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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