Founded in 2015, we are a top-tier surgical robot company dedicated to designing, developing and commercializing surgical robots to assist surgeons in performing complex surgical procedures. We are currently developing one Core Product, ToumaiR (圖邁) Laparoscopic Surgical Robot, or Toumai, for application in urologic surgery and will seek to expand its application to gynecologic, thoracic and general surgeries. As of the Latest Practicable Date, we owned two material patents, namely robotic arm and transmission mechanism and surgical instruments, relating to Toumai. Our three flagship products, Toumai, DFVisionR (蜻蜓眼) 3D Electronic Laparoscope and Honghu (鴻 鵠) Orthopedic Surgical Robot, have all been admitted to the NMPA’s innovative medical device special review and approval procedure (known as the “Green Path”). Toumai and Honghu are at the registration approval stage, and DFVision has recently received NMPA approval. Other than the flagship products, we also have six product candidates at various stages of development. We are the only company in the industry worldwide with a product portfolio covering the five major and fastgrowing surgical specialties of laparoscopic, orthopedic, panvascular, natural orifice and percutaneous surgical procedures, according to Frost & Sullivan.
WE MAY NOT BE ABLE TO SUCCESSFULLY DEVELOP OR MARKET TOUMAI, HONGHU AND DFVISION AS PLANNED, AND, EVEN IF THEY ARE COMMERCIALIZED, IT IS UNCERTAIN THAT THEY WILL ACHIEVE MARKET SUCCESS.
OUR PRODUCT PORTFOLIO
ToumaiR Laparoscopic Surgical Robot (“Toumai”)—Our Core Product
Toumai (meaning “hope of life” in an African tribal language) is a laparoscopic surgical robot designed by us to enable complex surgeries using a minimally invasive approach. Toumai is designed for a wide range of surgical procedures and features high robotic dexterity, operative precision and safety.
Toumai primarily consists of an ergonomic surgeon’s console, a patient-side cart with four interactive robotic arms and a 3DHD vision system. Seated comfortably at the console, a surgeon views an immersive 3DHD image of the surgical field and manipulates the surgical instruments inside the patient’s body by controlling the robotic arms. The 3DHD vision system provides real-time visualization of the target anatomy with natural depth-of-field, which facilitates accurate tissue identification and tissue layer differentiation.
Through the robotic arms with high degrees of freedom, Toumai provides surgeons with a range of motions analogous to those of human wrists, while filtering out the tremors inherent in human hands. Such dexterity allows greater precision in the operation, enhances safety of surgery and reduces surgeon fatigue. In particular, in addition to three robotic arms which hold the laparoscope and the surgical instruments as left and right hands, Toumai’s fourth arm allows it to hold additional surgical instruments necessary for certain most complex surgeries, which makes it far superior to three-arm laparoscopic surgical robots.
Toumai is classified as a Class III medical device under NMPA regulations and was recognized as an innovative medical device by the NMPA, or entered the “Green Path,” in October 2019. We are developing Toumai for application in urologic surgery. In November 2019, Toumai was used to successfully complete a robot-assisted laparoscopic radical prostatectomy (removal of the entire prostate) (RALRP) in Dongfang Hospital in Shanghai. This clinical success demonstrated for the first time that a Chinese-developed laparoscopic surgical robot is capable of handling a laparoscopic surgery as complex as RALRP, the prevalent “gold standard” for prostate cancer care in the developed world. Toumai has broken a number of other clinical records. In December 2020, it was used to successfully complete a robot-assisted partial nephrectomy (removal of kidney) (RAPN), a RAPN adopting a retroperitoneal approach (RPRPN), a RALRP adopting an extraperitoneal approach and a single-port RAPN, in each case the first of its kind completed with a Chinese-developed surgical robot.
We completed Toumai’s registrational clinical trial for application in urologic surgery in May 2021. This made Toumai the first and only Chinese-developed four-arm laparoscopic surgical robot that had completed a registrational clinical trial as of the Latest Practicable Date, according to Frost & Sullivan. The four robotic arms enabled Toumai to complete the registrational clinical trial comprised entirely of complex surgeries such as prostatectomies and nephrectomies. No Chinese-developed surgical robot had completed such a trial before, according to Frost & Sullivan. In this prospective, multicenter, randomized and parallel-controlled trial, Toumai demonstrated non-inferiority in the primary efficacy endpoint of surgery success rate to the da Vinci Si Surgical System (da Vinci Si), with a good safety profile. The da Vinci Surgical Systems, developed by Intuitive Surgical Inc. (“Intuitive Surgical”), are the most widely used surgical robots in the world. In China, da Vinci Si and a newer model, the da Vinci Xi Surgical System (da Vinci Xi), were the only laparoscopic surgical robots approved by the NMPA as of the Latest Practicable Date. Da Vinci Si is the predominant model installed and remains in widespread use in China today. Da Vinci Xi features upgrades in various functionalities from da Vinci Si (such as improved vision and dexterity) but they are not radically different products, according to Frost & Sullivan.
The registrational clinical trial evaluated Toumai’s efficacy and safety in urologic surgery through comparison with da Vinci Si. The efficacy results demonstrated Toumai’s non-inferiority to da Vinci Si in terms of surgery success rate, the primary efficacy endpoint, and no statistically significant difference in substantially all secondary efficacy endpoints. The safety results demonstrated Toumai’s good safety profile. There was no occurrence of medical device-related adverse event, or AE, in either the study group or the control group. All occurrences of AE were related to surgical operation or surgical treatment. See “Business—Our Product Portfolio— Laparoscopic Surgical Robots—ToumaiR Laparoscopic Surgical Robot (“Toumai”)—Summary of Clinical Trial—Registrational Clinical Trial” for details.
We submitted a registration application for Toumai’s application to urology surgery to the NMPA in May 2021, which was accepted by the NMPA in June 2021. We expect to obtain registration approval in the first quarter of 2022. We plan to expand Toumai’s application to gynecologic, thoracic and general surgeries. We began patient enrollment for the registrational clinical trial in October 2021 for Toumai’s use in these surgical areas. We will seek a separate NMPA approval of such expansion. As of the Latest Practicable Date, there had been no objection or material concern from the NMPA in relation to the registration application of Toumai.
DFVisionR 3D Electronic Laparoscope (“DFVision”)
DFVision (short for “dragonfly vision”) is a 3D electronic laparoscope designed to examine abdominal, thoracic and pelvic organs, among others. It is inserted through a small incision in the abdominal wall, and gathers images as it probes along.
DFVision’s dual objective lenses allow it to provide surgeons with 3D visualization with natural depth of field. Leveraging DFVision’s strong image gathering, processing and transmission technology, a surgeon views high-resolution, real-time images of the organs with natural depth of field. These features significantly flatten surgeons’ learning curve and allow them to operate the laparoscope with ease, which further enhances safety of the surgery. In October 2019, the first cholecystectomy (removal of gallbladder) using DFVision was successfully completed in Sir Run Run Shaw Hospital of Zhejiang University Medical School, which marked the first surgery completed with a Chinese-developed 3D electronic laparoscope.
DFVision is classified as a Class III medical device under NMPA regulations and entered the Green Path in April 2019. DFVision was the first Chinese-developed 3D electronic laparoscope admitted to the Green Path, according to Frost & Sullivan. We submitted a registration application to the NMPA in August 2020 and received approval in June 2021.
Honghu Orthopedic Surgical Robot (“Honghu”)
Honghu is an orthopedic surgical robot designed for joint replacement surgery. Currently, our research and development primarily focuses on the application of Honghu in total knee arthroplasty, or TKA, a surgery to remove damaged cartilage and bones from the surface of knee joint and replace them with artificial implants. We are also conducting design development on the application of Honghu in total hip arthroplasty, or THA. Honghu was the only Chinese-developed joint replacement surgical robot with a self-developed robotic arm as of the Latest Practicable Date, according to Frost & Sullivan.
Honghu’s preoperative planning software builds a 3D virtual bone model based on CT scans, and the surgeon further prepares a 3D image-based preoperative plan which defines the optimal size, fit, position and alignment of implants (which are made of metal and polymer materials) according to the patient’s anatomy. In a conventional TKA, the surgeon performs bone cutting and implant placement manually. As a result, lower limb alignment and soft tissue balance cannot be accurately quantified and rely heavily on the surgeon’s expertise. Inevitable inaccuracy causes patient discomfort and limits the longevity of the implants. In contrast, with the aid of the optical navigation system, Honghu’s robotic arm guides precise bone cutting and implant placement in accordance with the preoperative plan. The navigation technology minimizes the difference between the preoperative plan and postoperative outcome, reduces surgical complications and facilitates patient recovery.
Honghu is classified as a Class III medical device under NMPA regulations and entered the Green Path in May 2020. We completed the first surgery for Honghu in Ninth People’s Hospital of Shanghai Jiaotong University School of Medicine on June 30, 2020.
We completed a registrational clinical trial in China to evaluate the efficacy and safety of Honghu for TKA in July 2021 and submitted a registration application to the NMPA in the same month. We are also currently conducting design development for Honghu’s potential application in THA and plan to perform design validation in early 2022 and commence a clinical trial for THA in China by the end of 2022.
In addition to Toumai, DFVision and Honghu, we are also developing a spine surgical robot, a trans-bronchial surgical robot and a TAVR surgical robot. Our portfolio also includes a panvascular surgical robot, R-One, and two percutaneous surgical robots, ANT and Mona Lisa, which we jointly develop through collaboration with our international partners.
Source: MedBot-B (02252) Prospectus (IPO Date : 21/10/2021) |