MicroPort® MedBot® Announces Annual Results for 2021

Shanghai, China, 29 March 2022 - Shanghai MicroPort MedBot (Group) Co., Ltd. (hereafter referred to as "MicroPort® MedBot®"or the “Group”) today announced the annual results of the Company and its subsidiaries for the twelve months ended December 31, 2021 (hereafter referred to as the "Reporting Period"). This is the first annual performance report released by MicroPort® MedBot® since it was successfully listed on the main board of the Hong Kong Stock Exchange on November 2, 2021.

In 2021, the pandemic situation was stable and under control in China, with the demand from the healthcare industry recovering gradually. The number of surgical operations carried out in the hospital has steadily rebounded, along with growing popularity of robot-assisted surgeries. The gradual inclusion of robot-assisted surgery in medical insurance reimbursement will also become an important driver for the increase of penetration rate of surgical robots in China. In the condition, MicroPort® MedBot® focused on the establishment of surgical robot technology innovation platform and industrial operation system, continued to strengthen internal management and external market expansion, accelerated the deployment of surgical robots in multiple surgical specialties. We have achieved satisfactory progress in product research and development, clinical trials and commercialization.

Flagship Products Gain Significant Clinical Registration Progress

As the only surgical robot company in the world with a product portfolio covering the five major and fast growing surgical specialties of laparoscopic, orthopedic, panvascular, natural orifice and percutaneous surgical procedures, MicroPort® MedBot®’s product portfolio includes two products approved by the NMPA and eight product candidates at various stages of development.

The three flagship products of the Group, Toumai® Laparoscopic Surgical Robot (Toumai®), DFVision® 3D Electronic Laparoscope (DFVision®) and Honghu Orthopedic Surgical Robot (Honghu) have entered the special approval procedure for innovative medical devices of the NMPA (Green Path). Among these, the DFVision® and Toumai® were approved by the NMPA in June 2021 and January 2022, respectively.

The multidisciplinary, multicenter-registered clinical trials of Toumai®, the first and only four-arm laparoscopic surgical robot developed by a Chinese enterprise and approved for launching, were launched in October 2021 and completed in January 2022 successfully, covering many “First” or “Difficult” operations in the fields of general surgery, to fully cover the important and complex clinical applications in the fields of thoracic cavity, abdominal cavity and pelvic cavity. Furthermore, in December 2021, Toumai® Single-arm Laparoscopic Surgical Robot completed the first human trial of single-port laparoscopic robot cholecystectomy in China. This marks the first time that China's independently developed single-arm laparoscopic surgical robot has completed human trials and successfully applied in digestive surgery. Currently, the single-arm laparoscopic surgical robot is in the blank field of medical instruments in China, and no domestic even foreign products have been approved for listing in the Chinese market.

The other independent-developed flagship product, DFVision® is the first domestic 3D electronic laparoscope that entered the Green Path in China, and obtained the NMPA approval in June 2021. It has become one of the first batch of commercial 3D electronic laparoscopes developed by Chinese enterprises, breaking through the monopoly of imported laparoscopic brands in China’s 3D laparoscopic market, and creating a domestic era of 3D electronic laparoscopes. As the first commercial product of the Group, DFVision has performed the commercial promotion since November 2021, and already contributed sales revenue in 2021.

Honghu is an orthopedic surgical robot designed for joint replacement surgery. Honghu is also the only Chinese-developed joint replacement surgical robot with a self-developed robotic arm. In July 2021, the Group completed the registrational clinical trial of Honghu in Total Knee Arthroplasty (TKA), submitted registration application to the NMPA afterward, which is expected to obtain the registration approval of the NMPA in 2022. Meanwhile, MicroPort® MedBot® actively expands overseas markets. Honghu is the first product to apply for overseas listing in the global strategy of the Group. It submitted a 510K Application to the FDA in December 2021.

Besides, the trans-bronchial surgical robot independently developed by MicroPort® MedBot® has completed the design and development of the trans-bronchial surgical robot and are now steadily progressing with clinical preparation and validation. The R-ONE® introduced by Shanghai Cathbot, a joint venture established in China by the Group and Robocath S.A.S of France, has completed the first clinical enrollment for registration of the NMPA in November 2021, which is also its first application in markets outside Europe. With the continuing clinical development and subsequent launching of R-ONE®, it will fill the gap in the fields of domestic PCI surgical robots, making cardiovascular devices more intelligent and precise. Introduced by Shanghai Intbot, a joint venture established in China by the Group and Singapore Biobot Surgical Pte. Ltd., Mona Lisa is an innovative robot product designed by the Company in the percutaneous surgical procedure completed the first enrollment operation of the registrational clinical trial in November 2021. And it is also the first robotic assisted prostate puncture test clinical trial surgery in China.

Globalization Layout Accelerates Innovation

While deeply engaged in the R&D of five core underlying technologies (i.e. robot ontology, control algorithms, electrical engineering, image-based navigation and precision imaging) of surgical robots, MicroPort® MedBot® persisted on an innovation-driven approach, committed to meeting the demand for robotic surgery, and through years of solid accumulation in the five technical fields, and has been able to establish an innovative surgical robot platform and maintain the ability to develop new products continuously. During the reporting period, equipped with the self-developed interconnection platform, Honghu successfully completed the first three-place 5G remote knee arthroplasty with a Chinese-developed orthopedic surgical robot. The animal experiment of interventional cryoablation of benign prostatic hyperplasia was successfully tried for the first time by the independently-developed Madam Curie™ multi-departmental, fully-automated surgical platform.

In 2021, the Group has accelerated the commercialization layout and focus on building a training network. During the Reporting Period, the Group has established more than 10 clinical application and training centers. In December 2021, Toumai® Mobile Demonstration & Training Center has officially set sail to promote the surgical robot technology of “Made in China” to all over the country, providing a platform for more healthcare professionals to access and experience surgical robots.

At present, MicroPort® MedBot® has two China R&D centers respectively in Shanghai and Shenzhen. Meanwhile, as part of the globalization strategy, the Group also has an overseas R&D center in Singapore and plans to establish an R&D center in Boston, aiming at breaking through the core technology of minimally-invasive surgical robots, providing the whole chain of scientific and technological innovation services of minimally-invasive surgical robots, and preparing for the R&D, upgrade and iteration of the products in the future. As of 31 December 2021, the Group has a total of 317 R&D personnel, of which over 60% hold master’s degrees or above in related fields.

For global layout, MicroPort® MedBot® aims to “Build a globalized medical robots total solution innovation platform”, absorbing cutting-edge innovative ideas and resources in surgical robots worldwide. During the reporting period, Honghu, independently developed by MicroPort® MedBot®, has applied to FDA and is expected to become the first domestic surgical robot approved by FDA in China. In addition, the company has in-depth cooperation with many foreign top surgical robot innovation companies and established joint ventures to promote technological breakthroughs and the industrialization process jointly.

Dr. Chao He, President of MicroPort® MedBot®, commented, “The past 2021 was an important year for MicroPort® MedBot®. With the support and encouragement of people from all walks of life and partners, we achieved the approvals of two core products, Toumai® and DFVision®, and successfully listed the company on the Hong Kong Stock Exchange. In the future, we will remain the faith, forge ahead bravely, continue to explore and innovate, strengthen industrial integration, deepen the cooperation with doctors, and provide all-inclusive solutions for patients and doctors in China even the world.”

Mr. Hongbin Sun, Chief Financial Officer of MicroPort® and Chairman of the Board of MicroPort® MedBot®, stated,“ With the increasing acceptance and popularity of surgical robot technology among doctors and patients, and the improvement of medical infrastructure in China and around the world, we believe the surgical robot market is poised for robust growth. In the future, MicroPort® MedBot® will further strengthen corporate governance, implement active and efficient business strategies, strive to build a global layout of medical robot solution innovation platform, contribute to the high-end medical equipment ‘Made in China’, and better performance to the majority of investors.”

(All the revenue growth rates mentioned above are compared to the corresponding period of last year, and also adjusted to exclude the foreign exchange impact. Please refer to the 2021 Annual Results Announcement issued by the Company on March 29, 2022 for the data before excluding the foreign exchange impact.)