Performance of the ePrime System for Cellulite

Up to 60 healthy adult volunteers seeking cellulite treatment, females of 25 to 60 years of
age, from multiple investigational sites.

This is an open-label, multi-center study. Subjects in this study will receive a single
subcutaneous treatment with the ePrime device in one treatment session according to the
study protocol.

Prior to treatments, tissue to be treated will be injected with tumescence or local dermal
infiltration solution according to the protocol. Subjects will return for follow‐up (FU)
visits at: 1 week, 1 month, 3 months and 6 months following the treatment.

Methodology described in protocol to evaluate efficacy of treatments will be carried out at
each visit.

Inclusion Criteria:

1. Subjects seeking treatment of cellulite in the upper thighs and buttocks areas.

2. Subject have cellulite stage II or III as graded using Nurnberger-Muller scale
clasification (Appendix III)

3. Healthy female subjects ages 25 to 60 years of age

4. Informed consent process completed and subject signed consent

5. Willing to receive the proposed ePrime treatment and follow-up protocol

6. Not pregnant or lactating and 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. Willing to have photographs taken of the treated areas to be used de-identified in
evaluations, publications and presentations

Exclusion Criteria:

1. Subject had surgery or any other procedure for cellulite in the last 6 months

2. Pregnant or planning to become pregnant, having given birth less than 3 months ago,
and/or breast feeding

3. Known allergy to lidocaine or epinephrine or antibiotics

4. Active malignancy or history of malignancy in the past 5 years

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

6. Suffering from significant concurrent illness, such as cardiac disorders, diabetes
(type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any
disease state that in the opinion of the Physician would interfere with the
anesthesia, treatment, or healing process)

7. Having a known anticoagulative or thromboembolic condition or taking anticoagulation
medications one week prior to and during the treatment course (to allow inclusion,
temporary cessation of use as per the subject's physician discretion)

8. History of immunosuppression/immune deficiency disorders (including HIV infection or
AIDS) or currently using immunosuppressive medications

9. Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen

10. History of significant lymphatic drainage problems

11. History of cancer which required lymph node biopsy or dissection

12. Suffering from significant skin conditions in the treated areas or inflammatory skin
conditions, including, but not limited to, open lacerations or abrasions,
hidradenitis, or dermatitis of the treatment area prior to treatment (duration of
resolution as per the Investigator's discretion) or during the treatment course

13. History of keloid scarring, abnormal wound healing and / or prone to bruising

14. History of epidermal or dermal disorders (particularly if involving collagen or
microvascularity), including collagen vascular disease or vasculitic disorders

15. Use of isotretinoin (Accutane®) within 6 months of treatment or during the study

16. Subject on systemic corticosteroid therapy 6 months prior to and throughout the
course of the study

17. Dysplastic nevi in the area to be treated

18. Participation in a study of another device or drug within 3 month prior to enrollment
or during this study, if treatments of cellulite were involved

19. Subject has palpable lymphadenopathy at any visit. Standard palpation techniques will
be used

20. Subjects with history of severe edema

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