Shudao Robotics Successfully Completes Multiple Patient Enrollments in Pivotal Clinical Trial for Its Proprietary Hair Transplant Robot, Ushering China into the Era of Intelligent FUE

Hair Loss Affects Everyone Equally: Even Handsome Celebrities Like Daniel Wu Are Not Immune. However, the Hair Transplant Field Has Recently Welcomed Major Good News——

Recently, Shanghai Shu Zhi Dao Robotics (hereinafter referred to as “Shu Zhi Dao”) announced that its independently developed hair transplantation robot has successfully completed the enrollment of multiple patients in consecutive cases at Hangzhou First People’s Hospital, Affiliated to Zhejiang University School of Medicine.The successful completion of the series of clinical enrollments not only marks another step forward for the Shu Zhi Dao hair transplant robot on the path to regulatory approval, with the potential to break the void in domestically produced alternatives, but also brings an intelligent, automated, safe, and efficient solution to hair transplant treatment.

It is reported that the patients enrolled in this study had all been suffering from hair loss for many years. Scalp examinations and follicular analysis revealed that their primary areas of hair loss were concentrated at the vertex and bilateral frontal regions, consistent with the characteristics of Androgenetic Alopecia. According to the Hamilton-Norwood classification system for hair loss, all patients were currently at Stage II. Based on the diagnostic findings, the physicians performed robot-assisted hair transplantation surgery on the patients.

Results from multiple registration clinical trials conducted with the Shu Zhi Dao Hair Transplant Robot demonstrated a favorable safety profile, with no related adverse reactions or adverse events (AEs) associated with the hair transplant robot. The data obtained from these registration clinical trials will be used to evaluate the safety and efficacy of this system for hair transplantation in individuals with hair loss, through multicenter, randomized, blinded clinical trials.

Professor Zhang Jufang, Director of the Department of Medical Aesthetics, Hangzhou First People's HospitalHe stated, “I have full confidence in the hair transplant robot from Shanghai Shu Zhi Dao. Its operation is extremely simple, with a fully automated surgical execution process, allowing fellow physicians to quickly master its use. During this procedure, the robot demonstrated excellent performance in precise positioning and follicular unit extraction, significantly reducing the difficulty of manual operations for surgeons and minimizing patient discomfort, thereby addressing the challenge of surgeon fatigue during hair transplant surgeries. In the future, we will continue our collaboration to promote the high-quality development of this trial, bringing hope to patients suffering from hair loss.”

Yang Situ, CEO of Shu Zhi Dao“The successful consecutive enrollment of multiple patients in the registered clinical trial for the hair transplant robot marks a significant milestone in the clinical development of the project. We extend our gratitude to the team for their hard work, and we look forward to embracing further challenges and breakthroughs together.”

Unlike many other consumer markets, China’s hair transplant market, despite its later start, boasts a significantly higher market penetration rate and level of development than overseas markets. According to data from Ping An Securities, the surgical penetration rates in 2019 were 0.123% in the United States, 0.066% in Canada, 0.054% in Australia, 0.035% in Europe, and 0.020% in Asia. Within Asia, Japan’s penetration rate was only 0.04%. With a market penetration rate of 0.21%, China stands far ahead in the global hair transplant market.

FUE (scarless hair transplantation) is currently the mainstream hair restoration method on the market, requiring physicians to manually extract hair follicles and create recipient sites. This manual extraction technique not only demands that physicians maintain precise implantation force over extended periods but also requires them to possess exceptional technical skill and patience. Consequently, this leads to issues such as low procedural efficiency and high costs for hair transplantation.

As the first hair transplant robot in China to enter registered clinical trials, Shu Zhi Dao Hair Transplant Robot possesses full independent intellectual property rights, ranging from its robotic arm to its vision system. By integrating precise positioning, minimally invasive surgery, and artificial intelligence, it employs a high-definition stereoscopic imaging system and visual servoing technology to replace manual operations with a fully automated intelligent robotic arm. This system accurately locates each hair follicle, adaptively controls insertion angle and depth, and achieves a precision of up to 0.1 mm. Postoperatively, the skin tissue remains relatively smooth, facilitating faster recovery.

With its precision, efficiency, and safety, the Shuzhidao Hair Transplant Robot effectively reduces surgical risks and potential errors during procedures, shortens operation and patient recovery times, alleviates physician workload, and enhances patient satisfaction. Furthermore, the hair transplant robot ensures a follicle survival rate of up to 95%, significantly improving the outcomes of hair transplantation surgeries.

Unlike foreign robotic hair transplantation systems that require the installation of complex, invasive tensioners and needles with an outer diameter greater than 1 mm, the Shuzhidao Robotic Hair Transplantation System employs a convenient, non-invasive tensioning method, completing the procedure within 30 seconds in a completely non-invasive manner. Meanwhile, the Shuzhidao system incorporates micro-needle technology, featuring needle tips smaller than 1 mm that are fine and sharp. Under robotic control, these needles perform precise punctures to ensure minimal trauma, thereby accelerating healing, shortening recovery time, reducing surgical risks and postoperative discomfort, and improving graft survival rates. This significantly enhances the safety, accuracy, comfort, and aesthetic outcomes of hair transplantation surgery.

Its quiet design also effectively alleviates the anxiety of patients and doctors, creating a more comfortable and reassuring surgical environment.

Shu Zhi Dao was founded in 2021 as a platform company specializing in the field of surgical robotics, committed to building an intelligent consumables ecosystem tailored to the characteristics of robotic technology. Focusing on three key areas—medical aesthetics, oncology, and vascular intervention—the company has deeply deployed more than ten products using a “robotic platform + intelligent consumables” model, fundamentally transforming surgical procedures and progressively achieving “fully automated” surgical operations.

The company previously secured hundreds of millions of yuan in Series A financing from Lize Capital, Jifeng Capital, Huatong Capital, and IDG Capital.

The Shu Zhi Dao team brings together experts and engineers with extensive experience in medical device product development. Its core members are seasoned professionals who have been deeply engaged in the medical device industry and robotics field for decades, all possessing substantial expertise in product R&D. Team members’ backgrounds span interdisciplinary fields including robotic engineering, artificial intelligence, life sciences, and medicine, fostering a highly collaborative and diverse work environment. Currently, R&D personnel account for over 70% of Shu Zhi Dao’s existing team.

Through years of dedicated efforts in core technology development, Shuzhidao Medical has established foundational technology platforms, including a hybrid robotic arm system, a visible light navigation system, an adjustable catheter system, and an energy system. The company has also forged close collaborations with major domestic research institutes and medical device manufacturers. Looking ahead, it will further integrate top-tier R&D teams within the industry to continuously expand its technological platform and extend its “fully automated solutions” to a broader range of surgical procedures.