UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia)

Up to 40 adult male volunteers, who suffer from Pseudogynecomastia, and seek noninvasive
breast fat reduction will be enrolled at up to three investigational sites. Eligible subject
will be divided into one of the two treatment arms: Arm 1: Subjects will be treated on one
side of the breast, while the opposite side will serve as control - Up to 20 subjects; Arm
2: Subjects will be treated on both sides of the breast - Up to 20 subjects. Subjects will
receive 3 bi-weekly treatments (at 2-week intervals) with the UltraShape device.

Subjects will return for 3 follow-up visits post last treatment (Tx.3): four weeks follow-up
(4wk FU), eight weeks follow-up (8wk FU) and 12 weeks follow-up (12wk FU) for total expected
study duration of 16 weeks.

Inclusion Criteria:

1. Signed informed consent to participate in the study

2. Male subjects, 18 -70 years of age at the time of enrollment

3. BMI interval: BMI ≥ 22 and ≤30 (normal to overweight, but not obese)

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

5. Subject has clearly visible, palpable, excess fatty tissue in their breast area, and
minimal fibrous tissue.

6. Subject agrees to maintain their weight (i.e., within 3% weight change) by not making
any major changes in their diet or lifestyle during the course of the study.

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

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

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

Exclusion Criteria:

1. History of hypertension, ischemic heart disease, valvular heart disease, congestive
heart failure, pacemaker/defibrillator.

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) according to the investigator decision.

12. Obesity (BMI >30).

13. Unstable weight within the last 6 months (i.e., 3% weight change in the prior six
months).

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

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

16. 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
trial/s).

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

18. Personal history of previous breast malignancy.

19. Subject is taking any medication which could cause abnormal breast enlargement -
including but not limited to: digoxin, furosemide, gonadotropins, clomiphene,
phenytoin, and exogenous testosterone, ketoconazole, metronidazole, alkylating
agents, cisplatin, spironolactone, cimetidine, flutamide, finasteride, etomidate,
isonicotinic acid hydrazide, methyldopa, busulfan, tricyclic antidepressants,
diazepam, penicillamine, omeprazole, phenothiazines, calcium channel blockers,
angiotensin-converting enzyme (ACE) inhibitors.

20. Subject has history of the following medical conditions: Klinefelter syndrome,
Congenital anorchia, Testicular trauma, Testicular torsion, Viral orchitis, Kallmann
syndrome , Pituitary tumors, Malignancies that increase the serum level of hCG (eg,
large cell lung cancer, gastric carcinoma, renal cell carcinoma, hepatoma), Renal
failure, Hyperthyroidism, Malnutrition, Androgen insensitivity syndrome,
Five-alpha-reductase deficiency syndrome.