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Market Release of Honghu Orthopedics Surgical Robot Gained Approval from Australian Therapeutic Goods Administration (TGA)
2022-07-28 GMT+8 PM 10:44

On July 14, 2023, the Honghu Orthopedics Surgical Robot (under the name of SkyWalker when exported abroad, hereinafter referred to as Honghu Robot) developed by Microport Orthobot (Suzhou) Co., Ltd. under Shanghai MicroPort MedBot (Group) Co., Ltd., officially passed the evaluation by Australian Therapeutic Goods Administration (TGA) and gained Australian Register of Therapeutic Goods (ARTG), permitting it the access to Australian market.

 

Honghu Robot has obtained registration approvals from China National Medical Products Administration (NMPA), U.S. Food and Drug Administration (FDA), EU CE Certification and Brazil Agência Nacional de Vigilância Sanitária (ANVISA), and this ARTG marks another breakthrough. It witnesses the rapid development of the Chinese surgical robot industry and its pursuit of international advanced technology and world-class manufacturing level. With this as an opportunity, MicroPort® MedBot® will keep promoting its global strategic layout, leading the innovation - driven development of the domestic surgical robot industry, and benefiting more patients worldwide through technological innovation.

 

As a pioneer of medical robots in China, MicroPort® MedBot® spent years in building this Honghu Robot, which has become the first and the only China-made surgical robot that obtains market approval in Asia, North America, Europe, South America, and Australia. It can be used to assist in total knee arthroplasty (TKA). With a self-developed robotic arm and through the process of preoperative CT scanning–building a 3D model–generating an individualized prosthesis implant plan, the robot can enable the surgical process of intraoperative robotic arm registration–bone registration–navigation positioning –precise osteotomy–prosthesis implantation, so as to produce an integrated orthopedic surgical solution for the patients.

 

In recent years, Honghu Robot keeps challenging difficult surgical techniques, assisting clinical experts to achieve numerous breakthroughs. As of now, Honghu Robot has completed more than 600 robot assisted clinical surgeries in orthopedics, joint surgery, and sports medicine at over 40 hospitals in 16 provinces across the country, including many first-time and highly challenging robot assisted surgeries, for example the first China-made surgical robot assisted 5G remote arthroplasty, joint replacement following intramedullary nailing of femoral shaft fractures, arthroplasty for severe rheumatoid arthritis, etc. It has helped medical staff to complete the total knee arthroplasty in high altitude and cold environment, proving high stability in its role of assistance.
 

MicroPort® MedBot® set out early in its international expansion. Since November 2022, Honghu Robot has successfully conducted over 10 total knee arthroplasties in several US hospitals, including the Lighthouse Surgical Hospital in New Hampshire, USA. It thus enjoys a high reputation abroad.

 

In June 2023, four Polish orthopedic experts paid a special visit to Shanghai Ninth People's Hospital affiliated to Shanghai JiaoTong University School of Medicine. They were presented on site with live demo of 2 cases of total knee arthroplasties (TKA) performed by Director Huiwu Li by using Honghu Robot and got to know the equipment operations in depth. With the assistance from Honghu Robot, both surgeries made precise osteotomy within 20 minutes. The powerful intraoperative assistance, intelligent navigation, precise registration, and precision and efficiency deeply impressed the Polish peers.

 

During this visit and exchange, Director Huiwu Li gave a detailed introduction to the performance, indications, and clinical behaviors of the Honghu Robot. According to Director Li, Honghu Robot is not only capable of performing routine surgeries, but also capable of handling highly challenging surgeries such as severe stiff knees, extraarticular deformities, and complex joint cases with internal fixation rods installed at the distal end of the femur, all with good outcomes. Clinical data showed that Honghu Robot can help physicians complete every surgery in a standardized and precise manner, bringing patients faster recovery with less trauma, and assisting hospitals in continuously achieving high-quality progress in scientific research and medical services.

 

According to Mr. Yu Liu, Executive Vice President and Chief Commercial Officer of the MicroPort® MedBot®:

Honghu Robot has consecutively obtained registration approvals in less than 2 years from Aisia, North America, Europe, South America and Australia. It is not only an authoritative recognition to the Honghu Robot, but also a straightforward reflect of the transition in China's medical technology from "follower" to "innovation leader". On the basis of doing a good job in technological innovation and accelerating product iteration, we will work together with partners from various countries to promote the popularity and influence of Honghu Robot, and fully explore both home and international markets, providing more comprehensive robotic surgery solutions for surgeons and hospitals worldwide, enhancing the experience of professionals and patient, and benefiting more patients.

 

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