Simulines Non-Inferiority Pivotal Study

This is a prospective, randomized, double blinded, multi-center, parallel arm,
non-inferiority, pivotal clinical trial to demonstrate that the safety and efficacy of a new
transducer which delivers two simultaneous lines of treatment at the same treatment depth is
not inferior to a standard transducer to improve jawline definition and submental skin
laxity.

Changes from baseline in quantitative measures of neck and submental lift will be assessed at
study follow-up visits. Global Aesthetic Improvement Scale scores, Merz Jawline Grading Scale
scores, 3D volumetric changes from baseline to post treatment, patient satisfaction and
patient-reported improvement will be obtained.

Inclusion Criteria:

- Male or female, age 30 to 70 years.

- Subject in good health.

- Body Mass Index (BMI) of ≤30.

- Skin laxity in the area(s) to be treated as determined by trained physician assessors.

- Willingness to avoid excessive or prolonged exposure to sunlight, tanning booths, sun
lamps, or ultraviolet (UV) light sources.

- Willingness to apply study provided sunscreen (Neocutis Micro-Day Rejuvenating Cream)
daily until study exit to help limit sun exposure.

- Willingness to avoid or periodically stop use of Sunless Tanners (washout period of
two weeks prior to each study visit is required).

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

- Willingness to avoid non-emergent dental procedures in the 3 weeks prior to/ post
treatment.

- 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 (e.g. barrier methods used with a spermicidal
agent, hormonal methods, intrauterine device (IUD), surgical sterilization,
abstinence) during the study. Women will not be considered of childbearing potential
if one of the following conditions is documented on the medical history:

a. Postmenopausal for at least 12 months prior to study; b. Without a uterus and/or
both ovaries; or c. Bilateral tubal ligation at least six months prior to study
enrollment.

- 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. Washout period, if chronic user, for 4
weeks prior to the study treatment. After study treatment is completed, limited acute
NSAID use, i.e., a maximum of 2-3 doses in any 2 week period, is allowed if needed.

- Willingness and ability to provide written consent for study-required photography and
adherence to photography procedures (i.e., removal of jewelry and makeup).

- Willingness and ability to provide written informed consent and 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.

- History of Bell's Palsy.

- History of chronic or frequently recurring episodic (recurrent episode in past 12
months) autoimmune diseases such as Multiple Sclerosis, Crohn's Disease, Psoriasis,
Myasthenia Gravis, Lambert-Eaton Syndrome that has required immune suppressant therapy
(such as biologic drug or corticosteroid treatment).

- Palpable thyroid lesion, lymphadenopathy, or other pathological changes within the
treatment area.

- History of skin cancer in the areas to be treated, basal cell nevus syndrome, or jaw
cysts.

- Known allergy or sensitivity to Ibuprofen.

- Severe solar elastosis.

- BMI > 30.

- Significant changes in weight (e.g. more than 5 pounds) over the past 6 months or
anticipated significant changes in weight or diet over the course of the study.

- Pregnant within the past year.

- Excessive subcutaneous fat in the area(s) to be treated.

- Excessive skin laxity in the area(s) to be treated as determined by trained physician
assessors.

- 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 two weeks prior to study participation or during the study.

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

- History of chronic drug or alcohol abuse.

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

- Subjects who anticipate the need for surgery or overnight hospitalization during the
study.

- 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. Any energy based device (radio-frequency (RF), micro-focused ultrasound (MFU),
etc.) procedure for skin tightening 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 Hydroxylapatite fillers (e.g. Radiesse)

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

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

c. Neurotoxins within the past six months (neuromodulators are allowed in the glabella and
forehead, not allowed in the temples, crow's fee or anywhere below the lateral canthus);

d. Fractional and fully ablative resurfacing laser treatment within the past two years;

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

f. Surgical dermabrasion or deep facial peels within the past two years;

g. Facelifts, neck surgery (e.g. thyroid, neck lifts, neck liposuction, etc.) within the
past two years;

h. Micro needling within the past year;

i. Kybella, Coolsculpting, or Mesotherapy within the past two years; or

j. Any history of contour threads.

- History (in the prior year) or current use of the following prescription medications:

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

2. Initiation of topical retinoids within the past 6 months or throughout the course
of the study;

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

4. Systemic steroids including prednisone;

5. Dermal regulators of collagen;

6. Initiation of bioidentical hormones or human growth hormone (HGH) within the past
6 months or throughout the course of the study; or

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