving the detection rate of prostate cancer. The robot can avoid damaging the rectum and urethra of patients to a great extent. The R&D, clinical, medical and other related teams of MicroPort^®IntBot have provided professional supports, and quick and impressive responses. We look forward to the listing of Mona Lisa, strengthening of intelligent Made in China, and benefiting of more patients.”

Professor Lei Li of the First Affiliated Hospital of Xi 'an Jiaotong University said: "Mona Lisa marks a new era of prostate puncture procedure. The First Affiliated Hospital of Xi 'an Jiaotong University has been committed to promoting the application of new technologies such as robot-assisted and artificial intelligence in the medical field. We hope to bring maximum benefits to patients with precise diagnosis and treatment. The clinical performance of Mona Lisa further proves the help of new technology to patients. I look forward to the listing of Mona Lisa. It will provide more patients with better diagnosis and treatment.”

Professor Xuefei Ding from Northern Jiangsu People’s Hospital said: "I'm glad to participate in the multi-center clinical trial of Mona Lisa. Our hospital has conducted the first batch of robot-assisted prostate biopsy in China. We have witnessed the value of robot-assisted prostate biopsy in shortening the doctors' learning curve and improving the work efficiency. More importantly, robot-assisted puncture can improve the diagnositic rate of prostate cancer, and the doctors can develop more effective treatment plans for patients. On behalf of the team, I wish Mona Lisa will be approved soon. Then it can better help doctors achieve accurate and minimally invasive  diagnosis and treatment of prostate cancer.”

Mr. Yu Liu, Chief Commercial Officer of MedBot®, said: "Thanks for the joint efforts of experts and teams in various clinical centers! We have successfully completed all clinical trials of Mona Lisa, and we look forward to the Mona Lisa’s approval as soon as possible for the benefit of prostate cancer patients. MedBot® will continue to strengthen the collaboration with experts in various clinical application fields across the country, innovate the technology to drive development, accelerate the product iteration and update, dedicate to the development needs of minimally invasive surgery, provide more doctors and patients with high-quality and all-inclusive total intelligent surgical solutions, and realize the initial goal to Make Surgery Easier, Safer and Less Invasive”.

Dr. Chao He, president of MedBot®, said:“The completion of multi-center clinical trials of Mona Lisa Positioning System has promoted the perfect transformation from basic scientific research to clinical practice. It is a major breakthrough of MedBot® in the field of percutaneous puncture. MedBot® will continue to enhance the R&D and increase the clinical investment, seek the long-term development, provide the minimally invasive, intelligent, precise and all-inclusive robot technology, bring hope to human beings and prolong and reshape their lives!"

Mr. Sim Kok Hwee, General Manager of Biobot Surgical Pte. Ltd, Singapore, said: "It's really encouraging that Mona Lisa can complete the clinical trial study so efficiently under the guidance of MedBot®. We are very happy to collaborate with MedBot® and MicroPort^®IntBot to promote Mona Lisa into the Chinese market. We sincerely hope that with the large-scale popularization and use of this intelligent achievement of Mona Lisa in the world, especially in China, its performance and curative effect will benefit more patients and contribute to the development of human health."