At the beginning of 2021, the international orthopedic giant Johnson & Johnson DePuy Synthes sent good news, and the company's orthopedic surgical robot product VELYS™ was approved for listing by the US FDA.
However, in the layout of the field of orthopedic surgical robots, Johnson & Johnson has actually slowed down competitors by more than half a beat. Six months ago, Smith & Nephew's new generation of orthopedic surgical robot system Cori also passed the FDA audit and was officially launched in the United States.
Earlier, the joint and spine surgery robots of other orthopedic giants such as Stryker, Medtronic, and Zimmer Bangmei had already entered.
In particular, Stryker, as the first orthopedic giant to invest heavily in robotics, due to holding the "trump card" of MAKO joint robot, the company not only promotes the original weak growth of the orthopedic business to return to the rapid upward channel by constantly encroaching on the market share of other opponents, but also establishes its leadership position in the orthopedic surgical robot industry in one fell swoop.
In contrast, because of the one step behind, the former overlord Johnson & Johnson can only be defeated. Therefore, in the industry's view, the approval of VELYS™ may allow Johnson & Johnson orthopedics to win back another round.
Yes, this is the great change that the US orthopedic market is currently experiencing, surgical robots have become the standard for these orthopedic giants, and surgical robots are reshaping the entire orthopedic landscape.
The increasing clarity of overseas markets has made domestic enterprises and capital more and more eager. According to incomplete statistics from Wall Street, in the first four months of 2021 alone, at least 5 financing incidents occurred in the field of domestic orthopedic surgical robots, covering different categories such as trauma, joints, and spine.
Among them, perhaps because of the success model of MAKO in the front, articulated robots have thus become the most sought after subdivision track. However, it also means that the competition for this market may also be the most intense.
Especially after winning the blockbuster indication of total knee replacement, Scitech is determined to accelerate the commercialization of MAKO in the Chinese market this year. Previously, this only joint surgery robot approved for listing in China was mainly used for total hip replacement surgery with a relatively small amount of surgery.
The "big guy" is finally going to exert his strength, and here, the real contest has just begun.
<h2>A revolution in surgical robotics</h2>
Although in the field of surgical robots, the most well-known and prestigious is Intuitive Surgical's da Vinci surgical robot (laparoscopic robot, which can be applied to soft tissue surgery in the heart, prostate, thymus and other parts), from the perspective of market segmentation, orthopedics is actually one of the earliest fields entered by surgical robots, and it is also the most important hot field for the research and industrialization of surgical robots.
In the layout of orthopedic robots, Stryker began its own exploration very early, and in 2013, it spent $1.7 billion to acquire the Israeli surgical robot company MAKO Surgical. After completing the acquisition, Scitech organically combined the MAKO joint robot with its existing joint implant products, forming a synergy mechanism between the two, and ultimately making its orthopedic business shine again.
MAKO's success has attracted follow-up from other orthopedic giants: Zimmer Biomet subsequently acquired ROSA robots in 2016 through the acquisition of Medtech SA; followed by Medtronic's acquisition of Mazor Robotics in 2018 for $1.7 billion to lay out spinal surgical robots; Johnson & Johnson began developing the next-generation robot-assisted surgery platform for orthopedics after acquiring Orthotaxy in 2018.
The success of MAKO robots is not unrelated to Stryker's efforts in marketing.
In fact, orthopedic surgical robots came out very early, but the initial promotion in orthopedic surgery was very limited. One of the important reasons is that the use of orthopedic implants specially designed for surgical robots during surgery, while doctors prefer to use implants they are familiar with and are not willing to easily replace them with new products.
In order to improve the acceptance of MAKO by doctors and hospitals, Stryker has used various big moves, including: conducting secondary research and development, combining the MAKO joint robot with its existing joint implants, so that doctors can seamlessly connect the use of surgical robots; carrying out a large number of clinical trials to demonstrate the safety and effectiveness of MAKO; and creating two complete surgical programs for hip replacement and knee replacement around the MAKO joint robot.
However, without the premise of the revolutionary advantages of surgical robotics itself, these efforts may be in vain.
How can surgical robots be a disruptive technology? How can it be an outlet for capital chasing?
Shen Nanpeng, founding and managing partner of Sequoia Capital China Fund, once proposed that similar to scientific research, the essence of investment is to pay attention to the ultimate and pain points of the industry. The surgical robot solves the biggest pain point of traditional orthopedic surgery - the accuracy of surgery is not enough.
Insufficient surgical accuracy can lead to a series of problems, such as easy damage to soft tissues, slow recovery of patients after surgery, and poor long-term results of surgery, which requires revision surgery.
Taking joint replacement surgery as an example, the revision rate is one of the most important outcome evaluation indicators after joint replacement surgery. The level of renovation rate is related to many factors, including implant prosthesis design, operator operation techniques and experience, and postoperative lower limb line.
The current revision rate of traditional joint surgery is still high, and according to relevant literature statistics, this figure is even as high as 15%-20%. That is to say, about 15%-20% of patients implanted with prostheses will return to the hospital for revision surgery after 15 or 20 years.
"Why is this happening? One of the important reasons is that the installation of the prosthesis is not precise enough when the patient is first operated on. Ma Min, CEO of Stryker China, told Wall Street.
According to Ma Min's further explanation, the angle of joint surgical prosthesis implantation is closely related to the postoperative lower limb force line, which in turn affects the surgical revision rate. In the control of the angle of implantation, most of the doctor's manual operation can only control it between 5-10 degrees, but the robot can control each operation within 1 degree very well, so as to achieve the best line of force performance.
"What is the effect of this? That is, the patient's postoperative pain will be reduced, standing will be more stable, and the future surgical revision rate will definitely drop sharply. Ma Min said.
It is understood that compared with the initial replacement, the operation time of joint revision surgery is longer, the bleeding is more, the probability of infection and thrombosis is greatly increased, postoperative dislocation, nerve paralysis, femoral fracture or perforation is higher, which brings great pain to patients.
Moreover, the cost of revision surgery is much higher than that of the initial replacement surgery, which is 5-10 times that of the latter. In other words, in the long run, orthopedic robotic surgery may also have the significance of reducing medical costs and reducing social medical and health expenditures.
However, these are still not enough to summarize the profound impact of surgical robots on the entire orthopedic industry.
In the emerging field of orthopedics, orthopedic biomaterials (biotype prostheses) are another top technology in addition to surgical robots. Biological prosthesis, compared with traditional bone cement prosthesis, is also known as "non-bone cement prosthesis", with relatively low long-term loosening rate, longer service life and other advantages.
However, due to the extremely high precision requirements for intraoperative prosthesis placement, the implantation of biological prosthesis will be more difficult than that of bone cement prosthesis, which restricts its clinical application. Especially in knee surgery, which requires higher surgical skills, the current mainstream use of bone cement prosthesis in China is still a cement-type prosthesis, and bio-based products have not really entered the clinical application.
But surgical robots, with their advantages of precise implantation, are expected to change this trend.
In fact, with the assistance of intelligent orthopedic robots, the implantation of extremely difficult biotype prostheses in knee replacement surgery has begun in China.
At the beginning of January this year, the National Orthopedic and Sports Rehabilitation Clinical Medical Research Center completed the country's first intelligent orthopedic robot-assisted new biological artificial knee replacement surgery in Boao Lecheng. According to reports, the type of prosthesis to be applied during surgery and the position angle of placement can be accurately planned before surgery, and sub-millimeter-level accurate results can be achieved during surgery.
"The use of biotype prostheses is only the best solution with the blessing of robots. Therefore, in foreign countries, since the development of orthopedic surgical robots, the application of biological prostheses has increased. Ma Min told Wall Street What He saw. It is said that more than 40% of knee implants in the United States are biological-type prostheses.
"In contrast, the application of biological prostheses in China is still very limited, but in fact, the biological prostheses that have been approved for listing by local companies are not nothing, but the commercialization results of these products after listing are not ideal, and I think the reason behind them is here, because of the lack of robot assistance." Ma Min pointed out.
<h2>Battle of the Articulated Robots</h2>
According to the application area, orthopedic robots are mainly divided into three categories, including trauma, spine and joints. Launched in the United States in 2006, Stryker's MAKO joint robot is currently one of the world's commercialized surgical robots and an orthopedic joint robot.
In recent years, with the increase in the number of orthopedic robots approved for listing, competition in this market is intensifying. Zimmer Bumy's ROSA Knee Robotic System, Xerox's Cori Robot, and Johnson & Johnson's VELYS™ are all articulated robots and are therefore considered strong contenders for MAKO.
However, despite this, from the perspective of public information, overseas joint surgery robots are not the same, and latecomers have also strengthened their competitive advantages by increasing the differentiated design of products. For example, the newly approved Cori and VELYS™ robots will be more compact and portable, ideal for outpatient surgical centers (ASCs) and outpatient surgeries.
Even ROSA Knee and MAKO, where the application scenarios are closer, there are large and small differences between the two. Taking MAKEO as an example, from the perspective of public information, its "intelligent" characteristics are relatively prominent.
Robotic surgery can overcome the physiological limitations of human surgery, and has the characteristics of high operation accuracy, high repeatability and high stability. "Robotic surgery" is often thought of as a robot performing the operation autonomously, with no one involved in the entire surgical process, but in fact not all surgical robots are like this.
Da Vinci Robotics is the world's first surgical robot approved for marketing, and it is also the only robotic surgical system in the world that can be officially used in abdominal surgery. However, the da Vinci surgery is not done by the robot independently, it is actually controlled by the doctor to complete the operation with a robotic arm.
Therefore, from this point of view, the da Vinci robot can be seen as an extension of the doctor's hands, it can replace the doctor's hands to do the operation, but the success or failure of the operation ultimately depends on the success or failure of the doctor's operation.
"The intelligence of MAKO, that is, assisting clinicians in preoperative intelligent planning and intraoperative intelligent operation, simply put, after participating in the formulation of surgical planning, doctors no longer need to operate surgery, and during the operation, MAKO becomes the doctor's hands and brain." Ma Min defines THE INTELLIGENT FUNCTION OF MAKO in this way.
In terms of preoperative surgical planning, the MAKO joint robot can perform 3D intelligent modeling based on CT, which can generate personalized surgical plans for patients. One of the benefits it brings is that because the surgical plan has been designed to avoid a variety of important nerves and blood vessels, to find the least traumatic surgical approach, so not only can the patient's vascular and nerve damage be reduced during the operation, but also the patient recovers quickly due to less trauma.
In addition, MAKO also has some intraoperative intelligent operation design that its competitors do not have, including MAKO does not use a clamp during surgery, which can protect the soft tissue envelope and reduce the invasiveness of surgery; in addition, MAKO's robotic arm is attached to the bone saw, which can assist the doctor in completing osteotomy.
"The intelligence of MAKO can standardize the results of joint surgery and greatly improve the predictability of surgical results. A young doctor, if the traditional surgery is not done well, then the use of da Vinci robot is still not good, and MAKO is not the same, because intelligent, who will do it is the same, with a high degree of replicability. Ma Min said.
"MAKO is a very mature product, except for the expensive point, the other problems are not big." The industry also recognizes the clinical value of MAKO.
According to the information that has been publicly available, MAKO is currently the only joint surgery robot approved for marketing in China. Its total hip replacement indications were approved in 2014 and were first applied to the clinic in China in 2018.
Following the domestic listing of Total Hip Replacement (THR), according to Wall Street, the MAKO joint robot has also been approved as a total knee replacement (TKR) in China.
Due to the higher requirements and higher amount of total knee replacement surgery in orthopedic joint surgery, IT is of great significance that MAKO has been approved as an indication for total knee replacement.
For Stryker, the surgical volume of MAKO joint robots in China will certainly increase significantly in the future. "This year, we will definitely accelerate the commercialization of MAKO in China." Ma Min told Wall Street what he saw.
For domestic bone and joint surgery, because the precision of knee surgery is the highest, the clinical benefits brought by robot surgery will be more obvious, and domestic orthopedic surgery may usher in the era of true precision surgery.
For other companies in the industry, since robot-assisted total knee replacement is a new surgical method, companies need to undertake more market education work to improve the clinical awareness of orthopedic surgical robots. Now it seems that Stryker, as the first to enter the enterprise, will first shoulder this heavy responsibility, to a certain extent or good for the late entrants.
However, in addition to listed companies such as Minimally Invasive Medical, Tianzhihang, Chunli Medical, and a variety of start-up companies mentioned above, the current domestic joint surgery robots under development are expected to be as many as more than 10 models, and the market competition is not fierce.
Among so many products, who can not be eclipsed by the light of the "big guy" MAKO? Who can stand out in the fierce competition?
To answer these questions, perhaps we should still look overseas and look for answers from the every move of the multinational giants, such as their product differentiation strategies and their market strategies for combining surgical robots with their own orthopedic implants.
As Dr. Nie Hongxin, managing partner of Shanlan Capital and a senior medical device investor, said when reminding the market to pay attention to the overseas orthopedic robot investment boom:
"We have seen that in the past five years, mature multinational giants such as Stryker, Medtronic, Johnson & Johnson, whether they are incubating themselves or external mergers and acquisitions or strategic collaboration, in the field of orthopedic robotics and artificial intelligence (continuous action), so what are their assumptions (to make these decisions)? What future trends do they see that we don't see? I think these are all phenomena that deserve the attention of the industry and the investment community. ”
This article is from Wall Street Insights, welcome to download the APP to see more
![Why did the aborted MAKO advanced trainer become a technological breakthrough for the fourth generation of German aircraft?[fig]](data:image/gif;base64,R0lGODlhAQABAIAAAP///wAAACwAAAAAAQABAAACAkQBADs=)