A SINGLE CENTER OPEN-LABEL PILOT STUDY TO EVALUATE THE TOLERABILITY AND SAFETY OF A SYNTHETIC SOFT TISSUE IMPLANT MATERIAL IN THE SKIN OF NORMAL VOLUNTEERS

Each participant will receive two (diameter - 4.4 mm, thickness ~1 to 2 mm) Test Article implants, placed at the mid-to-deep dermal layer and/or superficial fat junction of their skin. The implant sites will be selected by the investigator within the anatomic region of the torso (superior pelvic rim to the apex of the shoulders) of each participant. The skin implant material will be placed by making a small single incision, up to 1.5 cm in length to the level of the mid-to-deep dermis or superficial fat junction, as appropriate. The implant will then be placed into the incision pocket and sutured closed. The implants will remain in place for 90 days with follow up visits at days 7, 14, 30, 60 for evaluation and grading of site per protocol. At day 90 the implants will be excised. All specimens will be submitted for histologic examination. A final visit will occur 30 days post excision for evaluation of the test sites.