Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region

This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure to improve the appearance of lax tissue in the neck and submental region. All study subjects will be treated with the Renuvion APR Device.

Phase I (n=17) of this study will be conducted primarily to provide safety data, however, effectiveness data will also be collected at the above stated timepoints through 6 months post-procedure.

Phase II (n=65) of this study is the expansion of the study to a pivotal study.

Inclusion criteria

• Male or female subjects 35-65 years of age (inclusive).
• Healthy as determined by the investigator examining the subject.
• Seeking improvement of the appearance of lax tissue in the neck and submental region.
• Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
• Willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits.
• Willing to release rights for the use of study photos, including in potential publication.
• Understands and accepts the obligation not to have significant weight loss or weight gain (≥8 pounds) post the treatment, and for the duration of participation in the study.
• Willing to abstain from the use of blood thinners (including, but not limited to, Coumadin, NSAIDS, Ibuprofen, vitamin K, other) for 2 weeks (14 days) prior to the procedure.
• Willing to abstain from smoking, vaping, or the use of e-cigarettes for 1 year prior to and for the entire duration of participation in the study.
• Willing to abstain from the use of marijuana for 2 weeks prior to and for the duration of participation in the study.
• Able to read, understand, sign and date the informed consent document (English only).

Exclusion criteria

• Pregnant or lactating.
• Pregnancy within 12 months prior to screening.
• Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other analgesics, anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia).
• Allergy to tumescent anesthetic (lidocaine/epinephrine).
• Excessive subcutaneous fat in the treatment area (as determined by the treating investigator).
• Active systemic or local skin disease that may alter wound healing.
• Significant or uncontrolled medical condition that, in the opinion of the investigator, participation in the study may compromise the patient's health.
• Severe solar elastosis.
• History of autoimmune disease (excluding Hashimoto's thyroiditis).
• Known hypersensitivity or adverse reaction to anesthetics.
• Known susceptibility to keloid formation or hypertrophic scarring.
• Cancerous or pre-cancerous lesions in the area to be treated.
• History or current diagnosis of cancer of any type (excluding skin cancer).
• History of uncontrolled cardiovascular disease (i.e. myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other).
• History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants.
• Possesses a surgically implanted electronic device (i.e. pacemaker).
• History of AIDs/HIV.
• Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
• Chronic hypoxia or dependence on supplemental oxygen.
• Participation in any other investigational study within 30 days prior to consent.
• Any surgical or transdermal neck/submental aesthetic procedures or plans to undergo any other aesthetic procedure during study participation. Such procedures include, but are not limited to, submentoplasty, liposuction, ultrasound, cryolipolysis, radiofrequency, and laser.
• History of or current injury to the head and neck or any area of the body being treated as a part of this study.
• Presence of more than mild platysmal banding as per the Geister, et al Validated Assessment Scale for Platysmal Bands.
• Subject requiring removal of adipose tissue prior index procedure.
• A family member of the investigator or sponsor; an employee of the investigator or sponsor.
• Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.