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InMode Workbook Pitchbook 2015 Part3 LR
InMode Workbook Pitchbook 2015 Part3 LR
InMode Workbook Pitchbook 2015 Part3 LR
RESURFACING &
REJUVENATION
PLUS
FACE & BODY
REMODELING
IPL SKIN
REJUVENATION
LASER HAIR
REMOVAL -
ULTIMATE SPEED
NON-INVASIVE BODY
CONTOURING &
CELLULITE TREATMENT
NEW
TECH BREAKTHROUGH
AS SEEN IN:
TABLE OF CONTENTS
Fractora
Forma
Lumecca
Diolaze
BodyFX
VE
C RESEA
LOPMEN
With InMode you may choose all or a combination of the
most in-demand applications based on your unique patient
demographics. Never before has there been a single
FI
platform that offers the best, the latest, and the exceptional. SCIENT
I T
“I HAVE NEVER BEEN MORE PLEASED WITH Dr. Victor Rueckl was able to earn $91,125 in
practice revenue from the use of just ONE of
THE RESULTS OF ANY OTHER TECHNOLOGY the applicators in 90 days, with no marketing
IN MY OFFICE THAN WITH FRACTORA.” expendititures. Ask to read his business case study.
2 $2000 = $4000 =
X Your
Monthly
Payment
Packages of Average Revenue
Your Choice Package Fee
Recouped!
2
FRACTORA
TM
by
VERSATILITY BENEFITS
• Multiple settings mimics aggressive fractional CO2, Er: YAG, IR laser
and deep (dermal/sub-dermal juncture) volumetric heating
• Tips with various depths and pin density configurations Before After
Dr. G. Lask - Multiple Session Low Level Fractora
DESIGNER DERMIS
Fractora achieves full-scale treatment depths with customizable fractional energy to
improve superficial skin tone problems (photo damage) to deep textural concerns
(rhytids and tightening). Clinicians can select between variable depths, densities and
energy levels previously only obtained with multiple devices.
Before After
Type Strong Epidermal Mid Dermal Whole Deep Dermal & Sub Dr. C. Feibleman - Single Session on Acne Scar Skin Type V
Impact Dermal Dermal
Configuration 14x9 10x6 6x4 6x4 coated
Pin Length 600 µ 600 μ 3000 μ 3000 μ
Ablation Depth 0.6 mm 0.6 - 1 mm 3 mm 3+ mm
Heating Depth Between 3-5 mm
Max Energy 62 mJ/pin
Frequency 1MHz
Before After
Rep. Rate Up to 2 pps
Dr. T. Loeb - Single Treatment at 60 mJ
BUSINESS CASE: PRACTICE REVENUE
PRACTICE BACKGROUND: Dr. F. Victor Rueckl, M.D. is a board certified dermatologist with a practice in Las Vegas,
Nevada. He opened Lakes Dermatology in 1999 and expanded his practice with The Spa at Lakes Dermatology in
2005. He has extensive experience with IPL/FotoFacial, Skin Tightening, and other lasers. Currently his office has 7
platforms and 25 applications, plus the Invasix platform with Fractora.
FRACTORA BACKGROUND: Fractora is the most advanced fractional radio-frequency treatment providing anti-aging
improvements on skin tone, texture, and wrinkles for a more radiant appearance through skin resurfacing. Fractora
uses a Designer Dermis approach that allows energy to target any part of the dermis and effect specific or all layers
to achieve superior results through its variable tip configurations. The added benefit of RF is the enhanced
contraction compared to most other energy treatments.
Dr. Rueckl acknowledges that Fractora is light years ahead of traditional CO2 laser or Fraxel and has several
advantages – much shorter length of redness, much faster recovery, and no pain post treatment. Additionally,
Fractora has the ability to treat the neck. According to Dr. Rueckl, “With Fraxel they tried to treat the neck, but the
results were just not what people wanted and the CO2 laser treatment had to stop at the jawline, leaving patients
with a white face and a brown neck.”
3 MONTH RETURN ON INVESTMENT:
Dr. Rueckl and his staff have performed 89
$100,000 $91,125 Fractora cases and amassed $91,125 in
$80,000 revenue in 90 days. Fractora is just one of the
applicators available on the Invasix platform.
$60,000 Other applicators include laser and/or RF
$41,775 applicators for skin tightening, body
$40,000 $29,025 tightening, body contouring, photofacial IPL,
$20,325 and laser hair removal.
$20,000
They acknowledge that their ROI could have
$- been even greater, but they haven’t
1-30 Days 31-60 Days 61-90 Days Total maximized all marketing efforts or existing
Tech Total $3,575 $7,875 $3,725 $15,175 patients yet. Additionally, his focus has
MD Total $16,750 $33,900 $25,300 $75,950 become more tuned lately to small treatment
Totals $20,325 $41,775 $29,025 $91,125 areas like the neck, crow’s feet, and perioral
regions. Targeting these areas is great for his
MD Total Tech Total Totals patients, his time, and the bottom line.
“Fractora is only one modality of this machine, and it works beautifully for me. The results are wonderful and it
makes financial sense. Based only on Fractora, in just months I’ve pretty much covered the costs of the entire
machine. If you take what I’ve been making in only three months and extrapolate it for a year, and then add in all
the other applications and their revenues, the return on investment is astonishing.”
TREATMENT PRICING EXCEPTIONAL PATIENT CONSULTATION AND CONVERSION: Dr. Rueckl
prefers to present the treatment in two stages. Patients are advised that if
they are going to treat their full face, they should also come back one month
PHYSICIAN: later for a neck treatment. This allows Dr. Rueckl a second chance to review
Treatment performed in a two- the face areas for areas that require a secondary pass or touch up. Treatment
step (face, then neck) process in two steps optimizes patient comfort, as most patients do not want a
at 50-60 mJ, always includes lengthy procedure and always want to minimize downtime.
anesthetic blocking.
A Fractora treatment will take between 45-120 minutes depending on
$1000: perioral or periorbital whether Dr. Rueckl does the treatment (more time is required for anesthetic
$1500-2000: neck or partial injections), as well as the size of the area being treated.
chest
$2500-3000: face For patients worried about discomfort and healing, Dr. Rueckl’s practice
encourages test procedures. The
TECHNICIAN: practice charges $100 for a Fractora
Low-level Fractora at 15-20 mJ, disposable tip and performs a few “Our practice has been
with a maximum setting of pulses so patients can experience the waiting for a great treatment
25 mJ. A cryo chiller and topical pulse sensation. All of the "test" for the neck for years. With
numbing cream are used to patients have now done full Fractora, patients are able to
increase patient comfort. procedures. achieve a beautiful mini-neck
$750: full face with lift result, without going
expectation of 3 sessions;
Overall Dr. Rueckl has been impressed under the knife. We are
with the speed of treatment as well as happy to finally provide a
$475: maintenance
the fast recovery time. All of his quality solution.”
patients are without complications.
INDICATIONS FOR TREATMENT: Smoker’s lines, creases throughout marionette lines, fine lines on face, crow’s feet,
laxity on the abdomen, and sun damage and laxity of the neck.
TREATMENT INFORMATION: 25
Number of Patients
MARKETING PROMOTIONS: Dr. Rueckl has had limited marketing exposure. He has not been on TV, or placed ads.
Fractora’s presence is only through their own website, one press release, online exposure through social media
(Facebook, Twitter, Pinterest, RealSelf), and marketing to the existing database. The majority of individuals who
received treatment are existing patients. Many of these patients have already had FotoFacials and RF tightening and
are offered Fractora in addition to what they have already purchased. Now, patients are starting to tell their friends
and learn about the procedure by other means, and the practice has started to see their patient base grow.
“I am booking a Fractora treatment every day and we’re gaining more and more momentum as we are starting to
have more individuals walk in off the street, mostly through word-of-mouth and internet searches. This is not a
hard sell because I am very confident in the Fractora results. The pictures sell the procedure and the patients do
very well. Even with an increase in my fees, patients are still thrilled with their results.”
Speak to your Fractora consultant to start growing your practice revenue today.
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New energy based treatment allows patients to look 10-15 years younger.
Dr. S. Mulholland
1 2Session
Sessions Dr. T. Loeb
2 Sessions Dr.S.S.Mulholland
Dr. Mulholland
Case Report:
Skin Resurfacing & Rejuvenation
Treatment Parameters:
Pin Type Energy Pulse Count
Single Session 10 x 6, 60 Pins First pass over the entire area @ 40 mJ 200 Pulses
10 x 6, 60 Pins Second pass over problematic areas @ 60 mJ 78 Pulses
A single Fractora fractionated RF session was used to treat a 75 year old female concerned with
compromised and sagging skin in the neck. Pre-treatment consisted of a local infusion field block.
There was no oral or IV medication.
During treatment the Fractora pins were cleaned with a BD EZ-Scrub Ultradex surgical sponge
approximately every 50 pulses, or as required, to remove excess debris that collected on the pins.
Isopropyl alcohol was added to the EZ-Scrub for even better cleaning results.
The patient experienced 5-6 days of redness and is very happy with results.
Fractora_TL_1tx4060
Case Report:
Skin Resurfacing & Rejuvenation
Fractora_VR_1_1tx_Neck
Case Report:
Skin Resurfacing & Rejuvenation
Before After
Treatment Parameters:
Pin Type Energy Pain Management
Subcutaneous hypodermal tumescent infiltra-
tive anesthesia with a mixture of 1 bottle of 1%
lidocaine mixed with 500ml of Ringers lactate
Single Session 10 x 6, 60 Pins 60 - 62 mJ / pin and 1ml of epinephrine 1:1000. Prior the tumes-
cent hypodermal infiltrative anesthesia, nerve
blocks were performed with 10cc of 1% xylo-
caine.
A single Fractora fractionated RF session was used to mimic the effects of a CO2 laser in terms of abla-
tion, coagulation and residual sub necrotic thermal zones. The patient was advised to take a few days
off during treatment and downtime was approximately 2 weeks with minor edema observed. Aquaphor
was used after one week at home to keep the skin moist until the injury healed over. Patient as very
happy with the tightening of the skin, improvement in skin texture, and overall improvement in pig-
mented lesion.
Fractora_SM_2_1tx
Case Report:
Skin Resurfacing & Rejuvenation
Before After
Treatment Parameters:
Pin Type Energy Pain Management
First 10 x 6, 60 Pins 25 mJ / pin Topical with Cryo Cooling
Second 10 x 6, 60 Pins 35 mJ / pin Topical with Cryo Cooling
Third 10 x 6, 60 Pins 40 mJ / pin Topical with Cryo Cooling
Fourth 10 x 6, 60 Pins 62 mJ / pin Lip Block
The Fractora handpiece was used in a series of treatments 6-12 weeks apart and at increasing energy levels.
A more conservative parameter with increasing energy levels was used due to the patient’s low tolerance
for pain and downtime. For lower settings pre-treatment was performed with a topical
anesthesia and a cryo cooler and the highest setting was performed with a nerve block, topical anesthesia
and a cryo cooler. Antibiotic ointment was applied immediately after the office based treatment.
Aquaphor was used to keep the skin until the fractional injury healed over (usually at 2-5 days).
Fractora_SM_1_4tx
Case Report:
Skin Resurfacing & Rejuvenation
Treatment Parameters:
Pin Type
Type Energy
Energy Interval
Interval of
of Sessions
Sesssions
First 10 x 6, 60 Pins 30 mJ / pin First Session
Second 10 x 6, 60 Pins 35 mJ / pin 30 Days After First Session
Third 10 x 6, 60 Pins 40 mJ / pin 60 Days after First Session
Fourth 10 x 6, 60 Pins 45 mJ / pin 90 Days after First Session
It was noted that after each treatment the skin tone became lighter and more uniform, allowing for the
application of higher energies at subsequent treatments. Following the Fractora treatment, edema and
erythema were observed and lasted for several hours and up to a few days at higher settings. Small
crusted spots appeared following treatment and were observed for 1-2 weeks after the procedure before
flaking off. Treatment always was performed on fully healed epidermal skin.
Fractora_DA_1_28
Case Report:
Skin Resurfacing & Rejuvenation
CaseFractora_AN_2a_2tx45mj_RS
Case Report:
Skin Resurfacing & Rejuvenation
Fractora_IN_Acne_1tx
Case Report:
Skin Resurfacing & Rejuvenation
Fractora_CF_1a_eyes
Case Report:
Skin Resurfacing & Rejuvenation
Treatment Parameters:
Pin Type Energy Microns to Depth Treatment Area
Single pass on entire face
10 x 6, 60 Pins 40 mJ / pin 600 Microns
and forehead
Single Session
Second pass on periorbital
4 x 6, 24 Pins 35 mJ / pin 3000 Microns
and cheeks
Fractora_IN_1tx
Case Report:
Skin Resurfacing & Rejuvenation
CaseFractora_AN_1a_1tx30ml_F_LS_BE
Fractional Ablative Radio-Frequency Resurfacing in Asian
and Caucasian Skin: A Novel Method for Deep
Radiofrequency Fractional Skin Rejuvenation
R. Stephen Mulholland1*, D. H. Ahn2, Michael Kreindel3, Malcolm Paul4
1
Private Plastic Surgery Practice, Toronto, Canada; 2Daeyoung Plastic Surgery Practice, Seoul, South Korea; 3Invasix Ltd., Toronto,
Canada; 4Department of Surgery, Aesthetic and Plastic Institute, University of California, Irvine, California.
Email: *mulhollandmd@spamedica.com
Received May 9th, 2012; revised June 13th, 2012; accepted June 28th, 2012
ABSTRACT
This paper reports the clinical experience of a multi-center, multiple physician trial with a novel fractional radiofre-
quency ablative skin resurfacing and rejuvenation device (Fractora, Invasix, Israel) deployed on both Caucasian skin
types I - III and Asian skin type IV. Histological study demonstrated deep ablation and collagen restructuring in the
papillary and reticular dermis. The Fractora device combines the more “cone shaped” ablation seen with CO2 and Er-
bium lasers with a deep non-ablative heating pattern, seen with other bipolar RF fractional needle resurfacing devices.
Ablation, coagulation zones and healing dynamics are analyzed for different energy settings. Two different treatment
protocols are suggested: one for light skin and then one for darker skin with a higher risk of post-inflammatory hypper-
pigmentation. Treatment results show improvement in skin texture, pores, wrinkles and skin dyschromia.
Figure 2. Zone treated with 60 mJ/pin immediately after the treatment (a), 1 week after the treatment (b) and 2 weeks fol-
lowing the procedure (c).
Figure 3. Histological images of a zone treated with 30 mJ/pin showing results immediately after the treatment (a), 1 week
after the treatment (b) and 2 weeks following the procedure (c).
Figure 4. Images capture of a zone treated with 10 mJ/pin immediately after the treatment (a), 1 week after the treatment (b)
and 2 weeks following the procedure (c).
3. Conclusions
Figure 6. Caucasian female patient before and 4 months This study confirms the efficacy and safety of a novel RF
after a single full face Fractora treatment. fractional ablative device. The histological results con-
firm the compatibility of Fractora treatment outcomes
and many of the clinical skin enhancement that are seen
with fractional CO2 resurfacing. The Fractora has the ad-
ditional benefits of a strong, bipolar RF non-ablative, non-
coagulative dermal matrix stimulation not seen with ab-
lative lasers. Fractora also reduces superficial and mid-
dermal melanin pigmentation. We also documented a re-
duction of facial telangiectasia in Caucasian patients, how-
ever future studies are recommended on a higher number
Figure 7. Female patient before and 6 months after a single of patients to fully assess the vascular reduction and pa-
full face Fractora treatment. rameters required. The review of patients 3 - 6 months
Fractional Ablative Radio-Frequency Resurfacing in Asian and Caucasian Skin: A Novel Method for 149
Deep Radiofrequency Fractional Skin Rejuvenation
Table 1. Visia and Aramo TS Skin Diagnostic measured improvements in light and dark skin type patients.
Indication Average Improvement Asian Skin (skin types III - IV) Average Improvement Caucasian Skin (skin types I - II)
Cross sectional imagery of the Fractora pulse structure where heat is represented by red and Thermal evaluation of ex-vivo tissue
radio-frequency is represented by purple. The white “cone shaped” regions are the zones of RF ablation.
shows temperature increase in papillary
and reticular dermis. This thermal stim-
after treatment, 1 and 2 weeks post craters and non-ablated thermally ulation is caused by the non-ablative
treatment to analyze the character stimulated tissue. Figure 2a is the flow of RF current from the pins to the
of fractional lesions and the wound histology taken immediately follow- side electrodes. The temperature in-
healing process. Samples were ing the treatment and shows a typical crease is approximately 10-15 degrees
stained with hematoxylin and eosin ablation crater. The ablated crater has Centigrade, or 46-51 degrees Centi-
show classic signs of fractional abla- a triangle or “cone” shape and the zone grade, depending on energy setting and
tive coagulated tissue which include of irreversible coagulation is clearly is well within the therapeutic range
(a) phagocytosis, (b) healing and (c) observed around the crater. Figure 2b required for non-ablative collagen and
collagen remodeling. Because differ- represents histology taken 1 week af- dermal stimulation and consequent
ent groups of patients are required ter the treatment. Re-epithelialization remodeling. Figure 4 demonstrates the
for different treatment parameters, was completed by 48 hours and now temperature distribution in the tissue
the histological study consisted of 3 an inflammatory infiltrate and phago- following the RF ablative pulse.
energy settings: 10mJ/pin, 30mJ/pin cytosis is observed in crater region. It is important to note that ablation
and 60mJ/pin. The ablated collagen and epidermis is craters are not visible in the image. Due
• Evaluation of treatment results being replaced by a new collagen, elas- to the very short pulse duration, the
using Visio system (Canfield Inc.) tin and ground substances. Two weeks spatial camera resolution does not al-
before the treatment and at the fol- after the treatment the acute heal- low for the visual depiction of the abla-
low up visits at 3 and 6 months. ing process is completed and a new tion zones with a size of 100 microns.
• Thermal profile monitoring on epidermis is fully restructured and the Sub-necrotic heating in the dermis
ex-vivo tissue using thermal camera reconstituted dermis is undergoing is very uniform with only a minor
FlirA320 (Trek Equipment Corp.). remodeling. (Figure 2c) reduction of temperature in the center
Heat distribution in the cross section Figure 3 shows collagen remodeling and a depth of the heating zone depth
of tissues were analyzed to correlate occurring in the zones of non-ablative reaching of 2.7 mm. This uniform deep
the thermal effect with clinical results. RF stimulation, between the pins and heating matrix of the dermal tissue
the ablative craters. This is the region allows energy to penetrates through the
Results and Discussion of RF sub-necrotic heating in entire entire papillary and reticular dermis to
The histological analysis demon- dermis induced by the flow of RF the dermal-fat junction, and remodel-
strated that ablation craters are varied current from the ablative pin tips to ing results in wrinkle reduction and
from a depth of 250 micron for the the side electrodes. One can see that skin tightening.
lower fluence settings, up to 1000 already at 1 week after the treatment Clinical evaluation of patients dem-
microns for the highest energies. The visible changes in collagen, specifi- onstrated improvement in skin texture,
coagulation zone around the crater cally shortening and thickening are wrinkles and fine lines, pigmented le-
measured 60-100 microns and, over observed. We expected that collagen sions and some vascular lesions.
time, consistent collagen remodel- remodeling is not limited by 1 week Figures 5-7 illustrate some before
ing was observed in both the ablative and continues for a few months. and after photos from the study.
Ablation crater histology taken immediately (a), 1 week after (b) and 2 weeks after the treatment (c).
Figure 4
Thermal image of tissue treated with Fractora: before the treatment (a), at the end of the pulse (b) and 1 sec after the pulse (c). The orange and yellow zone is the result of
the non-ablative RF heating.
Table 2 –Visia measured Improvements of The Visia system (Canfield Inc.) 3 months, indicating a long process of
the Signs of the Aging Face 6 Months after was used for quantitative analysis of collagen remodeling. There was no dif-
Treatment
treatment results. The results were ference in pigmentation between two
tabulated in Table 2. follow-up visits. Only two patients in
Average
Indication the study were presented with vascu-
Improvement
Conclusion lar lesions and both responded with
Texture 65% A single full-face Fractora treatment vascular reduction, however, more
Wrinkles and lines 65% is able to demonstrate more than 50% clinical research is required to assess
improvement in an array of indications the versatility treating a variety of
Pigmentation 60% for the aging face. Wrinkle and tight- vascular lesions. It is not uncommon
Vascular 45% ening improvement was slightly better for an aesthetic physician to invest in
at the 6 month follow-up than after 3-4 aesthetic devices to treat myriad
Figure 7
◗ Dr. Spero J. Theodorou, plastic surgeon, Manhat-
tan, New York, is an expert in aesthetic plastic
surgery and non-invasive laser, light and RF based
cosmetic treatments. Dr. Theodorou is a member
various organizations, including the American Anti-
Aging Society, American Association for the Ad-
vancement of Wound Care and American College
of Surgeons. info@bodysculpt.com. 212-517-5678
of diverse aging skin pathologies. Frac- nologies. In general, deep RF fractional ◗ Dr. Michael Kreindel is the Founder and Chief
tora Fractional RF is a tunable device treatment with Fractora was effective Technical Officer of Invasix Ltd. Dr. Kreindel was
previously involved in the development of laser,
that allows for the selection of ablative for most aging face signs and can be a
light and RF based products at Syneron Medical
and non-ablative approaches, and may versatile solution for medical-aesthetic Ltd. And ESC/Sharplan and holds over 50 world-
provide a single, cost effective, versa- practices dealing with the many com- wide patients on medical and aesthetic devices.
tile option to owning multiple tech- plexities of the aging skin. u michaelk@invasix.com. 905.707.6787
1
Hand-piece. For those regions with deeper rhytides, the fractional wound healing process. Samples were
such as the upper lips, lower lids or acne scars, a stained with hematoxylin and eosin showed classic
second pass was delivered. Lower lid, upper lid and signs of fractional ablative coagulated tissue,
deeper upper lip lines received a second pass with phagocytosis and collagen remodeling.
either the 60 Pin or 20 Pin tip.
Results and Discussion
Energy is applied to the skin through the matrix of
sharp pins, each having length of 600 microns.
Energy per pin was varied depending on skin type Following the treatment and depending upon the
and thickness. For light and thick skin 50-62mJ/pin parameters, intense edema and erythema were
was applied, while for darker and thinner skin 30-40 observed and lasted for up to 1 week, with a minor
mJ/pin were used. Figure 1 schematically shows RF degree of edema being observed for up to 2 weeks.
current distribution between pins and side electrodes. Small crusted dots, representing the ablated
epidermal–dermal tissue at the opening of the
The Fractora Pins create a typical “CO2 and laser
ablative crater, appeared the next day following the
like” injury with a zone of vaporization (ablation),
treatment and were observed for several days to 1
zone of coagulation and then zone of non-specific
week after the procedure before flaking off.
thermal stimulation. (Figure 1)
Histological images shown in Figure 1 presents
treatment results and healing process after the
Fractora fractional ablative RF treatment with energy
settings of 60mJ/pin. Histological study demonstrated
a typical, strong, ablation effect as shown in figure
2a. The crater depth (zone of ablation) is on average
500-600 microns deep going through the epidermis,
the papillary dermis and to the mid- and deep
reticular dermis. The architecture and shape of the
Figure 1 - Schematic distribution between pins and zone of ablation is a typical upside down pyramid
side electrodes. (smaller at the base) also seen with CO2 lasers. One
can also see the zone of coagulation measuring 60-
With the Fractora electrode geometry, in addition to
100 microns in width surrounding the ablation crater
the typical ablative injury seen with CO2, Fractora
(zone of ablation). (Figure 2a) Figure 2b shows
Pins also act as bipolar electrodes and send
phagocytosis in the healing crater (zone of ablation)
radiofrequency energy from the tip of the ablative Pin
at 1-week follow-up and the initiation of neo-
and injury to the electrodes on two non-pin, flat
collagenesis with new collagen fibers being formed.
electrodes on either side of the tip. This non-ablative,
Figure 2c shows the treated zone structure 2 weeks
non-specific dermal matrix heating adds significant
after the treatment. The phagocytosis is almost
additional skin tightening, that one does not receive
completed and new collagen was formatted in the
with traditional laser fractional ablative tissue
healed crater and the surrounding area of non-
injuries.
ablative heating.
Antibiotic ointment was applied after the treatment.
and the skin kept moist with Aquaphor for 3-4 days
until camouflage make-up can be applied. Standard
photographs were taken prior to the treatment and at
the 6-month follow appointment Patients were
advised to take a few days off following the
treatment. Histology was taken immediately after
treatment, 1 week and 3 weeks post treatment to
analyze the characteristics of the ablative lesions and
2
2a 2b 2c
Figure 2 - Treatment zone immediately after the treatment (a), 1 week after the treatment (b) and 2 weeks
following the procedure (c).
Figure 3 shows a female patient before and 6 months energy delivery was 50mj/pin and the treatment
after a Full Face Fractora treatment, together with demonstrated a significant reduction of pigmented
lower lid and orbital-malar volumization with a lesions comparable with IPL treatment, reduction of
Hyaluronic add gel. The Fractora treatment was peri-oral lines and significant improvement of skin
delivered at 60MJ/pin and the before and after quality.
photographs demonstrate skin tightening, lower lid
Patients with rosacea and facial telangiectasia were
and peri-oral wrinkle reduction, and an overall
treated effectively with the Fractora, which also acted
improvement of skin quality.
as an RF coagulator in improving these facial
Figure 4 shows a skin type IV patient before and 6 vascular lesions. (Figure 5)
months after a Full Face Fractora only treatment. The
Figure 3 - Female patient before the treatment and 6 months after the single full face Fractora treatment
3
Figure 4 - Female patient before the treatment and 64 months after a single full face treatment
Figure 5 - Nasal spider vessels before and immediately after Fractora treatment
Conclusion
additional skin tightening over and above that
seen with the ablation;
The histology confirms the Fractora fractional • improves melanin lesions and dyschromia;
ablative RF lesion reproduces many of the same • removes superficial vascular lesions.
characteristic features those seen with Fractional
Fractora is a novel skin rejuvenation fractional
CO2 and ablative laser resurfacing. The Fractora has
ablative system that combines the best of the Intense
the additional benefit of a strong, bipolar RF non-
Pulsed Light, non-ablative skin tightening and
ablative, non-coagulative dermal matrix stimulation
fractional ablative resurfacing as it delivers reduction
not seen with ablative lasers.
in hemoglobin and melanin based lesions, while
Fractional Ablative Radiofrequency treatment with a significant improvement in wrinkles, texture and skin
deep needle based delivery system is a novel and tightening .
unique fractional, ablative system in that acts as a
All patients re-epithelialized within 4-7 days. There
Total Skin Rejuvenation system that can:
were no cases of delayed healing, no significant
• induce wrinkle reduction and skin tightening; adverse reactions and specifically, no hypo-
• deliver additional non-ablative, bipolar dermal pigmentation, post inflammatory hyper-pigmentation
matrix thermal stimulation which provides (PIH) and no hypertrophic or hypotrophic scars.
4
Unique RF Device Considered
Clinical and Financial Winner
F. Victor Rueckl, M.D. By Rochelle Nataloni, Contributing Editor
Dermatologist
Owner With seven different devices, 25 ap- the results, and word-of-mouth referrals
Lakes Dermatology & The Spa at plicators and the InMode platform with are common.”
Lakes Dermatology
Las Vegas, NV Fractora from InMode (Richmond Hill,
Ontario, Canada), F. Victor Rueckl, Dr. Rueckl uses Fractora in two ways
M.D. – a dermatologist and owner of – high energy treatments, which he
Lakes Dermatology & The Spa at Lakes performs in his clinic; and lower en-
Dermatology (Las Vegas, Nev.) – has an ergy treatments in the spa portion of
impressive selection of anti-aging treat- his practice, which his staff performs.
ment modalities from which to choose. The high energy treatments are accom-
However, in his experience, “the Fractora panied by local anesthesia, and one or
has provided the best results from both a two treatments typically suffice, while
clinical and financial perspective.” lower energy treatments are performed
under topical anesthesia and are usu-
“I have found that Fractora is superi- ally provided in a series of three.
or especially for ablative treatments,” Patients who opt for the low energy
said Dr. Rueckl. “It is far superior to spa treatments tend to have dyschro-
modalities such as CO2 or erbium la- mia or early sun damage, as opposed
sers, not only because the results are
to tremendous wrinkling or skin laxity.
better, but also because the recovery
is dramatically easier,” he explained. Among Fractora’s capabilities is
“There is no pain after treatment, and its ability to tighten skin on the neck.
post treatment redness is gone within “There really is nothing else that can
a week.” safely and effectively tighten skin on
64 year old patient before Tx the neck without surgery,” Dr. Rueckl
According to users, Fractora pro-
noted. Fractora can be used in ar-
vides moderate to profound ablative
eas that demonstrate fine or deep
results up to 3,000 microns deep.
wrinkles, scars or excessively discol-
Radiofrequency (RF) energy heats
the skin in a controlled method to re- ored red and brown skin tone. The
model deep collagen and improve the most common areas of treatment are
appearance of the skin. This unique the crow’s feet, fine lines around the
treatment allows physicians to provide mouth, smile lines, cheeks and neck.
precise, optimal skin contraction. “While the full face and neck are of-
ten treated, it is also possible to treat
“Fractora is a unique and very pro- smaller areas like cheeks and crow’s
ductive piece of equipment,” Dr. Rueckl feet, where many people have local-
emphasized. “It works extremely well ized wrinkling,” he advised.
and it generates money.” In fact, within
64 year old patient eight weeks after one Fractora Tx session the first three months of having Fractora Remarkably, based only on Fractora,
(two passes with 60 pin applicator, 211 pulses) in just months Dr. Rueckl can cover
in his practice, Dr. Rueckl generated
Photos courtesy of F. Victor Rueckl, M.D.
$90,000 solely from the use of that the cost of the entire InMode plat-
single piece of equipment. “My staff form, but Fractora is only one modality
and I performed 89 procedures using of the system, he pointed out. “The
Fractora within the first 90 days of hav- results are wonderful, and it makes
ing the system,” he said. “Patients love financial sense.”
Before After
Dr. H. Ohanian - Treatment of Lax Skin on Skin Type VI
Heat
RF Energy
Before After
With no pulse counter or consumables, the Forma
and Plus skin tightening applicators allow physicians Dr. J. Shaoul - After 6 Treatments at 1 Month Post
to concentrate on perfecting treatment outcomes,
rather than monitoring their productivity!
SPECIFICATIONS
RF Output Frequency Up to 65 W
Output Frequency 1MHz
Temperature Cut-off Real time temperature measurements set by Before After
operator up to 43°C
Dr. S. Mulholland - 3 Months After 8 Treatments
8 Sessions Dr. A. Nelson
Improve the apperance of sagging skin to look years younger.
8 Sessions Dr.S.Ohanian
Dr. Ohanian
Case Report:
Skin Rejuvenation and Remodeling
Age: 43
Area Treated: Full Face Treatment
Energy: 55 mJ / pin
Sessions: 8 Sessions One Week Apart
Physician: A. Nelson, MD
Female pale with general laxity of the lower face and neck was treated with the Forma featuring
A.C.E. (Acquire. Control. Extend) Technology over a period of 8 weekly sessions. Each zone was
treated up to 10 minutes once critical temperature was reached.
Patient was extremely pleased with the contraction and lifting in the neck without having to
undergo more extensive surgical options.
Forma_AN_5a
Case Report:
Skin Rejuvenation and Remodeling
Forma_HO_1
Case Report:
Skin Rejuvenation and Remodeling
Female patient presenting with general laxity under the eyes and around the nasolabial folds.
The Forma treatment featuring A.C.E. Technology was used over a period of 6 sessions. Each
half face was split into three zones: cheeks, jowls and brow/lower lid, and treated with slow short
strokes of the Forma applicator. Each zone was treated for 10 minutes, for a total of 60
minutes for the entire face.
An average energy was 50 mj per pin with a treatment end-point of 42°C. Critical temperature
was reached within 1 minute and maintained for an additional 9 in each zone.
Forma_SM_1
Case Report:
Skin Rejuvenation and Remodeling
Fractional thermal contraction using the Forma was used on a female patient who demonstrated
visible wrinkles at rest, exacerbated by facial movement. In addition, the patient complained of
sagging skin in the lower third of the face and under the neck. Post-treatment, the texture of
the skin is improved and lax skin contracted.
The average energy was 45-50 mJ per pin. Energy was decreased in certain areas where the
skin was extra thin or sensitive. The neck was split into three zones, (upper left, upper right and
lower neck) for a total treatment time of approximately 30-40 minutes.
A.C.E. Technology (Acquire. Control. Extend.) ensured the treatment end-point, set at 42°C was
maintained.
Forma_SM_3
PLUS
by
Dr. S. Ohanian
8 Sessions Dr. S. Mulholland
No pain or downtime, with satisfied patients.
Smoother and firmer results for all areas of the body.Dr. S. Ohanian
Case Report:
Skin Tightening on Knees & Thighs
PLUS Plus_SM_1
by
Case Report:
Skin Treatment on Female Back
The patient complained of general laxity on the back and just below the bra-line. The Plus
treatment featuring A.C.E. Technology was used over a period of 8 sessions, each weekly treat-
ment lasting approximately 20-25 minutes.
Zones of 15 cm x 15 cm were used with RF energy between 55-60 mJ/pin and the endpoint cut-
off set at 42°C. RF energy was reduced in boney areas, such as the upper back, and dependant
on patient comfort levels.
Post treatment the patient noticed improvements in skin quality and overall tightening. Most
noticeable changes were in the lower back where fat pads were significantly reduced and
evened out. There was no changes in weight.
PLUS Plus_SM_2
by
LUMECCA
TM
by
Optimized for light and dark skin, Lumecca increases the potential for
clinicians to treat a variety of skin types and conditions ranging from facial
pigmentation, superficial vessels, skin texture and/or photodamage.
BENEFITS
• High efficiency of vascular and pigmented lesion due to
Before After
high peak power
Dr S. Mulholland - Improvements in brown age spots
• Reduction in clinician treatment time from large
treatment spot size and high pulse repetition rate
• Improved patient comfort (no pain) and safety from
strong sapphire cooling tip
• Fast pulse repetition rate at all settings
SPECIFICATIONS
Dr S. Mulholland - Resolves freckles, sun spots and age spots.
Wavelength
515 SR 515-1200 nm
580 SR 580-1200 nm
Spot Size 30 mm x 10 mm
Fluence 10-30 J/cm2
Pulse Duration 5-30 msec (Short/Long)
Light Cooling Guide 10°-25°C
Repetition Rate 1 pps
Superior solution to improve skin complexion and reduce skin irregularities.
Dr. A. Nelson
1 Session
Resolve freckles, sun spots and age spots.
1 Session
Treats redness, rosacea and spider veins.
Case Report:
Skin Rejuvenation
Patient with skin type II requested treatment to reduce hyperpigmentation on the face.
Results show the diffusion of lentigines on the cheeks and forehead. Results at two
weeks was comparable to 3 weeks, with no side effects. The patient was extremely
happy with her end result.
Physician: A. Nelson, MD
Lumecca_AN_1_1tx_33yo
Case Report:
Skin Rejuvenation
Area Treated: Left cheek using Lumecca 515nm filter; 1 session with 2 passes; 100 pulses
Energy: 16 Joules/cm2 energy with short pulse duration at 1/3 of the energy for ~5.3ms
Cooling: Strong cooling, set to 13°C
Area Treated: Right cheek using Lumecca 580nm filter; 1 session with 2 passes; 100 pulses
Energy: 1st Pass - 16 Joules/cm2 with short pulse duration at 1/3 of energy for ~5.3ms
2nd Pass - 8 Joules/cm2 with short pulse duration at 1/3 of energy for ~2.67ms
Cooling: Strong cooling, set to 13°C
“Lumecca is the strongest, most efficacious IPL device I have ever used. Clinical improvements
that used to take a series of 3-4 treatments with other devices, can now be achieved and even
surpassed with a single Lumecca treatment. Lumecca really is a revolution in IPL technology.”
-Dr. Andrew Nelson, MD
Note: These results show only the first session in a series of scheduled sessions.
Lumecca_AN_2_1tx_Cheeks
DIOLAZE
TM
by
DIOLAZE
TM
8 mm x 50 mm
3PC for Ultimate Patient Comfort
Pre Cooling
GOLD
Parallel Cooling STANDARD
Post Cooling
A.C.E.
TECH
N
A D VA O L O G Y
N TA G
E
BODY CONTOURING & CELLULITE TREATMENT Acq uire Co
nt
Extend rol
BodyFX treatments target problematic fatty tissues for ideal body contouring.
Controlled Heat
• Acquire. Control. Extend. Technology to safely optimize peak energy Dr. A. Carey - After 8 BodyFX Treatments
SPECIFICATIONS
Negative Pressure Up to 500 mBar
RF Output Frequency Up to 50 W
Output Frequency 1MHz
Temperature Cut-off Real time temperature measurements Before After
set by operator up to 43°C Dr. S. Mulholland – Substantial Cellulite Improvement
Breakthrough body contouring and cellulite reduction treatments.
Dr. C. Feibleman
Dr. S. Mulholland
Case Report:
Body Contouring
Objective: Increase temperature to 41°C and then provide HV pulses. Increasing overall
temperature before the HV pulse decreases discomfort. Cut off is set at 41°C.
Physician: S. Mulholland, MD
BodyFX_SM_1
Case Report:
Body Contouring
As the skin is more resistant and thicker on the buttocks, RF power (40-50 W) and 2nd RF energy
parameters (Level 6+) are higher, than the posterior thigh, which has greater sensitivity. Four
zones were treated in a cross-hatch pattern to ensure uniform heat build up.
In areas with high curvature, it is essential to use a second hand and additional weight on the
applicator to ensure the treatment area is flattened and all four sides of the BodyFX chamber has
complete contact with the skin.
BodyFX features A.C.E. (Acquire. Control. Extend.) Technology to achieve precise thermal
temperature, control against overheating, and allow for prolonged exposure at therapeutic
endpoints.
BodyFX_SM_2
A
NEW
APPROACH
TO
BODY
CONTOURING
USING
CONTROLLED
RF
HEATING
AND
HIGH
VOLTAGE
ULTRASHORT
ELECTRICAL
PULSES
R. Stephen Mulholland, MD, FRCS(C), Michael Kreindel, Ph.D
1
suction pressure to the soft tissue of the convex Irreversible electroporation is the process of creating
contour irregularity, drawing the skin and pores in cell membranes under an external electrical
subcutaneous tissue up into the cavity. Bipolar RF is field, leading to apoptotic death of cells in certain
passed between the two electrodes and through the conditions. Preheating of the skin with RF current
adipose tissue and skin (Figure 1). allows for a significant reduction in the electro-
poration threshold [9] and target selectively, as the
preheated large adipocytes are more sensitive to
electrical fields [10]. With the HVP adipocyte
apoptosis, the fat cells die and the adipose tissue
deflates and loses volume, thereby improving
contour. Another benefit of the RF energy and HVP
is that the controlled RF energy heats the skin
resulting in dermal tightening which enhances the
contour as the adipose tissue becomes reduced.
In the current study 20 female and male patients
were enrolled. The age range of the patients was 28
to 58 years old, with an average age of 36.5. Patient
BMI varied from 18 to 28 and all of patients were
interested in focal shape correction, without
anticipating any weight reduction. The patients were
Figure 1 - Hand piece geometry demonstrating RF current
treated in the abdominal and flanks regions once a
passing through the tissue in the suction cavity week over a period of 6 weeks. Patients were
observed for 3 months to determine the long-term
As the RF heats the tissue, the surface temperature adipose tissue effects and body contour changes.
rises. The TiteFX hand piece displays this measured Standard photography and circumferential
skin surface temperature on the hand piece. When measurements were taken prior to treatment and at 3
the temperature gets to an endpoint that is months following the last treatment.
established by the physician (the “trigger
temperature”) the device will emit a train of High The protocol during the treatment involved moving
Voltage Pulses (HVPs) directly into the adipose the TiteFX applicator on half of the target zone,
tissue. heating the soft tissue every three seconds and then
moving to the next area, overlapping 10-20% with
The TiteFX allows for very uniform skin heating to the previous treatment, rapidly rising the tissue
a depth of 15mm due to the vacuum suction and temperature to 41-43oC. Once the trigger
electrode placement. Figure 2 shows a thermal temperature of 42oC was achieved, HVP energy was
image of the skin with uniform temperature delivered in a pulse of 5-7 seconds with 3-5 passes
distribution. The uniformity of the skin temperature of High Voltage Pulses completed in each zone. RF
means a target “trigger temperature” of 42˚C can be power of 40-50W was used and the treatments were
reached with minimal patient discomfort. completed at an average of 30mins per zone.
Figure 2 - Uniform temperature distribution on treated skin Skin erythema, mild edema and a heat sensation
were typical following the treatment. The skin
2
erythema level depended on the final temperature
achieved and lasted up to 6 hours.
The average weight of patients was stable over the
treatment course without a significant reduction.
Circumferential reduction was obvious for most of
patients 3 months following the completion of their
6 treatments. The average circumferential reduction Figure 5 - Female before and 3 months following treatment
was 28.1mm with range of 15mm to 40mm. There
were no non-responders observed in the study.
Our clinical impression is that longer exposure to
the predetermined “trigger temperature” and
applying more HV pulses provides better results and
higher patient satisfaction, but additional clinical
studies are underway to refine and optimize the
treatment protocols.
Most of patients reported a high satisfaction level
and were able to detect visible improvement in their
body shape.
Figures 3 to 6 show a female and male patient Figure 6 - Male before and 3 months following treatment
before and 3 months following the TiteFX treatment
program.
Conclusion
References
3
Mulholland and Kreindel, J Clin Exp Dermatol Res 2012, 3:4
Clinical & Experimental http://dx.doi.org/10.4172/2155-9554.1000157
Dermatology Research
Research Article Open Access
Abstract
Objective: To evaluate the safety and efficacy of a new and novel radiofrequency (RF) device used for focal fat
reduction.
Materials and methods: 24 female and 1 male patients were enrolled in the study. The age range of the patients
was 28-62 years old and an average BMI was 26. All patients underwent focal shape correction, without anticipating
any weight reduction and 14/24 patients also had posterior or anterior grade 2 or 3 thigh cellulite treated. The patients
underwent a 6-treatment protocol where they were treated with a novel RF device on the abdominal and flank regions
once a week over a period of 6 weeks. 14 patients also had cellulite on their posterior or anterior thigh treated with
the same device and a 6-treatment, once weekly protocol. Therapeutic thermal end points for each treatment were
established and achieved as outlined in the paper. The RF device emits both basic RF and ultra-short High Voltage
Pulsing (HVP). All patients and zones were treated once per week for 6 weeks.
Results and conclusions: All patients were observed for 3 months following their last treatment to determine
the long-term adipose tissue effects and body contour changes. Standard pre and post-operative photography,
circumferential measurements were taken. 3 patients who were scheduled for future abdominoplasty surgery had
Investigational Review Board compliant lower abdominal subcutaneous biopsies performed at 72 hours and 14 days
following their initial RF treatment. The average circumferential reduction was 3.58 cm with range of 1.5 cm-4.4 cm. There
were no non-responders observed in the study. Using the modified Nurnberger-Muller 7 stage cellulite grading system,
the average cellulite score improved 2 sub-grades. Using the Vectra 3D imaging device and cellulite scoring software,
the average starting pit depth was 4.1 mm (range 0.5 mm-7.3 mm). Average Vectra measured improvement in the pit
depth or “smoothness score” was 2.9 mm or 60% (range 1.1 mm-6.3 mm). Biopsies revealed histological evidence of
the death of proportion fat cells by apoptosis. There were no complications that required medical management. We
conclude that the TiteFX appears to offer a safe and effective option for the non-invasive management of both focal fat
excess and cellulite. The basic RF and High Voltage pulses appear to result in a long-term, proportional death of fat
tissue, presumably through adipocyte apoptosis.
Keywords: Fat reduction; Cellulite improvement; Radiofrequency; electric fields have the ability to increase the permeability of mammalian
TiteFX; Electroporation; Adipocyte apoptosis; Ultra-short High cells, a process known as electroporation, which can be “reversible” or
Voltage RF Pulsing “irreversible”. Reversible electroporation has been widely deployed in
medicine to facilitate non-permeable chemicals to cross cell membranes
Introduction [6]. In practice, a non-permeable chemical is introduced in the body
and a direct current is applied to the target tissue and cells, typically,
Ablative therapy for neoplasm, both benign and malignant has
a sequence of eight, 100 microsecond pulses, with up to 1000 volts,
been deployed as an alternative for extirpative surgery for many years
each pulse separated by 100 millisecond pulse delays are delivered [6].
[1]. Reported ablative therapies include low temperature cryotherapy,
Reversible electroporation and trans-membrane chemical substance
focused ultrasound, intra-lesional chemical ablation, interstitial laser
delivery have had applications in cancer and genotherapy [6]. Ultra-
therapy and radiofrequency ablation or RFA [1]. Bio-electrics is a short nanosecond pulses have demonstrated direct, non-membrane
relatively new player in ablative therapy and apply pulsed, high voltage
electrical currents to cell biology, specifically cell membrane physiology
[2-4].
*Corresponding author: R. Stephen Mulholland, University of Toronto, Toronto,
The integrity and cellular functions of a mammalian cell are, in Canada, E-mail: mulhollandmd@spamedica.com
part, maintained by trans-membrane potentials that are controlled Received May 15, 2012; Accepted September 01, 2012; Published September
by complex cell membrane functions. Exposing a cell to specific 10, 2012
pulsed electrical currents can alter the trans-membrane potential of Citation: Mulholland RS, Kreindel M (2012) Non-Surgical Body Contouring:
mammalian cells and, if the duration of the applied electrical pulses are Introduction of a New Non-Invasive Device for Long-Term Localized Fat Reduction
less than the “charging time” of the outer cell membrane (approximately and Cellulite Improvement Using Controlled, Suction Coupled, Radiofrequency
100 nanoseconds), there is a non-thermal interaction with both the Heating and High Voltage Ultra-Short Electrical Pulses. J Clin Exp Dermatol Res
3:157. doi:10.4172/2155-9554.1000157
cell membrane and sub-cellular structures [5]. By manipulating the
pulse duration (creating ultra-short pulses), electric field intensity, and Copyright: © 2012 Mulholland RS, et al. This is an open-access article distributed
under the terms of the Creative Commons Attribution License, which permits
a train, or pulsed sequence of these pulses, it is possible to alter the unrestricted use, distribution, and reproduction in any medium, provided the
cell membrane and affect cell survival [5]. Specifically tailored pulsed original author and source are credited.
Page 2 of 9
intracellular structures, organelles and the nucleus with applications in Over the past few years there have been several non-invasive body
cancer, platelet function and gene therapy [2-4]. contouring technologies that have come to the market that do disrupt
and permanently damage the adipocyte and provide the potential for
Irreversible electroporation (IRE) delivers a tailored electrical
long-term focal fat reduction and body contour improvements. These
pulse configuration specific to the target cell and permanently alters
“disruptive technologies” damage and permanently injure the fat cell
cell permeability, resulting in an influx of ions, and altering the trans-
through: [28-42]
membrane potential and intracellular function such that the target
cells stop functioning and dies over time. Industrial applications have (i) Cavitation (the Ultra shape focused, high frequency ultrasound,
included water sterilization, where the IRE targets and kills bacterial or HIFU)
and yeast cells [7]. More recently, IRE has been shown to ablate tumor (ii) Thermal disruption (Liposonix high frequency focused
cells, both in vitro and in vivo in mammalian animal studies [7-9]. ultrasound)
The therapeutic advantages of IRE in treating tumors are the non- (iii) Freeze the fat cell and induce an adipocyte apoptosis through
thermal mechanism and the relative sparing of surrounding structures. cryolipolysis (Zeltiq)
By deploying IRE, the cell membrane electroporation thresholds are (iv) The creation of a temporary “pore” in the adipocyte cell
different from the tailored IRE pulsed electric profiles used on the membrane for triglyceride egress (Zerona)
tumor tissue, creating selectivity [7-10]. Pre-heating of tissue prior The Ultra shape uses gentle, non-thermal ultrasound waves to
to the train of ultra-short, high voltage pulses appears to reduce the induce a cavitational disruption of the cytosolic fat droplets and
electroporation threshold and enhance the efficacy of producing “non-thermal implosion” of the adipocyte. The Ultra shape protocol
IRE [11]. To date, we are not aware of any published studies on high generally calls for 3 treatments, one every two weeks and with the new
voltage, ultra-short, pulsed sequenced IRE on adipocytes. This study vertical depth focus ultrasound (simultaneous ultrasound treatments
analyzes the cellular effects of a novel basic Radiofrequency and ultra- at three different layers) and RF applicators, abdominal circumferential
short, high voltage pulsed system on adipose tissue and the aesthetic reductions 5-6 cm have been reported after 6 weeks. Advantages of
body contour changes that may result. the Ultra shape are a virtually essentially painless treatment, ease of
Non-invasive body contouring is one of the fastest growing market use with automated tracking systems for the ultrasound and minimal
segments in aesthetic medicine [12,13]. Non-invasive body contouring treatment edema so results can be seen within a short time. Ultra shape
technologies have progressed from non-thermal, mechanical rollers disadvantages are principally the disposable ultrasound pulse costs [28-
and suction systems used in the 1990’s, that enhanced lymphatic 35].
drainage in cellulite and fat deposits, to thermal based devices which Liposonix uses a thermal HIFU approach and multiple passes
combined laser, radio-frequency (RF), hypo- or hyperthermia and/ to induce layered adipose thermal necrosis. Liposonix purports
or infrared energies with or without mechanical massage and/or a single treatment protocol, but disadvantages include reports of
suction [14-27]. The most common optical energy sources used in significant patient pain (necessitating benzodiazapines and narcotics),
body contouring devices have been in the near and far Infrared (IR) ecchymosis, and edema and swelling following the adipose thermal
spectrum. These optical, IR or RF systems, with or without rollers, necrosis, so often, results are not visible for up to 3-6 months due to
with or without suction, deliver a thermal stimulus to the superficial gradual remodeling of the intense thermal necrosis. Circumferential
adipose tissue to enhance normal lipolysis metabolism. In addition, abdominal reductions of 3-6 cm have been reported using Liposonx
these devices decrease, by a reduction of the triglyceride cytosolic after a single session. Liposonx also has a pulses disposable cost [36,37].
volume, without cell destruction, the adipocyte volume (conversion
of triglycerides to glycerol and free fatty acids which egress out of Zeltiq’s “Coolsculpt” uses suction coupled “super-cooling”
the cell and are mobilized and metabolized through normal hepatic applicators applied to the flanks and abdomen. The patient and the
pathways), through thermal stimulation of epinephrine mediated device are left for between 1-4 hours (an hour for each love handle and
membrane bound lipase [13,14,27]. Infrared energy penetrates into one for the lower abdomen). The advantages of cryolipolysis are that it
the dermis, leading to a modest tightening effect on the skin and does not need a technician to perform the procedure and patients can
some improvement in cellulite, while RF devices, depending upon the be left in a side office and the treatment is relatively comfortable. Single
system, can penetrate 5-25 mm into the subcutaneous tissue affording treatment protocols have shown up to 20% of the adipose between
the opportunity to have a more direct effect on adipose tissue. Since the treatments paddles undergo apoptosis death resulting in a 3-6 cm
the earliest RF non-invasive body contouring systems, the VelaSmooth average in abdominal circumferential reduction after a single session,
and VelaShape which are suction couple IR, RF (Syneron Ltd, Israel) but results are not completed for 4-6 months following the adipocyte
and Thermage (Solta Medica, USA), there has been proliferation of RF apoptosis. Disadvantages include limited treatment zones as areas
systems with moving mono-polar, bi-polar, tri-polar and octi-polar other than the love handle or lower abdomen (you must be able to grab
electrode applicators. These thermal RF and optical systems are “non- and retract the adipose tissue and skin) cannot be currently treated
(although new applicators are planned), there is also a high disposable
disruptive” in that the adipocyte cell membrane and cellular functions
cost and there have been reports of painful dysaesthesias for several
are not damaged. Despite being temporary “metabolic enhancers”
months after treatment, presumably from a hypothermic injury of the
increasing physiological breakdown of triglyceride, most RF systems
sensory nerve lipid membrane [38-40,13].
for non-surgical body contouring report 2-4 cm circumferential
reductions in abdominal-hip measurements, 2-3 cm in thigh reduction, Zerona uses an array of 650 mn diodes strategically placed just
with an average 20-60% improvement in the appearance of cellulite above the skin to induce a cytochrome oxidase induced conformational
and, when well selected, consistently happy patients [14-27]. However, alteration in the adipocyte bi-lipid cell membrane and the transient
the disadvantages of these “non-disruptive” body contour and cellulite “pore”. It is through this temporary “fat pore” that triglycerides can
systems is the transient effect on adipose tissue and the contour migrate, resulting in a reduction in the adipocyte size and hence
enhancements that may be achieved [14-27]. adipose tissue reduction. The protocol for this painless Zerona
Page 3 of 9
procedure can also be performed in a side office, without a technician body contouring device, the TiteFX (Invasix, Israel) which offers many
and involves 6-12 treatment protocols every second day for 2-3 weeks. of the ideal body contouring features patients and physicians seek.
Disadvantages include a relatively modest incidence of non-responders
and a disposable cost [41,42,13]. Materials and Methods
All of the aforementioned “disruptive” fat contouring technologies The TiteFX device (Invasix Ltd.) combines, in a synergistic fashion,
have a disposable component and they are not designed, nor are there the following suction coupled therapeutic energy sources:
any prospective reports of cellulite reduction. • Uniform RF heating of the skin and subcutaneous fat with real
Although the etiology of cellulite is not completely understood, time monitoring of skin temperature using an infrared thermometer
there are hereditary, hormonal and perhaps other metabolic multi- built into the hand piece and a built in “on-line” temperature cut-
factorial influencers. It is estimated that 70% of post pubertal women off feature that prevents overheating, painful hotspots and ensures
have cellulite and it can be quite independent of BMI, as very thin prolonged thermal uniformity at the desired end-points.
woman can develop it and quite obese women may not [13,14-27]. • High-voltage (HV), ultra-short RF pulses applied to the
The clinical phenotypic appearance of cellulite is well know, the subcutaneous fat are designed to deliver irreversible electroporation
“lumpy-bumpy, cottage-cheese” or “orange peel” appearance of the (IRE) effects to the adipocyte leading to delayed apoptosis of the fat cell
skin. Anatomically, cellulite occurs most commonly on the posterior and adipocyte cell death. These HV pulse electroporation effects on cell
thighs and buttocks, followed by lateral thighs, anterior thighs and membranes can be seen in other tissues.
upper abdomen. Cellulite is commonly classified by the modified 7
stage Nurnberger-Muller score [34], according to severity (Table 1). The TiteFX applicator has a large suction cavity on the undersurface
Histologically, cellulite is characterized by the following [14-27]: of the hand piece with bipolar RF electrodes on each side of that cavity.
The hand piece applies suction pressure to the soft tissue of the convex
(i) Edematous, swollen lobules of superficial adipose tissue with contour irregularity, drawing the skin and subcutaneous tissue up
poor microcirculation and low tissue oxygenation to 1 cm into the cavity. Basic bipolar RF is passed between the two
(ii) Herniation of the swollen lobule of fat up into the deep reticular electrodes and through the adipose tissue and skin resulting in tissue
dermis and forming the “nodules” heating (Figure 1).
(iii) Dense, thickened vertical fibrous septae that are congealed,
contracted extensions of the oblique and vertical intra-lobular Basic RF heating
septae and result in dermal retraction or “pits”
The skin and subcutaneous tissue is drawn up to 10 mm into the
Although the exact cause of cellulite may be obscure, like the suction cavity and the RF energy passes between the electrodes, both
focal fat reduction technology, many of the RF, suction and massage directly through the fat drawn up into the suction chamber and down
devices discussed above have shown some variable improvement in the into the fat below the electrodes, a distance of 50% of the distance of the
appearance of cellulite, with average improvements of 20-70% after a two RF electrodes [14]. As the two RF electrodes are 2.5 m apart, the
series of treatments [13,14-27]. RF heats fat to a depth of 2.2 cm (1.0 cm of suction coupled elevation
The desirable features of a non-invasive body contouring, fat in addition to the 1.2 cm into the uncoupled fat). The suction cavity
reduction and cellulite improvement device include [13]: and controlled RF bipolar depth distribution allows for a very selective
targeting of only the superficial fat and sparing deeper tissues, such
(i) Some energy medicated thermal, chemical or as motor nerves or muscle from RF heating of the high voltage, ultra-
electrophysiological effect on the adipocyte that destroys the short pulsing.
cell permanently, or incapacitates the cellular function leading
to apoptosis (cell death). The final pathway can be thermal (high As the basic RF heats the tissue, the surface skin and adipose tissue
temperature or very low temperature), cavitation influences
or lipid bi-layer membrane disruption. The advantage of a
“disruptive” technology is a long-term body contouring and
cellulite reduction
(ii) High degree of safety
(iii) Minimal discomfort
(iii) High percentage of adipose tissue impacted
(iv) High degree of efficacy and reproducibility
(v) Disruptive effects on the adipocyte for long lasting body contour
and cellulite effects
(vi) Impacts the appearance of both focal fat and cellulite and can
be used on multiple potential body areas
(vi) Revenue efficient with low or no disposable costs
The objective of this study is to assess the safety, efficacy and
Figure 1: The TiteFX hand demonstrating RF current passing between the
possible mechanism of a novel basic RF and high voltage, ultra-
electrodes through the adipose tissue in the suction cavity and down into the
short pulsed device on the treatment of both focal fat collections and subcutaneous tissue.
cellulite. This paper reports a novel technology that represents a new
Page 4 of 9
temperatures both rise. However, because of the deeper thermal RF endpoint has been reached and the device will emit a train of pre-set
penetration pathways from the bipolar electrodes and lower resistance 7-10 (depending upon patient comfort) high voltage ultra-short pulses
of the fat, the adipose tissue temperature rises higher than the skin into the same subcutaneous tissue (the actual number of high voltage
temperature by 2-4°C [13]. The TiteFX hand piece constantly displays pulses can be controlled). The treatment technician then simply moves
the measured skin surface temperature on the hand piece, as well as on around the treatment zone keeping the area in double beeps (43.9°C),
the console. The user is able to set an ‘epidermal cut-off temperature”, as at this temperature the RF will automatically come back on until
which when reached turns off the emitted basic RF energy. With the the skin is 44°C again, at which time, the RF shuts off. In this fashion,
online temperature monitoring, the treatment professional is able to the epidermal skin temperature can be maintained at a uniform and
set the epidermal thermal end point, past which the TiteFX software comfortable 44°C, the subcutaneous adipose temperature at 43-
will turn off the basic RF until the measured skin temperature drops 45°C and high voltage, ultra-short pulses can be delivered constantly
just below the ‘cut-off” when the RF is turned on again. When the
epidermal temperature and the basic RF is turned off, the second RF, or
trains of ultras-short (nanosecond), high voltage pulsing (HVP) is then
triggered. The ultra-short, high voltage RF pulsing has been shown to
produce a cell membrane electroporation and a non-necrotic death
through cellular apoptosis in other non-mammalian, mammalian and
human cell lines [1-11]. There has been a reported synergy of pre-
heating tissue prior with basic RF before the HVP’s in facilitating more
effective and efficient irreversible electroporation (IRE) and apoptotic
cell death [11,42,43].
The thermal end-point that has been established as optimally
efficacious for RF heating is 43-44°C epidermal temperature. Using serial
cross sectional thermography on the perfused flaps of abdominoplasty
patients as well as thermo-coupled needles on in-vivo patients, we were
able to determine that the adipose tissue temperatures were 44-45°C at
depths up to 2.5-3.0 cm, while the skin temperatures were maintained Figure 2: A perfused abdominoplasty flap following 10 minutes of treatment
with the TiteFX applicator and thermal camera images showing epidermal
at a consistent 43-45°C (Figures 2-4). temperatures of 43-44ºC.
In vivo studies using a thermal coupler needle confirmed a uniform
temperature of 43-44°C from the epidermal surface to a depth of 2.5
cm.
The clinical TiteFX treatment protocol was as follows. The convex
distension of localized fat, or cellulite zone to be treated, was marked
out with the patient in the standing position. Each treatment zone was
divided into two smaller treatment areas, approximately 15×20 cm, or
about the size of a human hand (most actual commercial clinical zones,
such as outer thighs, love handles, inner thighs, lower abdomen, etc. are
the size of two hands, or 30×40 cm). With each “half zone” marked out,
the patient is placed in a supine or prone position, depending upon the
treatment area. No gel or interface medium is required for the TiteFX.
The treatment parameters are 40-50 watts of energy, 3 second pulse
duration, 44°C epidermal thermal “cut off”, and 7-10 High Voltage
Ultra-short pulses at the trigger point. The TiteFX applicator is then Figure 3: Undersurface of perfused abdominoplasty flap incised and showing
applied to the skin and the foot pedal switch activated (Figure 5). The adipose temperatures of 43-44°C at levels of 2.5-3.0 cm deep.
skin under the applicator is drawn up into the treatment cavity and
basic RF heats the skin and subcutaneous tissue. The tissue is heated
for the prescribed 3-second pulse duration and then the applicator
is moved to the next adjacent area within the treatment zone, over-
lapping the previous rectangular treatment area by 10-20%. The
treatment technician moves the TiteFX applicator in this fashion
around the treatment zone. The epidermal temperature monitor will
rapidly rise from starting temperature in the low to mid 30’s to 44°C
within approximately 1-2 minutes.
During the TiteFX treatment there is an audible beeping
sound when the suction is adequately coupled and the RF is being
administered. When the measured epidermal surface temperature gets
within 2°C of the set thermal end point (41°C), there is an doubling Figure 4: In-vivo needle Thermo-coupler study measuring the depth of the
in the audible beeping and when the end point of 44°C is reached, the heating following TiteFX treatment. The thermal profile was found to be a
very uniform distribution of 43-44°C epidermal temperature and this was
audible beep increases to a triple cadence, which alerts the treatment maintained at uniform 43-45° to a depth of 2.5-3.0 cm deep.
technician that there is no basic RF being administered, as the thermal
Page 5 of 9
Page 6 of 9
The third mechanism that basic RF in the TiteFX can result in a Results and Discussion
body contour improvement and cellulite reduction is skin tightening in
the treatment area. The basic RF energy and HVP results in a controlled All patients felt acceptable comfort at epidermal tissue
temperatures of 43-44°C and the majority were able to tolerate 44°C. At
RF heating of the skin, sustained at 44°C epidermal and a similar and
a skin temperature of 45°C or higher, even with extreme uniformity a
uniform 43-44°C intra-dermal for 10 minutes, which results in heating
significant number of patients experienced discomfort when there was
of the intra-dermal collagen, elastin and extracellular matrix leading to
no cooling or topical anesthesia. No adverse side effects were observed
non-ablative, inflammatory injury to the dermis and a wound healing
at any of these epidermal target temperatures. The train of ultra-short,
process with enhanced dermal collagen, elastin and ground substance high voltage pulses created an initial electrical “shock” sensation, but
production [13,45]. The production of new dermal type I collagen, was tolerable in all patients once the patient experience accommodated.
neo-elastosis and ground substances takes 5-12 weeks to mature and Most patients could tolerate 7-10 HV pulses at a time.
results in a thicker dermis and a more elastic, or “tighter” dermis.
The enhanced thermally mediated skin contraction also contributes Skin erythema, mild edema and a strong heating sensation were
to improvement in circumferential reduction, body contour and typical in the treatment zone following the TiteFX and these lasted
smoothens the appearance of cellulite by thickening the reticular up to 6 hours following treatment. The average weight of patients was
dermis and reducing the ability for subcutaneous fat to herniated into stable over the treatment course without a significant reduction.
the deep dermis [46]. Circumferential reduction was obvious for most patients 3
months following the completion of their 6 treatments. The average
Patient Studies circumferential reduction was 3.58 cm with range of 1.5 cm-4.4 cm.
In the current study, 24 female and 1 male patients were enrolled. There were no non-responders observed in the study.
The age range of the patients was 28 to 62 years old, with an average age The visual analogue 10-point patient assessment score for the
of 41.3 yrs. Patient average BMI was 26, but varied from 18 to 30 and cellulite improvement showed that over 90% of patients felt there
all of the patients were interested in focal shape correction, without was improvement in the appearance of their cellulite and the average
anticipating any weight reduction. In addition, 14/24 patients also had improvement score was 78%. Before and after cellulite photos were
posterior or anterior grade 2 or 3 thigh cellulite treated. evaluated by a blinded physician reviewer and subjected to the
The patients underwent a 6-treatment TiteFX protocol where they modified Nurnberger-Muller 7 stage grading system (Table 1). The
were treated on the abdominal and flank regions once a week over average cellulite score improved 2 sub-grades. The average starting pit
depth using the Vectra 3D was 4.1 mm (range 0.5 mm-7.3 mm) and the
a period of 6 weeks. 14 cellulite patients also had their posterior or
average vectra measured improvement in the pit depth or “smoothness
anterior thigh cellulite treated. Therapeutic end points were as outlined
score” was 2.9 mm or 60% (range 1.1 mm-6.3 mm).
above, where each zone measuring, 15×20 cm was heated to 44°C
epidermal and this was maintained with basic RF and HV pulse RF The tissue biopsies taken at 72 hours and 14 days after the first
for 10 minutes. The protocol during the treatment involved moving treatment revealed no evidence of fat necrosis in any patient. By 14
the TiteFX applicator heating the soft tissue for the three second pulse days, a substantial percent of adipocytes had undergone a histological
duration and then moving to the adjacent skin in that zone, overlapping “shrinkage” of the fat cell (Figure 8). It is not certain, if further death
10-20% with the previous rectangular treatment, rapidly rising the from delayed apoptosis from the HVP would yield further adipose
tissue temperature in the 15×20 cm treatment zone to 43-44°C. tissue collapse.
Once the trigger temperature of 44°C epidermal was achieved, Our clinical findings are supported by other in vitro and in vivo
HVP energy was delivered during the 3-second pulse duration and with studies of Radiofrequency heating on cultured and live in situ adipocytes
4-6 passes of a train of High Voltage, Ultra-Short Pulses completed in [45]. Cultured adipocytes show 89% cell viability when subjected
each zone over the 10 minutes. RF power of 40-50 W was used and to 45°C for 1 minute and 40% when heated at 45°C for 3 minutes.
the treatments were completed in an average 20 minutes per zone. All Adipocyte cell viability dropped to 20% when subjected to 50°C for one
minute. Other in vivo studies have confirmed that maintaining adipose
patients and zones were treated once per week for 6 weeks.
tissue at 44-45°C for 15 minutes at depths of 1.5-2.0 cm resulted in loss
Outcome Measurements
Grade I
Patients were observed for 3 months to determine the long- Skin is Smooth when standing. Cellulite may be induced by pinching
term adipose tissue effects and body contour changes. Standard the tissue
photography and circumferential measurements were taken prior to Grade II - MILD
Orange Peel or Mattress appearance when standing – MILD
treatment and at 3 months following the last treatment. Photography Grade II – MODERATE
was performed using standardized canfield lighting, camera, distances Orange Peel or Mattress appearance when standing – MODERATE
and was always taken during patient exhalation. Patient’s weights and Grade II – SEVERE
Orange Peel or Mattress appearance when standing – SEVERE
exhalation circumferential measurements were recorded weekly with Grade III – MILD
each visit. 3 patients who were scheduled for future abdominoplasty Cellulite plus raised and depressed areas and nodules when standing
surgery had Investigational Review Board compliant lower abdominal – MILD
Grade III – MODERATE
subcutaneous biopsies performed at 72 hours and 14 days following Cellulite plus raised and depressed areas and nodules when standing
their initial TiteFX treatment. – MODERATE
Grade III – SEVERE
All cellulite patients, in addition to photographic assessment, had Cellulite plus raised and depressed areas and nodules when standing
Vectra 3D cellulite analysis performed on the depths and elevations of – SEVERE
the pits and nodules, both pre and post treatment (Figure 7). Table 1: The Modified Nurnberger-Muller Cellulite Grading Scale.
Page 7 of 9
Page 8 of 9
long-term contour and cellulite enhancements. 16. Wanitphakdeedecha R, Manuskiatti W (2006) Treatment of cellulite with a
bipolar radiofrequency, infrared heat, and pulsatile suction device: a pilot study.
Synergistic controlled RF heating and ultra-short HV pulses J Cosmet Dermatol 5: 284-288.
appears to result in a consistent circumferential reduction that may 17. Sadick N, Magro C (2007) A study evaluating the safety and efficacy of the
be a result of both adipocyte deaths from uniform and sustained VelaSmooth system in the treatment of cellulite. J Cosmet Laser Ther 9: 15-20.
heating of the adipose tissue at 43-44°C for 10 minutes, over a series 18. Winter ML (2009) Post-pregnancy body contouring using a combined
of 6 sessions. In addition, an apoptotic death of adipocytes caused by radiofrequency, infrared light and tissue manipulation device. J Cosmet Laser
trains of ultra-short (nanosecond), high voltages pulses, resulting in Ther 11: 229-235.
irreversible electroporation (IRE) effects on the fat cell membrane may 19. Brightman L, Weiss E, Chapas AM, Karen J, Hale E, et al. (2009) Improvement
also be a major contributor to long-term adipose tissue reduction. in arm and post-partum abdominal and flank subcutaneous fat deposits and
skin laxity using a bipolar radiofrequency, infrared, vacuum and mechanical
The cellulite improvement was significant and the ability of massage device. Lasers Surg Med 41: 791-798.
the device to treat many of the underlying anatomical alterations in 20. Zachary, CB Mian A, England LJ (2009) Effects of monopolar radiofrequency
cellulitic skin may contribute to its efficacy. on the subcutaneous fat layer in an animal model. Abstracts Am Soc of Laser
Med and Surg 38: 105.
The TiteFX is able to treat both focal fat or cellulite zones, each in 21. Anolik R, Chapas AM, Brightman LA, Geronemus RG (2009) Radiofrequency
20 minutes, making multiple zone body contouring feasible. There is devices for body shaping: a review and study of 12 patients. Semin Cutan Med
no disposable costs associated with the use of the device and despite Surg 28: 236-243.
the thermal mechanism and HVP IRE, is very well tolerated by the 22. Rubbani S (2008) Advances in monopolar radiofrequency for the treatment of
patient with an apparent high index of safety. The authors believe that stretchmarks in the arms, thighs and abdomen. Abstracts in the Am Soc of
Laser Med and Surg 370: 111.
the TiteFX technology is effective in delivering a permanent adipocyte
apoptotic effect and thus long-term non-invasive fat reduction, cellulite 23. Rubbani S (2008) The immediate effect of a new monopolar radiofrequency
treatment tip on cellulite. Abstracts annual meeting Am Soc of Laser Med and
improvement and body contour enhancements. Further studies will Surg 369: 110.
help to confirm and position the role of TiteFX in body contouring and
24. Goldberg DJ, Fazeli A, Berlin AL (2008) Clinical, laboratory, and MRI analysis
cellulite reduction. of cellulite treatment with a unipolar radiofrequency device. Dermatol Surg 34:
204-209.
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2. Schoenbach KH, Hargrave B, Joshi RP, Kolb JF, Nuccitelli R, et al. (2007) Dermatol 5: 714-722.
Bioelectric effects of intense nanosecond pulses. IEEE Trans Dielectr Electr 26. Kaplan H, Gat A (2009) Clinical and histopathological results following TriPollar
Insul 14: 1088-1109. radiofrequency skin treatments. J Cosmet Laser Ther 11: 78-84.
3. Schoenbach KH, Xiao S, Joshi RP, Camp JT, Heeren T, et al. (2008) The effect 27. Teitelbaum SA, Burns JL, Kubota J, Matsuda H, Otto MJ, et al. (2007)
of intense subnanosecond electrical pulses on biological cells. IEEE Trans Noninvasive body contouring by focused ultrasound: safety and efficacy of the
Plasma Sci 36: 414-422. Contour I device in a multicenter, controlled, clinical study. Plast Reconstr Surg
4. Altunc S (2009) Subnanosecond pulsed-power generated electric fields for 120: 779-789.
cancer treatment. IEEE Nucl Plasma Sci Soc News: 34-37. 28. Brown SA, Greenbaum L, Shtukmaster S, Zadok Y, Ben-Ezra S, et al. (2009)
5. Garner AL, Chen G, Chen N, Sridhara V, Kolb JF, et al. (2007) Ultrashort electric Characterization of nonthermal focused ultrasound for noninvasive selective
pulse induced changes in cellular dielectric properties. Biochem Biophys Res fat cell disruption (lysis): technical and preclinical assessment. Plast Reconstr
Commun 362: 139-144. Surg 124: 92-101.
Background and Objective: A novel, noninvasive Key words: radiofrequency; adipose tissue; circumfer-
technology, utilizing suction-coupled radiofrequency (RF) ence reduction; noninvasive fat destruction; apoptosis;
heating and ultra-short pulse duration, high-voltage irreversible electroporation; neocollagenosis
electrical pulses was studied for its efficacy and safety on
adipose tissue reduction.
Methods: Twenty-one subjects underwent treatment of INTRODUCTION AND OBJECTIVE
their abdominal fat once weekly for 6 weeks. Clinical Adipocytes store energy in the form of cytosolic
outcomes including abdominal circumference, adipose triglycerides. These fat cells make up adipose tissue in
tissue thickness (measured by ultrasound), adipose tissue the body and are held together by an organized lobular
weight, body weight, and clinical photographs were network of collagenous fibrous septae. Adipocytes can
obtained at visits 1 and 3 months after last treatment. distend dramatically with increased triglyceride content.
Adverse events were recorded. Three subjects, who were Excess adipose tissue can lead to aesthetically displeasing
undergoing a future elective abdominoplasty, were treated body contour bulges and convex distensions. Fat lobules
with the same protocol, but on only one side of the abdomen are contained within and partitioned by fibrotic septal
before abdominoplasty. Biopsies from the RF-treated and divisions running perpendicular and oblique to the surface
untreated sides were harvested during abdominoplasty of the skin. In females, these partitions can weaken and the
and cultured; measurements of adipocyte size and shape, orientation of the septae be altered, resulting in focal
rate of apoptosis, collagen production, and dermal thick- herniations of fat into the dermis, creating the classic
ness were determined. bulging skin nodules of cellulite [1]. Suction-assisted
Results: Significant clinical improvements (P < 0.05) were Lipoplasty (SAL) performed under tumescent anesthesia
observed for the following clinical outcomes: reduction of has long been the gold standard treatment to reduce focal
abdominal circumference (113.4–110.7 cm), reduction of fat excess [2]. Recently, ultrasound, laser, and radio-
subcutaneous adipose tissue thickness (40.5–38.5 mm), frequency (RF) technologies have been added to traditional
and reduction in adipose tissue weight (32.2–30.7 kg) at lipoplasty, resulting in energy-based liposuction, to im-
3-month follow-up visits. Overall patient weight also prove the soft tissue contraction, and minimize ecchymosis
decreased, which was statistically significant at 1-month
follow-up, but was not statistically significant at 3-month
follow-up (73.9–73.3 kg, P ¼ 0.609). Histologically, adipo- Conflict of Interest Disclosures: All authors have completed
cytes were observed to have decreased size and withered and submitted the ICMJE Form for Disclosure of Potential
shape, with increased levels of apoptosis; increased Conflicts of Interest and have disclosed the following: S.B.: A
BodyFX device was provided for her use during this study;
collagen synthesis, with compaction and reorganization no other disclosures. M.D.: No relevant disclosures. A.A.N.:
of the dermis was also observed. Only minor, transient side Received speaking honoraria from InMode, Inc. and has stock
effects were reported. options with InMode, Inc. N.M.G.: No relevant disclosures.
G.P.L.: Received speaking honoraria from InMode, Inc. and has
Conclusions: This novel, noninvasive RF device stock options with InMode, Inc.
was effective for improving subcutaneous fat, reducing Correspondence to: Gary P. Lask, MD, Department of
abdominal circumference and reducing subcutaneous Dermatology, University of California Los Angeles, 200 UCLA
Medical Plaza, Suite 450, Los Angeles, CA 90095.
fat layer thickness. Histologically, these improvements E-mail: glask@mednet.ucla.edu
appear to be partly related to increased adipocyte Accepted 23 December 2013
Published online in Wiley Online Library
apoptosis. Lasers Surg. Med. 46:94–103, 2014. (wileyonlinelibrary.com).
ß 2014 Wiley Periodicals, Inc. DOI 10.1002/lsm.22223
and edema compared with traditional SAL [3–9]. While cyte to undergo apoptosis. The combination of these two RF
effective, these energy-based liposuction technologies still treatments should allow for more effective treatment of
require an invasive lipoplasty procedure. In the last few subcutaneous adipocytes, tightening of the skin in the
years, there has been a dramatic increase in demand for treatment area, and ultimately improved clinical outcomes.
noninvasive procedures for fat sculpting and reduction.
The ideal noninvasive fat treatment would safely and MATERIALS AND METHODS
effectively “destroy or deactivate” fat cells nonsurgically The Device
for long term, noninvasive body contour improvements.
The BodyFX device (InMode, Inc., Yokneam, Israel)
This has led to the development and popularization of
utilizes a suction-coupled, bipolar RF configuration, with a
noninvasive technologies based on suction-massage, high-
built-in infrared skin surface temperature sensor (Fig. 1).
intensity focused ultrasound (HIFU), cryolipolysis, low-
A vacuum draws the tissue up between the bipolar RF
level lasers, and RF [10]. To date, however, these devices
electrodes, facilitating a deep dermal and fat layer
have resulted in only modest improvement of adipose
treatment. The triple action system works by suction-
tissue. Additionally, current technologies do not simulta-
coupled, even heating of the skin and adipose tissue to a
neously enhance the quality, elasticity, or contraction of
uniform depth of 2.5 cm.
the dermis to tighten the treatment area, which is an ideal
The deep heating results in increased adipocyte temper-
goal for noninvasive body sculpting.
ature and metabolic activity leading to a nondestructive
Radiofrequency devices have several important charac-
reduction in adipocyte cell volume [10,11]. As the dermis is
teristics that may make them an ideal choice for noninva-
being heated, collagen remodeling and tightening occurs,
sive fat treatment and body sculpting. RF devices utilize
similar to effects seen with traditional noninvasive RF skin
electrical conductance, in the form of rapidly alternating
tightening technologies [11]. The device allows for the user
electrical current (at various frequencies and voltages) to
to determine the RF power level, as well as a preset cut off
cause oscillation of cellular structures that are in the
dermal/adipocyte temperature. In order to achieve and
electrical path, thereby increasing intermolecular motion.
maintain the skin temperature, the device hand piece
As the current alternatively flows, molecular collisions
incorporates several sensors, including: high and low
increase thereby creating thermal energy (heat). RF
impedance sensors, a contact sensor, and an epidermal
technology therefore utilizes the resistance (impedance)
thermal sensor. The device measures skin temperature,
of the tissue itself to generate heat rather than directly
impedance, and epidermal contact 10 times per second
transferring heat. Adipocytes have high tissue resistance,
allowing for real time feedback and a uniform, safe
which allows them to generate significant heat when RF
treatment. The device deploys a software algorithm that
energy is passed through the tissue. Additionally, adipo-
immediately, automatically, and temporarily terminates
cytes have relatively low heat transfer coefficients, which
the delivery of RF energy to the area once the preselected
means they do not transmit significant amounts of the
cut off temperature is reached. Once the temperature of
heat to unintended surrounding structures. As a result of
this treatment area drops to 0.18C below the set target
these characteristics, RF energy can be used to generate
temperature, or as the physician moves the treatment
substantial heating of adipocytes while limiting the spread
applicator over a new area that has not yet reached the
of this heat to surrounding structures, resulting in
predetermined temperature, the device automatically
localized adipocyte thermolysis. RF heating has also
reactivates the RF energy. This on-going, automated
been shown to improve dermal collagen, elastin, and
temperature modulation allows the temperature and
ground substance leading to skin tightening, which is
important in achieving an optimal body contour result
using noninvasive adipose reduction technology [11].
The objective of the study was to evaluate both clinically
and histologically, the efficacy, safety, and mechanism of
action of a novel RF device (BodyFX, InMode Inc,
Yokneam, Israel). The device utilizes two types of RF: (1)
initial basic RF pulses in the standard 1 MHz range, and (2)
ultra-short pulse duration, high-amplitude, high-voltage
RF pulses. The basic RF pulses precisely and uniformly
heats the dermal and hypodermal tissue, resulting in
collagen stimulation and skin tightening [10,11]. The
second RF (ultra-short pulse duration, high-amplitude,
high-voltage RF pulses), selectively targets the cell
membrane of adipocytes with an irreversible electropora-
tion (IRE) effect. IRE alters the adipocyte cell membrane
potential, impairing the ability of the cell to maintain its
internal pH. This disrupts the continuity of the adipocyte
cell membrane, impairs the adipocyte’s ability to regulate
cell homeostasis, and ultimately should cause the adipo- Fig. 1. The BodyFX applicator.
96 BOISNIC ET AL.
duration of adipose tissue exposure to be carefully were treated on the right side of the abdomen only, while
controlled by the user, facilitating a safe and effective the contralateral untreated side served as a control; these
treatment at a therapeutic thermal endpoint. three subjects provided tissue samples for histologic
When the preset dermal and adipose therapeutic end analysis following their abdominoplasty procedures. Since
point is reached, typically set at a range between 41 and abdominoplasty was scheduled immediately following the
438C, the device then begins to emit trains of high- RF treatment series, 1- or 3-month clinical follow-up data
amplitude, high-voltage, ultra-short (nanosecond) pulse were not obtained and only their histologic results were
duration RF pulses into the preheated adipose tissue. The included in this study. However, as discussed below, the
intensity of these ultra-short pulse duration RF pulses biopsies were harvested in a validated survival medium
is controlled and set by the user. The RF is triggered up to 14 days, which has been shown to be the equivalent
repeatedly once the preset cut off temperature is reached, to 6–8 weeks in vivo [13–21].
and as long as that temperature is maintained, trains of Subjects were bound to prescribed conditions related to
high voltage, ultra-short pulse duration RF (second RF) their eating habits 2 hours before and after each session
are emitted. These high-voltage, ultra-short pulse dura- and were specifically asked to avoid heavy meals, fasting,
tion RF pulses selectively target the cell membrane of carbonated drinks, coffee, or tea. The subjects’ abdomen
adipocytes, resulting in an IRE effect. IRE disrupts the was prepped clean before the start of the treatment and the
continuity of the adipocyte cell membrane, hindering its vacuum chamber of the device was prepped and disinfected
ability to regulate cell homeostasis. Once the continuity of with bleach pads following each session.
the cell membrane is irreversibly disrupted, this starts the Treatment parameters were set at 40 W and 428C,
cascade of apoptosis, ultimately resulting in permanent, representing the RF power and the skin surface cut off
programmed cell death of the adipocytes [11,12]. temperature, respectively. The basic RF pulse duration
was set at 3–3.5 seconds. The high amplitude, high voltage,
Subjects ultra-short pulse duration “second RF” was set at a level as
high as the subject could tolerate, typically ranging from 5
Twenty-four subjects between the age of 31 and 59
to 10 (correlating to the number of trains of RF pulses
(average age of 44.7 years), exhibiting clinical indications
emitted). The surface of the abdomen was divided into two
of a local excess of adipose tissue were selected and
zones, right and left, with each zone approximately the size
included in the study. Three of these patients were
of 6–8 vacuum chambers. Treatments were performed by
scheduled to undergo an elective abdominoplasty, at the
applying the device applicator for the entire pulse duration
completion of the study. Subjects were asked to maintain
(3–3.5 seconds) and then moving to the tissue immediately
their usual diet and exercise routine so that the device
adjacent with an overlap of the electrode footprint of 20%.
could be evaluated free from the influence of other
Each zone was treated in a clockwise fashion until that
variables.
zone reached the cut-off temperature (428C). Once the cut-
Only subjects of appropriate age and no adverse medical
off temperature was attained, usually in about 60 seconds,
conditions were included in the study. Subjects were
the second RF was then automatically emitted in the
excluded from participation if they had gained or lost
treatment zone. The cut off temperature was maintained
weight in the previous three months. General contra-
in the treatment zone for 5 minutes with a minimum of
indications included pacemakers, pregnancy and nursing,
10 passes of high-voltage second RF pulse treatments,
epilepsy, thyroid dysfunction, diabetes, cardiac arrhyth-
resulting in 5 minutes of high amplitude RF pulse treat-
mias, heart disease or uncontrolled hypertension, history
ments. The process was repeated on the other side of
of cancer (5 years of remission), liver or kidney disease,
the abdomen. A second treatment pass of both zones was
medical conditions causing immunosuppression, use of
then performed, resulting in a total tissue treatment time
isotretinoin (Accutane1) within the previous 6 months, or
of 10 minutes for each zone. The three abdominoplasty
any other skin disorders or condition such as abnormal
subjects, treated on one side only (one treatment zone),
wound healing. Diuretics and anti-coagulants were also
underwent their initial 5-minute treatment pass, then had
banned during the study. All participants in the study
a 5-minute rest period, and underwent a second 5-minute
signed an Informed Consent Form.
treatment pass. The number of zones treated per subject
depended on the surface area of the person’s abdomen with
Experimental Procedure greater treatment zones necessary for very large patients.
Twenty-four subjects were treated with six weekly Total energies ranging from 8.5 to 29 kJ was used per
sessions with the device. All patients were treated in session per subject on the full abdomen.
France in the clinic of two authors (SB and MD). Twenty-
one subjects were treated on the full abdomen and each
patient served as their own control for clinical assessment Clinical Assessments
immediately following the completion of RF treatments, as The precise circumference of the treatment area before
well as 1- and 3-month follow-up visits. The remaining and after treatment sessions was measured. A tape
three subjects were scheduled (at their request) for an measure was used to record circumference on a standing
abdominoplasty procedure immediately following the patient, based on a fixed vertical perpendicular measure-
completion of the series of treatments. These patients ment taken from the end of the tape measure at the level of
A CLINICAL AND BIOLOGICAL EVALUATION OF A NOVEL 97
the floor; furthermore, the tape measure was kept in near in vivo metabolic condition. The elapsed time for the
constant contact with the abdomen along the entire procedure is artificially accelerated three to four times that
circumference. While there are always limitations with of the normal time needed in vivo [15]. Thus, samples
circumferential measurements, this method allows for a analyzed after 14 days correspond to in vivo changes seen
reproducible method of measurement. These assessments 6–8 weeks following the completion of the treatment. The
were performed on day 0 (prior to the first treatment), histologic patient samples were maintained in 3 cm2 full-
immediately following the completion of the series of six thickness pieces, and were thinned to a depth of 3 mm of
weekly treatments, and 1 and 3 months after the final subcutaneous fat to facilitate tissue culture; as a result, in
treatment session. the accelerated tissue culture results, the analysis was
A Tefal1 BodySignal2 digital weight scale (REF: based on observation of the superficial adipocytes (up to
BM3100A9/26A-3810 R) was used to determine both the 3 mm of adipose tissue depth maintained in culture). The
weight of the fat tissue (kg) of the subjects, as well as their culture specimens were initially washed three times with
overall weight (kg). Jewelry and clothing, except for an antibiotic solution (300 U/ml penicillin and 300 mg/ml
undergarments, were removed for the weight measure- streptomycin). Skin biopsies were placed with the
ments. These assessments were performed on day 0 epithelium uppermost, at an air/liquid interface, on
(prior to the first treatment), immediately following the culture inserts (filter pore size 12 mm). These inserts
completion of the series of six weekly treatments, and 1 and were set on six-well plates and culture medium was added
3 months after the final treatment session. underneath three times a week. Medium was Dulbecco’s
Photographs were taken in standardized conditions in minimal essential medium (DMEM) containing antibiotics
exhalation before each treatment session in order to (100 U/ml penicillin and 100 mg/ml streptomycin), 200 mg/
document the appearance of each subject. These assess- ml L-glutamine, bovine pituitary extract, growth factors,
ments were performed on day 0 (prior to the first and fetal calf serum. All supplements were freshly made
treatment), immediately following the completion of the with each medium change every two days and applied at
series of six weekly treatments, and 1 and 3 months after the epidermal level. Skin biopsies were then put in a
the final treatment session. humidified atmosphere of 95% air–5% CO2 at 378C. These
Fat thickness was measured by ultrasound (Philips HD skin cultures were then used as the basis for histologic and
11 XE) on noncompressible fat, measuring the abdominal immunohistochemistry studies.
fat layer thickness 5 cm inferior to the umbilicus. Treated and untreated skin cultures were then com-
Ultrasound measurements were performed by a single pared at day 0 (day of abdominoplasty), day 3, and day 14.
technician, utilizing uniform pressure on the ultrasound At each of these time points, a portion of the soft tissue
transducer over noncompressible fat. While there are specimen was analyzed for traditional histopathology and
inherent limitations in ultrasound measurement of fat morphometric assessment; a comparison was conducted
layer due to compression, this method limits this potential between the treated and untreated abdominal skin,
variability. These measurements were performed before consisting of an analysis of adipocyte architecture and
beginning the series of treatments, and 1 month after function, as well as an evaluation of the appearance and
completing the treatment series. The initial examination thickness of the hypodermis (measured in microgram at
was completed within 48 hours preceding the first meas- 100 magnification). Photography was used to visualize
urements and treatment session. any alterations between treated and untreated areas.
At days 0, 3, and 14, a portion of the skin culture
was also analyzed with immunohistochemistry. A rabbit
Cellular and Histologic Assessments polyclonal antibody directed against human apoptosis
Three patients were scheduled to undergo elective protease activating factor 1 (APAF-1) (Spring Bioscience,
abdominoplasty at the completion of the treatment series IgG, 1/300 dilution) was used. The immune-detection was
as described above. Soft tissue composite skin and adipose made with an indirect technique of immunoperoxydase in
biopsies were taken from the treated and untreated four levels, amplified (kit CsA II, DAKO, Les Ulis, France)
abdominal regions of these three subjects, and the speci- and stained in red by 3-amino-9-ethylcarbazole (AEC).
mens were maintained as next described. Histologic Greater levels of expression of APAF-1 indicate greater
patient samples were cut into 3 cm2 full-thickness pieces, apoptotic activity in the cells.
with an initial depth of 2.5 cm. The histologic studies After 14 days of culture, the remaining soft tissue
performed immediately after the abdominoplasty included specimen was utilized for analyzing collagen synthesis
the full tissue depth, with a depth to 2.5 cm of adipose using a validated collagen assay [13–17]. Skin samples
tissue analyzed. were enzymatically digested in an acetic acid 0.5 M
Following the initial harvesting and analysis, the solution containing pepsin overnight at 48C. The fibroblas-
specimens were then maintained following a validated tic activity for collagen synthesis was evaluated by a
method of tissue culture, which permits the survival of spectrocolorimetric method (540 nm) measuring the acid-
normal skin and adipose tissue in ex vivo conditions to keep soluble new collagen synthesized after a specific fixation by
skin and adipose samples in survival condition [13–21]. Sirius red staining (Sircoll Collagen Assay, Interchim,
This alternative culture method avoids testing in vivo Montlucon, France). The results were expressed in
biopsy specimens and maintains the model in a validated microgram of collagen per mg protein.
98 BOISNIC ET AL.
TABLE I. Average Measurements of Abdominal Circumference, Fat Tissue Thickness, Fat Tissue Weight, and
Body Weight Before Treatment, Immediately Following Six Treatment Sessions, At 1-Month Follow-Up, and at 3-
Month Follow-Up Visits
Before treatment, mean SD 21 113.4 15.3 40.5 11.4 32.2 8.9 73.9 12.4
After six sessions, mean SD (95% CI) 21 111.5 15.0 N/A 31.2 8.4 73.0 11.8
(1.32–2.44), (0.62–1.36), (0.46–1.34),
P < 0.001 P < 0.001 P < 0.001
One month follow-up, mean SD (95% CI) 21 111.1 14.5 38.5 11.0 30.8 8.4 72.7 11.9
(1.45–3.12), (1.32–2.77), (1.02–1.92), (0.68–1.67),
P < 0.001 P < 0.001 P < 0.001 P < 0.001
Three months follow-up, mean SD (95% CI) 21 110.7 14.5 N/A 30.7 8.2 73.3 11.7
(1.78–3.75), (0.85–2.20), (1.55–2.58),
P < 0.001 P < 0.001 P ¼ 0.609
95% Confidence Interval reported reflect changes between before treatment and each consecutive time points.
P values calculated using Paired Sample T tests
a
Circumferential measurements of the abdomen (cm) before treatment (day 0), immediately following six treatment sessions, 1 month,
and 3 months after completing a series of six weekly noninvasive RF treatments.
b
Measurement of subcutaneous fat layer thickness as assessed with ultrasound (mm) before treatment (day 0) and 1 month after
completing a series of six weekly noninvasive RF treatments.
c
Fat tissue weight (kg) measured with digital weight scale before treatment (day 0), immediately following six treatment sessions,
1 month, and 3 months after completing a series of six weekly noninvasive RF treatments.
d
Overall subject weight (kg) measured with digital weight scale before treatment (day 0), immediately following six treatment sessions,
1 month, and 3 months after completing a series of six weekly noninvasive RF treatments.
A CLINICAL AND BIOLOGICAL EVALUATION OF A NOVEL 99
Cellular and Histologic Findings persisted and became more apparent in superficial adipose
Histological evaluation of skin and adipose sam- tissue at days 3 and 14 in accelerated culture (Fig. 5).
ples. After preparation and analysis of the skin samples Immunostaining for adipocyte apoptosis. Within
from the three subjects, alteration of the fat cells was found the adipose tissue of the treated areas, increased levels of
in treated areas of the hypodermis to a depth of 2.5 cm in adipocyte apoptosis were observed immediately following
the initial histologic analysis. Control, nontreated skin, the treatment series, with approximately 20% of all
contained adipose tissue with normal round adipocytes; adipocyte cells staining positive for APAF-1, a validated
skin treated with the RF device showed altered adipocyte marker of apoptosis. In contrast, the control untreated skin
histology, with a reduction of fat cell size with flattening only rarely had adipocytes undergoing apoptosis, with less
and/or elongation of the cells. Fat cell membranes in the than 1% of adipocytes staining positive for APAF-1. At
RF-treated adipose appeared shrunken and withered; day 14 of culture, fat cell apoptosis had further increased
occasionally, the adipocyte cell walls were partially (30% of adipocytes staining positive for APAF-1) within
ruptured. No necrosis was observed, and there was no the RF-treated adipose tissue (Fig. 6).
destruction of adjacent structures (epidermis, blood Dermal thickness and neocollagenosis. A signifi-
vessels, nerves or dermal collagen). These induced changes cant reduction in dermal thickness, with tighter, more
to the adipose architecture were noted immediately compact collagen, and an apparent decreased spaced
following the completion of the series of treatments (at between the collagen fibers, was noted following the RF
the time of abdominoplasty). Furthermore, these changes treatment series (Fig. 7). At day 0 the average dermal
Fig. 5. Histologic findings. Tissue specimens, obtained during abdominoplasty, were cultured and
processed for histologic analysis. Figures above (200 magnification) are from nontreated (control)
skin (A,C), and skin treated with a series of six noninvasive RF treatments (B,D). In (A) and (B), the
specimens were taken from culture immediately after completing the series of RF treatments. In (C)
and (D), the specimens were obtained following tissue culture for 14 days. Note the round
appearance of adipocytes in the untreated area, in contrast to the flattened, withered, and emptying
appearance of the adipocytes from the RF-treated area. Figures above (200 magnification).
A CLINICAL AND BIOLOGICAL EVALUATION OF A NOVEL 101
Fig. 7. Histology of the dermis in tissue culture. Tissue specimens, obtained during abdominoplasty,
were cultured and processed for histologic analysis with Sirius red staining. Figures above
(100 magnification) are from nontreated (control) skin (A), and skin treated with a series of six
noninvasive RF treatments (B), on day 0 of tissue culture. Figures (C) and (D) represent nontreated
(control) and treated skin, respectively, after 14 days in tissue culture. Note the reduction in thickness
of the dermis, more compact collagen and reduction in elastosis following the series of RF treatments,
and that the effects continue to improve over time (B,D). Figures above (100 magnification).
collagen resulted in a noticeably compacted, organized device appears to be a safe and effective option for treating
dermis. This synchronous dermal enhancement is an subcutaneous adipose tissue.
important effect, given that patients who undergo nonin- There are, of course, limitations to this study. First, the
vasive fat reduction typically also seek skin tightening study examined only 24 subjects, which may limit the
along with fat reduction. While other noninvasive devices power of the results; however, the results were statistically
have been able to achieve adipocyte destruction and fat significant with the number of subjects enrolled. Second,
layer reduction, this novel RF device is unique in its ability while the study demonstrated significant improvement
to simultaneously achieve long-term improvement in immediately following the series of treatments, as well as
subcutaneous fat through apoptosis and skin tightening 3 months after the completion of the series, it remains
with a single technology. This represents a substantial unknown whether this clinical improvement will be
improvement over currently available technologies. maintained over years. Third, the clinical parameters
Only mild and transient adverse events were noted utilized in this study were conservative, which may have
during the series of treatments. Most of the adverse effects contributed to a less dramatic clinical improvement;
were related to the device’s thermal mechanism of action recently, the authors have utilized higher temperature
and the mild electrical sensation of the high-voltage cut off values and higher intensity ultra-short pulse
pulsing. Notably, no patients suffered thermal burns to duration RF pulses, with associated greater clinical
the skin and there were no reports of cutaneous sensory improvement, greater reduction in abdominal circumfer-
changes or painful dysesthesia in any patients. Thus, the ence, and increased reduction of adipose tissue weight.
A CLINICAL AND BIOLOGICAL EVALUATION OF A NOVEL 103
Lastly, while the histologic and immunohistochemistry high voltage ultra-short electrical pulses. J Clin Exp Dermatol
data shown in this study are very promising, they are Res 2012;3(4):157–165.
13. Boisnic S, Branchet-Gumila MC, Benslama L, Le Charpentier
based on a limited series of only three patients. Y, Arnaud-Battandier J. Long term culture of normal skin to
Nonetheless, this device represents a novel treatment test the efficacy of a hydroxy acid-containing cream. Eur J
option for patients seeking noninvasive fat reduction. With Dermatol 1997;7(4):271–273.
the incorporation of two types of RF treatments: (1) a basic 14. Chapman SJ, Walsh A, Beckett E, Vickers CFH. A fully
differentiating epidermal model with extended viability:
RF pulse in the standard 1 MHz range for thermal heating, Development and partial characterization. J Invest Dermatol
and (2) trains of ultra-short pulse duration, high-ampli- 1989;93:762–768.
tude, high-voltage RF pulses to cause IRE, this device 15. Kondo S, Hozumi Y, Aso K. Long-term organ culture of rabbit
skin: Effect of EGF on epidermal structure in vitro. J Invest
achieves significant reductions in abdominal circumfer- Dermatol 1990;95:397–402.
ence, subcutaneous fat layer thickness, and adipose tissue 16. Branchet-Gumila MC, Boisnic S, Le Charpentier Y, Nonotte I,
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substance P in an organ culture of human skin. Skin
device also allows for remodeling and tightening of the Pharmacol Applied Skin Physiol 1999;12:211–220.
existing collagen in the treatment area, and stimulates 17. Boisnic S, Branchet-Gumila MC, Le Charpentier Y, Segard C.
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long-term subcutaneous adipose tissue reduction repre- retinaldehyde cream in an ex vivo human skin model.
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Expert Roundtable Series:
A
ccording to market research published by Medical
Insight, Inc. (Aliso Viejo, Calif.), sales of body shap-
ing and skin tightening devices are booming and ex-
pected to rise by 13.2% per year, driven by rising consumer
interest in these procedures. This exploding patient demand
for non-invasive aesthetic treatments has compelled many
practitioners to invest in energy-based body shaping devices,
but how does one determine the most effective, best perform-
ing technology? In this roundtable discussion, seven expert
physicians share their experience with various energy-based
systems, advising on how to apply solid evaluation criteria
when looking to upgrade or when buying for the first time.
Z. Paul Lorenc, M.D., F.A.C.S. — The first question that should be asked is: Is there
Andrew Nelson, M.D. a need in your practice for fat reduction or body contouring devices? Next, does
Dermatologist the technology work and is it cost-effective. Every device company is trying to
St. Petersburg, FL
be more innovative than the next one as far as leasing and marketing programs.
The valuation of bringing in a device is becoming more and more complex by
the minute. As a practice you need to evaluate and assess all of those things, but
Candace Thornton Spann, M.D.,
even then sometimes you don’t have a clear answer.
F.A.A.D.
Dermatologist
Las Vegas, NV
Andrew Nelson, M.D. — My two main criteria are: Is it safe and is it effective?
It is debatable which of these is most important. If you have an effective device
that isn’t safe, you don’t really have anything. If you have a safe device that is
not effective, you also don’t have anything. At the same time, if you’re a physi-
Marvin Spann, M.D.
Plastic Surgeon cian who is entering the world of aesthetics and you do not offer a non-invasive
Las Vegas, NV body contouring treatment then you’re going to lose your patients to somebody
who does. I use a platform-based approach that comprises several systems from
InMode Aesthetic Solutions (Toronto, Ontario, Canada), including the Body FX,
which is a non-invasive RF-based device.
Mark B. Taylor, M.D.
Dermatologist
Cosmetic Laser Surgeon Candace Thornton Spann, M.D., F.A.A.D. and Marvin Spann, M.D. — For many
Salt Lake City, UT
physicians, cost is a big issue, and a lot of systems involve disposables where
you are continually paying for a product just to use the system, which is a draw-
back. As well, expandability is important. We use the VShape platform from
Fredric A. Stern, M.D. Alma Lasers Inc. (Buffalo Grove, Ill.), which delivers RF-based energy via multiple
Plastic Surgeon
Bellevue, WA handpieces to promote a temporary reduction in cellulite, reduce wrinkles and
resurface the skin.
Mark B. Taylor, M.D. — When I began my search the first questions I asked were:
Douglas J. Key, M.D. What is the technology? How much pain is associated with it? How many treat-
Key Laser Institute for ments will it take to see results? Is it going to be cost-effective for both the patient
Aesthetic Medicine
Portland, OR and the clinic? Are any of the disposables expensive? There are a lot of differ-
ent factors that come into play with body shaping technologies. I use the whole
range of body shaping procedures – liposuction, Smartlipo, BodyJet and VASER –
including non-invasive. A segment of people just have small, localized areas of
Jon Perlman, M.D., F.A.C.S.
Cosmetic Plastic Surgeon fat. They’re busy and / or surgery averse, and will be satisfied with minimal im-
Los Angeles and Beverly Hills, CA
provement, no downtime and multiple treatments.
Douglas J. Key, M.D. — Due to thermal imaging we know the bulk volume be-
ing heated is very transient. When I heat under the surface with the ThermiRF
system from ThermiAesthetics (Southlake, Texas), the dermis is heated last. With
Before Tx
the neck and arms, we are interested in tightening structure, not skin and we
can achieve very sustained periods of tightening. We don’t want to injure the
patient or sub treat, either. When it comes to non-invasive body contouring,
tightening and shaping, there is a satisfaction among patients, but does it mea-
sure up to our criteria of reproducible photography?
Jon Perlman, M.D., F.A.C.S. — Liposuction is very thorough, the most complete
method of sculpting a body. I was looking for a non-surgical body sculpting
device that provided a good alternative to liposuction. The iLipo system from
Chromogenex U.S., Ltd. (Howell, Mich.) features low power 680 nm to 685 nm After eight BodyFX treatments
Photos courtesy of the Jannaé Institute
laser wavelengths, which stimulate the fat cells to create a pore that opens up
the cell wall and allows the triglycerides in the fat cell to exit as free fatty acids.
Vacuum massage stimulates the lymphatics and we hydrate the patients to help
the lymphatic flow. We also ask the patients to burn calories through exercise.
Dr. Stern — For bulk contouring, laser lipolysis combined with power and suction-
assisted liposuction is the gold standard. For more precise body shaping, I prefer
minimally invasive laser lipolysis using a tiny laser fiber. Also, not all heat is the
same. Heat flows and exhibits a changing spatial gradient with a specific temper-
ature profile. Temperature control is important to achieve reproducible results and
there are several good devices on the market. In my practice, the SkinTyte BBL
device from Sciton (Palo Alto, Calif.), with finesse adapters and no consumables, Before Tx
serves me very well as a standalone procedure. I use this device for all of my post
liposuction and post-CelluSmooth™ (Sciton) patients as well, to achieve optimal
skin tightening and stimulate collagen formation during the healing process.
Article: A Clinical and Biological Evaluation of a Novel, Noninvasive Radiofrequency Device for the Long-Term Reduction of Adipose Tissue
Authors: Drs. Sylvie Boisnic, Marc Divaris, Andrew A. Nelson, Nima M. Gharavi, and Gary P. Lask.
21 subjects underwent BodyFX and reported an average 2.7 cm abdominal circumference reduction.
Furthermore, histologies show 20% adipocyte cells staining positive for APAF-1, a validated market of
apoptosis after 6 weeks. At day 14 of culture, fat cell apoptosis increased to 30% of adipocytes staining
positive for APAF-1. Collagen synthesis (neocollagenosis) of 13.7% was reported.
BodyFX is just one of the many in demand aesthetic devices available by InMode Aesthetic Solutions.
To get a copy of the clinical study or book an in-office demonstration please contact InMode at:
info@inmodemd.com 1.855.411.2639 www.inmodemd.com
“INMODE OFFERS THE MOST COMPREHENSIVE COLLECTION OF
IN-DEMAND AESTHETIC APPLICATIONS. PREVIOUSLY, PHYSICIANS
HAD TO BUY 3-4 DEVICES IN ORDER TO SATISFY PATIENT NEEDS. Dr. Gary Lask
INMODE HAS DEVELOPED A PLATFORM THAT PROVIDES SUPERIOR Board Certified Dermatologist,
TREATMENT OUTCOMES AND CAN GROW WITH YOUR PRACTICE.” UCLA
Forma and BodyFX Featured on Extra TV as the Celebrity Secret for a Golden Globes Glow!
The secret is out! Extra TV one session. The skin’s elasticity continues
reveals Forma & BodyFX as Hollywood’s to improve as the therapeutic temperature
A-list celebrities’ favorite non-invasive from the radiofrequency treatment
treatments. These treatments keep skin stimulates the production of new collagen.
young, tight and glowing! In this video
celebrity skin care facialist, Joanna Vargas, BodyFX is a non-invasive body contouring
reveals her methods for getting Julianne and cellulite treatment, using negative
Moore, Naomi Watts, Maggie Gyllenhaal vacuum pressure and radiofrequency
and Bill Murray red carpet ready for the to reduce volume and simultaneously
Golden Globes. tighten skin. It can be used to tighten the
abdomen, flanks, thighs and other trouble
Forma uses non-invasive radiofrequency areas without surgery or downtime.
technology to rejuvenate skin and take Results are progressive and best seen after
years off the face. Forma smoothes crow’s a series of treatment sessions.
feet, tightens sagging skin on the jaw
and neck, and diminishes fine lines and
wrinkles. Results can be noticed after just
Lauren Kitt-Carter Tells Extra TV How She Keeps Her Skin Glowing
ExtraTV features Fractora RF: the new treatment celebs use to get red carpet ready
Video: http://www.youtube.com/watch?v=dEWR-03MF6s
Viva la Mañana: Fractora Demonstration
October 4, 2013
Dr. Natan Yaker and his assistant, One treatment takes from 45
Maria, demonstrate new radio frequency minutes to an hour, and an anesthetic
technology on Spanish morning show, Viva cream is applied to improve patient
la Mañana. Fractora helps to diminish the comfort. If a higher energy level is used a
appearance of wrinkles caused by aging, patient might only need 1-2 sessions, but
sun damage, and skin deterioration. could experience 3-5 days of downtime.
If the patient can’t take a week off of
Fractora delivers bipolar RF energy work then the treatments can be split up
to various depths in the skin through an every 1-2 weeks for 6-8 weeks at a lower
array of pin electrodes creating micro energy level. With this option there is no
lesion zones of ablation, coagulation downtime and the patient can go back to
and heating, leading to rejuvenation and work immediately after treatment.
contraction. It also helps to reduce pore
size and pigmentation of the skin. Some This treatment is not a
common treatment areas include: face, replacement for plastic surgery, but
jowls, neck, and chest. Dr. Yaker points out is very effective at treating the earlier
that the chest is often forgotten about but stages of wrinkles and for maintaining
it sometimes ages even faster than the results achieved with plastic surgery.
face and neck.
Video: http://www.youtube.com/watch?v=b3-CPo68IZQ
Dr. Garza On Fox 17 for Cosmetic Procedure BodyFX
Jan 28, 2014
BELLE MEADE, Tenn. – BodyFX is a one for facial procedures. Because there’s no
of a kind machine in Tennessee that’s surgery or anesthesia involved, the cost is
credited with killing body fat, giving the significantly lower than traditional plastic
same results as liposuction, without surgery.
surgery. Febock says the only thing she felt
Tara Febock thought non-invasive was some minor heat. After 2 treatments
lipolysis sounded too good to be true, she saw the results. Dr. Garza says though
but between working out and yoga, she this will reduce the amount of surgeries,
needed help with one last trouble spot: he doesn’t expect this procedure will
her thighs. Whether taming cellulite or completely replace liposuction. The only
slimming down, this hand held device risks with this non-invasive technique are
performs the procedure Febock says slight skin irritation or a burn that could
worked for her. It beeps with radio- be treated with topical cream.
frequency pulses that give the patient a
heat sensation.
Dr. Robert Garza is the only plastic
surgeon in Tennessee with this machine,
which uses radio frequency technology
to kill fat cells. The dead fat cells are then
re-absorbed into the body. A smaller
attachment, Forma, helps tighten the skin
Video: https://www.youtube.com/watch?v=LbHwX5BFqZw
Dr. Stephen Mulholland Introduces New Non-Surgical Procedures
April 25, 2012
Breakfast Television
Jenn Valentyne visits Dr. Stephen the fat cell in a safe way in which the body can then
Mulholland at SpaMedica to discuss new non- metabolize it. There are virtually no risks, and it
surgical procedures, including FaceTite. This new takes a series of treatments over several weeks.
procedure is performed in physician’s offices which 3-4 cm is the average reduction. Treatments like
smoothes away wrinkles caused by weight loss, TiteFX are usually half the cost of liposuction, which
dieting, pregnancy, etc.. The internal electrode comes out to about 1500-2000 dollars. This is
goes under the skin, however there is no cutting about the same cost as the Jenny Craig or Bernstein
or surgery necessary. This is the first device that programs. Dr. Mulholland’s patient, Laura, describes
safely and effectively heats under the skin, which the feeling as a mild electrical shock, which is fairly
is much more effective than on top of the skin. comfortable.
There is no bruising or down-time. Only a single Dr. Mulholland shows us the Fractora and
treatment is necessary to see the desired results, the Fractora Firm. It sends an electrical current
and the patient is able to return to work the same through tiny pores created by microscopic needles.
day. Dr. Mulholland has been doing the procedure An antioxidant is applied, which the Firm pushes
for 11 months and has seen impressive results in into the skin to tighten the skin. It is another
the tightening of the skin under the arms, above procedure after which the patient can head back to
the knees, etc. His patient, Jane, felt nothing at all work on the same day. If the patient goes in once a
during the procedure. week for 4-5 weeks the treatment can take off 4-5
Dr. Mulholland introduces TiteFX, which years (a year a week).
as the name suggests, gives a tightening effect.
This machine is a fat-melter. It melts away cellulite
and tightens the “wiggly-jiggly” areas. It emits
a high-voltage electrical current, which is quite
comfortable compared to other techniques. It kills
Video: http://youtu.be/4qfraSbic_M
Having It All: Hosted by Niki Taylor
December 13, 2012
Dr. Andrew Nelson, Harvard and choose their length of downtime. If the
UCLA board certified dermatologist, joins patient decides that they want a more
supermodel Niki Taylor on “Having It All” aggressive treatment, then downtime
to discuss Fractora by Invasix. can take up to a few days. Alternatively,
Fractora treats multiple signs of patients can choose a series of mild
aging by heating the deeper levels of the treatments that have no downtime at all.
skin and allowing collagen to remodel and Niki was so excited about Fractora
resurface itself. that Dr. Nelson returned to the studio
Dr. Nelson points out that the face after hours to give her an exclusive
is usually the first to get wrinkles from treatment. She absolutely loved
sun damage and aging. Fractora helps the session and calls Fractora a real
in fighting that battle by gently applying breakthrough.
heat through small micro pins using
fractionated radio-frequency energy.
This targets multiple layers of the skin,
treating discoloration on the surface
layers, and wrinkles in the deeper layers.
This procedure is very safe and
because of its flexibility the patient can
Video: http://youtu.be/ppsZ6Y61XP8
Dr. Youn on The Dr. Oz Show Featuring Fractora Firm
Dr. Anthony Youn, a well-known plastic This Fractora face lift is the biggest bang
surgeon, joins Dr. Oz to discuss the Fractora for the buck. Not only does it cost much less
Firm treatments. These treatments are less than compared to the traditional face lift, it is also
half the price and take less time than a regular not a painful experience. There is no down time
face lift. and the procedure only takes half an hour, as
Dr. Oz is amazed by how patients can opposed to traditional procedures that take 3-4
save $10,000 and avoid a surgical face lift hours.
with Fractora Firm. This procedure provides The pros of this device are numerous
immediate results that patients can see and is a and non-invasive procedures are increasing in
device that doctors can trust. popularity. This device is FDA approved and
Patient Noel receives a Fractora Firm available in many locations around the United
treatment live. To see the before and after States.
effects of the treatment she only treats half of
her face. She notices a huge difference from Airdate: January 22 2013
the side of her face that has been treated. Dr.
Oz points out that her cheek and eyebrow look
lifted, and she has less of a jowl.
Dr. Youn explains that Fractora Firm
utilizes radio frequency waves which reverses
aging. It helps decrease fine lines and wrinkles
that have accumulated over decades of aging
and sun damage. The thermal image camera
shows the heat on Noel’s face as the Fractora
Firm device is being used.
Video: http://www.youtube.com/watch?v=rNGVpz35nDs
Newest Trends in Tightening on NBC Miami
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Who hasn’t wanted to rid their body of fat and cellulite without the use of body creams? I know we can
work out till our hearts content, but a lot of times there are certain sections of fat pockets that doctors say
can’t be removed except through surgical procedures. Which, to be honest, really sucks. I mean, I never
want to be put under for any reason pertaining to vanity, but thinking that no matter how many crunches,
wall sits, kettle ball swings, particular areas will never be as tight as desired definitely makes me think twice.
Then again, there are many non-invasive treatments with an immediate recovery time that offer
the same results as invasive over series of sessions. This time around we’re talking about BodyFX. A non-
invasive body contouring technology designed for your bum, abs, flanks, and thighs that targets fatty tissues
and create optimal silhouette. With the use of radio frequency and vacuum massage technique, BodyFX
focuses on particular areas without altering the look of others with heating the skin and gentle pressure to
surpass the epidermis.
I actually tried the treatment and loved the experience. There was no bruising, no tender feeling,
and I could go about my daily business afterwards. It was one a time thing, to get a feel for what patients
would endure, so no results on my end were felt. And please don’t think I wussed out because of any
discomfort. If offered, I would absolutely follow through a series of sessions to show my firsthand before
and after, but as cost is an issue, I’m not able to. Then again, the photos above should be a true testament to
its capabilites.
a n ti - agi n g & beauty
The Body
would have had to have cosmetic plastic
surgery to turn back time, but now years
can be taken off your appearance by
The latest in Non Invasive simple in-office lunchtime procedures with
skin tightening and minimal downtime and risk.
Cellulite Fighters
by dr. ihab matta Whether it’s getting rid of your wrinkles,
restoring youthful volume to your face,
We all want to look our best. Thanks to improving your skin texture and cellulite,
continuing advances in medical tech- eliminating unwanted hair or reducing that
nology, treatments that were once only frustrating “mummy tummy” there
available to the rich and famous are now is a non-invasive affordable solution
accessible to everybody. In the past, one waiting for you.
Jowl/chin/batwing area integrity of the skin. Results are seen after the first
What to do: Pollogen Maximus treatment with peak results at 6-12 months. Most
Radiofrequency treatment to tighten loose skin on the patients require 6 sessions for optimal results.
neck, arms and below the chin.
The treatment is pain free and any area with skin
How it works: Radiofrequency delivers heat to the looseness can be treated; common areas include
skin and subcutaneous tissue below. By reaching and the jowl, chin, neck, batwings, mummy tummy, hips
maintaining a specific temperature, fat is released from and thighs. There is no downtime and clients can
the underlying fat cells and skin tightening is triggered. resume their normal daily routine immediately after the
The Maximus stimulates collagen production through procedure. Cost is usually $200 per session for face or
deep heating, which helps rebuild the structural neck and $300 per session for body.
48 re v i v emaga z i n e . c a
a n ti - agi n g & beauty
How it works: The TiteFX delivers radiofrequency energy to the area. Once the
target temperature is reached, it delivers a second energy pulse that actually
kills the fat cell. The treatment is applied to a given area for 5-10 minutes and
the heating effect stimulates collagen production, which helps tighten skin,
while the secondary pulse improves local fat deposits and cellulite. Results are
seen after the first treatment for fat and cellulite, while the tightening effects
take more time and reach a peak at 6-12 months. The best areas to treat
are the abdomen (for mummy tummy), hips and thighs both for cellulite and
fat. Most patients require 6 sessions. There is no downtime. Each treatment
usually costs $300 with packages available for multiple sessions.
re v i v emaga z i n e . c a 49
FRACTORA
E! News’ Live from the Red Carpet: The Golden Globes (Sunday at 4pm ET/1pm
PT) host Giuliana Rancic starts prepping for the red carpet weeks before the big
show. “I get a spray tan by Veronique at Infinity Sun the night before the event
and I schedule a few extra private training sessions with my trainer, Franklin
Westbrooks, at Equinox in Santa Monica about two weeks before the red carpet,”
she says. “I am also trying out a new skin treatment with Dr. Raj Kanodia called
Fractora. It has helped with the texture of my skin and has made my skin firmer. I
am loving it so much! It’s the best!”
my clients a real backlash against the 'pillow face'.
They don't want a wind‐tunnel look either, just
tighter pores and bouncy, firm skin. And more than
ever advanced treatments can deliver natural but
noticeable improvements."
The post‐fillers face The serious sag‐buster
By: Leah Hardy Fractora
Cosmetic surgeon Angelica Kavouni has introduced
11 January 2012
Fractora, an innovative radiofrequency treatment
that can tighten skin, and restore firm, taut skin
around the jawline, under eyes, on the cheeks and
forehead. It also improves skin texture and clarity.
The energy, delivered via tiny pins, gets right to
where sagging occurs. Recovery takes around a
week and two treatments may be needed.
Cost: From £950
Contact: 020 7486 9040
The painless powerhouse
Endymed PRO 3DEEP Skin Tightening
Brand new but approved by the picky US Food and
Drug Administration, this treatment tightens skin
and builds naturally volumising collagen using
Women no longer want the puffed‐up face that can radiofrequency waves delivered deep into the
result from using fillers. Leah Hardy picks the best dermis. It's particularly effective on sagging jowls
of the new firming treatments. and necks. It can feel hot but isn't painful, and it
creates a brighter complexion with smaller pores.
London's smartest women have had their fill of the Results are instant but a course of up to six
overfull face. With so many puffed‐up celebrity treatments is recommended
faces, and the latest breast implant scare leaving Cost: £200 per session, six sessions for
people much more wary of what they put in their £800 Contact: Jill Zander Laser & Skin Rejuvenation
bodies, it's no surprise women are turning their Clinic (01372 471448, jillzander.co.uk)
backs on the balloon‐faced look which often results
from the use of excessive fillers. The high‐tech treat
The Magnetic Melt by Venus Freeze
But they don't want jowls and drooping eyes either. It feels like a relaxing facial massage but the
Instead, they are opting for new treatments that leave Magnetic Melt takes just 30 minutes to deliver
skin naturally glowing, taut, and looking elegantly gentle skin tightening and leave skin glowing. It can
grown up. The role models? Gwyneth Paltrow and even be used on drooping eyelids. Yasmin Le Bon
Yasmin Le Bon, with their killer cheekbones rather than and Lisa Snowdon are both fans. The device
hamster cheeks. Even Madonna, once a pioneer of combines radiofrequency treatment with magnetic
youthful plumping techniques, has emerged in recent pulses that stimulate the skin to produce new
weeks looking leaner of face ‐ and arguably a lot collagen and elastin to tighten skin.
better. Cost: £130 per session or six treatments for the
price of five
Cult London facialist Debbie Thomas, whose clients Contact: Neville Hair and Beauty (020 7235 3654,
include Sophie Dahl and Billie Piper, says: "I see in nevillehairandbeauty.net)
Article: http://www.standard.co.uk/lifestyle/health/the‐postfillers‐face‐7306461.html
The skin‐changing superfacial The sound wave skin saviour
Debbie Thomas Advanced Skin Treatment Ultherapy
Skin care specialist Debbie Thomas has many years Introduced by surgeon Alex Karidis, this treatment
of experience with lasers. Her newest secret uses ultrasound to deliver heat to the lower
weapon is the Fotona Twin Light Fractional dermis, which stimulates collagen production and
Resurfacing Laser, which can tighten sagging necks skin tightening. It can also lift and rejuvenate the
and jowls and also smooth scars and eliminate neck and cheeks. It takes 45 minutes and full
broken veins. This treatment is given in the context effects take up to four months to be visible. It's also
of a luxurious facial, so is also a treat. painful.
Cost: From £250 Cost: From £750 for the brow to £2,500 for a full
Contact: Debbie Thomas, Advanced Skin facial treatment
Treatments, Hari's Salon, 305 Brompton Road, SW3 Contact: Alex Karidis (020 7432 8727,
(020 7581 5211) nipntuck.co.uk)
The face‐tightening massage The tried‐and‐tested lift
Gankin massage Thermage Thermacool CPT
Cult brand Suqqu has just introduced the Gankin Thermage radiofrequency skin tightening is a
massage: for those who fear lasers and high‐tech favourite of the best surgeons for tightening skin
gadgets, this is a new facial that promises to but it has always been high on the ouch factor.
tighten sagging skin using a unique massage However, Thermage Themacool PT cools the skin
technique. It is all about the relationship between and has a vibrating treatment head to make it far
stiff facial muscles and sagging skin, the theory less painful. Dr Nick Lowe was the first doctor in
being that stiff facial muscles mean lymph flow the UK to use Thermage, so is a very experienced
becomes blocked, making the face swollen and operator.
saggy. By loosening muscles and encouraging the Cost: From £2,000
flow of lymph, the skin becomes brighter, lifted Contact: The Cranley Clinic, 19A Cavendish Square,
and, vitally, tighter. W1 (020 7499 3223, drnicklowe.com)
Cost: £40 for 30 minutes
Contact: Suqqu at Selfridges (0800 123400)
Article: http://www.standard.co.uk/lifestyle/health/the‐postfillers‐face‐7306461.html
Q&A with Annette Pennington
Aesthetician and Skin Care Specialist
Q: What are some of the newer are cheeks, mouth, neck, smile A: Patients must be age 18 or over and
ways to tackle areas that demon- lines, forehead and upper and cannot be pregnant or nursing. They
strate fine or deep wrinkles, scars or lower eyelids. must not have a pacemaker or internal
discolored red and brown skin tone? defibrillator, impaired immune system,
Q: What are some of the benefits of severe cardiac disorders, uncontrolled
A: There are now two wonderful using Invasix treatments instead of hypertension, liver or kidney disease.
non-invasive treatments for rejuve- some of the other popular ones? They cannot have used Accutane for
nation, introduced by Invasix. They six months prior to treatment, or have
are Fractora and Fractora Firm. A: The use of fractionated energy used superficial injection of Botox or
has been proven over the years to fillers two weeks prior to treatment.
Q: What is Fractora and how does it vastly improve the appearance of
work? aging skin with minimal downtime. Q: How long does the treatment
Fractora treatments may be com- take, and how much downtime is in-
A: Fractora is a versatile skin resur- bined with other treatments and volved?
facing treatment providing superior post- procedure care is minimal. It’s
skin improvements by fractionally just the use of moisturizer and sun- A: The treatment involves a few ses-
ablating the skin (using tiny ”micro- screen! There are alternative meth- sions (one to five) a few weeks apart
points”) and restructuring the ods of treatment, such as lasers, (three to six). Downtime is minimal.
deeper tissue using bipolar radio CO2, IPL for skin rejuvenation, but, as Tiny scabs may appear on the face for
frequency. The rF energy is released of today, there is no system on the a few days, however make-up may be
into the skin using an array of pin market that can address the variety applied as soon as one to three days
electrodes, creating zones of of issues that Fractora does. after a session.
ablation, coagulation and heat. The
gentle heating promotes collagen Q: Is this medically-cleared? Q: How long do the benefits last? Is
restructuring for a deep treatment there a way to maintain the benefits
effect. The combination of ablation A: Yes. It was FDA-approved in 2011. for as long as possible?
and deep heat can provide dramatic
improvement of fine and deep lines, Q: Who performs the treatments? A: Treatment is concluded when the
skin tone and texture, as well as skin results are satisfactory to the patient,
tightening and the reduction of red A: Specially-trained licensed profes- or according to the physician’s
and brown spots sionals perform them. discretion. One treatment every one to
Fractora Firm uses rF to provide three months will maintain the
optimal skin contraction (tightening) Q: Are there any risks associated treatment results. IMAGE
in the deep layers of the skin. radio with use of Invasix? ______________________________
frequency energy will stimulate the Annette Pennington is the aesthetician
new formation of collagen and A: There are some possible side effects and skin care specialist at Aesthetic
elastin, causing lifting, tightening and that include local pain, skin redness, Plastic Surgery, P.C. in great Neck. She
an overall improved appearance. swelling, and change in pigmentation. works in conjunction with plastic
These effects are rare and temporary. surgeons Dr. Randall Feingold, Dr. Ron
Q: What are the most common areas of Israeli, Dr. Peter Korn and Dr. David
treatment with Fractora? Q: What would be the criteria that Light. For more information, call
a patient should meet in order for 516-498-8400 or visit
A: The most common areas to treat Invasix use to be successful? www.aestheticplasticsurgerypc.com.
30 • IMAGE • DECEMBER 2013 / JANUARY 2014 WWW.IMAGEMAGONLINE.COM
FRACTORA Restore &
TM
Rejuvenate
FRACTIONAL SKIN TREATMENT Your Skin
Before
Before After
After
Dr. S. Mulholland - Skin Texture and Rejuvenation
Before
Before After
After
Dr. J. Hellmen - Acne Treatment and Texture
Before After
Dr. T. Loeb - Neck Laxity
Please speak to your aesthetic provider to see if you are candidate for Fractora.
VFRPO041014
FORMA Discover
TM
Younger
THERMAL CONTRACTION Acting Skin
Before After
Dr. S. Mulholland
Before After
Dr. A. Nelson
Before After
Dr. S. Mulholland
by
Please speak to your aesthetic provider to see if you are a candidate for Forma.
VFOPO041014
PLUS Tone &
TM
Refine
ADVANCED BODY REMODELING
FOR LAX SKIN
Your Body
“ Iskinhadjustsomeabove
annoying and ugly sagging
my knees. I work out
a lot and just had no other way to get
the skin back to where I needed it to
go, the PLUS got me back in summer
“
shorts again.
KAYLA, PLUS CLIENT
Before After
Photo courtesy: Dr. S. Mulholland
Before After
Before After
Photo courtesy: Dr. S. Mulholland
Before After
PLUS
TM
ACHIEVE A SMOOTHER, SEXIER AND YOUNGER BODY.
by
Please speak to your aesthetic provider to see if you are a candidate for PLUS.
www.inmodemd.com VPLPO11113
Clear, Repair &
LUMECCA
TM
Rejuvenate
SKIN RENEWAL & CLARITY Your Skin
Before After
Before After
Before After
Before After
Before After
Please speak to your aesthetic provider to see if you are candidate for Lumecca.
VLUPO11213
BodyFX Smooth
TM
“ Ibody
lost inches in my thighs and my
looks and feels tighter. I would
recommend this treatment to anyone
who wants to get rid of that little extra
“
fat they are carrying.
SUSAN, BODYFX CLIENT, 36 YRS OLD
Before After
Dr. D. Duncan
Before After
Before After
Dr. S. Mulholland
Before After
Jannae Beauty Institute
Before After
Dr. S. Mulholland
Please speak to your aesthetic provider to see if you are a candidate for BodyFX.
www.inmodemd.com VBFPO11113