This is a prospective, single-arm (with two Sub-groups), multi-center, international, open-label, non-randomized, clinical study to evaluate the safety and efficacy of Hairstetics’ Hair Implant in subject affected with hair loss.  The study will enroll 36 subjects globally from 8 centers in total from India, UK, Belgium, France and Romania. 

The recruitment period for the study in India is 3 months. 

The primary endpoint of this study is safety of all subjects, Acceptable number, duration and severity of Expected Adverse Device/Procedure Effects during 3 months following implantation. 

The secondary endpoint of this study is Efficacy and Safety 

For Sub-group A (subjects that their hair loss CAN be scaled by Hamilton/Norwood’s Basic Scale for men and Ludwig scale for women)

o    6 months efficacy determined by alopecia scales (by the investigator) in the treated areas. Efficacy will be considered successful if less than 30% of the subjects will return to their baseline alopecia level at 6 months follow-up, in the treated areas. Once the study will convert to a post marketing one, after the initial 6 subjects, this secondary endpoint will become a primary efficacy endpoint.

o    Subject’s satisfaction with the procedure outcome, at 3 months and at 6 months post procedure.

o    Implanted fiber durability (fiber breakage, curling etc. to be defined as negligible, minor, mild, moderate and significant) at 6 months post procedure by the investigator.

o    Annual fiber fall rate based on hair count at pre-defined locations at 3 and 6 months post procedure.  If “hair count” cartridges will be implanted in the test implantation (see elsewhere), their fibers will be followed-up at the actual implantation visit and the 6 weeks visit post the actual implantation as well.

o    Acceptable number, duration and severity of Expected Adverse Device/Procedure Effects at 6 months following implantation.

For Sub-group B (subjects that their hair loss CANNOT be scaled by Hamilton/Norwood’s Basic Scale for men and Ludwig scale for women) 

o    Subject’s satisfaction with the procedure outcome, at 3 months and at 6 months post procedure.  Once the study will convert to a post marketing one, after the initial 6 subjects, this secondary endpoint will become a primary efficacy endpoint.

o    Implanted fiber durability (fiber breakage, curling etc. to be defined as negligible, minor, mild, moderate and significant) at 6 months post procedure by the investigator.

o    Annual fiber fall rate based on hair count by the investigator at pre-defined locations at 3 and 6 months post procedure.  If “hair count” cartridges will be implanted in the test implantation (see elsewhere), their fibers will be followed-up at the actual implantation visit and the 6 weeks visit post the actual implantation as well.

o Acceptable number, duration and severity of Expected Adverse Device/Procedure Effects at 6 months following implantation.

After signing the Informed Consent Form the subject will undergo synthetic hair implantation. The subject will be followed up after 6 month for evaluation.