No-Needle Mesotherapy™ lIpo KoNtoUr

No-Needle Mesotherapy™
LIPO KONTOUR
Presentation set
NO-NEEDLE MESOTHERAPY TM LIPO KONTOUR – basic introduction
1. What is BTL No-Needle Mesotherapy™ Lipo Kontour?
3
What diagnoses can NNM™ treat ?
4
Fat-dissolve
4
Cellulite
4
Wrinkle
5
Hyperpigmentation
5
2 How does NNM™ work ? 6
2.1
Break-through non invasive transdermal penetration principles
6
2.2
4 phases of Aquaphoresis™ in detail
8
2.3Active substances in detail
1.1
3 Can we prove the effectiveness of NNM™ ? 12
17
3.1Scientifical studies proving the effectiveness of transdermal penetration
17
3.2NNM™ patient verification studies
19
3.3NNM™ sample clinical cases
30
4 What is the typical workflow around NNM™?
38
5 What are NNM™ typical benefits ? 38
5.1Advantages for the owner of NNM™
38
5.2Advantages for patients
38
5.3
Financial model
39
5.4References
40
6 page 2
Contacts
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1.
What is BTL No-Needle Mesotherapy™ Lipo Kontour?
BTL No-Needle Mesotherapy™ Lipo Kontour (further only NNM™) is a modern alternative to traditional injection
mesotherapy method.
BTL NNM™ device is based on the introduction of new treatments designed to address multiple applications in body
recontouring. Treatment protocols are based on non-invasive transdermal penetration utilizing dual wavelength laser and
three proprietary electrical waveforms. The therapy protocols are designed to impact lipolytic processes in sub-dermal fat
layers.
BTL’s unique technology is positioned as a first choice treatment modality for spas and medical clinics seeking to attract
patients for body recontouring & facial therapies.
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1.1
What diagnoses can NNM™ treat ?
1.1.1fat-dissolve
1.1.2
Cellulite
1.1.3
Wrinkle
1.1.4
Hyperpigmentation 1.1.1
Fat-dissolve
NNM™ Fat-Dissolve care therapies represent a significant breakthrough in one of the most dynamic segments of
aesthetic therapy market. The NNM™ technique is the most complete, non-invasive solution to the challenge of treating
sub-dermal fat. Treatment protocols are free of pain, bruising,erythema and the potential for allergic reaction common
with invasive as well as traditional needle based procedures.
Protocol: Abdomen, age: 35, volume: 15 cm circ. decrease
Before Tx After 5 Tx After 10 Tx
2 months after
NNM™ Fat-Dissolve care is an innovative non-invasive alternative to injection lipo-dissolve therapy or liposuction. In
addition to small areas of fat-loss, stretch-mark, and cellulite reduction, the treatment that improves skin tone, elasticity,
and increase collagen production that is impeded through the natural aging process. However, Fat-dissolve care does not
stop the aging process. Fat deposits can appear again throughout your lifetime.
NNM™ Fat-Dissolve treatments are exploiting a new permeation enhanced active compound designed to address
multiple applications in body recontouring. Treatment protocols are based on non-invasive transdermal penetration
utilizing patented Aquaphoresis™ technology.
Fat-Dissolve care applications
Abdomen
Buttock
Lower back (Flanks)
Thighs (Inner, Back)
Under chin
Upper arm
Upper back
1.1.2
Cellulite
Over 80% of adult women experience cellulite problems. Cellulite, or dimpled skin on the thighs, buttocks and abdomen
appears to have little relation to lifestyle – even those who exercise regularly are not immune to the problem. Cellulite
impacts women frequently and men are rarely affected.
Protocol: Buttock, age: 38 years, cellulite stage: 2  1
Female skin is thinner, orientation of collagen and
elastine fibers is different and hormonal changes play
an important role.
Anti-cellulite care applications
Abdomen
Buttock
Flanks
Thighs (front, back)
Upper arm
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Before Tx After 5 Tx
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1.1.3
Wrinkle
Wrinkle appearance is a natural aspect of the human skin aging process – which causes worsening of skin hydration
and decrease of elastin and collagen production. Various factors play a role, including excess UV exposure, the presence
of pollutants in our environment, smoking, and higher concentrations of free radicals. Delivery of specialized active
substance cocktails that address various facets of the skin’s aging process contribute to skin rejuvenation and repair.
Generally, this problem is unstoppable however it can be significantly slowed down.
Anti-wrinkle care applications
Forehead
Cheeks
Chin
Neck
Perioral
Periorbital
After 7 Tx
1.1.4
Hyperpigmentation
Hyperpigmentation may occur as a result of genetic predisposition or as a result of ultraviolet light exposure, infection,
hormones, drugs, acne or topical chemicals applied to the skin. Significantly, incorrectly applied topical exfoliation
products may cause hyperpigmentation especially when applied to vulnerable, darker skin types.
Hormonal melasma is frequently exacerbated during pregnancy, at menopause, and with the use of oral contraceptives.
Consequently, brief sun exposures without sunscreen can cause dramatic changes in skin pigmentation. Medications
are also a frequent cause of rapid onset Hyperpigmentation. Significantly, post-inflammatory hyperpigmentation is
often seen after ‘over treatment’ with laser or intense pulsed light (IPL). Although the condition may resolve with time,
immediate treatment is important, since this will maintain the patient’s confidence as well as determine the ultimate
outcome.
NNM™ whitening care therapies are using transdermal delivery of specific ingredients is useful in the treatment and
reduction of hyperpigmentation. NNM™ utilizes a carefully balanced program based on the penetration of a proprietary
active substance formula that addresses the problem of excess melanin deposition. Treatment goals are aimed at
achieving improvements in skin quality and a reduction of pigment in affected areas.
Whitening care applications
Arms (Upper, Lower)
Forehead
Décolleté
Cheeks
Chin
Periorbital
Perioral
Pigmented spots (body)
After 5 Tx
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2
How does NNM™ work ?
NNM™ exploits most recent know-how in non-invasive transdermal penetration based on electroporation principles.
The NNMtm treatment is based on a new technique called Aquaphoresistm, which uses bi-wavelength low-level laser
therapy (LLLT) technology and specialized electrical waveforms to help reactivate specific physiological processes
in tissue that contribute to the formation of cellulite. These processes include microcirculation, lymph drainage and
enhanced blood flow.
Aquaphoresis™ is very patient friendly and the patient will not experience any discomfort. All parameters used in
Aquaphoresis™ are adjustable to suit each patient and may be fully customized to eliminate any discomfort. After each
session the patient may return to normal activity with no downtime.
The Aquaphoresis™ process is based on the synergic effect of:
Laser stimulation
Effect of active substances in deep tissue
Muscle toning & stimulation
Lymphatic stimulation
2.1Break-through non invasive transdermal penetration principles
Transdermal penetration of active substances through intercellular route
Electroporation – Lipid bilayer penetration model
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The efficiency and depth of penetration achieved with NNM™ has been verified through a University based radioisotope
lymphography study (see further reference).
Penetration on cellular level
aquaporin stimulation
Aquaporins are a family of specialized proteins that reside in the membranes of cells and control the inflow and outflow
different molecules incl. water based ones
2003 Nobel Award of Chemistry (Peter Agre, Rod MacKinnon)
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2.2 4 phases of Aquaphoresis™ in detail
NNM™ – The role of laser cluster in Aquaphoresis™ concept
Laser is a kind of light with special characteristics. The light has the crucial mean for cells. The lack of light causes deffects
in cells grow and other normal funcions.
Red laser light (685 nm) does not penetrate into much depth
– all its energy is “consumed“ in epidermis and subcutis.
The red laser energy is in the tissue absorbed by cytochromatic
cells (Image 1). The light energy is transformed to cell energy in
mitochondrias(6) which are than stimulated and better prepared
for fat consumption. At the same time during the light passing
the permeability of the cell membrane(13) is increased which
leads to better nourishment, functioning and division of the cells.
These processes:
activate macrophages in the tissue (large cells responsible for
searching and destroying of the bacterias and other alien stuff in
the body)
increase activity of fibroblasts (connecting cells which support
sythesis of collagen in tissue)
causes increases rinsing of specific enzymes.
Infrared laser light (830 nm) penetrates deeper and stimulates creation of
blood vessels in corium in long term) repeated application. This increases
blood flow in this area (this is to be seen at the echograph images) which
helps to wash away the waste products comming as byproducts from
metabolism of fat, sugar, and proteins. Another effect is global softening
of the tissue and this stimulates new lymphatic vessels to grow (this
multiplicates the effect
of “lymphatic support phase“).
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NNM™ – Active transport phase in Aquaphoresis™ concept
Mechanical massage performed with handpiece and the transport of active substances into epidermis done by special
electrotherapeutic currents with transport function ensures:
improving the metabolism in epidermis, subcutis and corium
local improving of microcirculation
enhancement of oxygen supply in the tissue
higher fat utilization
better cell nourishment
The current used is a sharp format delivered as a series of pulses of
set frequency and amplitude. The voltage used is set at the threshold
of the patient and delivered for a predetermined time period based
on the tissue area being treated. The physiological aspects of the
waveform used in this phase are based on the ability of the current
to increase the permeability of the skin which allows to carry the
ingredient molecules contained in the conductive gel through the skin
into the desired area. The gel composition is designed to increase
the hydration level of the treated tissue area. Increased hydration is a
critical aspect of the transfer process. The molecules are delivered via
three basic routes in order of importance:
1. Via microconduits in the stratum corneum classified as water
channels
2. Via the appendages - sweat ducts, sebaceous glands and the hair
follicles
3. Via the intercellular route between the corneocytes in the stratum
corneum
Due to the increase in hydration the intercellular route is made slightly
more efficient since the spaces between the corneocytes increases
with enhanced hydration. The current form in the first phase ‚pushes‘
the ingredients into the tissue via the routes described above and the
ingredient mixes with interstitial fluid.
Once penetration has occurred, the second challenge is represented
by the need to place the ingredients directly into the target cell. The
surface of the cell wall membrane is normally unresponsive to
molecules other than those the cell needs for optimum function. The
passage of molecules into the cell itself is therefore controlled by
receptors, gates and proteins that act as regulators of molecule entry.
A key entry mechanism into the cell is controlled by a protein called
Aquaporin that acts as the ‚garage door‘ into the cell itself. A code or
match of molecule is required to enable the Aquaporin to receive the molecule into the cell. This is achieved as a secondary
function of the electrical waveform used in the first phase of treatment.
The waveform acts as an electrical door opener to allow passage of the molecule into the cell to allow it to modify
the fat cell.
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NNM™ – The muscle tonization phase in Aquaphoresis™ concept
By application of the electrotherapeutical current with stimulation component it is possible to:
activate, partly locally stimulate and tonizate the muscle
fibres (very well seen at the echograph images)
accelerate the microcirculation process (started in the
previous transport phase)
multiplies the metabolic turning and energetic output in
the area initially caused by active substances
These processes results in increased blood flow in the
tissue, muscle tonizating and reinforcement.
The wave form used during this phase is two-poles
interference – the amplitude modulated middle-frequency
current with AMS of 50 and carrier frequency 8000
Hz. This current has tropotrophy effects and stimulates
muscle fibres in such a way that causes muscle tonization
and contraction.
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NNM™ – The lymphatic circulation support process phase in Aquaphoresis™ concept
In this final phase the stimulation of muscle micropump is done by special structure
of electrotherapeutical current. This causes:
another increasing of blood flow in the tissue
higher consumption of oxygen and another energy sources in the area
metabolic turning in muscle in also increased
however the main effect is increasing of lymphatic drainage flow and consequently the outflow of the waste products
from the area
tissue swelling is reduced
The waveform used is H-wave – contact low
frequency electrotherapy. It is charasterics with
symetrical biphasic sharp pulses. The length of one
double pulse is 11.2 ms. The shape and lenght of the
pulse imitates physiological action potencial which
is optimal for stimulating free nervous receptors and
strong alfa and beta nervous nervous fibres – these
causes the effects desrcibed above.
The waveform characteristics also activates spinal
and supraspinal centres which lowers possible pain
perceptions.
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2.3 Active substances in detail
Fat-Dissolve care active substances
The proprietary formula used for NNM™ is based on a carefully balanced active ingredient mix. The therapy protocol
uses Phosphatidylcholine combined with other active substances and is designed to impact lipolytic processes in
sub-dermal fat layers.
The main ingredient in Fat-Dissolve active substances is Phosphatidylcholine (PPC) - a natural product found in human
body. Its main role in the body is to help emulsify and breakdown fat and cholesterol. It is a key constituent of cell
membranes and high density lipoproteins (the good cholesterol). PPC is derived from soybeans and has the same
molecular structure as the human body PPC. It is focused on dissolving of unwanted localized areas of fat.
List of main ingredients and their purpose
INGREDIENT
Active agent
Function
Lecithin
(PhosPhatydilCholin
/ PPC)
Mixture of various phosphatides
and triglycerides
Non-specific subcutaneous fat solubilizer, lipolysis agent,
strong hydration agent, prevent dryness
Polysorbate 20
Sorbimacrogol laurate
Absorption enhancer, skin emolient, solubilizer of active
agents and destroyed fat tissue
Tocoferol acetate
Vitamin E ester
Skin softener, emolient, keratin plasticizer, antioxidant, free
radical scavenger, anti aging, anti carcinogenic
Cinnamon Essential oil
Eugenol, cinnamylaldehyde,
benzaldehyde, pinene, eugenol
acetate
Dilating agent for peripheral arteries, promote interstitial
transport of substances, accelerate lipolysis, warming
action, mild adstringent, natural preservative
Ethyl salicylate
ethylester of salicylic acid
Antiinflammatory agent, tonic, stimulant, absorption
enhancer, preservative, warming action
Caffeine
Xanthin derivative
Lipolysis agent, U.V. absorber
Carnitine base
Lipolysis agent, energy booster
Carnitine tartrate
Lipolysis agent, lipid metabolism promoter
Nicotinic acid
Vitamin B3
Peripheral arteries dilatating agent, increase blood supply
of subcutaneous tissue
Sodium salicylate
Salt of salicylic acid
Intiinflammatory agent, antiseptic and preservative
Ascorbyl palmitate
Ester of ascorbic acid, vitamin C
Antioxidant, collagen synthesis promoter, anti wrinkle
agent
Biotin
Vitamin B7
Keratinocytes metabolism synergist, improve skin strength,
regulatory element
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Whitening care active substances
INGREDIENT
Active agent
Function
Ascorbic acid
Vitamin C
Antioxidant, collagen synthesis promoter, anti wrinkle agent
Malpighia punicifolia
Extract from Brazilian tree fruit
Antioxidant, collagen synthesis promoter, skin whitener, anti
wrinkle
Nicotinamid
Vitamin B3
Skin whitener, anti wrinkle agent
Emblica officinalis
Extract from tree
Indian Ajurveda Natural skin whitener, anti oxidant
Liquiritia glabra
Herb root extract
Skin whitener, antiinflammatory agent, immunosupressant
Sepiwhite MSH
Undecylenoyl phenylalanine
Powerful modern whitening agent
Agaricus Blazei
Beta glucans from japanese or
brazil mashroom
Immunomodulating agent, enhances immune function of skin
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Anti-cellulite care active substances
methylsulfonylmethane (MSM)
helps to maintain collagen by bonding it together, thus aiding in the formation
of flexible bonds between cells, which is important for cellular tissues
helps replenish and repair damaged skin
nicotinamide
is needed for proper microcirculation in skin
aids in the functioning of the nervous system and metabolism
of carbohydrates, fats and proteins
carnitin
transports the fatty acids as the energy sources to consumption the cells
(helps to shorten the phase when sugars are consumed by cells
– so fat reduction phase starts sooner than at normal occassions),
the mitochorians in cell are stimulated from laser phase
so the fat consumption in cells is improved
helps to improve the energy production from fatty acid, which
accelerates and makes the lipolysis more effective
in combination with arginin stimulates the effluence of STH
coffein
stimulates operation of central nervous system
boosts the transformation from fats to energy
natural diuretic agent
sodium salicilate
analgesic effect
anti-inflammatory effect
Garsia Cambogia extract
natural source of hydroxycitric acid the competitive inhibitor of adenosine
triphosphate-citrate. In the cytosol, ATP citrate lyase catalyzes the conversion
of citrate and coenzyme A to oxaloacetate and acetyl coenzyme A
(commonly referred to as acetyl CoA). Acetyl CoA is required for the synthesis
of fatty acids, cholesterol and triglycerides.
HCA appears to block the conversion of sugars and starches into fats, that this,
HCA is believed to help inhibit fat production.
HCA may suppress appetite by raising levels of certain brain chemicals such
as serotonin, a key stimulator of appetite.
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Amino acids
asparalgine (C4H7NO4)
asparagine is a precursor for the synthesis of RNA, DNA, and ATP (energy). Other asparagine process include; antibody
functioning, conversion of aspartate for cellular function, collagen assembly of enzymatic activity, and cell-to-cell
recognition
glutamine (C5H10N2O3)
increases hydratation of cells
Contributes to normal immune-system function
tyrosine (C9H11NO3)
tyrosine is a precursor of the adrenal hormones epinephrine and norepinephrine as well as of the thyroid hormones,
including thyroxine. Melanin, the skin and hair pigment, is also derived from this amino acid.
DL-Methionine (C5H11NO2S)
methionine is particularly important because it supplies sulfur--a mineral--that helps to maintain healthy skin tone
it assists in the breakdown of fats and thereby prevents the build-up of fat in the arteries, as well as assisting with the
digestive system and removing heavy metals from the body since it can be converted to cysteine, which is a precursor to
gluthione, which is of prime importance in detoxifying
the amino acid methionine is also a great antioxidant as the sulfur it supplies inactivates free radicals
valine (C5H11NO2)]
stimulates the growth of human skin fibroblasts – crucial for collagen production
It has a stimulating effect and is needed for muscle metabolism, repair and growth of tissue and maintaining the nitrogen
balance in the body
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ANTI-WRINKLE CARE ACTIVE SUBSTANCES
carbamid
skin whitening effect
pigment defect removing
aloe vera extract
posses cell regenerative properties
soothes damaged, irritated skin
highly moisturizing
adenosin
an energy collector and transformer which is involved
in all energy consuming biological processes
improves the skin’s energy level and its moisture content
and smoothes it
allantoin
stimulates cell regeneration in stressed, affected skin
improves rough and chapped skin
has an anti-inflammatory effect
manganese sulfate
accelerates the skins exfoliation process
moisturizes
beta-glucan
helps the skin to better cope with UV radiation induced stress
film-forming and moisturizing
stimulates immunity
reduces trans-epidermal water-loss (=TEWL)
Boswellia Extract
natural source of NSAID (non-steroidal anti-inflammatory drug)
Boswellia was found to improve blood supply and restore integrity of vessels
Ginseng extract
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3Can we prove the effectiveness of NNM™ ?
3.1Scientifical studies proving the effectiveness of transdermal penetration
List of full white paper studies (available upon request)
Title
Year
Authors
A pulsed electric field enhances cutaneous delivery
1998
P.G.Johnson, S.A.Gallo, S.W.Hui,
A.R.Oseroft
Effects of alternating curernt iontophoresis on drug deliery
1995
J.P.Howard, T.R.Drake, D.L.Kellogg
Electrical properties of skin at moderate voltages
1998
Y.A.Chizmadzhev, A.Indenbom,
P.I.Kuzmin, S.V.Galichenko, J.C. Weaver,
R.O.Potts
D.Miklavčič,T.Kotnik – University of
Ljubljana
Electroporation for electrochemotherapy and gene therapy
Electroporation of mammalian skin: A mechanism to enhance
transdermal drug delivery
1993
M.R.Prausnitz, V.G.Bose, R.Langer,
J.C.Weaver
N. Wilke, J. O. Brien, G. Casey, T. Doody,
D. Soden, A. Morrissey
Influence of electrode design on electric field
Low voltage electroporation of the skin
1998
Sek Wen Hui
Physical enhancement of transdermal drug application
2004
S.E. Cross, M.S Roberts
Role of pulse shape in cell membrane electropermeabilization
2003
T. Kotnik, G. Pucihar, M. Reberšek,
D. Miklavčič, L.M. Mir
Skin electroporation for transdermal and topical delivery
2003
A.R.Denet, R.Vanbever, V.Préat
Time-dependent ultrastructural changes to porcine stratum
1999
S.A.Gallo, A.Sen, M.L.Hensen, S.W.Hui
2001
M. Misefari, A. D´ Africa, M. Sartori,
F. Morabito
Transdermal drug administration
Transdermal drug delivery
Transdermal transport by hydroelectrophoresis: A novel method
for delivering molecules
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List of studies’s abstracts (available upon request)
Title
Year
Authors
A practical assessment of transdermal drug delivery by skin electroporation
1998
Mark R. Prausnitz
Analysis of enhanced transdermal transport by skin electroporation
1995
EDWARDS DA, PRAUSNITZ MR, LANGER R,
WEAVER JC
Assessing the potentional of skin electroporation for the delivery of protein - and
gene - based drugs
1998
Banga AK, Prausnitz MR
Cell membrane electropermeabilization by symmetrical bipolar rectangular
pulses*1 - Part I. Increased efficiency of permeabilization
2001
T.Kotnik, L.M.Mirb, K.Flisara, M.Puca,
D.Miklavi
Cell membrane electropermeabilization by symmetrical bipolar rectangular
pulses*1 - Part II. Reduced electrolytic contamination
2001
T.Kotnika, D.Miklavia, L.M.Mirb
Clinical applications of electrochemotherapy
1998
R.Hellera, R.Gilbertb, M.J.Jaroszeskia
Effect of electroporation on transdermal iontophoretic delivery of luteinizing
hormone releasing hormone (LHRH) in vitro.
2003
Bommannan DB, Tamada J, Leung L,
Potts RO
Effects of iontophoresis and electroporation on the stratum corneum
1998
A.Jadoula, J.Bouwstrab, V.Préata
Electrical properties of skin at moderate voltages: contribution of appendageal
macropores
1998
Chizmadzhev YA; Indenbom AV; Kuzmin PI;
Galichenko SV; Weaver JC; Potts RO
Electropermeabilization of cell membranes
1998
J. Teissié, N. Eynard, B. Gabriel and
M. P. Rols
Electroporation in cells and tissues - A biophysical phenomenon due to
electromagnetic - fields
1995
Weaver JC
Changes in skin structure and electrical properties following high voltage exposure
1999
Gowrishankar TR, Pliquett U, Weaver JC
Changes in the passive electrical properties of human tratum corneum due to
electroporation
1995
Pliquett U, Weaver JC, Langer R
Imaging of fluorescent molecule and small ion transport trough human stratum
corneum during high voltage pulsing: Localized transport regions are involved
1996
Pliquett U, Weaver JC
In vivo efficacy and safety of skin electroporation
1998
Rita Vanbever1 and Véronique Préat*
Lasers have new uses in plastic surgery
2003
Low level laser could revolutionize liposuction
2002
Sharon Worcester, Tallahassee Bure
Mechanistic studies of molecular transdermal transport due to skin
electroporation
1998
Uwe Pliquett
Role of pulse shape in cell membrane electropermeabilization
2003
T. Kotnika, G. Pucihara, M. Rebereka, D.
Miklavia and L. M. Mirb,
Skin electroporation for transdermal and topical delivery
2003
Anne-Rose Denet , Rita Vanbever and
Véronique Préat
The effects of iontophoresis and electroporation on transdermal delivery of
buprenorphine from solutions and hydrogels
2002
Fang J-Y.1; Sung K.C.2; Wang J-J.3; Chu C-C.3; Chen K-T.3
Theory of electrical creation of aqueous pathways across skin transport barriers
1999
Weaver JC, Vaughan TE, Chizmadzhev YA
Theory of Electroporation
1994
Weaver JC
Theory of electroporation of planar bilayer membranes: predictions of the aqueous
area, change in capacitance, and pore-pore separation
1994
Freeman SA, Wang MA, Weaver JC
Tissue electroporation for localized drug delivery
1995
Weaver JC, Langer R, Potts RO
Transdermal delivery of fentanyl: rapid onset of analgesia using skin
electroporation
1997
R.Vanbevera, G.Langersa, S.Montmayeura,
V.Préata
Transdermal permeation of neutral molecules by skin electroporation
1998
Vanbever, R., Leroy, M.-A., Preat, V.,
Transdermal transport efficiency during skin electroporation and iontophoresis
1996
Prausnitz MR, Lee CS, Liu CH, Pang JC,
Singh TP, Langer R, Weaver JC
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3.2 NNM™ patient verification studies
NNM™ – Improving local microcirculation – thermocamera images
Date of treatment: 2005, 7th July
Treated area: left thigh
Device: DermaWave No-Needle Mesotherapy
Treatment protocol: Thighs
Recording device:
Model: NEC San-ei Instr. 6 T 62 with detector HgCdTe
Temperature range: -50° to + 2000 °C
sensitivity: 0,1 °C
Accuracy: +/-0,5% of the scale
1. Before treatment
The left thigh shows very unconsistent temperature
(small different colour spots). These prove the
disturbances in the system of local microcirculation,
which is one of the main reason of cellulite
formation.
2. Laser treatment
The laser treatment stimulastes the mesolayer which
prepares the treated area for the next phases of
aquaphoresis treatment. As the laser light affects deep
tissue, it is not possible to see any imediate significant
thermal changes.
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3. After the laser treatmnet
The stimulative process in the tissue has been
started and it is possible to observe the slow
effect at the skin surface. It gets get generally
warmer and the spotty area is decsreased. We
can say that the tissue is ready for the second
phase of the treatment.
4. Electro treatment
The phase using electrotherapy current is
performed via gel containg the mixture of
active substances. Unfortunately the presence
of gel causes general calming of the area. The
effects will be visible later.
5. After the electro treatment
This image taken 10 minutes after the end of
the treatment proves global inmprovement of
microcirculation in the area. It is displayed in the
global warming of the skin and in large reduction
of the thermal “spots“.
Generally saying, by using the method
of Aquaphoresis treatment large reduction
of mircocirculation disturbances was reached
within about 35 minutes.
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NNM™ – Improving Local Microcirculation – ThermoCamera Images
Date of treatment: 2005, 7th July
Treated area: Stomach
Device: DermaWave No-Needle Mesotherapy
Treatment protocol: Stomach
Recording device:
Model: NEC San-ei Instr. 6 T 62 with detector HgCdTe
Temperature range: -50° to + 2000 °C
Sensitivity: 0,1 °C
Accuracy: +/- 0,5% of the scale
1. Before treatment
The stomach area shows very unconsistent
temperature (small different colour spots).
These prove the disturbances in the system of
local microcirculation, which is one of the main
reason of cellulite and other skin aesthetic
problems formation.
2. After the laser treatmnet
The stimulative process in the tissue has been
started and it is possible to observe the partial
effect at the skin surface. It gets get generally
warmer and the spotty area is decreased. We
can say that the tissue is ready for the second
phase of the treatment.
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3. Electro treatment
The phase using electrotherapy current is
performed via gel containg the mixture of active
substances. Unfortunately the presence of gel
causes general calming of the area. The effects
will be visible later.
4. After the electro treatment
Shortly after the electrotherapy phase it is
already possible to observe slow changes
in the thermal changes in the area. The
processes started in the tissue warms the gel.
5. After the electro treatment
This image taken 20 minutes after the end of
the treatment proves global inmprovement of
microcirculation in the area. It is displayed in the
global warming of the skin and in large reduction of
the thermal “spots“. At the upper part of stomach the
warming of the area even almost exceeded the set
thermal scale (large violet area).
Generally saying, by using the method of
Aquaphoresis treatment large reduction of
mircocirculation disturbances was reached in about
30 minutes of active treatment.
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NNM™ – Improving Local Microcirculation – ThermoCamera Images
Date of treatment: 2005, 7th July
Treated area: upper right arm
Device: DermaWave No-Needle Mesotherapy
Treatment protocol: Upper Arm
Recording device:
Model: NEC San-ei Instr. 6 T 62 with detector HgCdTe
Temperature range: -50° to + 2000 °C
Sensitivity: 0,1 °C
Accuracy: +/- 0,5% of the scale
1. Before treatment
The upper arm area shows very unconsistent temperature (small different colour spots). These prove the
disturbances in the system of local microcirculation, which is one of the main reason of cellulite formation.
2. After the laser treatmnet
The stimulative process in the tissue has
been started and it is possible to observe
the slow effect at the skin surface. It gets
get generally warmer and the spotty
area is decsreased. We can say that the
tissue is ready for the second phase of the
treatment.
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3. Electro treatment
The phase using electrotherapy current is performed
via gel containg the mixture of active substances.
Unfortunately the presence of gel causes general calming
of the area. The effects will be visible later.
4. After the electro treatment
Shortly after the electrotherapy phase it is
already possible to observe slow changes
in the thermal changes in the area. The
processes started in the tissue warms the gel.
5. After the electro treatment
This image taken 20 minutes after the end of
the treatment proves global inmprovement of
microcirculation in the area. It is displayed in the
global warming of the skin and in large reduction
of the thermal “spots“.
Generally saying, by using the method of
Aquaphoresis treatment large reduction of
mircocirculation disturbances was reached within
about 35 minutes.
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NNM™ – BW Echography Measurement
Measurement Date: 16.2.2005
Measurement Place: BTL, Prague
Sonography Device: device BTL-8140, probe: BTL-8750DL
Description: The images taken before and after NNM™ treatment. The white measure line show volume loss in the fat layer.
Significant breaking of the fat structures is obvious (white objects in corium)
Before Treatment
After Treatment
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NNM™ – BW Echography Measurement
Measurement Date: 17.2.2005
Measurement Place: BTL, Prague
Sonography Device: device BTL-8140, probe: BTL-8750DL
Description: The images taken before and after NNM™ treatment. The white measure line show volume loss in the fat layer.
Significant breaking of the fat structures is obvious (white objects in corium)
Before Treatment
After Treatment
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NNM™ – Color Doppler Measurement
Measurement Date: 9.2.2005
Measurement Place: Hospital Na homolce, Prague
Description: The images taken before and after NNM™ treatment. Blue and red spots show increasing blood flow
in the corium.
Before Treatment
After Treatment
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Study to Verify the Transdermal Delivery of a Micronized Gel with Active Ingredients Using „No Needle Mesotherapy”
(NNM)
ALBERTO HUGO CROCI M.D., SALVADOR GUSTAVO NIETO M.D. LEIBASCHOFF M.D., A. JULIANA MELAMED
LEIBASCHOFF M.D.,
An instrumental study using radioisotope lymphography was
carried out to determine the effectiveness of the No-Needle
Mesotherapy device.
The study objective was to monitor absorption of the gel
ingredients to a specific depth in tissue and to determine if the
active ingredients were present after absorption in the lymphatic
system of patients with Edematous Fibrosclerotic Panniculopathy
(Cellulite).
CONCLUSION- The study confirmed that the micronized gel
containing the active ingredients was absorbed and was present
in tissue at specific time intervals up to 24 hours after
administration.
Effectiveness of the Treatment of Cellulite Using the Aquaphoresis Principle
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Prague, C-BB center
This study focuses on the assessment of effectiveness of using
the treatment based on aquaphoresis principle for cellulite
(orange skin). The study includes the effectiveness analysis of the
treatment by aquaphoresis device.
Conclusion – On the observed sample the study proved that
the cellulite treatment using device with aquaphoresis principle
was significantly effective. Although not reaching linear progress
in the effect of the treatment process, the whole duration of the
process brought indispensable improvement.
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NNM™ electroporation: transdermal drug delivery improves photoaged skin
Elsie Erika Visser, Supervisor Prof. J.R. Snyman, Department of
Pharmacology, University of Pretoria
An in vivo study was conducted to observe the effects of the
NNM™ (an electroporation system) on photoaging through
transdermal delivery of a combination of agents.
DermawaveTM electroporation of the combination drug
containing, DMAE, RA and HA resulted in a significant reduction
of coarse wrinkles after 5 treatments (1 treatment per week).
This is comparable better than reported results with mesotherapy
in literature.
In vitro effects of the combination of agents and individual
components on collagen synthesis and cell proliferation in chick
embryonic fibroblasts were also studied. Hyaluronic acid, retinoic
acid, DMAE and the combination drug reduced the effects of
photoaging.
Crystal violet st aining of in vitro cell cultures showed an
increase in fibroblast proliferation when treated with DMAE, and
a decrease in cell growth when treated with RA and HA as
anticipated. Alcian blue staining indicated increased collagen
synthesis with DMAE, HA and the combination drug. Thus the
combination drug showed an enhanced effect when compared
to its different isolated components.
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3.3 NNM™ sample clinical cases
Fat-Dissolving
Protocol: Abdomen, age: 35, volume: 15 cm circ. decrease
Before Tx After 5 Tx After 10 Tx
2 months after
Protocol: Abdomen, age: 28, volume: 9 cm circ. decrease
Before Tx After 6 TX After 8 Tx
Protocol: Buttock, age: 28, volume: 6 cm circ. decrease on each thigh
Before Tx page 30
After 5Tx After 10 Tx
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Cellulite
Before Tx After 4 Tx
Protocol: Buttock, age: 38 years, cellulite stage: 2  1
Before Tx After 5 Tx
Protocol: Abdomen, age: 58 years, cellulite stage: 3  2
Before Tx After 10 Tx
Protocol: Upper arm, age: 56 years
Before Tx page 32
After 4 Tx
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Wrinkle
Photos courtesy of Dra.Monica Monroy, Toluca, Mexico
Before TxAfter 1 Tx
46 years, after 7 Tx
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Hyperpigmentation
Before TxAfter 5 Tx
Protocol: Combined
Before TxAfter 5 Tx
Protocol: Perioral & chin, age: 45
Before TxAfter 10 Tx
Protocol: Perioral & chin, age: 41
Before TxAfter 10 Tx
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4
What are NNM™ typical benefits ?
4.1Advantages for the owner of NNM™
Enhance your portfolio of body recontouring therapies with this unique
and new method suitable for combination with other therapies
Long lasting profitable investment
Treats patients with broad scale of diagnoses (body + face treatments)
Operation delegated to ancillary staff
No periodical technical service required
Standardized drug cocktails for best results
Continuing research&development
Free upgrade to new applications
Central marketing support
Promotional materials
Method promotion
Clinical research
Events&conferences presence
Advertisements in media
4.2Advantages for patients
Pain free & pleasant
No swelling or bruising
Treatment of broad scale of diagnoses
Safe, non-invasive
No down time, no side effects
Lasting treatment achievements
Great results!!!
5
What is the typical workflow around NNM™?
Therapy characteristics
Typical treatment session lasts about 30 minutes
The whole protocol consists of a series of 8–10 sessions
Typical treatment benefits are seen after 4 or 5 visits although results
obviously depend on the severity of the cellulite, wrinkle or other conditions
Aquaphoresis™ is very patient friendly - the patient will not experience
any discomfort
All parameters used in Aquaphoresis™ are adjustable to suit each patient
and may be fully customized to eliminate any discomfort
After each session the patient may return to normal activity with no downtime
(lunch time sessions)
In the first phase of the treatment series, patients should schedule min. three visits
over 10–14 days to ‘kick start’ the repair process
Lasting results – refresh sessions (min. 2) recommended after 8-12 months
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5.3
Financial model
Purchasing price
21 000
EUR
Cost of borrowing the investment
9
% p.a.
Business model period
4
years
Monthly payment
540
EUR
Sum of purchasing price + all interests
25 928
EUR
Working days in 1 year
250
Session cost (Active Substance + Gel)
16
EUR
Average session price
80
EUR
# of sessions
4
6
8
Revenue (EUR)
320
480
640
# of months needed to pay the device
3,9
2,6
2,0
# of sessions
1 000
1 500
2 000
Revenue (EUR)
80 000
120 000
160 000
Active substances
16 000
24 000
32 000
Loan payment
6 482
6 482
6 482
Total
22 482
30 482
38 482
Profit (EUR)
57 518
89 518
121 518
Profit in 4 years (EUR)
230 072
358 072
486 072
Purchasing the unit
Per session
Per day
Per year
Costs (EUR)
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5.4 References
REFERENCE LIST
Christopher Ho M.D. – Steve; Tel: 323 578 6965 Tel: 213 687 3214
Irradience Medical Group
Dermatologist
Los Angeles, CA
Getting great results - does not select any overweight patients
Douglas J. Key M.D. – Patricia; Tel: 503 291 1953
Key Laser Institute
Plastic Surgeon
Portland, OR
Getting good results - doing both stand alone and combination treatments
Hale Hedley M.D. Contact Jennifer; Tel: 904 296 7100
Aelan Medical Spa
Medical Spa
Jacksonville, FL
[email protected]
Getting good results - patient selection is key to good results
Charles T. Goodson MD - Wendy; Tel: 803 796 3820
Bariatric Medical Clinic
West Columbia, SC
[email protected]
Getting excellent results. Not doing surgeries - bariatric treatments 5-10 NNM treatments,
nutritional support program and patient selection are key.
Carmen Meherg - Christie; Tel: 205 967 9944
SmartSkin Day Spa
Aesthetic Practice
Birmingham, AL
Getting great results - patient selection is key
Layne Nisenbaum M.D. - Joanna; Tel: 561 832 1950
Island Dermatology
Dermatologist
Palm Beach, FL
Loves facial treatment - has a regular clientele
Carol Ridenour M.D. Liz & Paula; Tel: 225 201 2090
Louisiana Women’s Center for Aesthetics
Aesthetic Medical Practice
Baton Rouge, LA
Great results - doing in combination with needle mesotherapy treatments
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Testimonials
„Our office has been doing the No Needle Mesotherapy treatments since October of 2005 and we have been very
pleased with the results thus far. Our clients are seeing great changes, not only the reduction in cellulite but in the
tightness and softer texture of their skin. We look forward to advancements in the treatment system that results in
even higher outstanding patient satisfaction.”
Marie Strickland
Clinic Director, A Beautiful You Med Spa
Austin, Texas
„The DermaWave No Needle Mesotherapy System is the firts device to combine several unique strategies to address
the problem of cellulite. It is easy for the staff to learn, and patients are excited about their smoother new look.“
Peter Cooperrider, M.D.
Dermatologist Kirkland Laser Center
Kirkland, WA, USA
“As a plastic surgeon, it is vital to my practice to offer non-surgical modalities. My patients present with a variety of
concerns and conditions that require a wide spectrum of options. Cellulite and skin tightening procedures are at the
top of the list and the DermaWave has provided us with a modality that is effective, pain free and safe. My patients
have been very positive about the results and refer other patients for the treatment.”
Patrick R. Felice, M.D.
Plastic Surgeon
Bloomfield, Connecticut, USA
„Patients are noticing increased tone and firmness at the treated sites. Very comfortable and enjoying the no needle
apporach.“
Layne Nisenbaum, M.D.
Cosmetic Dermatologist
Palm Beach, FL
6Contacts
Do not hesitate and become a member of our ever growing family
of satisfied practices using BTL NNM! Should you have any questions
please contact us at
[email protected]
www.noneedlemesotherapy.eu
Telephone: +420 220 517 012
Or contact your distributor directly
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