Proprietary Information of AMA Aurora DSR ELOS TM Technology and key features AMA.

Proprietary Information of AMA

Aurora DSR ELOSTM Technology and key

features

AMA


ELOSTM Technology for Aesthetic medicine

•Utilize optical energy and electrical (radio frequency) simultaneously

•Two different selectivity mechanism for optimal treatment

•Epidermal cooling

•Active dermal monitoring TM


Aurora applications

• Aurora DS indicated for non invasive hair removal– Light hair– Dark skin types

• Aurora SR indicated for Skin Renewal– Pigmented lesion– Vascular lesion– Skin texture improvement


Existing technology for selective photothermolysis

• Optical energy: penetrating into the skin and selectively absorbed by the target– Lasers - monochromatic light – IPL produces broad spectrum of light

• Electrolysis basing on delivery of RF energy to the hair root by insertion of needle to each follicle (Thermolysis)

• ThermaCool By Thermage (RF) –unipolar system for wrinkle treatment


Light-based Hair removal

• Hair chromophore melanin - the same as of epidermis

• Dark epidermis has higher risk of damage

• Treatment of light hair is not effective

• Does not effect hair follicle and buldge directly

• Indeterminacy of light effect because of its scattering and reflection

• Strong absorption by dark hair shaft

• Penetration depth of a few millimeters

• High selectivity between hair shaft and dermis

• High efficiency for dark hair and light skin

_ +


What is the main Light problem ?

En

erg

y

Epidermis damage

Hairdamage

Dermis damage

Light Skin Dark Hair

Dark Skin Dark Hair

Light Skin Light Hair

Dark Skin Light Hair


Treatment window for light based systems

Light skin Dark hair

Dark skin Dark hair

Light skin Light hair

Dark skin Light hair

Efficacy energy level

LowLowHighHigh

Adverse effect energy level

HighLowHighLow

Treatment window

WideNarrowNarrowNot exist!

Over allGoodPoor results/ High risk

Poor results/ High risk

Can’t do!


Syneron ELOS Technology

• Two types of energies sources with

different selectivity mechanism • Optical energy: absorbed in the target

by the right choice of wavelength and pulse duration

• Electrical RF energy: Chromophore independent not sensitive to skin or target color!


Syneron ELOS Technology

• Reduce the optical energy to a safe level for all skin types

• Compensate for the lack of optical energy with electrical RF energy that is not sensitive to skin or target color


Technology

RF

Cooling

Light


Temperature distribution created by light

• Light heats selectively hair shaft

• Bulge and follicle are damaged due to heat transfer from hair shaft

ShaftFollicle


RF energy properties

• Well known in medicine• Does not effect the melanin• All RF parameters (Voltage, Current,

Impedance) can be measured and controlled with high time resolution

• Skin impedance depends on temperature and can be used for skin heating monitoring where impedance drop is about 2% per C


Mechanism of RF selectivity I – Geometry Effect

Electrodes

• Current density is twice higher in the follicle than in surrounding tissue

• Heat generation is proportional to square of current density


Heat created by RF

• RF creates heat in the 30microns layer around the hair shaft

• Heated layer includes hair follicle and buldge


Mechanism of RF selectivity II – Impedance Decreases with Temperature

• Impedance linearly decreases with Temperature Increase

• RF current will flow at lower impedance part of the tissue and selectively heats it

• Light acts as a trigger – preheat the target for the RF current


Skin and follicle heating by RF

• Heat generationH=j2, where -conductivity, j-current density • Ratio between skin and follicle heating

Hfollicle=4 Hskin

• Skin temperature increase

Tskin=ERF /(S d Cskin)S-spot size, d-penetration depth, C-specific

heat

Tskin=16 /(2x0.4x4)=5°C• Follicle temperature increase

Tfollicle=4 Tskin=4x5=20°C


Heat created by combination of Light and RF

• Combination of two types of energy create uniform heating the shaft and follicle


Contribution of Light and RF in Heat generation

• Light provides high selectivity between hair shaft and dermis

• RF energy heats mostly hair follicle and does not react to melanin of epidermis

RFLight


RF Current Distribution

Cold epidermisCold epidermis

DermisDermis

Pre-heated vesselPre-heated vessel


Aurora pulse sequence

RF energy

Light

Testing pre-pulse to ensure

coupling and skin calibration for RF

monitoring

Intense pulse

Fine heat adjustment

RF energy


Short and Long Pulses

RF energy

Light

~25ms

50ms 50ms

Short

Long


ISL safety feature

RF energyLight

Testing pre-pulse Intense pulse Fine heat adjustment

Impedance

Temperature

Energy


Light

Light

Impedance safety limit (ISL)

Light

RF energy

Light

ISL= 10%, energy is cut off

0

10

20

30

ISL= 30%, all energy is delivered

40


Clinical results with the

Aurora DSR


Treatment technique

• Incomplete contact cooling• All RF current is concentrated in

one point, potential for increased tissue temperature at contact points.

• Complete contact cooling• RF current is distributed over

entire electrode surface


Hair removal results withELOS Technology


Cross Section of Hair from scalp:

Not-treated Hair Follicles


Cross Section of Hair from scalp:

Hair Follicles after Aurora DS treatment


How Deep Does RF penetrate?

Human hair follicles at the edge of a treated area.

Depth is 3.5mm

Treated Normal


AfterBefore

White hair (Aurora DS Treatment)


Light brown hair

Optical pulse at 20J/cm2 with no additional RF energy.

Optical pulse at 20J/cm2 and RF energy of 20J/cm3.


Treatment Case

Hair removal

RF: 18 J/cm3

Light: 25 J/cm2

Number of Sessions: 2

Pulse: Short

Pre-treatment Post-treatment

Follow-up: 6 months

Dr. J. Shaoul


Treatment Case

Hair removal

RF: 20 J/cm3

Light: 22 J/cm2


Pulse: Short


Follow-up: 10 months

Dr. J. Shaoul


Treatment Case

Hair removal

RF: 18 J/cm3

Light: 26 J/cm2


Pulse: Short

Pre-treatment

Post-treatment

Follow-up: 4 months

Dr. J. Shaoul


Hair Removal Study6 Month Follow-up

A. DelGiglio, J. Shaoul

0

10

20

30

40

50

60

70

80

90

Per

cen

tag

e A

vera

ge

Cle

aran

ce

3 Month 6 Month

Axilla

Bikini Line

Legs

Trunk

Face


Conclusion

• The Aurora DS device has a definite biological effect on hair including reddish blonde and gray hair

• Further studies in skin types 5 and 6, and on white hair, are on going

• With an observation period of ten months it is possible to say that this is the same degree of permanent hair loss that one sees with any other laser technology


Photo-rejuvenation Treatment Using ELOS Technology

• Pigmented Lesion• Vascular Lesion• Wrinkle and skin texture treatment


Treatment Case

Lentigo

RF: 20 J/cm3

Light: 15 J/cm2


Pulse: Short

Pre-treatment

Post-treatment

Follow-up: 1month

Dr. J. Shaoul

Immediately


Treatment Case

Age spots

RF: 15 J/cm3

Light: 22 J/cm2


Pulse: Short

Pre-treatment

Post-treatment

Follow-up: 1 month

Dr. C. Chess


Treatment Case

Rosacea

RF: 18 J/cm3

Light: 24 J/cm2


Pulse: Short

Pre-treatment

Post-treatment

Follow-up: 1 month

Dr. S. Laughlin


Treatment Case

Rosaceaskin texture

RF: 20 J/cm3

Light: 15 J/cm2


Pulse: Short


Follow-up: 1 month

Dr. J. Shaoul


Treatment Case

Skin renewal

RF: 20 J/cm3

Light: 26 J/cm2


Pulse: Short

Pre-treatment

Post-treatment

Follow-up: 1 month

Dr. S. Laughlin


Aurora Photo-rejuvenation Treatment

Before After


Treatment Case

Telangiectasia

RF: 20 J/cm3

Light: 23 J/cm2


Pulse: Short

Pre-treatment

Post-treatmentFollow-up: 1 month

Dr. S. Laughlin


Treatment Case

Telangiectasia

RF: 15 J/cm3

Light: 22 J/cm2


Pulse: Short

Pre-treatment Post-treatmentFollow-up: 1 month

Dr. C. Chess


Treated sites by clearance FDA Multi-Center Study

24%

20%

22%

28%

6%

0-20%

21-40%

41-60%

61-80%

81-100%


Aurora Competitive

Advantages


• Safety: use less optical energy – less epidermal damage•Deliver more selective energy to the treated target• Treat dark skin without compromising efficacy or safety• Treat light hairs • Additional safety features• Portable, multi-applications platform

Aurora major advantages

Proprietary Information of AMA Aurora DSR ELOS TM Technology and key features AMA.

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