Gene Expression Following Ultherapy® Treatment

This is a prospective, multi-center, pilot clinical trial to evaluate the molecular changes
following an Ultherapy® treatment. Subjects will be randomized to one of five treatment
groups and, based on study group assignment, will receive one single-side Ultherapy®
treatment at varying timepoints prior to an already planned facelift procedure. Treatment
will be delivered to the pre-auricular region on one side of the face; the contralateral side
will serve as control. During an already planned facelift procedure, treated and non-treated
resected tissue will be obtained for analysis.

Inclusion Criteria:

- Male or female, age 45 to 70 years.

- Subject in good health.

- Understands and accepts the obligation not to undergo any other procedures in the
areas to be treated through the follow-up period.

- Willingness and ability to comply with protocol requirements, including returning for
follow-up visits and abstaining from exclusionary procedures for the duration of the
study.

- Subjects of childbearing potential must have a negative urine pregnancy test result
and must not be lactating at the Screening Visit and be willing and able to use an
acceptable method of birth control during the study.

- Absence of physical or psychological conditions unacceptable to the investigator.

- Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other
Non-Steroidal Anti-Inflammatory Drug (NSAID) prior to study treatment and chronic use
during the entire post-treatment study period.

- Willingness and ability to provide written informed consent and Health Insurance
Portability and Accountability Act (HIPAA) authorization prior to performance of any
study-related procedure.

Exclusion Criteria:

- Presence of an active systemic or local skin disease that may affect wound healing.

- Severe solar elastosis.

- Significant scarring in the area(s) to be treated that would interfere with assessing
results.

- Open wounds or lesions in the area(s) to be treated.

- Severe or cystic acne on the area(s) to be treated.

- Active implants (e.g., pacemakers or defibrillators), or metallic implants in the
treatment areas (dental implants not included.)

- Inability to understand the protocol or to give informed consent.

- Microdermabrasion, or prescription level glycolic acid treatment to the treatment
area(s) within four weeks prior to study participation or during the study.

- Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the
area(s) to be treated.

- BMI equal to or greater than 30.

- History of chronic drug or alcohol abuse.

- History of autoimmune disease.

- Concurrent therapy that, in the investigator's opinion, would interfere with the
evaluation of the safety or efficacy of the study device.

- Subjects who, in the investigator's opinion, have a history of poor cooperation,
noncompliance with medical treatment, or unreliability.

- Concurrent enrollment in any study involving the use of investigational devices or
drugs.

- Current smoker or history of smoking in the last five years.

- Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum,
nicotine patches, etc.

- History of the following cosmetic treatments in the area(s) to be treated:

1. Skin tightening procedure within the past year;

2. Injectable filler of any type within the past:

i. 12 months for Hyaluronic acid fillers (e.g. Restylane)

ii. 12 months for Ca Hydroxyapatite fillers (e.g. Radiesse)

iii. 24 months for Long-lasting Hyaluronic acid (Juvéderm Voluma) and Poly-L-Lactic acid
fillers (e.g. Sculptra)

iv. Ever for permanent fillers (e.g. Silicone, ArteFill)

c. Neurotoxins within the past three months;

d. Ablative resurfacing laser treatment within the past six months;

e. Nonablative, rejuvenative laser or light treatment within the past six months;

f. Surgical dermabrasion or deep facial peels; or

g. Facelifts within the past year.

- History of using the following prescription medications:

1. Accutane or other systemic retinoids within the past six months;

2. Topical Retinoids within the past two weeks;

3. Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix);

4. Psychiatric drugs that in the investigators opinion would impair the subject from
understanding the protocol requirements or understanding and signing the informed
consent.