Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Device for Non-Invasive Abdominal Fat Reduction

This study is a prospective, baseline and blinded controlled, one arm clinical study showing
the performance and safety of the UltraShape treatment for non-invasive abdominal fat
reduction.

Up to 60 Healthy subjects in up to 4 investigational sites will be enrolled in this study.
All subjects will undergo an assessment of their general health. During the treatment period,
subject's fat thickness and circumference will be measured and three successive UltraShape
treatments, two weeks interval, will be performed.

The study subjects will undergo UltraShape treatments on the abdomen. During the follow-up
period visit will be conducted as follow: 4 weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks
(12wk FU) post last treatment (Tx.3). Subject's abdominal fat thickness and circumference
will be measured in the measurements points and will be assessed at each visit. Additionally,
a subject questionnaire will be completed in each follow-up visit (4wk, 8wk and 12wk FU).
Finally, photography will be performed under visible light conditions of the front, right,
left and back view. Most of the assessments will occur at each of the visits (all treatments
and all follow-up visits) to the clinic.

Inclusion Criteria:

A subject is eligible to participate in the study if he/she meets all the following
inclusion criteria:

1. Signed informed consent to participate in the study.

2. Female and male subjects, 18 and 60 years of age at the time of enrollment

3. Fitzpatrick Skin Type I to VI.

4. Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).

5. BMI interval: BMI between 22 to 30 (normal to overweight, but not obese).

6. If female, not pregnant or lactating, must be either post-menopausal, surgically
sterilized, or using a medically acceptable form of birth control at least 3 months
prior to enrollment (i.e. oral contraceptives, contraceptive implant, barrier methods
with spermicide or abstinence).

7. In addition, negative urine pregnancy test as tested before each treatment and at the
last follow-up visit for women with child-bearing potential (e.g. not menopause).

8. General good health confirmed by medical history and skin examination of the treated
area.

9. Willing to follow the treatment and follow-up schedule and post-treatment care
instructions.

10. Willingness to refrain from a change in diet/ exercise/medication regimen for the
entire course of the study.

11. Willing to have photographs and images taken of the treated areas to be used,
de-identified in evaluations, publications and presentations

Exclusion Criteria:

A subject is not eligible for participation in this study if he or she meets any of the
following exclusion criteria:

1. History of hypertension, ischemic heart disease, valvular heart disease, congestive
heart failure, pacemaker or defibrillator, abdominal aortic aneurism

2. Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive
status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue
disease

3. Having or undergoing any form of treatment for active cancer, or having a history of
skin cancer or any other cancer in the areas to be treated, including presence of
malignant or pre‐malignant pigmented lesions

4. Having any active electrical implant anywhere in the body, such as a pacemaker or an
internal defibrillator

5. Having a permanent implant in the treated area, such as metal plates or an injected
chemical substance such as silicone

6. Having undergone any other surgery in the treated areas within 12 months of treatment
or during the study, including liposuction

7. Previous body contouring procedures in the treatment area within 12 months

8. History of skin disease in the treatment area, known tendency to form keloids or poor
wound healing

9. Suffering from significant skin conditions in the treated areas or inflammatory skin
conditions, including, but not limited to, open lacerations or abrasions and active
cold sores or herpes sores prior to treatment (duration of resolution as per the
Investigator's discretion) or during the treatment course

10. Skin lesions in the treatment area other than simple nevi on physical examination
(e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment
area

11. Very poor skin quality (i.e., severe laxity)

12. Abdominal wall diastasis or hernia on physical examination

13. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count
within the last 3 months

14. Obesity (BMI above 30)

15. Childbirth within the last 12 months or breastfeeding women. Any acute or chronic
condition which, in the opinion of the investigator, could interfere with the conduct
of the study

16. Unstable weight within the last 6 months (i.e., ± 3 percent weight change in the prior
six months)

17. Inability to comply with circumference measurement procedure (e.g., inability to hold
breath for the required duration).

18. Fat thickness lower than 2.5 cm after strapping at the treated area.

19. Participation in another clinical study involving same anatomical areas within the
last 6 months (or 30 days in case different anatomical areas were treated in previous
trials).

20. As per the Investigator's discretion, any physical or mental condition which might
make it unsafe for the subject to participate in this study