Editor's Note:

　　We sincerely thank the hospital experts who participated in this study: Through professional validation, HAIRO has been recognized for its precision and safety in the follicular extraction process. Additionally, its intelligent operational workflow effectively reduces the physical strain on physicians. We look forward to future technological advancements that will deliver even higher-quality hair transplant solutions for both doctors and patients. (Please note that this sample is an exceptional case, and the conclusions reflect only a preliminary academic achievement at this stage.)

　　The following article is sourced from Professor Wu Wenyu, a hair expert, and was written by Wu Wenyu.

Hair expert Professor Wu Wenyu

This official account features direct interaction and responses from Professor Wu Wenyu, a renowned hair expert. Our main services include: hair transplant consultations, hair restoration for both men and women experiencing hair loss, scar revision hair transplants, vitiligo hair transplants, and hairline enhancement procedures.

Abstract

　　Purpose : Comparing the efficacy and safety of the HAIRO system with traditional follicular unit extraction in harvesting hair follicles from patients with androgenetic alopecia.

　　Method : This study employed a multicenter, randomized, self-controlled, left-right comparison design. From June 2023 to September 2024, male and female patients aged 18 to 59 with androgenetic alopecia were recruited at Huashan Hospital Affiliated to Fudan University, the First People’s Hospital of Hangzhou, and China-Japan Friendship Hospital as study subjects. Each patient’s scalp was randomly divided into two equal sections—left and right—using an envelope method. Hair follicle extraction was performed on the dominant posterior occipital donor area using either the follicular unit extraction system (experimental group) or traditional follicular unit punch technique (control group), followed by transplantation into the corresponding hair-loss areas on the same side. The primary efficacy endpoint was the hair transection rate immediately after follicular extraction during surgery. Secondary efficacy endpoints included the follicular unit dropout rate and changes in recipient-site hair density at 14 days postoperatively. Safety outcomes were assessed based on the incidence of donor-site folliculitis and the overall rate of adverse events at 14 days postoperatively. Surgical outcomes were evaluated via a 9-month follow-up visit. Group comparisons for all outcome measures were conducted using paired t-tests or Wilcoxon signed-rank tests.

　　Result Fifty-five patients with androgenetic alopecia completed hair transplantation surgery and postoperative follow-up, including 51 males and 4 females, with an average age of 32.71 ± 5.75 years. The results showed that the hair transection rate in the experimental group was M (Q1, Q3) at 6.65% (4.56%, 10.16%), compared to 5.28% (3.04%, 8.89%) in the control group—a difference of 1.24% (95% CI: -0.24%, 2.65%). Additionally, the follicular unit dropout rate was 2.00% (1.00%, 3.50%) in the experimental group, versus 0.50% (0%, 2.00%) in the control group; this difference was statistically significant (P = 0.008). At 14 days post-surgery, the changes in hair density were (72.20 ± 25.95) hairs/cm² in the experimental group and (76.49 ± 30.84) hairs/cm² in the control group (P = 0.173). By the 9-month follow-up, both the experimental and control groups showed overall improvements in investigator-assessed scores for the recipient areas. Furthermore, 7 subjects (12.72%) in each group experienced a total of 7 mild episodes of donor-site adverse events, all classified as mild folliculitis with no severe complications.

　　Conclusion Compared to the traditional follicular unit extraction technique, the domestically produced follicle extraction system demonstrates similar efficacy and safety in hair transplantation procedures.

Hair transplantation surgery is an effective treatment for androgenetic alopecia.

　　Traditional Follicular Unit Excision (FUE) has now become the mainstream hair transplantation technique, offering minimal surgical trauma, faster patient recovery, and excellent results. However, FUE requires a highly specialized medical team that dedicates significant time and effort to the procedure—particularly the follicular extraction phase, which is both time-consuming and physically demanding, posing a major challenge to the operator's stamina and energy. Moreover, for beginners, the learning curve for FUE tends to be quite long. Hair transplant robots, on the other hand, can significantly reduce the workload for surgeons while ensuring consistent follicular extraction outcomes, ultimately enhancing both comfort for patients and convenience during the surgical process.

　　Currently, only the foreign ARTAS hair transplantation robot system is available on the market and widely used in clinical practice. However, due to its high cost, only a very limited number of medical institutions in China have purchased this equipment, thereby restricting access for most patients. Meanwhile, China has a large population of androgenetic alopecia patients with a strong demand for hair transplant surgery. Moreover, Asian individuals, whose dark, straight hair is particularly well-suited for robotic-assisted procedures, stand to benefit significantly from this advanced technology.

　　Based on this, numerous domestic manufacturers have independently developed hair transplantation robot systems tailored for the Chinese population, focusing on follicle extraction and implantation—achieving significant progress in the process. To evaluate the differences in efficacy and safety between the HAIRO system and traditional manual FUE techniques in treating androgenetic alopecia, we organized a multicenter, randomized, controlled clinical study involving three hospitals.

　　Since its approval by the U.S. Food and Drug Administration in 2011, the ARTAS hair transplant robot system has undergone more than a decade of development. Today, it can seamlessly perform the entire surgical process—from follicle extraction to implantation—with high precision, rapid extraction speed, and minimal invasiveness. This not only reduces the physical strain on surgeons but also ensures highly consistent surgical outcomes. However, due to its high cost, its use remains limited in most countries and regions.

　　Currently, Thai scholars have developed a prototype hair transplantation robot system and conducted in vitro validation, though no reports on its clinical studies have yet emerged. In China, the hair transplantation robot industry started relatively late; however, with the rapid advancements in technologies such as cameras, robotic arms, computer processors, image-processing units, and artificial intelligence, China now enjoys a technological advantage as a latecomer. Moreover, China boasts a massive demand for hair restoration procedures, coupled with strong government support for high-end manufacturing, enabling the domestic hair transplantation robot industry to achieve rapid growth.

　　The HAIRO domestically produced hair transplant robot follicle extraction system boasts fully independent intellectual property rights. Compared to the ARTAS system, the HAIRO system features a highly precise robotic arm and a simple, intuitive operation process.

　　This study marks the first clinical investigation in China comparing the HAIRO domestically produced hair follicle extraction system for hair transplantation with traditional manual FUE techniques. By employing a randomized, controlled, left-right side comparison and maintaining blinding during the follicle separation process, the study effectively minimizes biases arising from individual differences in patients' follicles as well as variations introduced by the surgical team. The results indicate that, compared to traditional manual FUE, both procedures cause minimal damage to the hair follicles, and the rate of hair shaft breakage in both groups meets the criteria for non-inferiority design.

　　The follicular unit dropout rate reflects the proportion of hair follicles that are completely damaged and thus ineligible for transplantation. In this study, the experimental group performed worse than the control group, though both rates remained below 2%. At the 14-day postoperative follow-up, there was no statistically significant difference in hair density between the two groups. Long-term follow-up revealed that both the experimental and control groups achieved excellent clinical outcomes, with consistent results over time. Notably, no serious adverse events were reported in either group.

　　We look forward to HAIRO's domestically produced hair transplant robot system further integrating the follicular unit implantation module on top of its existing follicle extraction capabilities, enabling fully automated operations from extraction to implantation. This will significantly enhance the standardization and clinical efficiency of hair transplantation procedures.