On the evening of December 14, Beijing Tianzhihang Medical Technology Co., LTD. (hereinafter referred to as "Tianzhihang") announced that the company has obtained the North American certification certificate of surgical robot (referred to as "CSA certification") issued by the Canadian Standards Association, thus becoming the first surgical robot company in China to obtain the certificate.
Breguet Robotics Robotics Orthopedic Surgical System, known as Phecda II, has become the first Orthopedic robot in China to be certified as a compliant Orthopedic Surgical System. It is reported that The international version of Phecda 2.0 orthopedic surgery robot is suitable for cervical, thoracic, lumbar, sacral spine surgery and trauma surgery of pelvis, acetabulum, limbs and other parts.
The certification is based on product safety regulations, EMC, medical software, availability and robot performance special standard (IEC80601-2-77) and other latest industry standards, so far, the company Phecda ii orthopaedic surgery robot international edition in terms of technology fully meet the requirements of north American market access standards.
However, tianzhihang products want to enter the international market, but also need to obtain overseas marketing authorization (FDA, CE), according to Tianzhihang Secretary Huang Junhui revealed that Tianzhihang has been preparing for the product to apply for FDA, CE marketing certification. The CSA certification obtained by Phecda ii Orthopedic Surgery Robot International Edition will not have a significant impact on Tianzhihang's performance in the short term.
01
High r&d investment rate, still losing money
Tianzhihang is a robot company focusing on the research and development, production, sales and service of orthopaedic surgery robots. In terms of revenue structure, Tianzhihang mainly consists of four main businesses: orthopaedic surgery navigation and positioning robots, surgical center professional engineering, supporting equipment, consumables and technical services. From 2017 to 2019, Orthopedic surgery navigation and positioning robot sales accounted for between 75% and 93% of the revenue, "the main force".
Since 2010, Tianzhihang has completed the research and development of the third generation of products. In 2010, the first-generation product "GD-A" was registered. From 2012 to 2014, gD-2000 and GD-S, the second-generation products, successively completed CFDA certification and went on sale; Since 2016, the third-generation product, Phecda orthopaedic surgery robot system, has been registered and launched for sale, forming a business model with "Phecda" orthopaedic surgery navigation and positioning robot as the core, and accelerating the layout of the industrial chain.
In 2020, Phecda 2.0 orthopedic surgery robot appears. It takes 3 to 4 years for Phecda to develop and iterate a surgical robot. The core product Phecda can be applied to trauma surgery of pelvis, acetabulum, limbs and other parts as well as full-segment spine surgery. Phegda 2.0 orthopaedic surgery robot USES the six degrees of freedom mechanical arm as the core component, compared to previous generation significantly enhance technical degrees of freedom, can realize the operation of different angles at different positions of the body of the robot operation requirements, it is worth mentioning that the clinical accuracy can reach the mm level (< 1 mm), greatly improved the operation security.
At present, Tianzhihang has 98 r&d team members, accounting for 34% of the total number of r&d personnel. Among them, 40 have master's and doctor's degrees and have years of work experience in the medical clinical field. By the end of the first half of this year, Tianzhihang has obtained 270 patents and applied for 29 software Copyrights, including orthopedic robot control system.
Although it wise to achieved a certain effect on r&d spending, but in fact, days wisdom navigation product marketing is not and expectations, in the past three years, hasn't been profitable days wisdom, and loss of expanded year by year, just like most surgical robots at home and abroad, it is difficult to escape from research and development cycle is long, high cost, realize large-scale sales before continuing to pour money into profit difficult such as "curse".
Share of R&D from 2018 to 2020
According to the financial report, from 2018 to 2020, the company achieved operating revenue of 127 million yuan, 230 million yuan, 136 million yuan, and the net profit attributable to the shareholders of the parent company was -85600 yuan, -30,9578 yuan, -54.4709 yuan, respectively. From 2018 to 2020, the company invested 41.486,500 yuan, 77.012,900 yuan and 74.11 million yuan in R&D respectively, with the r&d expense ratio higher than comparable listed companies in the same industry. In the first three quarters of 2021, the company achieved operating revenue of 105 million yuan, a year-on-year increase of 37.09%, and a net loss of 63.7646 million yuan, a year-on-year increase of 24.49%.
Production and sales from 2017 to 2019
2020 Annual Sales volume
Phecda robot mainly sells to the hospital, the sales volume is not high, but has increased year by year. From 2018 to 2020, 20, 41 and 30 units were sold respectively, with an average production and sales rate of about 70%. In 2020, due to the impact of the epidemic, the demand for medical devices purchased by hospitals decreased, resulting in a significant decline in sales of The company's main product, Phecda Orthopedic Robot (Phecda 1.0), with only 30 units sold, a year-on-year decrease of 26.83%. By the end of the first half of this year, Tianzhihang orthopedic surgical robots have sold 127 units in total (excluding the number of units used in scientific research).
In 2019, Tianzhihang accounted for about 80% of the market share in the same industry, including more than 100 third-class a hospitals and orthopedic hospitals such as Beijing Jishuitan Hospital and Shanghai Sixth People's Hospital. Since 2020, the company has explored the business model of co-constructing minimally invasive surgery center for orthopedic surgery robot with medical institutions: the company provides orthopedic robots and technical support to medical institutions, and collects corresponding service fees and consumables income. At present, this model has been tried in Beijing Haidian Hospital and other hospitals.
02
Commercial breakthrough of tianzhihang
On November 16, Tianzhihang replied on the investor relations platform that "the number of orthopedic surgery robots assisted by the company has exceeded 20,000 units in total". At present, Breguet 2.0 orthopedic surgery robot international version has completed prototype development, has passed the CSA(Canadian Standards Association) iec60601-1 medical electrical equipment - basic safety and main performance of the general requirements of certification, Tianzhighang is expected to further commercialization road.
In addition to increasing investment in research and development of iterative products, Tianzhihang has also been investing in medical robot enterprises and layout in the upstream and downstream of the industrial chain. In 2017, Tianzhihang invested in SPW, A French company, and set foot in spinal medical supplies business. In 2018, Tianzhihang invested in GYS and Mobius to participate in the mobile CT field. In the same year, Shuimu Oriental, a subsidiary of Tianzhihang, invested in a number of companies related to the field of medical robots, including Inte Medi, Shanghai Chammai, Rosenbot, Chengdu Jieside, etc. In 2019, Tianzhihang invested in Anjie Robotics In Germany to participate in the development of mechanical arm. Most of these foreign investment cases did not end up as expected.
In order to make up for the lackluster performance caused by foreign investment, Tianzhihang tried multi-party cooperative research and development mode in order to achieve synergistic effect. This "production, learning, research and medicine" R&D system includes undertaking a number of national and provincial research projects with universities and colleges.
On the one hand, universities and research institutions focus on basic generic technology research to provide support for product development; On the other hand, the hospital is responsible for putting forward clinical requirements and carrying out clinical application verification; Tianzhihang is responsible for breakthroughs in key technologies of product research, so as to realize commercialization of technical and clinical research results.
This year on June 23, the day wisdom navigation disclosed for the first time in 2021 to A particular object issue a-share stock plan, plans to raise the total amount of money less than RMB 1.34 billion yuan, the money raised by the many to the few respectively into A new generation of orthopaedic surgery robot research and development and industrialization projects, marketing system and technology upgrade, the wisdom medical center construction project reserves.
But since the days of intellectual traffic listed less than one year, and 1.34 billion yuan is 1.2 times that of the company's total assets, raise funds, nearly three times as short term again raise large capital Shanghai attention, so that the audit information letter sent out three times in a row, request additional information, and illustrates the rationality and necessity of financing.
On the evening of November 25, Tianzhihang issued 17 announcements focusing on the issue of "2021 A-share stock plan for specific targets", and lowered the ceiling of total fundraising from 1.34 billion yuan to 963.85 million yuan. The funds originally planned to be invested in the r&d and industrialization projects of A new generation of orthopedic surgery robots shrank by 34.15%, and many project funds were reduced or cancelled.
Tianzhihang has previously said that the commercialization of surgical robots needs the education market as well as policy promotion. At present, there is still a lot of room for improvement in the recognition of surgical robots in China, and it will take a long time to improve the cognition of doctors and patients on surgical robots.
It is worth noting that at the end of August this year, surgery and disposable supporting consumables supported by Breguet orthopedic surgery robots entered the scope of medical insurance payment in Beijing, which has a certain benchmark significance. At present, The orthopedic surgery robot products of Tianzhihang have entered the charging catalogue of 18 provinces/cities, and will gradually enter the medical insurance in the future.
03
The surgical robot track is still hot
With the natural growth of global population, the aging of population, the economic growth of developing countries and the continuous improvement of consumer demand in the medical and health industry, the global medical device market will continue to grow.
In terms of market segments, in vitro diagnostics, cardiovascular, medical imaging and orthopedics are the largest market segments in the medical device industry. In 2019, the market size of in vitro diagnostics was $58.8 billion, ranking first. Orthopedic medical device market size of 40.8 billion DOLLARS, ranked fourth, will continue to grow in the future.
Surgical robot is the most promising subdivision field of medical robot at present, which can effectively solve the problems of poor precision of traditional surgery, long operation time, doctor fatigue and lack of 3d precision vision. Although China's surgical robot market has completed the early stage of market education, the technical competitiveness of high-end medical equipment for surgical robots in China is still weak due to the limitations of technological innovation ability, incomplete innovation chain and industrial chain. Some Korean companies are doing well in orthopedics, neurosurgery and interventional surgery by avoiding their strengths such as Da Vinci robot.
Based on the competition of surgery robot may lead to shock, in recent years, the history of cyc, medtronic, jie mai orthopaedic giant with financial strength advantages, such as state beauty are buying a national orthopaedic surgery robot source technology start-ups, completed the orthopaedic surgery robot industry industry layout, and with the aid of their sales channel advantages, focus on market development, To consolidate their lead. See the following figure for details:
Sources: Public information; Note: The sales scale of stryker, Jeme Bonme and Medtronic, the three medical device giants in the figure above, includes all their product lines
Currently, the orthopedic surgery robot industry includes Mazor Robotics, MEDTECH, MAKO Surgical, and Shenzhen Xinjunte Intelligent Medical Device Co., LTD. (xinjunte), which has obtained the registration certificate of spinal surgery navigation and positioning robot medical devices. Shanghai minimally invasive surgery robot, Jijia robot, Konosten, etc.
The main enterprises in the industry are as follows:
1. Xinjunte, founded in 2015, focuses on the most intelligent orthopedic surgery robot research and development innovative platform in China, and realizes the organic combination of "robot +AI".
Its navigation and positioning system for spinal surgery successfully obtained the NMPA registration certificate in February 2021. The approved product is the first fully intelligent orthopedic surgery robot with navigation + surgical operation in China.
2. Mazor Robotics is an Israeli manufacturer of robotic guidance systems for spine surgery founded in September 2000. It develops, manufactures and sells orthopedic surgical robots such as Spineassist, Renaissance and Mazor X, and was acquired by Medtronic in December 2018.
Renaissance is FDA and CE certified, and Mazor X is an upgrade of Renaissance, which received FDA certification in 2016 and NMPA certification in April 2021.
3. After The acquisition of MEDTECH, ROSA Knee robot was certified by FDA in 2019. It is mainly used for total Knee replacement surgery. In December 2019, ROSA ONE was certified by the NMPA for use in brain and spine surgery. According to FDA certification information, ROSA ONE's auxiliary surgical function of Brain surgery is inherited from ROSA Brain, and ROSA Spine's auxiliary surgical function is inherited from ROSA Spine.
4. MAKO Surgical is an American company founded in 2004 to manufacture and sell joint replacement robots and acquired by Stryker in December 2013. The company's main product is the RIO robot, which is used in joint replacement surgery. The RIO was approved by the FDA in 2009 for knee and hip replacements.
5. Minimally Invasive Medical Robot was established in May 2015. The hhSKYwalker joint replacement robot developed by minimally invasive Has entered the green Channel special approval procedure for Innovative Medical Devices of The State Medical Products Administration, and is mainly used for total knee replacement.
6. The first joint replacement robot product "ARTHROBOT" has entered the clinical trial stage, and is expected to become the first domestic joint replacement robot to obtain the NMPA registration certificate.
In terms of products, The surgical robot with independent intellectual property rights of Jianjia can provide an overall solution for joint surgery, realizing the whole process of "preoperative, intraoperative and postoperative" coverage. It not only innovates in key technologies, but also meets the needs of doctors in clinical applications to solve the pain points of traditional artificial joint replacement surgery.
7, weigao "wonderful hand surgery robot" is China's independent research and development of a new generation of robot operation system, in the mechanical design, master-slave robot system control, three-dimensional image and the key technology such as system integration have made significant breakthrough, with seven degrees of freedom, can achieve more than the end of 540 ° rotating operation, and can pass the 5 g technology to achieve more than 3000 kilometres away in the operation.
8. Suzhou Kondo Robot Co., Ltd. was established on January 7, 2014. In the beginning and middle of 2019, the company completed the world's first 5G network-based robot remote surgery test and the world's first multi-point collaborative 5G remote robot surgery test respectively, and the products passed the special approval of innovative medical devices.
Its multi-minimally invasive surgical robot system is a multi-arm endoscopic minimally invasive surgical robot product, including doctor console, multi-arm robot system, multi-degree of freedom surgical micro-instruments, HIGH-DEFINITION 3D vision system and other products and related auxiliary equipment.
9. Tianzhihang is the first orthopedic robot navigation and Positioning system in China to obtain the REGISTRATION certificate of CFDA Class III medical devices, and the only "international original" product among 2018 innovative medical devices. "Breguet", the third-generation surgical navigation system of Tianzhi Hang, obtained the CFDA class III registration certificate in November 2016, which is the first in China
Navigation and Positioning System for Orthopaedic Surgery "(Breguet ®2.0)
On February 10, the company's "Orthopaedic surgery navigation and Positioning System" (Phecas ®2.0) was approved for market. Breguet 2.0 orthopedic surgery robot uses a 6-dof mechanical arm as the core component, which greatly improves the degree of freedom compared to the previous generation of technology, and can meet the surgical operation requirements of the robot covering different parts of the body and different angles during surgery. It is worth mentioning that its clinical accuracy can reach sub-millimeter level (<1mm), greatly improving the safety of surgery.
Robotics-guidedorthopedic Surgical System, also known as Breguet II Orthopedic Surgical Robot International edition, has become the first orthopedic Surgical robot product certified to meet this standard in China. It is reported that The international version of Phecda 2.0 orthopedic surgery robot is suitable for cervical, thoracic, lumbar, sacral spine surgery and trauma surgery of pelvis, acetabulum, limbs and other parts.
In 2017, the Ministry of Industry and Information Technology and the National Health Commission jointly issued the Notice on organizing the Establishment of orthopedic surgery Robot Application Center, calling on domestic major hospitals to introduce orthopedic surgery robots. In February this year, the Ministry of Industry and Information Technology released a draft of the Medical Equipment Industry Development Plan (2021-2025), proposing to "promote the standardized application of surgical robots in the treatment of major diseases."
It is clearly stipulated in the draft that places with conditions are encouraged to take the lead in medical insurance payment and pricing of relevant medical equipment, and promote the promotion and use of relevant products. This may be one of the reasons for including surgical robots in medical insurance in Beijing and Shanghai.
In addition, in the first four months of 2021, at least five financing events have taken place in the domestic orthopedic surgical robot sector, covering different categories such as trauma, joints and spine. And yida health care, xinwei medical care, First Ruida and other enterprises have launched an impact on the capital market.
Harvest this year A new round of financing of xin jun, sharp, long feng medical, wood, intelligent identification, red dragon valley, yuan jia robot, and key schouten, connor behind companies such as softbank, sequoia China, suitable for capital and other well-known investment Banks, many round A or B are hundreds of millions of magnitude, Meituan dragon ball, medtronic companies such as incoming surgery robot market in succession, and its capital. With further policy relaxation and capital influx, the surgical robot track will continue to grow in the future.
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