New FDA-Approved,

Clinically Proven,

Non-Cavitation

Ultrasonic Skin Device

This presentation contains confidential information, intended

only for the person(s) it has been released to, which may also be

privileged. Any use, distribution, copying or disclosure by any

other person is strictly prohibited.

This device generates the non-cavitation, calibrated ultrasonic wave forms which OPENS PORES and PUSHES actives in the skin without heat. These alternating wave forms are calibrated to penetrate no deeper than the epidermis, thus never interfering with delicate, live dermal tissue.

The disposable cap is designed as aprotective, hygienic cover for the transducerhead of the device, and helps distribute theactives evenly on the skin. The user appliesthe product to the desired part of the skin andthen runs the device over the area to dilatethe pores and push the active(s) into the skin.The cap is disposed of after every clientservice.

Applying the Cap

Hygienic Cap

Device

Non-Cavitating Ultrasound

Skin Device

ACTIVATION

TRIGGER

TRADITIONAL ULTRASONIC DEVICES

How They Work – The Sine Wave

� Ultrasonic sine waves are a smooth, repetitive

oscillation of sound.

� Current ultrasonic in-spa therapy devices employ

high and low ultrasound frequencies. The

wavelength, waveform, and intensity determine the

depth of penetration; and the form of the waves

creates varying levels of heat within the tissue

called Cavitation.

� You will see these types of ultrasound therapies

used in fat-reduction, and in hand-held devices to

increase heat and circulation within the tissues.

However, there are many instances in which heat is

detrimental to your therapies.

Sine Wave

TRADITIONAL ULTRASONIC DEVICES

Disadvantages of the Sine Wave

The use of traditional form Ultrasound can be contraindicated for the

following reasons:� It can create intense heating through

cavitation, which can damage and discolor the skin.

� The cavitation heating effect can breakdown and alter active compounds applied to the skin.

� At traditional low frequency levels, its pore penetration capabilities are very limited.

� The unknown-long term effects of traditional ultrasound devices affecting the live tissue is still unknown.

Conventional Ultrasound Waveform

Sine Wave

Sawtooth/Square Wave Forms – The solution to the current ultrasound disadvantages is to use

an alternating waveform dynamic, which propagates two different waveforms in succession to

each other to dilate and penetrate the skin.

This new device stops immediately before the generation of heat (cavitation) using a “Sawtooth”

waveform; then, the ultrasonic transmission switches to a “Square waveform”, creating a

momentary drop off of energy, thereby ceasing the cavitation formation process, thus producing

NO cavitation or spot heating effects.

The result is no damage to the skin and no damage to the compound being delivered. In this dual

action configuration, the Sawtooth Waves are the dilating force and the Square Waves are the

transport force.

A UNIQUE, NEW ULTRASONIC DELIVERY SYSTEM

The Device - How It Works

Here is a confocal image* of the skin showing the before and after effect of the Sawtooth wave.As seen below, there was a doubling of the size of the pore after just 10 seconds expandingfrom 5 microns to 10 microns. The expansion effect lasts only 30 minutes.

PORE EXPANSION IMAGING OF THE SKINSawtooth Wave Effect

Consider the benefits of temporary pore dilation…

*using a microscope whose imaging system only collects light from a small spot on the

specimen, giving greater resolution.

In this test, a blend containing hydrogel with a blue dye was deposited in a thin layer upon the

outer surface of the epidermis. The device was placed over the dye and turned on for 1 minute.

This photo of the skin section reveals spikes of the dye penetrating the pores of the skin.

DYE MARKER PENETRATION INTO PORESSquare Wave Effect

THE DEVICE’S IMPACT ON COLLAGEN

The Collagen Elevation Effect on Wrinkles

�The ultrasound application to the face, as

shown in the diagram to the right,

demonstrates that the device’s dual action

ultrasound alone tends to rapidly elevate the

collagen level within the skin tissue.

�Collagen settles lower within the tissue as

the body ages. This loss of collagen often

results in severe wrinkles and line expansion

within the skin.

�Using the device, the collagen density

changes with ultrasonic excitation, elevating

the level of the collagen within the skin,

moving the collagen closer to the skin

surface, and thereby filling the lines and

rhytides, lessening their appearance on the

surface of the skin.

POST - ULTRASONIC THERAPY UPON WRINKLES

Initial Research

Tri-Peptide Cell Activator anti -aging serum, a non-invasive

wrinkle treatment.

Before After

Note Wrinkles around Eyelids

Right image: Three days usage of the device incorporating a hyaluronic acid gel.

Note Major Skin Crevice under

eye

Persistent redness for 7

days following microdermabrasion

Indentations in Eye lid Reduced

Wrinkles, filled and

skin redness

eliminated

Tissue is plump and hydrated; tone is more even

ULTRASONIC THERAPY UPON NASO-LABIAL FOLD LINES

Initial Research

Before After

PRONOUNCED NASO-LABIAL FOLD LINES

and DEHYDRATION

REDUCTION OF LINES and INCREASED HYDRATION

AFTER 7 DAYS OF DEVICE USAGE WITH HYALURONIC ACID GEL

Before and after photo-comparisons:

Two male volunteers with severe Acne were recruited for a pre-test where they followed the same regimen

as the full trial volunteers for 2 weeks.

Based upon these preliminary results a full clinical trial was organized with a diverse younger population.

ULTRASONIC THERAPY UPON ACNE

Initial Research with Benzoyl Peroxide Gel

Trial Documentation & Results – The clinical trials ended

in early 2011. To monitor the trial, the device manufacturer

used a company that is an industry leader in providing the

imaging systems and support necessary for high definition

photographic documentation in the medical and skincare

fields. According to their analysis, the average reduction in

facial lesions from the use of the device with their acne

treatment system was 70.3% over all the volunteers in 4-

weeks. The highest reduction score recorded by this

company prior to this clinical trial was a 20% reduction in

lesion count compared to other skincare modalities.

ULTRASONIC THERAPY UPON ACNE

ONE MONTH CLINICAL ACNE TRIAL

20%

70.3%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Lesion

Reduction

maximum using

other modalities

Lesion Reduction

Using device with

Benzoyl-peroxide

gel

This ultrasonic device is certified under the FDA’s Abbreviated Device Application

for Ultrasonic Skin Contact as a non-medical device. The requirement was to

demonstrate that the device does not irritate the skin and that its breadth of ultrasound

falls into a range that is considered safe by FDA, in which this device easily does –

as it generates only ¼ the energy of a sonic toothbrush.

FDA APPROVED

Current FDA Status

The Device Compared to Other Ultrasonic Devices

Competitive Landscape

There is no product or technology in the

cosmetic industry that is comparable in its

ability, which is proven to temporarily open

the pores, deliver active products deep into

the pores without cavitation, while encouraging

collagen elevation.

: There are a range of therapeutic devices

using light therapy, radio waves, low ultrasonic

frequencies, and electricity that claim to

increase blood circulation, treat fine lines and

wrinkles, improve moisture content, and

stimulate collagen. But, there is no other

ultrasonic delivery system on the market

that can dilate the pores without creating

cavitation heat, nor does any other device

create micro-channels pushing product into

dilated pores using ultrasound.

What is the Difference?

Conventional Ultrasound

• Creates Heat from Cavitation

• Continuous sine waveforms

• Can penetrate to dermis or further –

future effects unknown

• Does not elevate collagen levels

• Degrades actives in products

• Does not temporarily open pores

• Requires a Class I or Class II Medical

Device Rating

New Ultrasonic Device

• Made in USA

• FDA approved

• Clinically tested

• Current technology used for painless

and accurate drug delivery systems

through the skin without injections

• NO cavitation

• PROVEN to open pores for ~30

minutes

• Increased product penetration with

no degradation of products or actives

• Elevates Collagen

• Alternating Sine Waveforms

• Creates micro-channels without heat

Benefits of New Ultrasonic Device to the

Esthetic Practice� New Technology

� Clinically-Proven

� Safe & Effective

� Very Affordable

� FDA approved

� Hygienic

� Time Saving

� Product-Sparing/Saves you on high priced actives and products

� No product degradation

� Increased service revenues – you can charge extra incorporating this device in your services

� Client retention from enhanced results:

– Immediate, positive visible changes

– Lessening of lines

– Enhanced hydration

– Better post-treatment feel

– Deeper penetration of actives for long-term results

– No inflammatory heat

– Less redness with improved esthetic look

What Makes it Great

• Great for use with clients/patient that have a compromised barrier, or when you need to get an active deep into the epidermis without adding inflammation/redness, or additional heat from massage. Think:Think:Think:Think: inflammatory acne, rosacea, sunburn, post-peel, post-microdermabrasion, thin epidermis, sensitive-skin types

• Can be used in conjunction with other devices such as microdermabrasion, LED therapy, dermafiling, dermaplaning, etc.

• Can be used post-peel, pre-cleansing, pre-extraction to soften and dilate pores, post treatment to work in actives and reduce product heaviness/look/feel on the client

• The device is product-sparing. Dispense less product & achieve better penetration and results = $$Savings

• Saves the practitioner time, while enhancing the service and increasing results.

No heavy post-treatment

product-feel for the client. You

and they will notice a softer,

smoother epidermal feel;

without the heaviness, or shiny

look some moisturizers cause.

What Makes it Great… Continued

IT’S CORDLESS!

The Science Behind It

• Of all the electronic systems, ultrasound offers the most promising capability for

transdermal delivery. It has an ability “push” the substance from the transdermal

device through the skin because of vibrational energy. However, the sinusoidal

ultrasound, through cavitation, can damage both the substance and the skin. In

order to use ultrasound, the problem of cavitation had to be defeated.

• Any electronic signal sent through a transdermal device can cause liberation of the

product. Iontophoresis was found to inject electrical charges to the product,

changing it.

• Laser or infra-red transmissions through the product also had the effect of photo-

damaging the product, or clouding the compound, which can be an indication of

the denaturing it.

• Sonophoresis, the application of sinusoidal ultrasound, through the skin can

induce a process called cavitation which can micro-porate (create microchannels)

in the skin and develop micro pathways through the skin, but the explosive energy

of cavitation has the possibility of over heating the skin. Sinusoidal ultrasound,

through cavitation can cause severe damage to the skin and discoloration.

• Some molecules are too large to passively massage into the skin.

Pore Expansion Skin Transport

Sawtooth waveform Square waveform

Wave form “A” for 50 msecs Wave form “B” for 50 msecs

Alternating Waveform First Enlarges Pore Size (Sawtooth), Then Rams Active Through The Enlarged Pore Into The Epidermis Under

Squarewave

Null Gap for 5

msecs

Sawtooth Skin

Priming for 30

seconds

ALTERNATING WAVEFORM SECTION

Why I Personally Use This Device

T w o y e a r s a g o I w a s a s k e d t o d o i n - s p a t r i a l s u s i n g a c o m p l e t e l y n e w

f o r m o f i n n o v a t i v e , n o n - c a v i t a t i o n ( n o t h e a t - p r o d u c i n g ) u l t r a s o n i c

t e c h n o l o g y t o i n c o r p o r a t e s o m e c a r e f u l l y s e l e c t e d a c t i v e s i n t o t h e

e p i d e r m i s . T h e r e s u l t s h a v e b e e n a m a z i n g ! T h e t r e a t e d s k i n s h o w s

v i s i b l e i m p r o v e m e n t i n f i n e l i n e r e d u c t i o n ; p l u m p e r , m o r e h y d r a t e d

e p i d e r m a l t i s s u e , l e s s h e a v y p r o d u c t f e e l – & - l o o k f o r t h e c l i e n t , a n d

b e s t o f a l l … N O i n f l a m m a t i o n ! N o m o r e p r o d u c t w a s t e b e c a u s e y o u o n l y

u s e a s m a l l a p p l i c a t i o n o f y o u r p r o d u c t . S e r u m l a y e r i n g i s m o r e

s u c c e s s f u l . T h i s p a t e n t e d & F D A a p p r o v e d f o r m o f u l t r a s o u n d

t e c h n o l o g y i s n o w b e i n g u s e d t o p u s h p h a r m a c e u t i c a l s a n d

c h e m o t h e r a p e u t i c d r u g s t h r o u g h t h e s k i n w i t h e x t r e m e a c c u r a c y , n o d r u g

d e g r a d a t i o n , a n d n o h e a t . T h i n k o f t h e t i m e s y o u n e e d e d t o g e t

s o m e t h i n g i n a c l i e n t ’ s s k i n , b u t d u e t o w h a t e v e r i n f l a m m a t o r y i s s u e ,

y o u c o u l d p e r f o r m l i t t l e o r n o m a n i p u l a t i o n d u e t o a n i n c r e a s e i n

r e d n e s s a n d i n f l a m m a t i o n ( i n f l a m m a t o r y a c n e , s u n b u r n , p o s t - p e e l a n d

p o s t - m i c r o d e r m , r o s a c e a & a n d o n c o l o g y s k i n t y p e s w i t h c o m p r o m i s e d

b a r r i e r s , e t c . ) . T h i s d e v i c e w i l l g e t t h o s e a c t i v e s i n w i t h o u t t h e h e a t

a n d f r i c t i o n o f m a s s a g e . I t i s a l s o t i m e - s a v i n g , p r o v i d i n g r e s u l t s i n l e s s

t r e a t m e n t t i m e .

Important Information You Need to

Comply With

• ALWAYS OPERATE THE

DEVICE WITH THE CAP

ON

• NEVER RE-USE A CAP

• DISPOSE OF CAP AFTER

USE

• SANITIZE THE HOUSING

BETWEEN CLIENTS

• ONLY MAKE A

MAXIMUM OF 2 PASSES

OVER THE FACE

• DO NOT USE OVER THE

LIPS OR EYES

• FOLLOW ALL STANDARD

CONTRAINDICATIONS

WHEN USING ANY

ULTRASOUND DEVICE

PRODUCTS THAT CANNOT BE USED WITH

THIS DEVICE

As you know, ultrasound needs a hydrophilic medium for proper sound wave

transmission.

Carefully consider what you are pushing into your clients’ skin! You may cause

severe damage or injury to your client. Know and Understand your ingredient

decks thoroughly. NEVER use any skincare product or active that contain the

following:

� Colors, Pigments, or Dyes

� Waxes, acrylic fillers & stabilizers, unknown gelifiers, gums or thickeners

� Nano-particles and microbeads

� Minerals, talc, clays, mineral sunscreen

� Essential Oils or fragrance

� Acids

� Enzymes

ACTIVESBecause ultrasound is used to dilate pores and push actives, always consider

what you are pushing into the epidermis. Why you want the active deeper in the

epidermis? In what order you are applying the actives, and why? What benefit are

you hoping to achieve? Conventional piezoelectric transducers generate a

Sinusoidal Wave Dynamic, which leads to cavitation, product degradation and

skin damage.

This device is completely UNLIKE a skin spatula and traditional heat-creating

conventional ultrasound. It uses a totally different multiple sine wave modality,

and will not heat the skin, create mist, or debride the surface. It purpose is to

open pores, create micro-channels, and push actives in the interstitial spaces

without creating heat in the skin.

Two Distinct Devices/Two Distinct Uses

New Device• No Cavitation Heating of the Tissue.

• No Inflammation

• Alternating Sine Waves

• Temporary Pore Dilation

• Calibrated for Precise Target Depth within the

epidermis only

• FDA Approved

• Clinically Proven Results

• Sine-wave Driven/Non Vibrating

• Proudly Made in the USA

• No Product Degradation

• Proven to Quickly Elevate Collagen

• Does Not Debride the Surface

• Used Clinically for Drug/Chemotherapy Delivery

• No vibratory mechanical energy and thermal

energy to involve subcutaneous fat.

Skin Spatula/Scrubber• Creates Atomized Mist

• Creates Heat

• Does Not Open Pores

• Aids in Surface Debridement & Ablation

• Vibrates

• . Cancer cells travel via the lymphatic system,

as does waste produced by Ultrasound

Cavitation. A treatment with cavitation

heat presents an unacceptable risk of

moving cancer cells in Oncology Patients.

• Elevation of the temperature within blood

vessels may cause blood clots within the vessels.

If the blood vessels that supply an area of skin

with oxygen becomes blocked by clots, then the

skin could die.

Traditional Cavitation Ultrasound &

Oncology Esthetics Contraindications• Cancer: Cancer cells travel via the lymphatic system, as does waste produced by Ultrasound Cavitation.

A treatment may present an unacceptable risk of distributing cancer cells.

• Cold or flu symptoms or fever: Ultrasound Cavitation releases toxins from the body via the lymphatic

system, and treatments can exacerbate flu symptoms which also leave the body the same way.

• Swollen lymph nodes: Treatments cannot be performed in areas where lymph nodes are swollen,

infected, or not draining properly.

• Edema or localized swelling indicates poor lymphatic flow. Treatments are not designed to alleviate

edema and may in fact exacerbate the condition.

• Active Infections & Immunosuppression: These factors compromise the healing ability of the body, and :

compromises the ability of the body to recover from treatments.

• Liver, Kidney, Heart Disease & Pacemakers, severe Hypertension, Hyperlipidemia, Diabetes Mellitus, or

poor circulation of blood and lymph, are all contraindicated.

• Lymph nodes, Thyroid, Eyes, and Joints cannot be treated with cavitation.

• Metallic Implants: People who have metal implanted in their bodies, including prosthetic dental devices

and implants, including skull plates and bone pins.

• Skin allergies

• Minors

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Contact:

Nancy L. Swankie, LE

n lswank ie@sk inp l i c i t yo fcary.com

580 New Waverly Place, Suite 140

Cary, NC 27518 USA

(919) 389-2707