The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement of a permanent breast implant Ergonomix2®.
This trial phase represents an early or specialized stage of clinical development.
Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.
Establishment Labs (ESTA) is the sponsoring company for this trial. BiotechSign currently grades this company D (43/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.