HA-Coated and Non-HA Threads for Midface Lifting and Nasolabial Fold Correction

Inclusion Criteria:

1. Male and female subjects, 22+ years of age.
2. Subjects who desire cheek lifting to correct age-related wrinkles in the mid-face as recommended by the treating investigator.
3. Subject received a rating, in each cheek, by Investigator of at least Grade 3 or Grade 4 for wrinkling of the NLF in the mid-face according to the WSRS.
4. If a woman is of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile), then she must have a confirmed negative urine pregnancy test result at screening. If treatment is not provided at the screening visit, a negative urine pregnancy test result is required within 7 days before treatment.
5. If a woman of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile), subject confirms she will utilize at least one form of contraception throughout the duration of the study (6 months).
6. Subjects who are able to understand the study requirements, including the obligation not to receive any other facial procedures or treatments affecting mid-face at any time during the study. These include procedures or treatments done at home or with a professional. Facial treatments include lasers, facial massages, and anything beyond common skincare routine.
7. Subjects who are willing to participate in the study and to sign a witnessed/informed consent form.
8. Subjects who are logistically able to present for all study visits and meet all study requirements.
9. Subjects who are willing to complete a 30-day diary.
10. Subjects who pass the pinprick and/or cotton swab facial nerve assessment

Exclusion Criteria:

1. Abnormal rating in mid-face sensation, with inability to feel a 0.4 G monofilament or a cotton wisp at any site on the mid-face.
2. Active acne or prominent acne scars in the treatment area.
3. Active inflammatory or infectious conditions.
4. Allergy or foreign body sensitivities to plastic biomaterials.
5. Known bleeding disorder.
6. Breast feeding, pregnant, or not on/willing to use contraception if of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile).
7. Known collagen skin disorder.
8. Pre-existing facial asymmetry.
9. History of any device use on the mid-face in the prior 6 months (laser, Intense Pulsed Light [IPL], radiofrequency (RF), ultrasound, micro needling, micro needle RF, or cool based treatments).
10. History of autoimmune or connective tissue disease.
11. History of facelift, mid-face lift, lower facelift or neck lift that changes the facial structure and anchor points.
12. History of fat transfer to the mid-face.
13. History of injectable fillers other than temporary fillers such as HA or Radiesse to the mid-face at any time. Permanent and semi-permanent fillers are not allowed (Poly-L-lactic acids [PLLA], Sculptra).
14. History of Kybella in the prior 6 months.
15. History of facial trauma in the mid-face.
16. History of facial surgical procedures.
17. Inability to chew, puff cheek, or smile broadly.
18. Metabolism irregularities.
19. Receiving immunosuppressive therapy.
20. Recent weight loss or intention to lose a significant amount of weight during the study period (2 body mass index [BMI] points).
21. Subjects who have undergone cosmetic facial plastic surgery (with the exception of rhinoplasty or upper blepharoplasty) more than 2 years prior to enrollment, tissue grafting, or tissue lifting or augmentation with any permanent or semi-permanent filler.
22. Subjects who have had temporary facial dermal filler injections below the orbital rim with HA-based fillers or Radiesse within 18 months, porcine-based collagen fillers within 24 months, or neuromodulator injections to the mid-face or lateral canthal lines, mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) within 6 months of entry in the study or who were planning to undergo any of these procedures at any time during the study.
23. Subjects who have very thin skin in the mid-face region, who have a tendency to accumulate fluid in the lower eyelids, or who have large infraorbital fat pads (i.e., significant convexity or projection from the infraorbital fat pads).
24. Subjects who have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or HIVrelated disease.
25. Subjects who are included to list of vulnerable populations (pediatric, pregnant, elderly individuals with visual or hearing impairments, mentally ill subjects).