THERAVEX® REGENERA Tissue Care Plus for Hair Regeneration and Follicular Microenvironment Modulation

This clinical investigation was designed to evaluate the clinical performance and safety of THERAVEX® REGENERA Tissue Care Plus as a supportive regenerative therapy in hair restoration and scalp regenerative procedures. Hair loss disorders and follicular density reduction are commonly associated with alterations in the scalp microenvironment, postoperative tissue stress, and impaired regenerative conditions that may influence hair restoration outcomes and postoperative recovery.

THERAVEX® REGENERA Tissue Care Plus is a sterile bioactive mineral-ionic formulation intended for local supportive use during regenerative scalp procedures. The investigational approach focused on evaluating its use as an adjunctive supportive therapy during follicular graft preparation, postoperative scalp care, and regenerative scalp support protocols under standardized clinical conditions.

The investigation included adult participants undergoing autologous hair transplantation procedures as well as participants presenting with non-scarring alopecic conditions requiring regenerative scalp treatment approaches. The investigational device was evaluated in combination with routine clinical hair restoration procedures and supportive regenerative scalp protocols, including topical scalp application, follicular graft conditioning, Dermapen-assisted scalp procedures, and mesotherapy-assisted scalp support techniques.

Clinical follow-up assessments included standardized scalp evaluation, digital photographic documentation, postoperative tissue response assessment, follicular density observation, tolerability monitoring, and longitudinal regenerative scalp follow-up. Participants were monitored throughout the predefined observation period according to standardized clinical evaluation schedules.

The study was conducted to further investigate the feasibility, tolerability, and clinical applicability of extracellular microenvironment supportive approaches in regenerative scalp care and hair restoration procedures.

Inclusion criteria

Adults aged 18 years or older Diagnosis of androgenetic alopecia Candidates for hair restoration procedures

Exclusion criteria

Active scalp infection or inflammatory scalp disease Cicatricial alopecia or severe scalp pathology Uncontrolled systemic disease or unstable medical condition Pregnancy or breastfeeding Immunosuppressive therapy hypersensitivity to any component of the investigational device