Revitalis - Midface (Cheek Area) (ReMi)

Inclusion Criteria:

1. Male or female participants aged 18- 75 years (inclusive) at screening.
2. Willing and able to provide written informed consent prior to any study related procedure.
3. Willing and able to comply with all study-related requirements, including visit schedule, treatment procedures, and follow-up assessments.
4. Moderate to severe deficit in midface (cheek area) skin smoothness, as assessed by the live evaluator on the Canfield Skin Quality Scale - Skin Smoothness (CSQS-SS).
5. Healthy skin in the treatment area.
6. Willingness to refrain from other aesthetic procedures during thestudy.
7. For females of childbearing potential: negative urine pregnancy test and agreement to use a highly effective method of contraception throughout the entire study.
8. For male participants with female partners of child-bearing potential: agreement to use contraception throughout the entire study such as surgical sterilization or a physical barrier such as a condom.
9. FACE-Q™ Satisfaction with Skin score 39 or less at screening (equivalent of Rash-transformed score of 69).

Exclusion Criteria:

1. Females, who are pregnant and/ or breastfeeding or planning to become pregnant during the clinical investigation.
2. Known hypersensitivity or allergy to hyaluronic acid preparations, gram-positive bacterial proteins, or any component of the investigational device.
3. History or presence of severe allergic reactions, anaphylaxis, or multiple severe allergies.
4. History or current diagnosis of autoimmune or connective tissue disease, or current use of immunosuppressive or immunomodulating therapy.
5. Presence of active infection, inflammation, or pre-malignant/ malignant lesions in the treatment area.
6. Active herpes simplex infection in the treatment area.
7. Known tendency to develop keloids, hypertrophic scars, or pigment disorders.
8. Any prior treatment or planned treatment with permanent or semipermanent dermal fillers, in the treatment area or adjacent areas that may interfere with the study assessments
9. Use of anticoagulants, antiplatelet agents, NSAIDs, or thrombolytics
10. Known or suspected bleeding disorders associated with increased risk of injection-related complications.
11. Recent or planned treatment with temporary dermal fillers, botulinum toxin, mesotherapy, laser treatments, chemical peels, dermabrasion, thread-based lifting, or energy-based devices (including, but not limited to, devices for muscle mass improvement or collagen stimulation) in the treatment area or adjacent areas that may interfere with the study assessments , within 12 months prior to screening.
12. Presence of acute skin conditions in the treatment area, including acne, cysts, rashes, hives, or other inflammatory skin disorders.
13. Any other condition that would compromise the participant's safety or interfere with study participation or data interpretation, including but not limited to marked hyperpigmentation, acne scarring, severe textural irregularities, facial tattoos, excessive facial hair (e.g. patients unwilling to shave the beard) or other conditions judged by the investigator.
14. Any condition or situation that, in the opinion of the investigator, may interfere with study participation or interpretation of results, including mental disorders.
15. Previous treatment administration in this clinical investigation.
16. Current participation in another clinical trial, or treatment with any investigational drug/ medical device within 30 days prior to screening or within five half-lives of an investigational drug, whichever is longer and during the entire investigation.
17. Individuals whose willingness to volunteer in this clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants).
18. Close affiliation with the investigator or employment relationship with the sponsor or sponsor-affiliated companies that may create bias or undue influence.
19. Covid vaccination received within the past 3 weeks before screening or planning to receive in the 2 weeks following the treatment.
20. Patients with facial dysmorphic features that may interfere with study assessments.
21. Patients under strict diet or intending to lose weight.