Copyright 2008 © Mattioli Engineering All rights reserved Dermoelectroporation®: the only one US FDA approved alternative to injection Mattioli Engineering.

Copyright 2008 © Mattioli Engineering All rights reserved

DDermoelectroporation®ermoelectroporation®: the : the only one US FDA approved only one US FDA approved

alternative to injectionalternative to injection

MMattioli Engineeringattioli Engineering


DDermoelectroporation®ermoelectroporation®

The only top No.1 The only top No.1 technology alternative to technology alternative to

injectionsinjections


Dermoelectroporation® is a technology that allows Dermoelectroporation® is a technology that allows product delivery into the various layers of the skin or product delivery into the various layers of the skin or subcutaneous tissues. subcutaneous tissues.

Any water soluble ingredients can be inserted into the Any water soluble ingredients can be inserted into the skin without additional carrying Gels.skin without additional carrying Gels.

Dermoelectroporation® utilizes the skin water basedDermoelectroporation® utilizes the skin water basedchannels to allow product penetration due tochannels to allow product penetration due tocontrolled current pulses delivered to the patient.controlled current pulses delivered to the patient.

DDermoelectroporation® ermoelectroporation®


Mattioli Engineering microdermabrasion leader since Mattioli Engineering microdermabrasion leader since 1991 1991

Empowering Skin Care specialists across the world with Empowering Skin Care specialists across the world with revolutionary technologies to treat skin. revolutionary technologies to treat skin.

Additional opportunities to further enhance delivery of Additional opportunities to further enhance delivery of active ingredients into the skin was sought.active ingredients into the skin was sought.

Combining the concept of Meso therapy (by Dr. Pistor, Combining the concept of Meso therapy (by Dr. Pistor, 1952) and Mattioli Engineering’s technical expertise led 1952) and Mattioli Engineering’s technical expertise led to development of Dermoelectroporation.to development of Dermoelectroporation.

WWhy Dermoelectroporation® hy Dermoelectroporation®


WWhat Dermoelectroporation is nothat Dermoelectroporation is not

MicrodermabrasionMicrodermabrasion GalvanicGalvanic IonthophoresisIonthophoresis Ultrasound / SonophoresysUltrasound / Sonophoresys AquaphoresysAquaphoresys Massagers Massagers Laser deviceLaser device

Transderm® is the ONLY and REAL alternative to injections. Transderm® is the ONLY and REAL alternative to injections.


EExistingxisting Technolog Technologies for deliveryies for delivery

MicrodermabrasionMicrodermabrasion

Medical and Aesthetic applicationMedical and Aesthetic application – 11stst transdermal pathway transdermal pathway– Skin surface action onlySkin surface action only– No current appliedNo current applied

– Small sized molecules onlySmall sized molecules only– Low delivery rate Low delivery rate


EExistingxisting Technolog Technologiesies

Low Dc current level applied

Traditional Galvanic (1to 5mA)Traditional Galvanic (1to 5mA)

Aesthetic applicationAesthetic application – Pushes ions into the skin.Pushes ions into the skin.– Low Dc current level applied.Low Dc current level applied.

– Ineffective for high weight molecules.Ineffective for high weight molecules.– Pre-charged compounds needed.Pre-charged compounds needed.– Small sized molecules only.Small sized molecules only.– Substance PH will change.Substance PH will change.– Electrolysis (product separation).Electrolysis (product separation).



Traditional Pulsed IonthophoresisTraditional Pulsed Ionthophoresis (1to 5mA)(1to 5mA)

Medical and Aesthetic applicationMedical and Aesthetic application – Pushes ions into the skin.Pushes ions into the skin.– Low Ac current level applied.Low Ac current level applied.

– Ineffective for high weight molecules.Ineffective for high weight molecules.– Pre-charged compounds needed.Pre-charged compounds needed.– Small sized molecules only.Small sized molecules only.– Substance PH may change.Substance PH may change.– Electrolysis (product separation).Electrolysis (product separation).

Sinus Low Ac current level applied

Alternative Low Ac current level applied



Electroporation Electroporation

In lab application onlyIn lab application only

– MacromoleculesMacromolecules delivery delivery

– High peak currents needed High peak currents needed

to porate the external skinto porate the external skin

layers (18,000volts)layers (18,000volts)– High risk of High risk of permanent permanent

skin damageskin damage– Many Many Adverse effectsAdverse effects

High peak currents

Ionthophoresys currents



High Frequency vibration 3MHz or higher

UltrasoundsUltrasounds

Medical and Aesthetic applicationMedical and Aesthetic application

– No current appliedNo current applied – High vibration frequency on the skinHigh vibration frequency on the skin

– Ineffective Ineffective for high weight moleculesfor high weight molecules– Small sized molecules Small sized molecules onlyonly



High Frequency vibration Lower than 3 MHz

Sonophoresys (Sound)Sonophoresys (Sound)


– Low frequency UltrasoundLow frequency Ultrasound

– Ineffective Ineffective for high weight moleculesfor high weight molecules– Small sized molecules Small sized molecules onlyonly



AquaphoresysAquaphoresys (1to 5mA)(1to 5mA)


– Ultrasounds + current stimulationUltrasounds + current stimulation– Low Ac current Low Ac current – High freq. UltrasoundsHigh freq. Ultrasounds

– Ineffective Ineffective for high weight moleculesfor high weight molecules– Small sized molecules Small sized molecules onlyonly– Ionic drug solutions PH may changeIonic drug solutions PH may change– Electrolysis (ionic separation)Electrolysis (ionic separation)

Low Ac current level applied



Is a Proprietary Patented Technology from Mattioli Engineering Engineering.

The only US FDA Cleared Device as alternative to injections (Top n.1) Micro-molecules and MACRO-molecules are safely delivered. Using the skin’s water based “channels” (aquaporins). Low and controlled current pulses delivered to the skin No skin damage, no adverse effects, no contraindications No effect on the substance being inserted/”injected”. Faster than traditional Ionthophoresis / Galvanic devices (same

amount of product)



What the Technology is What the Technology is used for?used for?


FOR EDUCTIONAL PURPOSES ONLY

Dermatology treatments.Dermatology treatments.Skin rejuvenation and bio revitalization. Skin rejuvenation and bio revitalization. Cellulite treatments.Cellulite treatments.Fat depositsFat depositsHyperHidrosis (Botulinum toxine administration)HyperHidrosis (Botulinum toxine administration)Acne pathologies.Acne pathologies.Hormone replacement treatmentsHormone replacement treatmentsPre laser treatments.Pre laser treatments.Pre and post plastic surgery sessions.Pre and post plastic surgery sessions.Replacing injections for Mesotharapy applications.Replacing injections for Mesotharapy applications.

Transderm® Meso® System®Transderm® Meso® System®



Transderm® Meso® System ®Transderm® Meso® System ®

Meso-Botulinum Toxine applications.Meso-Botulinum Toxine applications.Wrinkles treatments.Wrinkles treatments.Stretch mark treatments.Stretch mark treatments.Actinic Keratosis applications.Actinic Keratosis applications.Steroids applicationsSteroids applicationsPain managementPain managementRheumatic and post rheumatic pathologies.Rheumatic and post rheumatic pathologies.Sports medicine (F.C. Juventus)Sports medicine (F.C. Juventus)



Who is this Top No.1 Who is this Top No.1 technology available for?technology available for?


Dermoelectroporation® is available for:Dermoelectroporation® is available for:

Skin Care Specialists that want to optimize the delivery of a Skin Care Specialists that want to optimize the delivery of a high range of ingredients and not only a very few of high range of ingredients and not only a very few of them…..them…..

Clinics/salons that realize the limitation of conventional Clinics/salons that realize the limitation of conventional beauty treatments and want to offer additional beauty treatments and want to offer additional treatments with a significant improvement in efficacy to treatments with a significant improvement in efficacy to move ahead off common level clinics / salon….move ahead off common level clinics / salon….

..Providing a wide range of applications in only one device ..Providing a wide range of applications in only one device and/or improving existing protocols on use.and/or improving existing protocols on use.



MMattioli Engineering’s Solutionattioli Engineering’s Solution

Scientific principleScientific principle


Dermoelectroporation® utilizes the skin water basedDermoelectroporation® utilizes the skin water basedchannels to allow ionic drug solutions to penetrate due tochannels to allow ionic drug solutions to penetrate due tocontrolled current delivered to the patient.controlled current delivered to the patient.

((Dermoelectroporation® stimulates the opening of the existing water based Dermoelectroporation® stimulates the opening of the existing water based channels to channels to

create a transdermal passage to deliver drugs deep into the derma.)create a transdermal passage to deliver drugs deep into the derma.)



SScientific principlecientific principle

-Reproduces transient changes in skin microstructure Reproduces transient changes in skin microstructure

-Current flowing through the extra cellular matrix -Current flowing through the extra cellular matrix

(mainly composed by water, ions, and glycosaminoglycans) to make the (mainly composed by water, ions, and glycosaminoglycans) to make the

--Long-chained glycosaminoglycans to ,transiently, orient themselves to Long-chained glycosaminoglycans to ,transiently, orient themselves to create “channels” create “channels” (Water based ones)(Water based ones) allowing the delivery of allowing the delivery of Macromolecules Macromolecules through the skin. through the skin.

No cell injury No cell injury (i.e. fragmentation of cytoplasm or nucleus, abnormalities of (i.e. fragmentation of cytoplasm or nucleus, abnormalities of plasma membrane due to low current intensity used).plasma membrane due to low current intensity used).

((V., Ruggiero, M., and Magnelli, L.: Angiogenesis and the unique nature of tumor matrix. Mol. Biotech. 21: 85-90, 2002.).V., Ruggiero, M., and Magnelli, L.: Angiogenesis and the unique nature of tumor matrix. Mol. Biotech. 21: 85-90, 2002.).


Cells

SScientific principlecientific principle



Substances drivenSubstances driventthroughhrough


Transderm® Meso® System ®Transderm® Meso® System ®


What substances are driven?What substances are driven?•Collagen•Hyaluronic Acid•Lidocaine•L-Carnitine•Vitamins•Amino Acids•Heparin•Elastine•Mesotharapy Procedures•Glutathione

•Hormone Replacement•Phosphatidylcoline•Aminophylline•Hyaluronidase•MTE-4•Ionic skin tissue growth gel•Steroids•Botulinum toxine (Studies available from May 2007)(Studies available from May 2007)•Growth Factors•Lymidiral•Veno-M•Placentex•Diclofenac

•And many other “cocktails”…..


EExistingxisting Technolog Technologiesies

Why Transderm has been Why Transderm has been indicated as alternative to indicated as alternative to

injectioninjection



Dermoelectroporation®: Dermoelectroporation®: Delivery pulses principleDelivery pulses principle


DDelivery pulses principles elivery pulses principles

Dermoelectroporation (0 - 5mA)Human use

– Low and controlled current - No skin damage– Macro molecules deliverable– No adverse effects– No Contraindications– To be used on human beings Low and controlled Low and controlled

current level appliedcurrent level applied



Practicing with Practicing with Dermoelectroporation®.Dermoelectroporation®.



Dermoelectroporation is a 2 steps Procedure:Dermoelectroporation is a 2 steps Procedure:

It forsees a preventive Microdermabrasion to reduce the skin It forsees a preventive Microdermabrasion to reduce the skin impedance and to optimize the useimpedance and to optimize the use

ofof

Transderm® Meso® System ® for transdermal delivery of productsfor transdermal delivery of products





Dermoelectroporation®: Dermoelectroporation®: Features,Advantages & Features,Advantages &

BenefitsBenefits


FeaturesFeatures of Dermoelectroporation® of Dermoelectroporation®

- Capability to transdermally deliver ionic drug solutions

- Capability to transdermally deliver both micro and macromolecules (greater than 800,000Dalton)

- No electrolysis of ionic drug solution or variation in the ionic drug solution pH

- Both positive and negative ions of the drug are transdermally delivered at the same time

- Performing Microdermabrasion first promotes the transdermal delivery rate

- Reproducibility of dose delivered

- Non-invasive

- No trauma from injections


-Transderm fits perfectly in already existing protocols to improve -Transderm fits perfectly in already existing protocols to improve and shorten outcome and shorten outcome (compatibility)(compatibility)..

-Transderm allows users to have so many different applications in -Transderm allows users to have so many different applications in only one device.only one device.(substances delivered)(substances delivered)

-Transderm cancel completely the fear of needles and other -Transderm cancel completely the fear of needles and other invasive treatments.invasive treatments.(Needles free injection system)(Needles free injection system)

-Transderm is the Top N.1 technology FDA cleared as “alternative -Transderm is the Top N.1 technology FDA cleared as “alternative to injections”.to injections”.

AdvantagesAdvantages of Dermoelectroporation® of Dermoelectroporation®


The Growth of non surgical procedures. (source (source Aesthetic Buyers Aesthetic Buyers

Guide 2006 )Guide 2006 )

“Growth of non-surgical aesthetic procedures is outpacing surgical

procedures by a margin of three to one, with dermal fillers being only

second to Botox in this category. This demonstrates that the consumer

shift towards less invasive correction and heavily towards the non

invasive segment.”

“The global dermal fillers market was valued at $442 million in 2005 – an

increase of 25% from the previous year.”



BODY SHAPING MARKET

Aesthetic Buyers Guide 2006 –

“The global market for body shaping devices continues to expand strongly. Over

the next five years, overall sales of body shaping systems will rise 25.1% per year,

from $182.8 million in 2005 to an estimated $559.9 million in 2010.”

“In 2005, almost 69% of procedure fees were represented by liposuction, asurgical technique that offers virtually guaranteed removal of small fat

deposits ina single procedure. However, risks associated with surgery and relatively

longrecovery times will result in minimal procedure growth of just 3.5% per

year forliposuction, while newer, non-invasive therapies will expand rapidly.”



Benefits Benefits of Dermoelectroporation®of Dermoelectroporation®

Some of the Benefits Some of the Benefits Dermoelectroporation®Dermoelectroporation® can give: can give:

1)1) Patients are not more afraid of any “was-invasive” procedurePatients are not more afraid of any “was-invasive” procedure2)2) No psychological shock in getting the treatment done No psychological shock in getting the treatment done 3)3) No risk of contamination hazard due to needlesNo risk of contamination hazard due to needles4)4) Increasing number of treatments per day/month because…Increasing number of treatments per day/month because…


Benefits Benefits of Dermoelectroporation®of Dermoelectroporation®

TransdermTransdermIncreases theIncreases thenumber ofnumber ofhappy patient’s! happy patient’s!

..word of mouth!!..word of mouth!!



Dermoelectroporation®: Dermoelectroporation®: ResultsResults


Courtesy of Dr. Jaggy Rao, MD University of Edmonton ,Alberta,CanadaCourtesy of Dr. Jaggy Rao, MD University of Edmonton ,Alberta,Canada

Before

RRhythids - Canadahythids - Canada

After

2 sessions – 2 weeks apart each other3ml Hyaluronic acid 15mg/ml


Stratum CorneumStratum Corneum

EpidermisEpidermis

DermisDermis

HypodermisHypodermis

1.700.000dalton Hyaluronic acid delivery through the dermis to hypodermis using Transderm® ionto system1.700.000dalton Hyaluronic acid delivery through the dermis to hypodermis using Transderm® ionto system

Courtesy of Dr. Jaggy Rao, MD University of Edmonton ,Alberta,CanadaCourtesy of Dr. Jaggy Rao, MD University of Edmonton ,Alberta,CanadaBBiopsy on HA - Canadaiopsy on HA - Canada


CCellulite treatment - Italyellulite treatment - Italy

Mattioli Engineering © All rights reserved – Do not distribute – For internal use only


AfterBefore

Hairdresser , 44 years oldHairdresser , 44 years old

Courtesy of Prof. Massirone, Courtesy of Prof. Massirone, President A.M.E , A.M.I.Est. -. Milan ItalyPresident A.M.E , A.M.I.Est. -. Milan Italy

11 patients - 11 patients - Females.Females.

II, III and IV level II, III and IV level cellulite.cellulite.

8 consecutive weeks, 8 consecutive weeks, once per week once per week session.session.

1 ml Aminophylline + 1 ml Aminophylline + 2 ml Lymdiaral + 2 ml 2 ml Lymdiaral + 2 ml Veno-N. Veno-N.


CCellulite treatment - Italyellulite treatment - Italy

Mattioli Engineering © All rights reserved – Do not distribute – For internal use only


AfterBefore

Shopkeeper, 34 years oldShopkeeper, 34 years old

Courtesy of Prof. Massirone, Courtesy of Prof. Massirone, President A.M.E , A.M.I.Est. -. Milan ItalyPresident A.M.E , A.M.I.Est. -. Milan Italy

11 patients - 11 patients - Females.Females.

II, III and IV level II, III and IV level cellulite.cellulite.

8 consecutive weeks, 8 consecutive weeks, once per week once per week session.session.

1 ml Aminophylline + 1 ml Aminophylline + 2 ml Lymdiaral + 2 ml 2 ml Lymdiaral + 2 ml Veno-N. Veno-N.


CCellulite & Adiposity Treatment -ellulite & Adiposity Treatment -USAUSA


before

after

Cellulite Treatment Protocol:Delivered every 1-2 weeks until desired result is achieved (usually 3-8 treatments) Areas are referred to as abdomen, thighs, etc.Per 5 cc syringe:4 cc Hyaluronidase 300 units/mL+ 4 cc L-carnitine 500 mg/mL+2 cc Phosphatidylcholine 100 mg/mL4 syringes used per session.

Courtesy of Dr. suneil JainCourtesy of Dr. suneil Jain -. Scottsdale AZ - USA -. Scottsdale AZ - USA


PPost-liposuction correction for ost-liposuction correction for abnormal fat deposition-USAabnormal fat deposition-USA


before

after

Courtesy of Dr. suneil JainCourtesy of Dr. suneil Jain -. Scottsdale AZ - USA -. Scottsdale AZ - USA

Body Sculpting Protocol: Delivered every 1-2 weeks until desired result is achieved (usually 2-10 treatment) Areas are referred to as abdomen, lateral thigh, medial thigh & back.Per 5 cc syringe: 2 cc L-carnitine 500 mg/mL + 3 cc Phosphatidylcholine 100 mg/mL4 syringes used per session.


Courtesy of Dr. Chuah, MD Kuala Lumpur - MalaysiaCourtesy of Dr. Chuah, MD Kuala Lumpur - Malaysia

LLifting - Malaysiaifting - Malaysia

Delivered once for total Delivered once for total of 1 treatment.of 1 treatment.

Prepare solution using a 5cc5cc syringe filled by Hyaluronic Acid cocktails through Super Super PLDPLD.

Ultrapeel Ultrapeel microdermabrasionmicrodermabrasion - arm test, 2 passes mid lvl power -followed by hand gommage. Deliver transdermally HA cocktail 10mins10mins each side medium time using TransdermTransderm® ® technology.

Apply Calmin MaskMask for 10 minutes

Apply BasicBasic cream and SPF SPF cream


Stratum CorneumEpidermisDermisHypodermis

800.000dalton Hyaluronic acid delivery 800.000dalton Hyaluronic acid delivery throughthrough the dermis to hypodermis using Transderm® ionto system the dermis to hypodermis using Transderm® ionto system

BBiopsy with Hyaluronic acidiopsy with Hyaluronic acidCourtesy of Dr. Stefania Pacini, MD University of Florence,ItalyCourtesy of Dr. Stefania Pacini, MD University of Florence,Italy


Test of minor on an untreated part


BBotulinum toxine for HyperHydrosisotulinum toxine for HyperHydrosisCourtesy of Dr. M.CavalliniCourtesy of Dr. M.Cavallini , Plastic surgery specialist , Milan , Italy , Plastic surgery specialist , Milan , Italy

Before

After

6 cases – all female patients6 cases – all female patients Sweating measurement with Test of minorSweating measurement with Test of minor Delivery of 50 units of botulinum toxine per axilla Delivery of 50 units of botulinum toxine per axilla

(diluted with 2ml saline solution)(diluted with 2ml saline solution) Time of treatment: 10 minutesTime of treatment: 10 minutes Control after 2 weeksControl after 2 weeks Test of minorTest of minor to quantify the result after 14 – 20 to quantify the result after 14 – 20

days.days.


–Botulinum Toxin magnificationBotulinum Toxin magnification

150.000dalton Botulinum Toxin transdermal delivery till muscles using Transderm® ionto system150.000dalton Botulinum Toxin transdermal delivery till muscles using Transderm® ionto system

Courtesy of Dr. Stefania Pacini, MD University of Florence , ItalyCourtesy of Dr. Stefania Pacini, MD University of Florence , Italy

BBiopsy with Botulinum toxineiopsy with Botulinum toxine

Stratum CorneumStratum Corneum

EpidermisEpidermis

DermisDermis

Deep HypodermisDeep Hypodermis

MusclesMuscles

Scientific complete doocumentation available from April 2007Scientific complete doocumentation available from April 2007



Dermoelectroporation®: Dermoelectroporation®: Summarizing……Summarizing……


InIn other words…. other words….

Dermoelectroporation technology ……

– utilizesutilizes the skin’s water based “channels” – IncreaseIncrease the skin permeabilitypermeability to allow transdermal delivery of

micro-molecules and macro-moleculesmacro-molecules – ControlledControlled electrical pulsespulses delivery ((Average current value on the patient is zero)Average current value on the patient is zero)..

– No modificationNo modification of the ionic drug solutions pHpH and nono electrolysiselectrolysis effect of the ionic solution itself.

– Dermoelectroporation is fasteris faster than traditional Ionthophoresis devices to deliver the same amount of ionic drug solution.

– Dermoelectroporation does not needdoes not need any skin pH-Compensating patch, nor pre-charged compounds, nor carrying Gel nor others media to get the drug successfully delivered.


Any Questions?Any Questions?

DDermoelectroporation® ermoelectroporation® provides..provides..

Copyright 2008 © Mattioli Engineering All rights reserved Dermoelectroporation®: the only one US FDA approved alternative to injection Mattioli Engineering.

Documents

dermoelectroporation

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delivery existing technologies

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revolutionary technologies

delivery of active ingredients

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