Xinjunte Files IPO Prospectus: China's First Active-Needle Orthopedic Surgical Robot Receives NMPA Approval

Recently, information on the official website of the National Medical Products Administration (NMPA) indicated that Futurtec’s surgical navigation and positioning system for spinal surgery has successfully obtained NMPA registration certification. This approved product is the first domestically produced fully intelligent orthopedic surgical robot integrating navigation with surgical operation!

Shenzhen Futurtec Medical Co., Ltd., established in 2015, is a National High-Tech Enterprise. The company is committed to building China’s most intelligent R&D and innovation platform for orthopedic surgical robots, achieving an organic integration of “Robotics + AI.” In addition to its approved spinal surgery robot, the company is simultaneously accelerating the independent development of its osteotomy robot (a global first) and joint replacement surgical robot.

The company is composed of an international team with extensive industry experience and innovative capabilities, boasting a strong technological foundation in the fields of orthopedic surgical robots, medical imaging, and medical artificial intelligence. Mr. Jiang Liwei, the Chairman, has nearly 30 years of experience in management, operations, and integration within global healthcare groups and domestically listed medical device companies. Mr. Jiang previously served as a physician at Shanghai Ruijin Hospital before leaving the hospital system to hold senior executive positions at orthopedic giants Zimmer and Smith & Nephew. He also served as General Manager of Chuangsheng Holdings, a leading domestic orthopedic company; General Manager of Biomet China; and CEO and Executive Director of Puhua Heshun, a company listed on the Main Board of the Hong Kong Stock Exchange, demonstrating profound industry expertise.

China’s large population base, high prevalence of disease, and accelerating aging trend have made orthopedic conditions common and frequently occurring in modern society. In China, most orthopedic surgeries still rely on traditional “freehand” techniques, which are associated with significant challenges—including complex anatomy, deep surgical sites, substantial trauma, and difficult intraoperative judgment—leading to elevated surgical risks. Surgical outcomes depend heavily on surgeons’ experience; however, the current shortage of orthopedic surgeons with extensive clinical expertise fails to meet market demand. Moreover, orthopedic surgeons face considerable radiation exposure during conventional procedures, resulting in a heightened risk of cancer. Orthopedic surgical robots can effectively address these clinical pain points by enabling minimally invasive and precise interventions, thereby substantially improving surgical efficiency.

Amidst the sweeping tide of volume-based procurement (VBP), the orthopedic industry is undergoing accelerated consolidation. It is an inevitable trend for the orthopedic surgical robotics sector—largely insulated from VBP—to thrive. China’s orthopedic surgical robotics industry started relatively late and remains in its early stages of commercialization. As market education deepens and products become more diverse and iteratively advanced, physician acceptance and market penetration are poised to rise significantly.

To enhance surgical precision and efficiency, technologies related to spinal surgery have been continuously evolving. The field has progressed from early freehand techniques to tool-assisted methods, and now to the currently mainstream robotic systems for spinal surgery. Although these robots address certain pain points in spinal procedures to some extent, their functionality remains relatively limited. They primarily provide navigation combined with robotic arm assistance for positioning the surgical channel, meaning they participate only in the navigation and positioning step of the overall surgical procedure.

Futurtec’s newly approved spinal surgery navigation and positioning system includes independently developed modules for preoperative planning, surgical navigation, and active screw placement. Notably, its surgical navigation capability has broken through long-standing foreign technological barriers, ending China’s reliance on imported equipment as the foundational platform for navigation systems.

This surgical system enables both surgical navigation and screw placement. The navigation system designs the optimal trajectory for guide pin insertion, while the screw placement system, under the physician’s control and utilizing front-end surgical instruments, precisely executes surgical procedures to ensure accurate bone screw implantation. In clinical practice, it effectively reduces physicians’ workload, shortens operative time, enhances surgical precision, and minimizes patient incision size. Compared with existing technologies domestically and internationally, this spinal surgery navigation and positioning system features a higher level of intelligence, enabling more precise surgical operations. It further standardizes orthopedic procedures, reduces reliance on surgeons’ experience in spinal surgeries, and improves surgical accuracy and precision, marking the true entry of orthopedic surgery into the era of intelligent surgery.

The orthopedic robotics market is gradually transitioning from the introduction phase to the growth phase, with Futurtec officially entering its inaugural year of sales. The company has assembled an elite team; its marketing and sales professionals boast an average of over 15 years of sales and operational experience, hailing from major corporations such as Johnson & Johnson, Zimmer Biomet, GE, Philips, Siemens, and Boston Scientific.

Futurtec leverages significant late-mover advantages, using academic engagement as a cornerstone for its marketing efforts. From nationwide academic exchanges to regional thematic forums, the company closely aligns with clinical practices and cutting-edge technologies to advance professional education in the field of orthopedic robotics. This initiative aims to increase awareness, understanding, and adoption of Futurtec’s robotic systems among clinicians, thereby benefiting patients while continuously enhancing the company’s brand recognition. Furthermore, Futurtec’s business model creates a closed loop through “robot sales + consumables sales + maintenance services,” providing sustainable growth momentum. The company is vigorously expanding its distribution channels and accelerating the deployment of a nationwide distribution network.

In the future, the Company will accelerate commercial implementation, strengthen its coverage of hospitals in China, and continuously iterate on existing products based on clinical feedback. It will further enrich its product pipeline and expand horizontally to cover a broader range of orthopedic surgical indications. Meanwhile, leveraging its existing surgical robot systems, the Company will independently develop or integrate and acquire related orthopedic implants, extending its reach across the upstream and downstream segments of the industry chain. By driving growth through equipment, consumables, services, and implants, the Company aims to create an innovative, comprehensive smart orthopedic surgical solution to benefit patients widely.