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艳艳 潘

China Surgical Robotics Industry Weekly: Includes updates on Jianjia Robot, Yuanhua Orthopaedic Robotics, Edge Medical, Borns Robot, Sagebot, SHURUI Robotics, and other entries.

NO.1 Approved for Market Launch! Jianjia's Tri-Procedure Joint Robot

On July 22, 2024, the National Medical Products Administration announced the delivery of medical device approval documents. Jianjia Robot's independently developed Arthrobot orthopedic surgical robot has passed the National Medical Products Administration's approval for market launch, with a new upgrade of a tri-procedure in one (product name: Joint Replacement Surgical Navigation and Positioning System, registration number: National Medical Device Registration 20233010087).

In April 2022, Jianjia Robot was the first to pass the National Medical Products Administration's innovative medical device approval, obtaining the first registration certificate for a joint surgery robot. In January 2023, Jianjia Robot's independently developed Arthrobot knee replacement surgery robot was approved.

In August 2023, Jianjia Robot's independently developed Arthrobot hip and knee multi-application joint replacement surgery robot was approved, achieving a single surgical robot that can be used for both hip and knee replacement surgeries.

The approval and market launch of this joint surgery robot, which is compatible with hip, knee, and unicompartmental applications, signifies another upgrade of "Made in China" in the field of surgical robots. It further breaks the monopoly of imported brands, accelerates the clinical application capabilities of Chinese surgical robots, and provides a strong handle for the domestic substitution of surgical robots, benefiting more Chinese patients.



NO.2 Baheal Invests in the World's First Self-Shielding Radiotherapy Surgical Robot!

On July 22, 2024, Baheal Pharma Group  and the world-leading American radio-surgical robot company ZAP Surgical (hereinafter referred to as "ZAP") signed a strategic cooperation agreement. The strategic cooperation mainly includes three aspects: Baheal's equity investment in ZAP, the large-scale production of ZAP-X® Mars Boat Radiosurgical Robot, and commercial operation.

ZAP-X® is the world's first radiation therapy equipment with self-shielding capabilities. It adopts a unique self-shielding structural design, innovatively combining a linear accelerator with a self-shielding radiation structure into one, eliminating the need for traditional radiation shielding facilities costing tens of millions. Outpatient offices, primary medical institutions, and even high-speed railway stations or conference rooms can provide immediate radiotherapy services with simple expansions, enhancing the possibility of radiation therapy from a spatial perspective.

In 2018, ZAP-X® obtained special approval for innovative medical devices in China, and in 2019, it was installed at the General Hospital of the People's Liberation Army for clinical trial research. On June 20, 2023, ZAP-X® Mars Boat Radiosurgical Robot was officially approved for market launch in China.


NO.3 Unicompartmental Approval! Yuanhua Kunlu Full Joint Tri-Application Surgical Robot Officially Approved

On July 31, 2024, the Kunlu® Full Joint Orthopedic Surgical Robot achieved approval for total knee replacement, hip replacement, and unicompartmental knee replacement (also known as partial knee replacement) indications. This achievement marks  Yuanhua Orthorpaedic Robotics's Kunlu® as the first full joint orthopedic surgical robot in China to pass the NMPA's innovative medical device (green channel) special review process for hip, knee, and unicompartmental applications.

Kunlu Full Orthopedic Surgical Robot has been approved for three indications in three consecutive years, with  Yuanhua Orthorpaedic Robotics's "Shenzhen Speed" opening up the innovative development of domestic surgical robots.

 In April 2022, Kunlu® Full Orthopedic Surgical Robot for total knee replacement received NMPA's market approval, becoming the first open implant total knee replacement surgical robot system to enter the NMPA's innovative medical device special review process and be approved for market launch.

 In March 2023, Kunlu® Full Orthopedic Surgical Robot for hip replacement was approved by NMPA for market launch, becoming the first domestically developed hip and knee replacement robot in one.

On July 31, 2024, Kunlu® Full Orthopedic Surgical Robot for unicompartmental joint replacement was approved for market launch.


NO.4 Edge® Multi-Port Laparoscopic Surgical Robot Surgery Volume Breaks 3,000 Cases!

As of June 27, 2024, the cumulative number of clinical surgeries assisted by Edge® Multi-Port Laparoscopic Surgical Robot MP1000 (hereinafter referred to as: Edge® MP1000) has exceeded 3,000 cases. This number not only represents a leap in technology but also witnesses Edge Medical's relentless efforts in improving medical quality and ensuring patient safety.Edge Medical is gradually winning the trust and recognition of more doctors and patients through continuous technological innovation and product upgrades.

Among these 3,000 surgeries, surgeries of grade 3 and above accounted for 100%, with more than 2,910 grade 4 high-difficulty surgeries, accounting for 97%. To date, more than 200 external surgery broadcasts have been conducted, fully demonstrating the extraordinary technical strength and extremely reliable stability of domestic surgical robots. This data not only highlights the excellent performance ofEdge® MP1000 in complex surgeries but also reflects its huge potential in improving surgical efficiency and reducing surgical risks. In addition,Edge® MP1000 has successfully carried out nearly a hundred remote surgery explorations. This innovative model not only breaks the geographical limitations but also achieves the sharing of high-quality medical resources, paving a new way for the development of the medical field in the future.


NO.5 Going Global! Borns Robot Strategically Positions in German Private Healthcare

Recently, Borns Robot announced the completion of a new international strategic layout. Borns Robot has previously completed the first step of the European market layout with Klinikum Aschaffenburg-Alzenau, a representative of the German public healthcare system, and based on this successful cooperation, Borns Robot has reached a strategic cooperation with the German Gateway Clinics GmbH to officially start the layout of the European private hospital sector.

This cooperation aims to rapidly promote the commercial application of Borns Robot's series of surgical robot products in Europe. Both parties will conduct in-depth cooperation in fields such as clinical registration, product education, international training, and new business models.

The entry of Borns Robot's Tors Surgical Robot products and artificial intelligence technology into the German private healthcare system will comprehensively increase market penetration and fully meet the needs of different medical institutions.

 

NO.6 Successful Acceptance of the Major Special Project of Sagebot Surgical Robots!

Recently, the Heilongjiang Provincial Department of Science and Technology organized an acceptance meeting for the major special projects of the "Bai Qian Wan" project in Heilongjiang Province. The "Development of Remote Minimally Invasive Surgical Robots" project undertaken by Harbin Sagebotbot Intelligent Medical Equipment Co., LTD. and Harbin Institute of Technology passed the acceptance smoothly.

The "Development of Remote Minimally Invasive Surgical Robots" project undertaken by the company is a major special project of the "Bai Qian Wan" project of the Heilongjiang Provincial Science and Technology Department in 2020. The project carried out integrated research on institutions, drives, and sensors, and constructed an integrated system for minimally invasive medical surgical robots, developing core technologies such as a robot remote control channel based on 5G's ultra-large bandwidth, ultra-high reliability, and ultra-low latency network.

The project has been industrialized, and the project results have been applied clinically in nearly 50 hospitals across the country, including Peking Union Medical College Hospital, the First Hospital of Peking University, and the Second and Third Affiliated Hospitals of Harbin Medical University. It has been widely used in departments such as urology, gynecology, general surgery, and thoracic surgery, and has completed more than two thousand clinical surgeries. The project results have independent intellectual property rights, breaking the foreign technology monopoly and achieving domestic substitution. The company was rated as a national intellectual property advantage enterprise in 2023.


NO.7 SHURUI Robotics Moves into a New R&D Base!

On July 23, 2024, SHURUI Robotics ushered in an important milestone in its development history - the grand celebration of the relocation of the SHURUI Robotics Shanghai R&D Center was held in the spotlight.

The relocation not only marks SHURUI Robotics's official entry into a new R&D base but also heralds the company's infinite possibilities on the road to future technological innovation and industrial upgrading.

 

The snake-arm technology equipped on SHURUI Robotics's single-port surgical robot greatly improves the load capacity and structural reliability of the surgical instruments, achieving flexibility beyond the fingers. It delivers a 3D electronic high-definition endoscope and three surgical tools into the patient's body through a single incision of about 2.5cm in diameter, achieving minimally invasive treatment effects, greatly reducing patient trauma and postoperative recovery time. The snake-arm balances load capacity and flexibility, capable of pulling and moving, and can bend in any direction, operating freely in narrow spaces, providing doctors with greater operational freedom and more refined surgical effects. At the same time, more than ten super-elastic nitinol alloy rods run through the snake-arm from head to tail, each rod can withstand push and pull forces, with strong load capacity, ensuring stability and safety during the surgery.

Currently, SHURUI Robotics's single-port surgical robot has been widely applied in various departments such as urology, gynecology, general surgery, and thoracic surgery, providing more minimally invasive surgical options for the treatment of many diseases.

SHURUI Robotics founder Professor Xu Kai said that at the new R&D production base, the company will further increase R&D investment, promote technological innovation, and continuously improve product quality and service levels. At the same time, the company will also strengthen cooperation with domestic and foreign hospitals and research institutions to jointly promote the development and progress of the surgical robot industry.


NO.8 Intuitive Fosun Ion System Accelerates Local Layout!

Recently, the Intuitive Fosun Ion Bronchoscopy Navigation Operation Control System (hereinafter referred to as "Ion") was successfully launched in China Wuhan.

Previously, on March 21, 2024, the Ion system was successfully approved by the National Medical Products Administration.

On June 27, the Chinese government procurement website published the winning announcement of Xuzhou Medical University Affiliated Hospital for the bronchoscopy navigation control system, and Intuitive Medical's Ion system won the bid at 1497.25 million yuan.

This marks the official commercialization of the Ion system in China.

 

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