Open Label, Multi-Center Study, Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Facial Fat Grafting

Exclusion Criteria

• •1. Subjects without decisional capacity
• •2. Subjects unable to give informed, written consent
• •3. Subjects with active infection (redness, swelling, pain, suppuration)
• •4. Subjects with any uncontrolled systemic disease
• •5. Subjects with a history of severe allergic/anaphylactic reactions or multiple allergies
• •6. Subjects with conditions within the treatment area including acne, scarring, acute lupus erythematosus, dermatitis, or melasma
• •7. Subjects planning to become pregnant, are pregnant, or are breast-feeding
• •8. Subjects with history or current evidence of drug or alcohol abuse within 12 months prior to screening visit
• •9. Subjects who have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months in the treatment area. Have had neuromodulator injections, mesotherapy, or resurfacing (laser or other ablative or non-ablative procedures) within 5 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study.
• •10. Subjects who have undergone facial plastic surgery (except for rhinoplasty or a brow lift), tissue grafting, or tissue augmentation with silicone, fat, or other permanent or semi-permanent dermal fillers or be planning to undergo any of these procedures affecting the treatment area, at any time during the study that may interfere with the study procedure and results
• •11. Subjects who have active autoimmune disease
• •12. Subjects who are unwilling to undergo fat graft injections
• •13. Subjects with current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
• •14. Subjects who have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time from 10 days pre- to 3 days post injection. A wash out period of 10 days is allowed
• •15. Subjects who have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit.