TriActive+ Radiofrequency (RF) for Non-Invasive Treatment of Wrinkles and Rhytides

Collagen varies genetically and structurally. Collagen breakdown increases with
chronological age and photoaging. While fibroblasts normally replace damaged collagen fibers
with new ones, the ability of fibroblasts to replace collagen is compromised by natural
aging and environmental stress. Although collagen fibers form a loose interlacing network
that is deformable, increased collagen breakdown leads to thinning and loss of the elastic
fiber network in the dermis. This breakdown results in the formation of wrinkles, especially
in areas of the skin exposed to the sun, which are most prone to wrinkles and imperfections.
Nonablative dermal remodeling has gained tremendous popularity among patients and
practitioners, offering a low incidence of adverse effects and modest improvement in the
various signs of cutaneous photoaging, including rhytides, dyschromias and telangiectasias.
Controlled thermal skin injury has been shown to effect a conformational change in the
structure and length of collagen and may also induce fibroblast response for long-term
collagen remodeling. Interest in utilizing radiofrequency energy to enhance deep tissue
tightening and thus improve skin laxity has grown, as radiofrequency energy has been shown
in multiple studies to tighten tissue, producing a noticeable skin lifting.

This study is intended to evaluate the clinical performance of a radiofrequency (RF) source
as engendered in the TriActive+ RF for the non-invasive treatment of wrinkles and rhytides.

Eligible subjects who have signed an ICF will receive up to 8 treatments on at least two
facial sub areas (left peri-orbital, right peri-orbital and peri-oral). Up to 25 subjects
will be enrolled in the study at two sites. Treatments will start at a low power and then
gradually increase, based on tolerability and tissue reaction. The goal is to progressively
reach and maintain an epidermal temperature end-point. The site will use an IR thermometer
to ensure the rise in temperature does not exceed 43° C.

Treatments will be once a week with follow-up visits at one week, one month, and three
months following the final treatment. Clinical assessments by the investigator and digital
photographs will be taken prior to the baseline treatment, immediately prior to the 5th
treatment, and at the 1 week, 1 month and 3 month follow-up visits.

Inclusion Criteria:

- Informed consent agreement signed by the subject.

- Healthy male or female subjects 30-60 years of age.

- Having at least two facial sub-areas (left peri-orbital, right peri-orbital or
peri-oral) with visible lines/wrinkles and elastosis, which correlate to a score of
2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis.

- Willingness to follow the treatment and follow-up schedule and the post-treatment
care.

- For female candidates - post-menopausal or surgically sterilized, or using a
medically acceptable form of birth control at least 3 months prior to enrollment and
during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive
implant, barrier methods with spermicide, or abstinence).

Exclusion Criteria:

- Pregnant or planning to become pregnant, having given birth less than 3 months ago,
and/or breastfeeding. Females of childbearing potential must agree to take a urine
pregnancy test at the Screening visit. The urine pregnancy test must be negative.
Females of childbearing potential include anyone who has experienced menarche and who
has not undergone successful surgical sterilization or is not post-menopausal for
more than 2 years.

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

- Having a permanent implant in the treated area, such as metal plates and screws, or
an injected chemical substance.

- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in
the treated area, unless treatment is conducted following a prophylactic regimen.

- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing
agents) one week before and after each treatment session.

- Use of retinoids, antioxidants or skin nourishing supplements within 1 month of
treatment or during the study.

- Having received a facial within 1 month of treatment or during the study.

- Having received a facial dermabrasion or chemical peel treatment within 2 months of
treatment or during the study.

- Having received treatment with light, RF or other devices in the treated area within
6 months of treatment or during the study.

- Having received Botox in the treated area within 6 months of treatment or during the
study.

- Having received collagen/Hyaluronic Acid (HA) in the treated area within a year of
treatment or during the study.

- Having undergone a resurfacing procedure, face lift or eyelid surgery within a year
of treatment or during the study.

- Having undergone any other surgery in the treated area within 6 months of treatment
(or more if skin has not healed completely) or during the study.

- Having ever received fat injections or other methods of augmentation with injected or
implanted material in the treated area or planning to during the study.

- History of keloid scarring or of abnormal wound healing.

- Suffering from current or history of significant skin conditions in the treated area
or inflammatory skin conditions, including, but not limited to: excessive skin
dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage),
indurate acne, varicella scars, 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.

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

- History of epidermal or dermal disorders (particularly if involving collagen or
microvascularity).

- History of pigmentary disorders, particularly tendency for hyper- or
hypo-pigmentation.

- Suffering from hormonal imbalance, as per the Investigator's discretion.

- 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).

- 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.

- Suffering from significant concurrent illness, such as cardiac disorders, diabetes
(type I or II), or pertinent neurological disorders.

- Vascular lesion, tattoo or permanent make-up in the treated area.

- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning
during the study.

- Participation in a study of another device or drug within one month prior to
enrollment or during the study.

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