"From the vast space to the deep sea, from the factory workshop to the field, from the weight of the country to the life of the people, we are entering a colorful new world of harmony and co-prosperity with robots." At the opening ceremony of the 2021 World Robot Conference, Xin Guobin, vice minister of industry and information technology, said so.
Human beings have never lacked imagination and creativity, from homes, factories to hospitals, robots are everywhere, and in 2020, China's robot industry will exceed 100 billion yuan for the first time. As the crown jewel of the robot industry, medical surgical robots have always been the commanding heights of technology that human beings want to break through.
In 2020, the global surgical robot market size reached 8.32 billion US dollars, but the vascular interventional surgical robot market is always in the early stage of development, and there is no approved product in mainland China. In such a product desert, the seeds of technology are germinating.
Recently, the Flash Robot vascular interventional surgery robot launched by Runmaide Medical successfully conducted the first animal experiment. The Flash Robot robot developed by Runmade Medical adopts the world's first design, covering the whole process of vascular intervention, and realizes automated visual positioning puncture, contrast guided push, rapid functional diagnosis, intervention channel construction, surgical navigation guidance, postoperative evaluation management and other links.
First animal experiment operation scenario
This animal experiment successfully performed coronary intervention surgery with the assistance of vascular interventional surgery robots. During the whole experiment, there were no surgical complications such as vasospasm, and the experiment verified the clinical operability, safety and efficacy of the vascular interventional surgical robot system. This animal experiment has also been paid attention to and recognized by well-known domestic experts, and the follow-up Runmade Medical will also sign a clinical trial agreement for vascular interventional surgery robots with well-known domestic top three hospitals.
The success of this animal experiment marks another big step forward for Runmade Medical towards the goal of the world's leading vascular interventional surgical robot company. The company has deep experience in automatic control, imaging algorithms, fluid power, hardware development, consumables development, and evidence-based medicine.
In the field of cardiovascular intervention, Runmade Medical is one of the few enterprises with intelligent interventional software and hardware research and development and production capabilities.
There is no shortage of giants in the track of surgical robots, and the competition of vascular interventional surgical robots is equally fierce, with overseas giants such as Siemens and Johnson & Johnson, and domestic minimally invasive medical, Runmaide Medical, and Aopeng Medical are also actively deployed. How will Runmaide Medical run out of this high-growth track, and how will China's vascular interventional surgery robot market develop?
The scale will exceed 4 billion! Vascular interventional surgical robots have always been a scarce target in the surgical robot market
Surgical robot is undoubtedly one of the hottest keywords in the medical field in recent years.
In the hot surgical robot market, laparoscopic and orthopedic surgical robot tracks have taken the lead in building, running out of intuitive surgery, minimally invasive medical robots, Tianzhihang and other leading players, Stryker, Medtronic, Johnson & Johnson and other multinational giants have also laid out.
According to Frost & Sullivan data, the global surgical robot market size reached 8.32 billion US dollars in 2020, of which the market size of endoscopic surgical robots was 5.25 billion US dollars, and the market size of orthopedic surgical robots was 1.39 billion US dollars, occupying most of the market.
In contrast, the pattern of vascular interventional surgical robots is undecided, and there is a global market of more than 4 billion yuan waiting for domestic and foreign companies to develop. The market size of China's vascular interventional surgical robots will reach 0.34 billion yuan in 2022 and further grow to 5.824 billion yuan in 2030, with a compound annual growth rate of 90.3% from 2022 to 2030. The domestic market has nearly doubled its growth, and it is urgent to be driven by innovative products.
Global Vascular Interventional Surgical Robotics Market Size, 2022-2030
Vascular interventional surgical robots mainly perform intravascular instrumental drive and surgical navigation in surgery. The surgical robot constructs a three-dimensional model of the patient's blood vessels based on preoperative and intraoperative image data, and analyzes the characteristics of vascular forks, curves, elasticity and plaques to track and locate surgical instruments during surgery.
Different from orthopedics and laparoscopic robots, vascular interventional surgery robots face more fragile human blood vessels, and at the same time need to operate interventional instruments such as catheters, guide wires, balloons, etc., and the performance and stability of products have higher requirements. Therefore, vascular interventional surgical robots have always been a scarce target in the surgical robot market.
At present, the vascular interventional surgery robot is mainly used for PCI (percutaneous coronary interventional therapy) surgery, and it is expected to be widely used in vascular intervention surgery in the future to assist doctors to complete neurological intervention and peripheral interventional surgery.
Cardiovascular disease has been the leading cause of human death and loss of healthy lifespan, ranking first in the global burden of disease. In the last 30 years, the number of people affected by cardiovascular diseases worldwide has doubled. Focusing on the country again, the mainland is a big country with coronary heart disease.
According to the report of CCI, the number of coronary heart disease patients in China will reach 17 million in 2020 and is expected to reach 28.8 million by 2030. With the aggravation of the aging of the population, the number of patients with coronary heart disease in mainland China continues to increase, and the volume of PCI surgery continues to grow, with nearly 1 million PCI operations in China in 2020.
PCI surgery is difficult and highly dependent on the doctor's personal experience and level of intervention. According to the registration data of the interventional treatment of coronary heart disease in Chinese mainland in 2020, the number of coronary heart disease patients in Shandong Province, Henan Province and Guangdong Province accounted for the top three provinces/regions/municipalities directly under the Central Government in mainland China.
However, the distribution of domestic medical resources is uneven, PCI surgery is mostly concentrated in first- and second-tier cities, and the treatment rate of patients with coronary heart disease in grass-roots areas is not high. Moreover, even in the top three hospitals in first-tier cities, the level of intervention of doctors is also different, and excessive medical burden may affect the accuracy of doctors' operations.
In addition, in coronary interventional surgery, doctors often need to wear heavy lead coats, stand on the operating table for several hours for surgery, exposed to radiation, and long-term physical health will also be affected.
Vascular interventional surgery robots can transform the doctor's work into mechanical operation, achieve millimeter-level operation accuracy, improve the accuracy and efficiency of PCI surgery, and reduce the dependence of the operation on the doctor's personal ability. At the same time, doctors can also operate remotely through vascular interventional surgery robots, away from radiation. Studies have shown that vascular interventional robotic-assisted PCI surgery can also reduce stent use.
Globally, CorPath GRX from Turing (a subsidiary of Siemens Healthingers) is the only VAS interventional surgical robot in the world that has both CE and FDA certification for vascular interventional surgery such as coronary intervention and peripheral intervention; Robocath's R-One (Minimally Invasive Medical Robotics Collaboration) has been CE certified; Johnson & Johnson's Sensei X2 and Stereotaxis' Genesis RMN have been approved by the FDA.
At present, no vascular interventional surgical robot has been approved in China, but the seeds of technology have begun to germinate. Siemens Medical CorPath GRX coronary interventional surgery system entered the nmPA special approval channel for innovative medical devices; the R-One vascular interventional robot introduced by minimally invasive medical cooperation completed the first registered clinical trial of NMPA; and the domestic Luban surgical robot took the lead in completing clinical trials.
Vascular interventional surgical robot route homogenization,
Coronary angiography and diagnostics are neglected
Surgical robots are the only way for vascular intervention to be precise.
In the face of the peak of technology, surgical robot companies have been moving forward and choosing to climb and climb over. Correspondingly, the market also gives back to enterprises with the same enthusiasm. In 2021, there were many financing events of nearly 100 million yuan and over 100 million yuan in the vascular interventional surgical robot market, of which Runmaide Medical completed two large financings within one year.
2021 Vascular Interventional Surgery Robotics Company Financing Source: Public Information
However, the homogenization of vascular interventional surgery robots on the market is serious and lack of differentiated innovation. Intravascular manipulation is a core part of PCI surgery, so most companies focus on this area, but ignore the importance of contrast and diagnosis.
The existing surgical robot products mostly carry out surgical navigation and intravascular operations, and the time to play a role in surgery may only be a few minutes, and the pre-puncture, contrast, diagnosis and other work still depends on the doctor's personal experience and technology. In fact, in interventional surgery, the angiography and diagnostic process account for 70%-80% of the entire surgery time. These tasks are trivial and difficult to regulate, but they will affect the subsequent diagnosis and treatment of diseases.
Only based on precise, standardized puncture contrast procedures can physicians obtain high-quality coronary angiography images that can evaluate coronary heart disease and decide whether the patient needs to implant a stent and what surgical modalities to use. Moreover, patients who require PCI therapy after coronary angiography are still in the minority.
The amount of coronary angiography surgery far exceeds the amount of PCI surgery. According to the CCI Consulting Report, the total number of coronary angiography tests in mainland China in 2020 is nearly 4 million units, compared with less than 1 million PCI surgeries. From the data, it can be seen that nearly three-quarters of patients did not undergo intervention after coronary angiography.
Whether it is from the target market scale or from the standardization and automation of the whole process of coronary intervention, the vascular intervention market needs surgical robots covering the whole process of PCI. Among the many surgical robot enterprises in the world, Runmade Medical has taken the lead in laying out and launched China's first vascular interventional surgical robot covering the whole process of PCI to meet the diagnosis and treatment needs of most patients with coronary heart disease.
The Flash Robot vascular interventional surgery robot organically integrates functional diagnostic system, image surgery navigation, ECG monitoring and other software, as well as hardware such as interventional multi-functional catheters and high-pressure syringes to form a multi-system function integration and data closed loop, realizing full automation of contrast, diagnosis, navigation and postoperative evaluation.
The world's first!
Surgical robot covering the entire flow of vascular intervention
The Flash Robot vascular interventional robot is composed of three functional units: surgical image navigation system, console system, bedside robotic arm and instrument control device. They coordinate with each other to form a closed loop of signal transmission, acting as the robot's "eyes", "brain" and "hands", assisting the surgeon to complete the whole process of surgical diagnosis and treatment.
In the design of the "brain", the Flash Robot vascular interventional surgery robot integrates multimodal medical images to achieve accurate navigation.
The surgical image navigation system is both the brain of the vascular intervention robot and the eye of the surgeon. It reconstructs the three-dimensional vascular model through different types of medical images, accurately and meticulously observes the location of the patient's lesions, and matches the original medical image information with the real-time movement information of the instrument to do accurate navigation to assist the surgeon in preoperative decision-making, intraoperative guidance, and postoperative evaluation.
The console system serves as a bridge between the surgeon and the vascular interventional surgical robot, which can accurately operate the instrument control device and the catheter guide wire, and support the remote transmission of the operator's surgical operation instructions. Through continuous and accurate information transmission, good human-computer interaction is realized.
As an extension of the "hand" of the surgeon, the bedside robotic arm and instrument control device can imitate the two-hand pushing and twisting action, and control the medical device to complete the operation of pushing, rotating, and withdrawing. Flexible overlap, conversion and combination can be realized between different actions to meet the generalized requirements of various types of vascular luminal surgery and meet the surgical needs of different parts and different surgical styles.
It is the precise coordination of "eyes", "brain" and "hands", and the vascular interventional surgery robot can achieve millimeter-level control and measurement, avoiding mistakes caused by operations such as trembling. At the same time, the Flash Robot vascular interventional surgery robot is equipped with a touch screen in the surgical image navigation system and the console system, allowing doctors to capture the screen or add marker lines with a single click to improve the doctor's clinical experience and improve surgical efficiency.
In addition, Runmade Medical integrates the coronary functional diagnosis module independently launched in the early stage into the surgical robot system, and with the help of the robot, it can realize rapid, standardized and automated functional diagnosis, and the functional diagnosis module assumes the responsibility of "commander", providing professional diagnostic tips for the surgeon, and connecting the two main interventional processes of contrast and treatment.
Subsequently, the company will also integrate a variety of treatment modules such as intervention and ablation into surgical robot products to achieve full automation of diagnosis and treatment.
The research and development of such a product is not an easy task, and the enterprises behind it also need to have the comprehensive strength of combining software and hardware. Runmade Medical's caFFR products have the highest accuracy among the national FFR products, and the company's coronary microcirculation diagnostic product, caIMR, is also the world's first non-interventional coronary microcirculation diagnostic product. At the same time, Runmade Medical has strong hardware development capabilities to meet the research and development needs of integrated surgical robots.
In addition, the company will cooperate with nationally renowned KOLs, PIs and hospitals to jointly promote clinical trials of vascular interventional surgical robot products.
Flash Robot vascular interventional surgery robot is expected to pass China's NMPA certification in 2024 and launch EU CE registration, promoting large-scale commercialization of products at home and abroad. In the future, the Flash Robot vascular interventional surgery robot will also be fully compatible with a variety of diagnostic and therapeutic methods, covering the whole process of diagnosis and treatment of blood vessels such as heart, brain, lung and kidney.
Runmaide Medical Vascular Interventional Surgery Robot
The rich product line and the organic combination of multiple modules are inseparable from the strong R&D team behind Runmaide Medical. Huo Yunfei, the founder of the company, has rich experience in computer system research and development and project management; CTO Liu Guangzhi has more than 8 years of experience in medical device development and more than 15 years of experience in software and algorithm development.
At present, the company has set up a R&D team of 114 people led by doctors and masters, which has created a very high technical barrier, of which nearly 200 patents have been authorized and applied.
If the research and development and approval of products is a cornerstone of the early stage of enterprise development, then the commercialization and profitability of products are a carriage that drives the long-term stability of enterprises.
Runmade Medical has established a sound commercial network. Lv Yonghui, executive director and co-CEO of the company, relies on his 20 years of experience in the medical industry, sets up a marketing team of more than 100 people, and establishes two major marketing centers at home and abroad, which greatly improves the sales and admission speed of products. At present, the commercial network of Runmade Medical covers 29 provinces, municipalities and autonomous regions across the country, nearly 100 distributors, and has established a distribution network in Europe, Africa, Southeast Asia and other regions.
The pattern is undecided,
Differentiation will help seize industry opportunities
So far, vascular interventional surgical robots are still in the early stage of development, especially the competition pattern in the domestic market is undecided, and no leading enterprises have yet appeared. Moreover, the existing products are relatively single, and can only replace some surgical operations such as instrument pushing and stent implantation. Under the existing pattern, the development progress of vascular interventional surgical robot enterprises at home and abroad has been gradually flattened, and it is a good time for innovative enterprises to catch up.
Differentiation is the key for companies and products to move out of the vascular interventional surgery robot market. As mentioned above, the functions of most surgical robot products are currently focused on intravascular operation, and if a product wants to "stand out" from it, it needs to be at least an order of magnitude higher than other products in terms of accuracy and stability.
With its own excellent hardware and software strength, Runmade Medical has found another breakthrough in the vascular interventional surgical robot market and developed a surgical robot covering the whole process of vascular intervention. This animal experiment is just the beginning, and the company is gradually building a future of "unmanned catheter rooms".
Reference Articles:
《CCIF 2021 | In 2020 Chinese mainland The Registration Data of Interventional Treatment for Coronary Heart Disease Was Released"——Cardiovascular Health Alliance Information Platform
"[2021 World Robot Conference] The era of robot need is coming- 2021 World Robot Conference Side Note" - Guangming Daily
"Runmaide Medical Prospectus"
"Surgical Robot Industry Research Report: 50 billion high-barrier track to see the domestic leader ready to go" - Southwest Securities