MicroPort Honghu Robotics has obtained CE certification again, opening up the Chinese, American and European markets

On December 5, MicroPort Robotics announced that its independently developed SkyWalkerTM knee joint navigation and positioning system (registered name in China: Honghu) successfully obtained the European CE certification, becoming the first joint replacement surgical robot in China to obtain the European CE certification.

At the same time, Honghu is also the first and only domestic surgical robot that has been approved by the China National Medical Products Administration (NMPA), the U.S. Food and Drug Administration (FDA) and CE certification. Affected by this, today's minimally invasive robot once rose by more than 10% during the trading session. Since October 14, its stock price has doubled.

It is understood that the Honghu orthopedic surgical robot has technical advantages such as precise operation, efficient coordination, safety protection and strong compatibility. Before the operation, its planning system can assist doctors in formulating personalized prosthesis implantation plans based on the patient's preoperative CT scan data and prosthesis model data. During the operation, it can quickly complete osteotomy and improve surgical accuracy and efficiency based on the precise positioning of the surgical plan through registration technology and combined with the independently developed highly dexterous and lightweight robotic arm .

The Honghu orthopedic surgical robot can avoid the medullary cavity positioning in traditional surgery, and there is no intramedullary rod implantation during the operation, which reduces surgical damage and bleeding, improves the postoperative lower limb force line, reduces complications, and helps patients achieve rapid recovery after surgery.

On November 22, MicroPort announced that its Honghu orthopedic surgical robot completed the first total knee replacement surgery in the United States. Its precise operation, efficient coordination, safety protection and strong compatibility have laid a solid foundation for China's smart manufacturing technology to benefit American patients.

The announcement stated that the CE certification of Honghu is the first step for the group to enter the EU market. At the same time, this is another major achievement created by Honghu after obtaining NMPA approval for listing in April this year and FDA certification in July. Honghu has been certified in China, the United States and the European Union within one year, demonstrating the strong technical strength and product advantages of domestic surgical robots, and marking that the group has initially completed the global key regional access layout.

According to information, Minimally invasive robotics is the only surgical robot company in the world whose business covers five major specialties: laparoscopy, orthopedics, pan-vascular, natural orifice and percutaneous puncture. It has many products entering the clinical trial stage, and its flagship products Dragonfly Eye, Touma and Honghu have obtained NMPA approval for marketing and have the prerequisites for commercialization.

However, as far as the situation in the first half of the year is concerned, the commercialization process of minimally invasive robots is not satisfactory. The financial report shows that the revenue in the first half of the year was only 1.048 million yuan, compared with zero in the same period last year, mainly from the Dragonfly Eye, a product launched last year; the loss attributable to shareholders was 459 million yuan, an increase of 89.7% year-on-year, mainly due to the substantial increase in R&D expenditures. The cumulative R&D costs during the reporting period reached 336 million yuan, an increase of 110.2% over the same period last year.

To this end, minimally invasive robots are also accelerating the process of commercialization and have made many preparations:

On the one hand, it is to increase production capacity to meet sales demand. The first half financial report shows that as of June 30, MicroPort Robotics had inventory of 194 million yuan, a year-on-year increase of 76.5%, mainly raw materials, products in process and some low-value consumables.

In addition, MicroPort Robotics has production bases in Shanghai and Suzhou. As of June 30, the book value of its properties, plants and equipment was RMB 435 million, an increase from the end of last year. This is obviously a preparation for the initial sales of Tumai and Honghu in the second half of the year and the mass production of Dragonfly Eye, which is expected to be launched in 2023.

On the other hand, sales and marketing expenses have increased. In the first half of 2022, the sales and marketing expenses of Minimally Invasive Robotics reached 64 million yuan, a year-on-year increase of 337.7%. The increase mainly came from the increase in business team personnel, doctor training costs and marketing materials consumption. These are all used to improve the product marketing system and clinical promotion, and are necessary expenses to help the large-scale commercialization of subsequent products.

Surgical robots have higher precision, consistency and controllability, which can effectively reduce the burden on surgeons and improve the success rate of operations. At the same time, minimally invasive surgery has smaller wounds and shortens the postoperative recovery period. They are high-end medical devices with extremely high clinical value. As the aging population intensifies, the demand for surgical robots will also increase.

In recent years, favorable policies for surgical robots have been continuously introduced. Last year, Beijing and Shanghai included some surgical robot applications in the scope of medical insurance payment; the "14th Five-Year Plan for the Development of the Robot Industry" also mentioned the need to accelerate the development of medical robots and increase the supply of high-end products, such as surgery, nursing, inspection, rehabilitation, consultation, and distribution medical rehabilitation robots.

In October this year, the National Health Commission issued another notice, proposing to use fiscal interest-subsidized loans to update and renovate medical equipment. It is revealed that relevant departments are currently negotiating the details, and it is expected that the loan amount for each hospital will be no less than 20 million yuan.

And based on the ever-expanding demand for high-quality medical resources, the number of surgical robots approved for marketing by the National Medical Products Administration (NMPA) has also increased significantly. The surgical robot industry has begun to enter a rising period. Some institutions believe that 2022 will be the first year of the explosion of surgical robots in my country.

According to data from Frost & Sullivan, the global surgical robot market size reached 85.4 billion yuan in 2021, and is expected to reach 402.8 billion yuan by 2030, with a compound annual growth rate of approximately 21.5%. Among them, the Chinese surgical robot market has grown from 880 million yuan in 2017 to 4.2 billion yuan in 2021, with a compound annual growth rate of 47.6%.

In the future, as the penetration rate of surgical robot-assisted surgery increases, China's surgical robot market will continue to grow. It is estimated that China's surgical robot market will reach 18.88 billion yuan in 2025, with a compound annual growth rate of 45.7% from 2021 to 2025. In 2030, China's surgical robot market will reach 68.72 billion yuan, with a compound annual growth rate of 29.5% from 2025 to 2030.