KangDuo Robot has passed the registration review of the NMPA and has been approved for marketing

On June 24, 2022, the KangDuo—Endoscopic surgery robot independently developed by Harbin Sagebot Intelligent Medical Equipment Co.,Ltd. (hereinafter referred to as "Sagebot") was approved for marketing by the National Medical Products Administration (NMPA)! This is the second time that the product registration certificate of the abdominal endoscopic surgery system has been approved after the first Class III product registration certificate of innovative medical devices for endoscopic surgery was approved in January 2021. KangDuo Endoscopic Surgical Robot (hereinafter referred to as " KangDuo Robot") is a high-tech original product that has been built by the research team of Sagebot for several years.

The approval not only marks the formal opening of KangDuo Robot industrial operation, but also marks the technological development and clinical application of domestic surgical robots will usher in a new vitality!

Surgery robots are known as the "crown jewels of the robot industry". On the one hand, because of its intelligent, efficient, accurate and other characteristics, it has a broad application prospect in the field of surgery. On the other hand, due to its high technical barriers, long research and development cycle, involving a wide range of disciplines, large resource investment and other reasons, it restricts the entry of participants. For a long time, internationally renowned surgical robot brands have occupied a monopoly position. The high cost not only restricts the equipment allocation of hospitals and the choice of patients, but also aggravates the imbalance of the distribution of high-end medical resources in China. Therefore, it is one of the core strategies for the development of Chinese robot industry and intelligent medical equipment industry to create domestic independent brand and break the international monopoly of surgical robot. In this context, in 2013, Sagebot stepped into the field and became one of the first high-tech enterprises to carry out the research and development of endoscopic surgery robot technology and system.

Since its establishment, Sagebot has established the development idea of "no imitation, no plagiarism, independent research and development, original design", and has always internalized the strict standards of high-end intelligent medical equipment enterprises. After years of deep exploration, with the development of surgical robot design, system improvement, functional iteration and continuous progress of clinical trials, KangDuo Robot has accumulated a large number of original technical achievements in the open physician console, multi-degree of freedom surgical robotic arm, intuitive master-slave operation, and a wide variety of surgical instruments. Up to now, the company has owned nearly 300 independent intellectual property rights in the category of endoscopic surgery robots. These original achievements are not only the core technical support for KangDuo Robot to successfully complete clinical surgery, but also the tenacious foundation for the rise and take-off of domestic surgical robot industry.

The company has carried out in-depth clinical application cooperation with domestic first-class medical institutions such as Peking University First Hospital and Peking Union Medical College Hospital, and has successfully completed hundreds of clinical operations so far. On August 7, 2020, the first group of domestic endoscopic surgical robots successfully performed upper urinary tract repair surgery. On November 20, 2020, the first transabdominal adrenal resection operation was successfully completed in China. On April 1, 2021, the 100th multi-center registered clinical trial of the domestic KangDuo Endoscopic surgical robot system -- robot-assisted partial nephrectomy was completed.

Based on the excellent performance of clinical application, more than 10 related research papers have been published in top journals at home and abroad. The Chinese Journal of Urology was the first in China to publish related studies on partial nephrectomy for renal tumors and adrenal tumor resection, and the first prospective one-arm cohort study on pyeloplasty with a domestic surgical robot system was published in BJU International, the official journal of the British Urological Association. In particular, as the first group of clinical application studies of domestic laparoscopic surgical robot for radical prostatectomy published in the Journal of Urology, the official journal of the American Urological Association (AUA), It represents a high degree of recognition of the western academic circle, led by the Da Vinci surgical robot system, to the clinical application of the domestic laparoscopic robotic surgical system with Chinese independent intellectual property rights. Clinical data and reports show that KangDuo Robot can replicate the main hand movements with micromillisecond delay, intelligently recognizing and filtering the wobble while performing a series of actions by the surgeon, including cutting, suturing, and hemostasis, maximizing surgical accuracy and safety. Compared with traditional minimally invasive surgery, patients lose less blood and recover more quickly after surgery. These superior clinical performances have earned KangDuo Robot recognition from both doctors and patients.

As the leader of intelligent medical services for robotic surgery, KangDuo Robot has actively explored and created several "firsts" in the application of new technologies: In 2018, KangDuo Robot completed the world's first 5G remote robotic surgery animal experiment; In 2019, the world's first multi-point collaborative 5G remote robotic surgery animal experiment was completed; In 2021, it became the unveiling unit of the "5G+ remote treatment" project of the Ministry of Industry and Information Technology and the National Health Commission; In 2022, the world's first cross-operator and cross-network domain "5G+ fixed-network dedicated line" multi-point collaborative remote real-time clinical interactive teaching operation was completed... These innovative practices mean that KangDuo Robot is not only capable of performing highly complex, highly precise minimally invasive surgery, but also leads the industry in the integration and application of innovative technologies.

In order to further promote the research and development of high-end medical devices in China, since 2021, Sagebot has cooperated with several medical institutions, such as Peking University First Hospital and Peking Union Medical College Hospital, to set up KangDuo Robot "Clinical Application Demonstration and Training Center" and "Medical Robot Joint Innovation Research and Development Center". "Dual Center" integrates technology research and development, clinical trials and talent training. Through the in-depth expansion of medical and industrial cross-cooperation of surgical robots, it reserves all-round core capabilities for domestic surgical robots to accelerate their occupation of industrial strategic heights.

Stay true to original intention and forge ahead. Obtaining the product registration certificate from the State Medical Products Administration is not only a milestone, but also a new starting point. Sagebot will continue to keep up with the national robotics industry development strategy, continue to shoulder the lofty mission of "accelerating the key core technologies, breaking through the bottleneck of technology and equipment, and realizing the autonomy and control of high-end medical equipment", and continue to practice the core values of "creation with thought, diligence, excellence, and surpassing with wisdom". Further increase the investment in scientific research, accelerate the speed of clinical popularization, and strengthen the industrial operation capacity, to contribute to the rise of domestic surgical robots, and escort the life and health of the people!