Introduction: Baldness is a current problem in aesthetic medicine. This cosmetic defect can lead to serious psychological and emotional stress. Most of the time, the solution to this problem consists of removing or attenuating its cause: alopecia. Among the current hair restoration technique to treat alopecia, one is the biocompatible artificial hair implant.Materials and Methods: The certified medical device used for this study is the biocompatible artificial hair Biofibre4.0. The clinical study was done by collecting clinical data from 18 clinics located in 15 different countries and 4 continents to evaluate the efficacy, safety, and performance of a new artificial hair device generation compared to previous artificial hair. Automatic and manual implanter were utilized by doctors participating in these trials. A new needle material was also used for this study. The standard medical protocol was applied with some differences in the doctor’s personal experience, patient’s situation, and climate.Results: The data collected show that in a sample of about 1337 patients treated in 2020/2021, inflammation and infections are around 7%, and curling is<1%. There were no phenomena of fibre breakage. Itching appeared in about <3% of cases. The problems encountered in most cases were mild and resolvable with appropriate therapy, and only in rare cases (<1%) it was necessary to proceed with the total removal of the fibres. In some cases (<1%), it was just necessary to partially extract the fibres that cause recurrent discomfort for the patient. In most patients, satisfaction was 96%. The limitations in patient movement and lowering of the immune response in many of them caused by COVID SARS 2 might partially affect the final data.Conclusion: This surgery does not imply scar formation and hospitalization. It can be used alone or with other treatments to provide psychological benefits and improve quality of life. Indications are poor donor area, request for immediate aesthetic result and scarce trauma. Patient selection, respect for medical protocol and proper aftercare must be complied with. Contraindicated cases must be avoided, and partial or total removal of fibres is required in case of recurrent problems. Additional improvements to this technique are expected to enable an ever vaster application.