FRACTIONAL

RESURFACING &
REJUVENATION

PLUS
FACE & BODY
REMODELING

IPL SKIN
REJUVENATION

LASER HAIR
REMOVAL -
ULTIMATE SPEED

NON-INVASIVE BODY
CONTOURING &
CELLULITE TREATMENT

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 TABLE OF CONTENTS
Fractora

Forma

Lumecca

Diolaze

BodyFX

Print & Media

InMode Aesthetic
Patient Materials
Solutions
 F
or over two decades the leaders and scientists behind
InMode have been revolutionizing the medical aesthetic
industry with state-of-the-art light, RF and laser solutions
that essentially launched and shaped an industry. The
research and development team holds over 70 patents and H & DE
has a proven track record of success. RC

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

New Technology, Saves Time, High Patient Satisfaction.

Fast ROI Clinically No Pulse Lunch Time No Consumables*

Validated Counters Procedures

*Exception is Fractora with nominal consumables

“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!

Can you afford to pass up this opportunity?

2
FRACTORA
TM

by

FRACTIONAL RESURFACING & REJUVENATION

FRACTORA BRIDGES THE GAP BETWEEN

CO2 LASERS, FACELIFTS AND FRACTIONAL
LASERS WITH THE ULTIMATE IN PATIENT
RESULTS AND DOWNTIME.

Fractora delivers targeted bipolar RF energy to various depths in the skin.

Fractora mimics the results of more aggressive treatments without their
associated downtime, prolonged redness, and pigmentation drawbacks.

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

No pulse counter limitations or expensive tip refills

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

SPECIFICATIONS Dr. S. Mulholland - 60 mJ at 6 Months

126 HIGH DENSITY 60 24 24 COATED 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

Fractora Increases Revenue $90K in 90 Days

This practice case examines how Dr. F. Victor Rueckl introduced Fractora Skin Treatment to his menu of
services leading to an increase in revenue of $90,000 in 90 days.
This is especially remarkable considering most practices “I have never been
experience a slowing of patient traffic during spring and summer more pleased with the
months. In addition, the state of Nevada holds the highest results of any other
unemployment rate in the U.S., providing a tough economy for technology in my office
discretionary spending to flourish. However, the results speak for than with Fractora.”
themselves and even with few marketing expenses, Fractora has - Dr. F. Rueckl -
been able to truly affect his office’s bottom line.

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
PHYSICIAN:
Treatment performed in a two-
step (face, then neck) process
at 50-60 mJ, always includes
anesthetic blocking.
 $1000: perioral or periorbital
 $1500-2000: neck or partial
chest
 $2500-3000: face
TECHNICIAN:
Low-level Fractora at 15-20 mJ,
with a maximum setting of
25 mJ. A cryo chiller and topical
numbing cream are used to
increase patient comfort.
 $750: full face with
expectation of 3 sessions;
 $475: maintenance
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
later for a neck treatment. This allows Dr. Rueckl a second chance to review
the face areas for areas that require a secondary pass or touch up. Treatment
in two steps optimizes patient comfort, as most patients do not want a
lengthy procedure and always want to minimize downtime.
A Fractora treatment will take between 45-120 minutes depending on
whether Dr. Rueckl does the treatment (more time is required for anesthetic
injections), as well as the size of the area being treated.
For patients worried about discomfort and healing, Dr. Rueckl’s practice
encourages test procedures. The
practice charges $100 for a Fractora
disposable tip and performs a few “Our practice has been
pulses so patients can experience the waiting for a great treatment
pulse sensation. All of the "test" for the neck for years. With
patients have now done full Fractora, patients are able to
procedures. achieve a beautiful mini-neck
lift result, without going
Overall Dr. Rueckl has been impressed under the knife. We are
with the speed of treatment as well as happy to finally provide a
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

 50 full face, 8 full face and neck or chest, 20

5 full face, neck and chest, 6 neck, 15
2 stomach, 14 small regions
 17 had more than one Fractora treatment 10
5
DEMOGRAPHIC INFORMATION:
 92% Female 0
 Age Range: 22-84 years old 21-30 31-40 41-50 51-60 61-70 71+
 Average Age: 55 years old Age Range

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.
 F
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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

Industry leading transformation of the neck after a single Fractora treatment.

2 Sessions Dr.S.S.Mulholland
Dr. Mulholland

Designer dermis for superficial and deep layers of the skin.

Contact us to discuss your skin resurfacing needs:

contact@inmodemd.com | www.inmodemd.com |1.855.411.2639
 2 Sessions Dr. C. Feibleman
Providing a more youthful appearance, taking years off a patient’s age.

1 Session Dr. C. Feibleman

Improvement to deep acne scaring.

Dr. S. Mulholland

Contact us to discuss your skin resurfacing needs:

contact@inmodemd.com | www.inmodemd.com |1.855.411.2639


Case Report:
Skin Resurfacing & Rejuvenation

Before After 30 Days

Background: 75 year old Caucasian Female

Area Treated: Neck Treatment - Compromised Aged Skin
Number of Sessions: One Session with Two Passes

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.

Physician: Dr. Thomas Loeb, New York, USA

Fractora_TL_1tx4060


Case Report:
Skin Resurfacing & Rejuvenation

Before After 9 Weeks

Area Treated: Loose, crepey skin on neck with underlying fat

Patient: 64 year old female
Applicators: Fractora 60 pin
Session: Single session for 30 minutes
Energy Level: 45 mJ/pin
Treatment: 5 or 6 rows done horizontally for 2 passes, not stacked.
Total of 211 pulses.
Pain Management: Numbing cream, then blocked with lidocaine using 2, 10cc
syringes with 4 cc’s of lidocaine with epinephrine injected at
very shallow depth under the dermis.
Physician: Dr. F. Victor Rueckl, MD

Fractora_VR_1_1tx_Neck


Case Report:
Skin Resurfacing & Rejuvenation

Before After

Background: Caucasian Female, Skin Type II

Area Treated: Full Face - Deep Wrinkles, Fine Lines, Texture

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.

Physician: Dr. S. Mulholland, Canada

Fractora_SM_2_1tx


Case Report:
Skin Resurfacing & Rejuvenation

Before After

Background: Caucasian Female, Skin Type II

Area Treated: Full Face - Deep Wrinkles, Fine Lines, Texture
Time Between Sessons: 6-12 Weeks between Sessions

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).

Physician: Dr. S. Mulholland, Canada

Fractora_SM_1_4tx


Case Report:
Skin Resurfacing & Rejuvenation

Before 3 Months After Last Treatment

Patient: 28 Year Old Male

Nationality: Asian, Skin Type IV
Area Treated: Full Face For Acne Scars and Skin Texture
Physician: Dr. D. Ahn, South Korea

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

Before After 6 Weeks

Area Treated: Full face

Areas of Concern: Bilateral cheeks, perioral area
Age of Patient: 39
Applicator: Fractora
Pin Type: 60 pin tip
Energy Level: - 45 mJ/pin on cheeks
- 50 mJ/pin on perioral area
Sessions: 2 treatments
Passes: 2 passes
Pain Management: Treated with topical EMLA for 30 minutes under occlusion. Nerve
blocks of the supraorbital, suptratrochler, infraorbital and mental
nerves were done with 1% lidocaine.
Physician: Dr. A. Nelson

CaseFractora_AN_2a_2tx45mj_RS


Case Report:
Skin Resurfacing & Rejuvenation

Before After 2 Months Before After 2 Months

Skin Healing With Fractora 24 Pin Silicone Coated

Before During Immediately 1 Hour 1 Day 3 Days 1 Week

After

Active Acne Treatment on 26 Year Old Female

24 Pin Silicone Coated: 1 pass, double-stacked @ 20 mJ/pin
Patient is very satisfied and experienced no pain during treatment. Pain was managed by numbing cream
and a cryo chiller. Due to the deep 3000 micron pins and penetration of the skin, hemoglobin was
present during treatment, but easily wiped away. After two months, Fractora has eliminated any existing
and new cystic acne in the treatment area with no signs of hyper- pigmentation or hypopigmentation.
Additional sessions are recommended to resolve pit scarring (24 pin) and overall complexion (60 pin).

Fractora_IN_Acne_1tx


Case Report:
Skin Resurfacing & Rejuvenation

Before After 6 Weeks

Age of Patient: 65 year old Caucasian

Gender: Female
Applicator: Fractora
Session: 1 session
Physician: Dr. C. Feibleman

Pin Type Energy Treatment Area

Single pass on the
24 Pin 40 mJ face with the 24 pin
Single Session 3000 micron tip
Fractora 60 Pin 40 mJ Two passes of the
lips, chin, and lateral
canthi with 60 pin
and 600 micron

Fractora_CF_1a_eyes


Case Report:
Skin Resurfacing & Rejuvenation

Before Left Eye After 4 Weeks

Right Eye After 4 Weeks

Age: 43 years old

Ethnicity: Caucasian
Fitzpatrick: Skin Type II
Number of Sessions: 1
Area Treated: Full Face – Deep Wrinkles, Fine Lines, Texture
Pain Management: BLT Cream consisting of 20% Benzocaine, 8% Lidocaine, and 4% Tetracaine.

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

Before After 4 Weeks

Area Treated: Full Face

Areas of Concern: Cheeks, chin, periocular area
Age of Patient: 59
Applicator: Fractora
Pin Type: 60 pin tip
Energy: 30 mJ/pin
Sessions: 1 treatment
Passes: 2 passes
Pain Management: Treated with topical EMLA for 30 minutes under occlusion. Nerve
blocks of the supraorbital, suptratrochler, infraorbital and mental
nerves were done with 1% lidocaine.
Physician: Dr. A. Nelson

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.

Keywords: Skin Resurfacing; Skin Rejuvenation; Fractional Treatment

1. Introduction through targeting the relatively thick dermal layer of skin,

Since its inception in the 1990’s, carbon dioxide (CO2)
laser resurfacing has enjoyed the distinction of being the
gold standard in the treatment of rhytides, texture con-
cerns, acne scars and photo-damage skin. Numerous peer
reviewed articles documenting its excellent long-term
skin resurfacing results have been reported [1-8]. One of
the unique characteristics of the CO2 laser is that it cre-
ates almost equal degrees of ablation, coagulation and re-
sidual sub-necrotic thermal zones in the skin with vol-
umes of 50 - 100 microns [3]. Although full surface CO2
laser ablation provides some highly regarded results in
the treatment of wrinkles, acne scars and photo-damage,
it also presents some disadvantages. These problems in-
clude a long recovery period, prolonged erythema, un-
certain wound healing characteristics derived from the
re-epithelialization process, post-inflammatory hyperpig-
mentation in darker skin types, and long-term hypopig-
mentation in the majority of patients [9-12].
In response to the disadvantages of ablative CO2 and
Erbium YAG lasers, the era of non-ablative near-infrared
wavelength lasers and radiofrequency devices arose for
sub-necrotic tissue heating inducing collagen remodeling
[13,14]. All of these non-ablative technologies worked
*
Corresponding author.
sometimes in combination with external cooling, to pre-
serve the epidermal skin surface from damage and create
significant heating in the sub-dermal space. With the cor-
rect parameters and wavelengths, the temperature in the
dermis can be very close to necrotic levels, inducing col-
lagen remodeling and delivering modest results for skin
tightening and wrinkle reduction. With the “non-abla-
tive” approach to skin enhancement, multiple treatments
were usually required and results were generally less
dramatic than ablative therapies. Clinical data suggests
that RF based devices provide stronger tightening effect
[15-18], through the ability to penetrate more deeply into
the sub-dermal space, while laser penetration depth is
limited by the dermis.
Fractional skin resurfacing with non-ablative near in-
frared laser wavelengths were introduced in 2004, in an
effort to deliver high non-ablative columns of energy into
the dermis, creating micro-coagulation zones and colla-
gen remodeling, but leaving a significant portion of the
adjacent skin untreated to act as a healing reservoir of
cells for the non-ablative micro-coagulation zones [19].
The first of the fractional devices were in the near-to mid-
infrared wavelengths range including 1550 nm Erbium
lasers, 1320 nm and 1440 nm wavelengths Nd: YAG la-
sers [19-21]. in this article may also serve to deliver ablative and reju-
In order to produce more significant results than could venative outcomes in more difficult dyschromia prone
be achieved with fractional non-ablative coagulative de- skin type IV patients.
vices, the ablative technologies, like CO2, used a frac-
tionated approach to create ablation columns with depth 2. Materials and Methods
up to 2 mm. These fractional ablative lasers provided the
The Fractora hand piece used in this study is powered by
outcome advantages of ablative technique, but with im-
the BodyTite platform (Invasix, Israel). The Fractora hand
proved recovery and minor risk of side effects. Fractional
pieces come in an array of sharp RF conductive needles.
CO2 and other fractionally ablative wavelengths have
Each needle is 600 µ long and 100 µ wide. There is a 60
shown excellent improvements in wrinkles, photo-aging
pin tip array that provides 10% surface coverage and a 20
and acne scars [22-27]. With the advent of ablative frac-
pin tip for the lower lid, upper lid, lip lines and vascular
tional CO2, Thulium and Erbium ablative lasers, dramatic
lesions. RF energy per pin and repetition rate is set on the
improvement in skin discoloration, texture, wrinkles and
interface prior to treatment. Energy per pin was varied
acne scars with short downtime and low rate of side ef-
depending on the skin type and thickness. For light skin
fects can be achieved in a single treatment with only seve-
types I - III and thick skin 50 - 62 mJ/pin was applied,
ral days of recovery time or no downtime and multiple
while for darker skin type IV patients and thinner skin 10
lower fluence treatments.
- 40 mJ/pin was used.
More recently, alternative ablative technology was in-
With the Fractora electrode geometry (Figure 1), in
troduced that fractionates radiofrequency (RF) energy for
addition to the typical “cone shaped” ablative injury seen
skin resurfacing. It creates a low density fractional epi-
with CO2, Fractora pins also acts as an array of multiple
dermal and superficial dermal coagulation under the con-
bipolar electrodes and each sends RF energy through the
ductive pins and delivers RF travelling through the reti-
whole thickness of the papillary and reticular dermis,
cular dermis combining a low density ablative effect in
from the tip of the ablative pin effects to the side flat rail
the epidermis with sub-necrotic heating in deeper layers
electrodes. This non-ablative, non-specific dermal matrix
of the skin [28]. This fractional RF approach, with rela-
heating adds a very significant potential of additional
tively low impact epidermal-junctional effect and deep
skin tightening, that one does not receive with traditional
dermal effect, has been coined fractional “sublative re-
laser fractional ablative treatment. The resulting “double
surfacing”. This relatively comfortable treatment demon-
injury” of this device is combination of a “cone shaped”
strates improvement in lines, acne scars and pigmenta-
superficial epdiermal-dermal ablation seen with CO2, com-
tion after multiple treatment sessions. The technology
bined with a dense woven matrix of deep dermal heating
compromises with treatment efficiency in comparison to
in a pyramidal distribution (Figure 1).
deep ablative fractional lasers, but due to deeper collagen
20 Caucasian (skin types I - II) and 30 Asian patients
remodeling delivers consistent results after a number of
(skin types III - IV) with an age range of 21 - 70 years
non-aggressive treatment sessions and is particularly good
old, received a single full face, ablative fractional radiof-
for tissue tightening and some results in acne scar treat-
requency treatment using the Fractora hand piece. All
ment.
patients were observed 3 and 6 months following treat-
This paper reviews the results of using a new frac-
ment. For pain control some Caucasian patients treated
tional RF ablative technology, Fractora (Invasix Ltd.), on
with high parameters (40 - 60 mJ/pin) underwent subcu-
Caucasian skin types I - III and Asian skin type IV. Frac-
tora introduces RF energy to the reticular dermis through Side Electrode Electrode Pins Side Electrode
ablative craters that reproduce the ablative effects of a
fractional CO2 laser and an expanded zone of sub-necro-
tic dermal heating seen with the non-ablative lasers and
RF devices. The Fractora combines in one treatment the
histological and clinical benefits of epidermal-dermal do-
minant ablative “cone” type laser resurfacing with the
pyramidal shape sublative dermal effect seen with other
fractional RF systems. The combined effect of the new
technology does not appear to be limited only to skin
Figure 1. Schematic distribution between pins and side elec-
tightening, wrinkles and acne scar improvement, but ini- trodes. The Fractora pins create a “CO2 like injury” with a
tial work appears to provide a synchronous fractional RF zone of vaporization (ablation), zone of irreversible coagu-
improvement in melanin pigmentation, facial telangiec- lation (red) and zone of non-specific thermal stimulation
tasia, and active acne. The fractional RF device described (purple).
taneous hypodermal tumescent infiltrative anesthesia with
a mixture of 1 bottle of 1% lidocaine mixed in 500 ml of
Ringers lactate and 1 ml of epinephrine 1:1000. Ap-
proximately 150 cc of infiltrate was used in the hypo-
dermal space of the brow, cheek and lower face and an-
other 100 cc if the neck was treated. Prior the tumescent
hypodermal infiltrative anesthesia, supra-orbital, infra-
orbital, zygomatical facial, temporal, and mental nerve
blocks were performed with 10cc of 1% xylocaine. At
medium settings (30 - 40 mJ/pin) nerve blocks, topical
anesthesia and a Zimmer cold air cooler were used, while
at low energy settings (10 - 30 mJ/pin) pretreatment was
performed with a topical analgesia and a Zimmer air
cooler, or no anesthesia at all.
A single pass, ablative fractional RF treatment was
applied using the 60 pin Fractora hand piece. For those
regions with deeper rhytides, such as the upper lips,
lower lids or acne scars, a second pass was delivered for
patients with lighter skin. Smaller areas such as the lower
lid, upper lid and the area around the nose, was treated
with the 20 pin tip.
RF energy settings used for Asian and Caucasian pa-
tients differed significantly. For Caucasian patients, the
energy per pin was varied depending on skin type and
thickness. For light and thick skin types I - III patients,
50 - 62 mJ/pin was applied, while for darker skin type IV
and thinner skin patients, 30 - 40 mJ/pin was used. In
most cases a single treatment was effective enough at high
energy settings to achieve the treatment objectives.
For Asian patients the energy per pin was varied in the
range of 10 - 20 mJ/pin at the first treatment and was gra-
dually increased up to 30 - 40 mJ/pin over the next 3 treat-
ments, performed once a month intervals. It was discov-
ered that after several treatments the skin tone of Skin
type IV patients became lighter and more uniform, al-
lowing for the application of higher energies at subse-
quent treatments. For lighter skin tones and younger pa-
tients, higher energy was used, while more conservative
parameters were selected for darker and older patients.
Antibiotic ointment was applied immediately after the
office based treatment. At home, Aquaphor was used to
keep the skin moist and until the fractional injury had
healed over (usually at 2 - 5 days) at which camouflage
make-up could be applied. Standard Herpes Simplex pro-
phylaxis consisting of 500 mg of Valtrex orally twice dai-
ly for 7 days was used. Standard photographs were taken
prior to the treatment and at the 6 month follow up ap-
pointments. Patients were advised to take a few days off
following the treatment.
Following the treatment and depending upon the pa-
rameters, intense edema and erythema were observed and
lasted for several hours and up to 1 week, with a minor
degree of edema being observed for up to 2 weeks. Small
crusted dots, representing the ablated epidermal–dermal
tissue at the opening of the ablative crater, appeared the
next day following the treatment and were observed up to
1 - 2 weeks after the procedure before flaking off.
Histological samples were taken immediately after treat-
ment and at 1 week, 2 and 6 weeks post treatment to ana-
lyze character of fractional lesions and the wound heal-
ing process. Samples stained with hematoxylin and eosin
show classic signs of fractional carbon dioxide ablative
coagulated tissue (a), phagocytosis and healing (b) and
collagen remodeling (c). Because different groups of pa-
tients are required for different treatment parameters, the
histological study consists of 3 energy settings: 10 mJ/pin,
30 mJ/pin and 60 mJ/pin.
Histology images shown in Figure 2 presents treatment
results and healing process after the Fractora fractional
ablative RF treatment with energy settings of 60 mJ/pin.
Histology of this treatment demonstrated a typical, strong,
“cone shaped” epidermal-dermal dominant ablation ef-
fect as shown in Figure 2(a). The ablation crater depth is
about 500 - 600 µ in depth, going through the epidermis,
the papillary dermis to the mid- and deep reticular dermis.
The architecture and shape of the zone of ablation is a
typical “cone shaped” lesion (smaller at the base), also
seen with CO2 ablative lasers. The zone of coagulation
measures 60 - 100 µ surrounding ablation crater (Figure
2(a)).
Figure 2(b) shows phagocytosis in the healing crater
(zone of ablation) at 1 week follow-up. Figure 2(c)
shows the treated zone structure at 6 weeks post treat-
ment. The phagocytosis is mostly completed and initia-
tion of new collagen formed in the healed crater and
around.
At medium energy settings the ablation crater is more
shallow, reaching 300 - 400 µ in depth (Figure 3(a)).
When using lower energy the ablation crater ablative
depth is approximately 200 - 250 µ (Figure 4(a)). Simi-
larly, phagocytosis is less active when using lower en-
ergy settings (Figure 3(b)) and is completed after one
week when using minimal (Figure 4(b)), indicating
much faster healing. Collagen remodeling is observed
even at minimal energy (Figure 4(c)), but it is more su-
perficial.
Highest energy histologies taken 1 week following treat-
ment is presented in Figure 5. The histology shows the
skin with multiple fractional zones and collagen con-
traction and remodeling in the deep dermal space be-
tween the craters, supporting the effect of RF sub-necro-
tic heating through the entire dermal matrix, from the RF
current that flows from the ablative pins to the side rail
electrodes. This pyramidal zone of sub-necrotic collagen
tightening and remodeling is reflective of the “sublative
effects” seen with other fractional RF pin technologies
 Fractional Ablative Radio-Frequency Resurfacing in Asian and Caucasian Skin: A Novel Method for 147
Deep Radiofrequency Fractional Skin Rejuvenation

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).

[28]. Fractora is unique in that it combines the strong

epidermal “cone shaped” ablation of carbon dioxide with
the deep non-ablative tightening, or “sublative” effects
seen with fractional RF devices that have a relatively low
epidermal impact.
Treatment results and before and after photographs of
each patients individual improvement were analyzed and
scored using software driven photographic analogue
scoring devices for the following clinical concerns:
 Tightening of lax skin;
 Improvement in wrinkles and lines;
 Skin texture improvement;
 Reduction in pore size;
 Improvement in pigmented lesions and skin tone;
 Reduction in facial telangiectasia;
Figure 5. Histology of skin treated with 60 mJ/pin at 1 week
 Acne scar improvement.
after the treatment showing collagen restructuring in the
space between the two healing craters. From 50 patients’ satisfaction survey we had 1 patient

Copyright © 2012 SciRes. JCDSA

non-satisfied with treatment results, 10 patients mildly
satisfied, 14 patients satisfied, 18 patients happy with
results and 7 patients extremely happy.
Figure 6 shows a female patient before and 4 months
after a full-face Fractora treatment. The Fractora treat-
ment was delivered at 60 mJ/pin and the before and after
photographs demonstrate skin tightening, peri-oral wrin-
kle reduction and an overall improvement of skin quality. Figure 8. Caucasian patient with vascular lesions (left) and
Figure 7 shows a Caucasian patient before and 6 months immediate improvements after treatment (right).
after a full-face Fractora treatment. The energy delivery
was 60 mJ/pin and the treatment demonstrated a signifi-
cant reduction of pigmented lesions (comparable with an
IPL treatment), reduction of peri-oral lines and signifi-
cant improvement of skin quality. Figure 8 shows a male
patient before and immediately after Fractora treatment
on vascular lesions. Figure 9 illustrates an Asian 50 years
old male with skin type IV before the treatment and 3
months following the last treatment. The patient received
2 treatments with a gradual energy increase from 10 mJ/
pin at the first treatment up to 25 mJ/pin at the second
treatment. Improvement of peri-orbital lines, skin texture
and skin tightening was indicated 3 months following the
last treatment. Figure 10 shows a 28 years old skin type Figure 9. Asian male patient with aged skin before (left) and
IV Asian patient with acne scars before the treatment and 3 months after the treatment (right).
3 months following the last treatment. The patient re-
ceived 4 treatments where energy was gradually in-
creased from 30 mJ/pin up to 45 mJ/pin.
The Visia system (Canfield Inc.) and Korean analog
Aramo TS skin diagnostic device (Aram Huvis Co. Ltd.)
were used for quantitative analysis of treatment results.

Figure 10. A 28-year-old Asian male before (left) and 3 months

after the last treatment (right).

The results are presented in Table 1.

Figure 6. Caucasian female patient before and 4 months
after a single full face Fractora treatment.
Figure 7. Female patient before and 6 months after a single
full face Fractora treatment.
3. Conclusions
This study confirms the efficacy and safety of a novel RF
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
of patients to fully assess the vascular reduction and pa-
rameters required. The review of patients 3 - 6 months
 Fractional Ablative Radio-Frequency Resurfacing in Asian and Caucasian Skin: A Novel Method for
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)
Texture 70%
Pores 40%
Wrinkles and lines 45%
Acne scars 40%
Pigmentation 30%
following treatment confirms that the Fractora delivers
significant improvements in wrinkles, laxity, brown pig-
mentation, skin tightening and acne scars.
The safety profile was excellent with no significant ad-
verse events. Patients with skin type IV appear as suit-
able candidates for treatment using the graduated low
fluence parameters set out in this paper without an exces-
sive risk of post inflammatory hyper-pigmentation (PIH)
or hypo-pigmentation when receiving gradual energy in-
crease over the series of treatment sessions or accompa-
nied with melanocyte suppression management regimen
prior and post treatment.
Fractional ablative RF treatment with a deep needle
based delivery system is a novel and unique fractional,
ablative technology that provides a total skin rejuvena-
tion solution:
1) Stimulates and produces the wrinkle reduction and
skin tightening seen with ablative fractional CO2 resur-
facing;
2) Provides additional non-ablative, bipolar dermal ma-
trix thermal stimulation which provides additional skin
tightening similar to non-ablative RF devices;
3) Improves pigmented lesions and dyschromia similar
to intense pulsed light;
4) Potentially improves superficial vascular lesions (ad-
ditional study with higher statistics is required to deter-
mine consistency);
All patients re-epithelialized within 4 - 7 days. There
were no cases or instances of delayed healing, no signi-
ficant adverse reactions and specifically, no hypo-pig-
mentation, PIH and no hypertrophic/hypotrophic scars.
The fractional RF multi-needle technology appears to
be a suitable for facial treatment of both Caucasian and
Asian patients.
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22%
63%
40%
60%
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[10] C. A. Nanni and T. S. Alster, “Complications of Carbon
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JCDSA
 ­Synchronous Fractional ­
Radio-Frequency Ablative ­
and Non-Ablative Treatment for
Comprehensive Rejuvenation ­
of Aging Skin
By: Spero Theodorou, MD, PPS, New York, NY, USA
R. Stephen Mulholland, MD, FRCS(C), Toronto, Canada
Michael Kreindel, PhD., Invasix Corp, Toronto, Canada
Introduction
Facial aging is a combination of in-
trinsic, hereditary and extrinsic forces.
Extrinsic factors, including UV light
exposure, smoking and diet, com-
bined with the heretics and intrinsic
aging factors results in facial defla-
tion (loss of fat), descent (laxity) and
deterioration (aging skin). Skin aging
and deterioration is characterized by
reduced and abnormal collagen, elas-
tin and ground substances, together
with discoloration, both in increased
melanin based lesions and vascular
proliferation. Anti-aging physicians
have generally had to combine vari-
ous lasers, intense pulsed light (IPL),
infrared (IR) and radio-frequency (RF)
energy systems to treat the combina-
tion of these aging dermal and epider-
mal elements. (Table 1). Fractional and
non-fractional radio-frequency energy
systems have become popular options
in the treatment of skin laxity and
wrinkles, but have not been gener-
ally effective in treating vascular and
melanin based dyschromia of the aging
skin. This paper reports on the com-
prehensive anti-aging effects of a novel
new fractional radio-frequency device,
the Fractora (Invasix, Yokneam, Israel).
An analysis of the technologies
listed in Table 1 reveals the following
therapeutic interventions are required
for the wide array of aging effects we
see in the skin:
• Pigmented malformation treatment
requires superficial ablation or co-
agulation
• Vascular lesion treatment requires
coagulation of blood vessels in papil-
lary and reticular dermis
• Wrinkle treatment requires ablative
and/or sub-necrotic heating of the
reticular dermis
• Skin laxity improvement requires
deeper heating of the reticular der-
mis and dermal-fat junction
The ideal situation for the aesthetic
professional would be to have one
technology with the tunable ability to
address all the clinical manifestations
of aging skin. The principal difference
between the ablative and non-ablative
RF in the novel device used in the
current study, when compared with
light based deep fractional ablation is
that the action of RF is not limited by
the ablation crater and adjacent tissue
based upon a chromophore, but rather,
RF current flows through the ablative
lesion and the entire reticular dermis,
creating the potential for additional
anti-aging effects [10].
This current study describes the
results of the clinical evaluation of a
novel fractional radio-frequency abla-
tive and semi-ablative treatment used
to treat the multiple aging pathologies
of the skin.
Materials and Methods
The Fractora radio-frequency reju-
venation hand piece has a matrix of
600 micron sharp pins and flat side
electrodes. The RF current, operating
at 1Khz, flows down each positively
charged pin, causing epidermal-dermal
ablation in a classic CO2 cone-shaped
lesion. Following the ablative effect,
the RF current then flows from the tip
of each pin to the negatively charged
side electrodes, closing the RF cur-
rent loop. Consequently, this flow of
energy exposes the entire non-ablated
papillary and reticular dermis to a
strong non-ablative RF thermal effect.
(Figure 1) This unique combination
of synchronous ablative RF resurfac-
ing with non-ablative RF remodeling
facilitates superficial wrinkle, texture
and discoloration improvements with
skin tightening in the same pulse.
As demonstrated in Figure 1, the
RF current (purple) is concentrated at
the tip of the pins, creating the high
RF power density for tissue ablation.
Following divergence of RF current
toward side electrodes, there is a sub-
necrotic thermal stimulation (red) in the
reticular dermis and dermal-fat junc-
tion, leading to a non-ablative, thermal
neo-collagenasis and neo-elastosis. The
ablative effects of the Fractional RF
injury will provide thermal disruption
of superifical brown spots, sun damage
and melanin based dyschromia, while,
if the tips of the Fractora applicator are
purposely applied over superifical spider
telangiectasia, there will be a coagula-
tion of the vessels.
The maximal applied RF energy per
pin was 60mJ. 30 patients, with an age
range of 29 to 70, Fitzpatrick skin type
I to V, and demonstrating multiple
cutaneous aging signs, were treated
once and observed for a period up
to 6 months. Patients with skin type
IV and V received a hydroquinone
treatment for a period of two months
prior the treatment and two months
following the treatment to reduce
the risk of post-inflammatory hyper-
pigmentation (PIH). For pain control
some Caucasian patients treated
with high parameters (40-60mJ/pin)
underwent subcutaneous tumescent
anesthesia with a mixture of 1 bottle
of 1% lidocaine mixed in 1 liter of
Ringers lactate and 2ml of epineph-
rine 1:1000. Approximately 150 cc of
infiltrate was used on the brow, cheek
and lower face and another 100 cc if
the neck was treated. Prior the tumes-
cent anesthesia, supra-orbital, infra-
orbital, zygomatical facial, temporal,
and mental nerve blocks were per-
formed with 10cc of 1% xylocaine. At
medium settings (30-40mJ/pin) nerve
blocks were used, while at low energy
settings (10-30mJ/pin) pretreatment
was performed with a topical analgesia
or no anesthesia at all. Antibiotic oint-
ment was applied after the treatments
and the skin was kept moist with
Aquaphor for 3-4 days, at which point
camouflage make-up could be applied.
The clinical outcomes were collected
using 3 evaluation methods:
• Histological evaluation of treated
skin and ablation craters. Histologi-
cal samples were taken immediately

Table 1. Summary of Technologies by Application

Aging Pathology Technology Treatment Effect

Coagulation of the portion of the epidermis with higher

IPL [1]
melanin concentration
Q-switch Lasers [5] Selective destruction of melanin
Pigmented Lesions
Dermabrasion Removes pigmented stratum corneum

Fractional ablation of the epidermal and junctional

Fractional Laser and RF [6,9,10]
pigmented lesions
IPL [1,2] Coagulation of superficial blood vessels
Coagulation of superficial blood vessels, including small
Vascular Lesions Pulsed Dye Laser [2]
capillary vessels

Nd:YAG Laser [4] Facial telangiectasia

IR Light [3] Sub-necrotic heating of the reticular dermis

IR Lasers Sub-necrotic heating of the reticular dermis

Wrinkles
Sub-necrotic heating of the reticular dermis and the
Mono-polar and Bi-polar RF [7,8]
dermal-fat junction
Fractional Laser and RF [6,9,10] Fractional ablation of the papillary dermis
Sub-necrotic heating of the reticular dermis and the
Skin Laxity and Mono-polar and Bi-polar RF [7,8]
dermal-fat junction
Tightening
IR Light [3] Sub-necrotic heating of the reticular dermis

30 ❘ ANTI-AGING MEDICAL NEWS WINTER 2011

Figure 1
Cross sectional imagery of the Fractora pulse structure where heat is represented by red and
radio-frequency is represented by purple. The white “cone shaped” regions are the zones of RF ablation.
after treatment, 1 and 2 weeks post
treatment to analyze the character
of fractional lesions and the wound
healing process. Samples were
stained with hematoxylin and eosin
show classic signs of fractional abla-
tive coagulated tissue which include
(a) phagocytosis, (b) healing and (c)
collagen remodeling. Because differ-
ent groups of patients are required
for different treatment parameters,
the histological study consisted of 3
energy settings: 10mJ/pin, 30mJ/pin
and 60mJ/pin.
• Evaluation of treatment results
using Visio system (Canfield Inc.)
before the treatment and at the fol-
low up visits at 3 and 6 months.
• Thermal profile monitoring on
ex-vivo tissue using thermal camera
FlirA320 (Trek Equipment Corp.).
Heat distribution in the cross section
of tissues were analyzed to correlate
the thermal effect with clinical results.
Results and Discussion
The histological analysis demon-
strated that ablation craters are varied
from a depth of 250 micron for the
lower fluence settings, up to 1000
microns for the highest energies. The
coagulation zone around the crater
measured 60-100 microns and, over
time, consistent collagen remodel-
ing was observed in both the ablative
WINTER 2011 ANTI-AGING MEDICAL NEWS
craters and non-ablated thermally
stimulated tissue. Figure 2a is the
histology taken immediately follow-
ing the treatment and shows a typical
ablation crater. The ablated crater has
a triangle or “cone” shape and the zone
of irreversible coagulation is clearly
observed around the crater. Figure 2b
represents histology taken 1 week af-
ter the treatment. Re-epithelialization
was completed by 48 hours and now
an inflammatory infiltrate and phago-
cytosis is observed in crater region.
The ablated collagen and epidermis is
being replaced by a new collagen, elas-
tin and ground substances. Two weeks
after the treatment the acute heal-
ing process is completed and a new
epidermis is fully restructured and the
reconstituted dermis is undergoing
remodeling. (Figure 2c)
Figure 3 shows collagen remodeling
occurring in the zones of non-ablative
RF stimulation, between the pins and
the ablative craters. This is the region
of RF sub-necrotic heating in entire
dermis induced by the flow of RF
current from the ablative pin tips to
the side electrodes. One can see that
already at 1 week after the treatment
visible changes in collagen, specifi-
cally shortening and thickening are
observed. We expected that collagen
remodeling is not limited by 1 week
and continues for a few months.
Figure 3
Ablation crater histology taken 1 week after treat-
ment showing collagen restructuring between 2
healing craters.
Thermal evaluation of ex-vivo tissue
shows temperature increase in papillary
and reticular dermis. This thermal stim-
ulation is caused by the non-ablative
flow of RF current from the pins to the
side electrodes. The temperature in-
crease is approximately 10-15 degrees
Centigrade, or 46-51 degrees Centi-
grade, depending on energy setting and
is well within the therapeutic range
required for non-ablative collagen and
dermal stimulation and consequent
remodeling. Figure 4 demonstrates the
temperature distribution in the tissue
following the RF ablative pulse.
It is important to note that ablation
craters are not visible in the image. Due
to the very short pulse duration, the
spatial camera resolution does not al-
low for the visual depiction of the abla-
tion zones with a size of 100 microns.
Sub-necrotic heating in the dermis
is very uniform with only a minor
reduction of temperature in the center
and a depth of the heating zone depth
reaching of 2.7 mm. This uniform deep
heating matrix of the dermal tissue
allows energy to penetrates through the
entire papillary and reticular dermis to
the dermal-fat junction, and remodel-
ing results in wrinkle reduction and
skin tightening.
Clinical evaluation of patients dem-
onstrated improvement in skin texture,
wrinkles and fine lines, pigmented le-
sions and some vascular lesions.
Figures 5-7 illustrate some before
and after photos from the study.
❘ 31
Figure 2

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

32 ❘ ANTI-AGING MEDICAL NEWS WINTER 2011

Figure 5
References

1. Li YH, Wu Y, Chen JZ, Gao XH, Liu M, Shu CM,

Dong GH, Chen HD. Application of a new intense
pulsed light device in the treatment of photoa-
ging skin in Asian patients. Dermatol Surg. 2008
Nov;34(11):1459-64.
2. Galeckas KJ, Collins M, Ross EV, Uebelhoer
NS. Split-face treatment of facial dyschromia:
pulsed dye laser with a compression handpiece
versus intense pulsed light. Dermatol Surg. 2008
May;34(5):672-80.
3. Carniol PJ, Dzopa N, Fernandes N, Carniol ET,
Renzi AS. Facial skin tightening with an 1100-1800
nm infrared device. J Cosmet Laser Ther. 2008
Jun;10(2):67-71.
4. Vascular lesions. Ting PT, Rao J. Curr Probl Derma-
tol. 2011;42:67-80.
5. Kim S, Kang WH. Treatment of congenital nevi with
the Q-switched Alexandrite laser. Eur J Dermatol.
Female patient with skin type V demonstrating multiple signs of aging skin pre-treatment (pigmentation, 2005 Mar-Apr;15(2):92-6.
poor skin texture, wrinkles and lines) and 6 months after a single full face Fractora treatment. 6. Schwartz RJ, Burns AJ, Rohrich RF, Barton RE, Byrd
HS. Long term assessment of CO2 facial laser re-
surfacing: aesthetic results and complications. Plast
Figure 6 Reconstr Surg. 1999;103:593-601.
7. Weiss RA, Weiss MA, Munavalli G, Beasley KL. Mono-
polar radiofrequency facial tightening: a retrospective
analysis of efficacy and safety in over 600 treatments. J
Drugs Dermatol. 2006 Sep;5(8):707-12.
8. Yu CS, Yeung CK, Shek SY, Tse RK, Kono T, Chan
HH. Combined infrared light and bipolar radiofre-
quency for skin tightening in Asians. Lasers Surg
Med. 2007 Jul;39(6):471-5.
9. David J. Goldberg, Alexander L. Berlin and Robert
Phelps, Histologic and Ultrastructural Analysis of
Melasma After Fractional Resurfacing, Lasers in
Surgery and Medicine 2008;40:134–138.
10. Hruza G, Taub AF, Collier SL, Mulholland SR. Skin
Female patient before and 6 months after a single full face Fractora treatment. The patient shows dramatic rejuvenation and wrinkle reduction using a fractio-
improvements in peri-oral wrinkles and improvements in skin tightening. nal radiofrequency system. J Drugs Dermatol. 2009
Mar;8(3):259-65.

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

◗ Dr. R. Stephen Mulholland is a plastic and recon-

structive surgeon, certified by the Royal College
of Physicians and Surgeons of Canada and by
the American Board of Plastic Surgery. He cur-
Improvement in nasal telangiectasia 6 months after treatment. Vasoconstriction resulting from RF heating rently restricts and focuses his practice solely to
allows results to be seen immediately after the Fractora treatment. Cosmetic Plastic Surgery. info@spamedica.com.
416-642-1330

of diverse aging skin pathologies. Frac-
tora Fractional RF is a tunable device
that allows for the selection of ablative
and non-ablative approaches, and may
provide a single, cost effective, versa-
tile option to owning multiple tech-
nologies. In general, deep RF fractional
treatment with Fractora was effective
for most aging face signs and can be a
versatile solution for medical-aesthetic
practices dealing with the many com-
plexities of the aging skin. u
◗ Dr. Michael Kreindel is the Founder and Chief
Technical Officer of Invasix Ltd. Dr. Kreindel was
previously involved in the development of laser,
light and RF based products at Syneron Medical
Ltd. And ESC/Sharplan and holds over 50 world-
wide patients on medical and aesthetic devices.
michaelk@invasix.com. 905.707.6787

WINTER 2011 ANTI-AGING MEDICAL NEWS ❘ 33

FRACTORA: A NOVEL METHOD FOR DEEP RADIO-FREQUENCY
FRACTIONAL RESURFACING AND TOTAL SKIN REJUVENATION

R. Stephen Mulholland, MD, FRCS(C), Michael Kreindel, Ph.D

Introduction
Carbon Dioxide laser skin resurfacing (LSR) gained
great popularity in the 1990’s because of impressive
results seen with skin tightening, wrinkle reduction,
improving skin texture and tone after a single
treatment session. [1,2] One of the unique features of
CO2 laser resurfacing is that it creates almost equal
ablation, coagulation and residual sub-necrotic 50-
100 micron thermal zones in the skin. [3] The main
disadvantages of the procedure were relatively long
downtimes with surface discharge followed by
prolonged erythema and then long-term risks of
hypopigmentation resulting from a poor reservoir of
epidermal cells and melanocytes after deep skin
ablation.
One of the significant advances in laser skin
rejuvenation was the introduction of ablative
fractional skin resurfacing [4-6], where small areas of
skin, with depths in the range of 100-800 microns
were treated with in a fractional fashion, leaving a
proportion of the skin intact around the ablative
thermal column, keeping this undamaged skin around
for fast skin healing after the fractional ablative laser
treatment. Over several years and multiple different
lasers and wavelengths, the majority of laser
manufactures have focused on Fractional CO2
resurfacing [7-8], either as a single aggressive
treatment or in several more mild sessions, providing
dramatic improvement in skin dyschromia, texture,
wrinkles and acne scars, with relatively short
downtime and a low rate of side effects that can be
minimized by correct patient selection.
An alternative ablative technology is radio-frequency
(RF) fractional skin resurfacing [8], which in
published studies promotes more superficial ablation
and is more focused on non-coagulative dermal
residual heat. This relatively comfortable treatment
demonstrates some level of improvement over a
multiple treatment program. We believe that RF
technology need not be limited by this superficial
ablative approach, but rather, it can be extended to
CO2 like ablative results for effective resurfacing
combined with simultaneous non-coagulative deep
dermal heating.
The current study demonstrates the results with a
new fractional RF ablative rejuvenation technology
providing a complete single treatment solution for
aging patients.
Materials and Methods
15 patients with an age range of 34-65 years old and
skin type I to V received a single full face, ablative
fractional radiofrequency treatment using the
Fractora hand piece of the BodyTite device (Invasix
Ltd.). The Fractora hand-piece comes in an array of
sharp RF conductive needles. Each needle is 600
microns long and 100 microns wide. There is a 60
Pin tip that provides 10% surface coverage and a 20
Pin tip for the upper and lower lid and lip lines for
localized small lesions. The 20 Pin tip is a row of 20
bipolar Pins, while the 60 Pin tip has flat rail
electrodes on either side of the needle array (see
figure 1). The Fractora hand-piece is powered by the
Bodytite platform and RF energy per pin, pulse
sequencing and repetition rate is set on the device
interface prior to treatment.
All patients were observed for a minimum of 4
months following the treatment. For pain control all
patients underwent subcutaneous tumescent
anesthesia with a mixture of 1 bottle of 1% lidocaine
mixed in 1 liter of Ringers lactate and 2ml of
epinephrine 1:1000. Approximately 150 cc of
infiltrate was used on the forehead, cheek and lower
face and another 100 cc if the neck was treated. Prior
the tumescent anesthesia, Supra-orbital, Infra-orbital,
Zygomatical-facial and –temporal, and mental nerve
blocks were performed with 10cc of 1% xylocaine.
After waiting 8-10 minutes for the epinephrine effect,
a full face, single pass, ablative fractional RF
treatment was applied using the 60 Pin Fractora

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
after a Full Face Fractora treatment, together with
lower lid and orbital-malar volumization with a
Hyaluronic add gel. The Fractora treatment was
delivered at 60MJ/pin and the before and after
photographs demonstrate skin tightening, lower lid
and peri-oral wrinkle reduction, and an overall
improvement of skin quality.
Figure 4 shows a skin type IV patient before and 6
months after a Full Face Fractora only treatment. The
energy delivery was 50mj/pin and the treatment
demonstrated a significant reduction of pigmented
lesions comparable with IPL treatment, reduction of
peri-oral lines and significant improvement of skin
quality.
Patients with rosacea and facial telangiectasia were
treated effectively with the Fractora, which also acted
as an RF coagulator in improving these facial
vascular lesions. (Figure 5)

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
The histology confirms the Fractora fractional
ablative RF lesion reproduces many of the same
characteristic features those seen with Fractional
CO2 and ablative laser resurfacing. The Fractora has
the additional benefit of a strong, bipolar RF non-
ablative, non-coagulative dermal matrix stimulation
not seen with ablative lasers.
Fractional Ablative Radiofrequency treatment with a
deep needle based delivery system is a novel and
unique fractional, ablative system in that acts as a
Total Skin Rejuvenation system that can:
• induce wrinkle reduction and skin tightening;
• deliver additional non-ablative, bipolar dermal
matrix thermal stimulation which provides
additional skin tightening over and above that
seen with the ablation;
• improves melanin lesions and dyschromia;
• removes superficial vascular lesions.
Fractora is a novel skin rejuvenation fractional
ablative system that combines the best of the Intense
Pulsed Light, non-ablative skin tightening and
fractional ablative resurfacing as it delivers reduction
in hemoglobin and melanin based lesions, while
significant improvement in wrinkles, texture and skin
tightening .
All patients re-epithelialized within 4-7 days. There
were no cases of delayed healing, no significant
adverse reactions and specifically, no hypo-
pigmentation, post inflammatory hyper-pigmentation
(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-
Lakes Dermatology & The Spa at plicators and the InMode platform with
Lakes Dermatology
Las Vegas, NV Fractora from InMode (Richmond Hill,
Ontario, Canada), F. Victor Rueckl,
M.D. – a dermatologist and owner of
Lakes Dermatology & The Spa at Lakes
Dermatology (Las Vegas, Nev.) – has an
impressive selection of anti-aging treat-
ment modalities from which to choose.
However, in his experience, “the Fractora
has provided the best results from both a
clinical and financial perspective.”
“I have found that Fractora is superi-
or especially for ablative treatments,”
said Dr. Rueckl. “It is far superior to
modalities such as CO2 or erbium la-
sers, not only because the results are
better, but also because the recovery
is dramatically easier,” he explained.
“There is no pain after treatment, and
post treatment redness is gone within
a week.”
64 year old patient before Tx
According to users, Fractora pro-
vides moderate to profound ablative
results up to 3,000 microns deep.
Radiofrequency (RF) energy heats
the skin in a controlled method to re-
model deep collagen and improve the
appearance of the skin. This unique
treatment allows physicians to provide
precise, optimal skin contraction.
“Fractora is a unique and very pro-
ductive piece of equipment,” Dr. Rueckl
emphasized. “It works extremely well
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
(two passes with 60 pin applicator, 211 pulses)
in his practice, Dr. Rueckl generated
Photos courtesy of F. Victor Rueckl, M.D.
$90,000 solely from the use of that
single piece of equipment. “My staff
and I performed 89 procedures using
Fractora within the first 90 days of hav-
ing the system,” he said. “Patients love
2 THE Aesthetic Guide November/December 2013 www.miinews.com
the results, and word-of-mouth referrals
are common.”
Dr. Rueckl uses Fractora in two ways
– high energy treatments, which he
performs in his clinic; and lower en-
ergy treatments in the spa portion of
his practice, which his staff performs.
The high energy treatments are accom-
panied by local anesthesia, and one or
two treatments typically suffice, while
lower energy treatments are performed
under topical anesthesia and are usu-
ally provided in a series of three.
Patients who opt for the low energy
spa treatments tend to have dyschro-
mia or early sun damage, as opposed
to tremendous wrinkling or skin laxity.
Among Fractora’s capabilities is
its ability to tighten skin on the neck.
“There really is nothing else that can
safely and effectively tighten skin on
the neck without surgery,” Dr. Rueckl
noted. Fractora can be used in ar-
eas that demonstrate fine or deep
wrinkles, scars or excessively discol-
ored red and brown skin tone. The
most common areas of treatment are
the crow’s feet, fine lines around the
mouth, smile lines, cheeks and neck.
“While the full face and neck are of-
ten treated, it is also possible to treat
smaller areas like cheeks and crow’s
feet, where many people have local-
ized wrinkling,” he advised.
Remarkably, based only on Fractora,
in just months Dr. Rueckl can cover
the cost of the entire InMode plat-
form, but Fractora is only one modality
of the system, he pointed out. “The
results are wonderful, and it makes
financial sense.”
 Fractora’s RF Technology Achieves
Excellent Results with Less Downtime
F. Richard Noodleman, M.D.
Board Certified Dermatologist
Campbell, CA
Jason B. Diamond, M.D., F.A.C.S.
Board Certified Facial Plastic Surgeon
Beverly Hills, CA
Before Tx
After Fractora Tx
Photos courtesy of Jason B. Diamond, M.D., F.A.C.S.
By Amy Di Leo, Contributing Editor
Fractora™ RF fractional rejuvenation
by Invasix Ltd. (Yokneam, Israel) im-
proves the appearance of aging skin
while offering less downtime than previ-
ous technologies. According to the com-
pany, the Fractora achieves results that
would normally require up to four differ-
ent technologies. Benefits include stimu-
lating collagen production, a smoother
appearance of skin texture, evening of
pigmented lesions and an improvement
in fine lines and wrinkles.
For F. Richard Noodleman, M.D.,
a board certified dermatologist in
Campbell, Calif. (in the Silicon Valley),
Fractora is “a new and very popular tech-
nology.” In his practice Dr. Noodleman
and his staff perform about 75 proce-
dures a month with this machine. “Our
Invasix device is being utilized all day
every day,” he stated.
“Instead of using light or sound,
like many other lasers, this technol-
ogy uses heat in the form of radio-
frequency (RF) in an innovative way,”
Dr. Noodleman explained. “Depending
on which of the modalities you are
using, you’re heating the entire skin
from the epidermis down to the fat.
This application of heat results in tis-
sue shrinkage and tightening, which
makes it fundamentally different from
older technology.”
Jason B. Diamond, M.D., F.A.C.S.,
a board certified facial plastic sur-
geon in Beverly Hills Calif., prides
himself on providing the most state-of-
the-art treatments for his patients. He
has also observed excellent and effec-
tive results with Fractora.
“It is one of the newest devices
I have introduced to my patients,”
Dr. Diamond advised. “This device
utilizes RF technology in a very safe
and effective way.”
Dr. Noodleman noted that, “Fractora
is resurfacing, just heated up. He also
pointed out that his patients don’t
complain of pain like with earlier pro-
cedures; they tell him it is gentler. Dr.
Noodleman uses Fractora frequently for
tightening along the jaw line and under
the chin, but added that it is uniquely ef-
fective for improving wrinkling in other
areas, including the arms.
Nevertheless, Dr. Noodleman said
there are other important reasons
he likes the Fractora: “When we do
light-based resurfacing, there is often
a somewhat unnatural change in the
color or texture of the skin, and lines
of demarcation. We don’t get that with
Fractora technology.” Additionally, “it
is very friendly for darker skin types,”
he advised. “Using a laser or intense
pulsed light (IPL) procedure on Asian,
southern European or Hispanic skin
sometimes can worsen pigmentation
indications, but this is not the case
with Fractora RF.”
Dr. Diamond agreed, adding, “Fractora
is effective in providing a non-surgical
solution to people with any skin tone
or type. With my varied patient popu-
lation, I see a lot of darker skin tones,
including Asian and Middle Eastern
patients. With the Fractora, we can
safely and effectively treat these skin
types without ever having any side
effects of hyperpigmentation. I don’t
have to turn away patients.”
Significantly, Invasix also offers ad-
ditional modalities on their device, in-
cluding facial collagen skin contraction,
body tightening and body contouring
(invasive and non-invasive).

2 THE Aesthetic Guide January/February 2013 www.miinews.com

Fractora’s RF Technology Achieves
Effective Fractional Resurfacing
Thomas Loeb, M.D.
By Sean McKinney, Contributing Editor
Plastic Surgeon When first introduced, CO2 based laser
New York, NY
resurfacing emerged as the gold standard
for skin rejuvenation. However, it quickly
lost its appeal due to post-procedure re-
covery issues and long-term side effects
– particularly loss of pigment. Recently,
“It seems that Fractora’s RF fractionated lasers restored the popularity
of skin resurfacing by offering a more pal-
stimulation is optimal for atable recovery and reducing pigmentary
initiating new collagen loss. Unfortunately, the trade-off included
and thereby encouraging shorter-term, less dramatic outcomes.
tightening. Again, Now, practitioners are taking advan-
tage of a new dimension in treatment:
traditional fractional does Fractora radiofrequency (RF) fractional
not do this as well or with resurfacing from Invasix Ltd. (Yokneam,
the same consistency.” Israel). Allowing greater flexibility for
fractional RF ablative resurfacing through
interchangeable tips that vary based on
configuration (60, 20 and 126 pins), depth
of penetration and density, this device
overcomes the limitations of CO2, Erbium
and certain other fractionated lasers.
Coined “Designer Dermis”, physicians can
tailor results based on skin tone, condition
and patient recovery preferences.
Fractora delivers RF energy to the skin
through an array of pins, which produce
localized heat and small micro-lesion
points in the treatment area. In addition
to the fractional ablative injury, gentle
75 year old female before Tx
heat generated at the end of the abla-
tive pulse travels to the deeper dermal
layers to the negatively charged side
electrodes that promote collagen restruc-
turing for skin rejuvenation and an over-
all improved appearance. The fractional
method scattering of micro-lesions allows
the skin to heal faster than if the entire
area were ablated.
“In essence, I think Fractora does a
better job because it goes deeper and
combines ablative and non-ablative RF,”
said Thomas Loeb, M.D., a plastic sur-
75 year old female after one Fractora Tx session geon in New York, N.Y. “RF influences
Photos courtesy of Thomas Loeb, M.D. all of the skin underneath, not just where
2 THE Aesthetic Guide September/October 2012 www.miinews.com
the pins penetrate and heat the skin.
Traditional laser fractional therapy only
influences the tissue under or next to the
point of ablation. The secondary heat-
ing next to this point is not as well con-
trolled as with Fractora’s RF method.”
Invasix was founded in 2008 to pro-
vide safe and effective in-demand solu-
tions for aesthetic procedures. Michael
Kriendel, Ph.D., the company’s co-found-
er and chief technology officer – also the
co-founder of Syneron and developer of
elōs technology – has overcome the limi-
tations of light by complementing it with
RF. As a result, Invasix’s development
team has established numerous patents
and applications protecting unique, ad-
vanced RF technologies. Other products
include BodyTite and TiteFX. BodyTite is
a surgical, RF-assisted form of liposuc-
tion and TiteFX is a non-invasive body
contouring procedure. Both have been
cleared by Health Canada and are
pending FDA approval.
Fractora is considered a non-invasive
skin resurfacing and restoration treat-
ment that has been approved by the FDA
and Health Canada. It treats a wide-
range of patient conditions, including
acne scarring in patients with ethnic skin.
“I use this technology primarily to treat
wrinkles,” said Dr. Loeb. “However, I am
impressed by its versatility, enabling it be
used for a variety of indications.”
One of Fractora’s key mechanisms
of action, also not available from frac-
tional laser technology, is a stimulating
effect in the deep tissues. The tightening
effects are due to deep RF being deliv-
ered into the skin. “It seems that the RF
stimulation is optimal for initiating new
collagen and thereby encouraging tight-
ening,” said Dr. Loeb. “Again, tradition-
al fractional does not do this as well or
with the same consistency.”
 FracTotal Facial Offers Complete
Combination of Skin Resurfacing and Tightening
By Sarah Franz Wheeler, Contributing Editor

When radiofrequency (RF) fractional or attach another needle tip to deliver

skin resurfacing meets thermal-based energy a few hundred to thousand mi-
RF collagen remodeling in a single ses- crons deeper for a layered thermal and
R. Stephen Mulholland, M.D., sion, the result is a completely new fractional ablative effect. Or use both
F.R.C.S.(C)
Owner
facial treatment called FracTotal by tips in the same session.”
SpaMedica Infinite Vitality Clinics Invasix (Yokneam, Israel). By perform- The second step in the FracTotal Facial
Toronto, Canada ing Fractora Firm skin tightening and treatment uses the Fractora Firm hand-
Fractora skin resurfacing in succession, piece to deliver non-invasive, non-ablative
aesthetic physicians are able to success- dermal heating for collagen remodeling.
fully address deterioration and descent Featuring ACE Technology (Achieve,
– two of the three “D’s” (deterioration, Control, Extend), the Fractora Firm allows
descent and deflation) in the aging face. users to achieve physician-programmed
R. Stephen Mulholland, M.D., optimal temperatures, control the thermal
50.0°C F.R.C.S.(C), owner of SpaMedica Infinite profile and extend the temperature with-
50
Vitality Clinics (Toronto, Canada), of- out concerns of overheating.
45
fers FracTotal Facial treatments and “In aesthetic medicine, we know that
40 sees very positive patient response in RF heating devices offer the best skin
35 textural smoothing with lifting and tight- tightening therapeutic outcomes,” Dr.
30 ening. “As co-developer of the original Mulholland noted. “The problem has
25
FotoFacial with intense pulsed light (IPL), been finding an RF device that gets you
I was looking for something with more to the optimal epidermal endpoint of 42°
20.0°C
20
clinically efficacious tightening and tex- to 43° C quickly, and then maintains it
Thermal photography shows a uniform heat profile of 42° C on tural outcomes, which has led to the without patient discomfort.”
the lower right facial zone after four minutes of Fractora Firm FracTotal Facial. My treatment protocol
Photo courtesy of Invasix begins with 20 minutes of Fractora Firm’s Fractora Firm includes a revolutionary
non-ablative RF tightening, followed im- internal thermistor sensor that constantly
mediately by 20 minutes of Fractora RF monitors internal dermal impedance
ablation,” he explained. and superficial epidermal tempera-
ture. According to Dr. Mulholland, “the
As the first step, Fractora is a unique Fractora Firm automatically stops heating
fractional ablative system that com- when the temperature reaches the 43° C
bines mildly ablative dermal heating endpoint (the physician programmed
by RF, inducing tightening with vari- temperature), or when the impedance
able depth, pin-based fractional RF rises too quickly. When the skin temper-
ablative resurfacing. ature cools down to 42.9° C it will turn
“Fractora’s unique design deposits on again, much like an air conditioning
fractional RF energy into the epidermal thermostat. Such a finely regulated ther-
Before Tx and dermal tissue. The family of variable mal system allows the treatment techni-
depth and density pins allows the physi- cian to maintain the optimum therapeutic
cian to perform selective fractional der- endpoint without temperature spikes,
mal ablation, depending upon the needs which improves the collagen, elastin and
of the patient’s skin,” Dr. Mulholland ad- ground substance production and tight-
vised. “This lets the physician design the ening effect. ACE Technology is a game
kind of individualized, custom thermal changing advancement.”
injury that the patient requires, namely a Dr. Mulholland’s patients are extreme-
After FracTotal Facial Tx “Designer Dermis Treatment.” ly pleased with overall skin texture and
Photos courtesy of R. Stephen Mulholland, M.D., F.R.C.S.(C)
“In some areas such as the lips or appearance following FracTotal treat-
cheeks there may be both fine and ments. To address the third “D” of aging
deep lines,” Dr. Mulholland continued. – deflation – Dr. Mulholland completes
“I can elect to treat using a superfi- the FracTotal treatment with an injectable
cial, high density impact fractional RF dermal filler for volumization.

2 THE Aesthetic Guide November/December 2011 www.miinews.com

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-
Lakes Dermatology & The Spa at plicators and the InMode platform with
Lakes Dermatology
Las Vegas, NV Fractora from InMode (Richmond Hill,
Ontario, Canada), F. Victor Rueckl,
M.D. – a dermatologist and owner of
Lakes Dermatology & The Spa at Lakes
Dermatology (Las Vegas, Nev.) – has an
impressive selection of anti-aging treat-
ment modalities from which to choose.
However, in his experience, “the Fractora
has provided the best results from both a
clinical and financial perspective.”
“I have found that Fractora is superi-
or especially for ablative treatments,”
said Dr. Rueckl. “It is far superior to
modalities such as CO2 or erbium la-
sers, not only because the results are
better, but also because the recovery
is dramatically easier,” he explained.
“There is no pain after treatment, and
post treatment redness is gone within
a week.”
64 year old patient before Tx
According to users, Fractora pro-
vides moderate to profound ablative
results up to 3,000 microns deep.
Radiofrequency (RF) energy heats
the skin in a controlled method to re-
model deep collagen and improve the
appearance of the skin. This unique
treatment allows physicians to provide
precise, optimal skin contraction.
“Fractora is a unique and very pro-
ductive piece of equipment,” Dr. Rueckl
emphasized. “It works extremely well
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
(two passes with 60 pin applicator, 211 pulses)
in his practice, Dr. Rueckl generated
Photos courtesy of F. Victor Rueckl, M.D.
$90,000 solely from the use of that
single piece of equipment. “My staff
and I performed 89 procedures using
Fractora within the first 90 days of hav-
ing the system,” he said. “Patients love
24 THE Aesthetic Guide Winter 2013 www.miinews.com
the results, and word-of-mouth referrals
are common.”
Dr. Rueckl uses Fractora in two ways
– high energy treatments, which he
performs in his clinic; and lower en-
ergy treatments in the spa portion of
his practice, which his staff performs.
The high energy treatments are accom-
panied by local anesthesia, and one or
two treatments typically suffice, while
lower energy treatments are performed
under topical anesthesia and are usu-
ally provided in a series of three.
Patients who opt for the low energy
spa treatments tend to have dyschro-
mia or early sun damage, as opposed
to tremendous wrinkling or skin laxity.
Among Fractora’s capabilities is
its ability to tighten skin on the neck.
“There really is nothing else that can
safely and effectively tighten skin on
the neck without surgery,” Dr. Rueckl
noted. Fractora can be used in ar-
eas that demonstrate fine or deep
wrinkles, scars or excessively discol-
ored red and brown skin tone. The
most common areas of treatment are
the crow’s feet, fine lines around the
mouth, smile lines, cheeks and neck.
“While the full face and neck are of-
ten treated, it is also possible to treat
smaller areas like cheeks and crow’s
feet, where many people have local-
ized wrinkling,” he advised.
Remarkably, based only on Fractora,
in just months Dr. Rueckl can cover
the cost of the entire InMode plat-
form, but Fractora is only one modality
of the system, he pointed out. “The
results are wonderful, and it makes
financial sense.”
 & PLUS A.C.E.
TECHN
A D VA O L O G Y
N TA G E
Ac quire C
ontr
Extend ol
FACE & BODY REMODELING

THE ONLY AUTO ADJUSTING THERMAL

SKIN TREATMENT FOR COLLAGEN
REMODELING AND SKIN CONTRACTION
FOR THE FACE, NECK AND BODY AREAS. PLUS

Two configurations of non-invasive sub dermal heating for collagen

remodeling. RF current flows uniformly between the electrodes to provide
a comfortable thermal experience. Built in temperature controls allow for
the attainment of clinically proven optimal epidermal temperatures, and the
exclusive capacity for prolonged exposure at therapeutic temperatures.

Before After
Dr. H. Ohanian - Treatment of Lax Skin on Skin Type VI

Heat
RF Energy

A.C.E. TECHNOLOGY BENEFITS

Before After
• Acquire: Acquire: Smart RF thermistors built into the hand piece
Dr S. Mulholland - After 6 Forma Sessions at 50 mJ
reads skin temperature 1000x per second so clinicians can acquire
optimal epidermal settings.
• Control: Unprecedented safety with programmable
“cut off” temperature.
• Extend: Clinical evidence indicates prolonged exposure to
(41°C-43°C) is advantageous for skin tightening.

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

Safe and effective for all skin tones.

Contact us to discuss your skin tightening needs:

contact@inmodemd.com | www.inmodemd.com |1.855.411.2639
 Skin tightening procedure to remodel sagging skin.

6 Sessions Dr. S. Mulholland

Significant contraction and recontouring of the neck and jowl area.

6 Sessions Dr. S. Mulholland

Improvement to skin texture and fine lines after six sessions.

Contact us to discuss your skin tightening needs:

contact@inmodemd.com | www.inmodemd.com |1.855.411.2639


Case Report:
Skin Rejuvenation and Remodeling

Before After 8 Weekly Sessions

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

Before After 8 Weeks

Before After 8 Weeks Before After 8 Weeks

Area Treated: Neck Treatment

Energy: 62 mJ / pin
Cut off Temp: 43.0 ⁰ C
Sessions: 8 Sessions One Week Apart
Physician: H. Ohanian MD
Skin Type: V

Forma_HO_1


Case Report:
Skin Rejuvenation and Remodeling

Before After 6 Weekly Sessions

Area Treated: Full Face Treatment

Energy: 50 mj / pin
Sessions: 6 Sessions One Week Apart
Physician: S. Mulholland, MD

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.

RF energy was reduced in boney areas, dependant on patient comfort levels.

Forma_SM_1


Case Report:
Skin Rejuvenation and Remodeling

Before After 6 Weekly Sessions

Area Treated: Full Face Treatment & Neck

Energy: 50 mJ / pin
Sessions: 6 Sessions One Week Apart
Physician: S. Mulholland, MD
Area Treated: Full Face Treatment

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

8 Sessions Dr. S. Mulholland

Dr. A. Nelson
Significant lifting of sagging skin on aging patients.

Dr. S. Ohanian
8 Sessions Dr. S. Mulholland
No pain or downtime, with satisfied patients.

Contact us to discuss your skin tightening needs:

contact@inmodemd.com | www.inmodemd.com |1.855.411.2639
 PLUS
Body remodeling and skin contraction.

6 Sessions Dr. J. Shaoul

Improvements in body contour and skin texture.

8 Sessions Dr. S. Mulholland

Smoother and firmer results for all areas of the body.Dr. S. Ohanian

Contact us to discuss your skin tightening needs:

contact@inmodemd.com | www.inmodemd.com |1.855.411.2639


Case Report:
Skin Tightening on Knees & Thighs

Before After 8 Weekly Sessions

Area Treated: Knees and Thighs

Sessions: 8 Sessions One Week Apart
Physician: S. Mulholland, MD

A thin layer of gel was applied to the

treatment area and the Plus was moved in
small circular motions. Special attention was
made to ensure constant contact of the Plus with the skin. Once critical temperatures were reached,
treatment was continued for another 5-10 minutes to maintain the temperature over the treatment
zone.

Area Energy Cut -Off Notes

Adjust energy and cut-off
Anterior &
30 mJ / pin 42°C temperatures depending on patient
Posterior Thigh
response and comfort.
Sensitive areas such as the inner thigh
Interior Thigh 40 - 50 mJ / pin 40-42°C may require a reduction in typical
treatment parameters.
Lower energy and RF due to smaller
Knee 30 - 40 mJ / pin 38-40°C
zones and boney area.

PLUS Plus_SM_1
by


Case Report:
Skin Treatment on Female Back

Before After 8 Sessions

Area Treated: Back

Sessions: 8 Sessions One Week Apart
Physician: S. Mulholland, MD

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

IPL SKIN REJUVENATION

BREAKTHROUGH IPL THAT DELIVERS

3X MORE ENERGY IN THE 500-600NM
RANGE TO IMPROVE EFFICACY FOR
RED & BROWN SPOTS.

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

ABSORPTION COEFFICIENT CHART

Before After
Lumecca treats a wide array of skin
Dr S. Mulholland - Suitable for multiple treatment areas
rejuvenation concerns with a novel
designed low pressure xenon flash
lamp with the highest peak power
that produces efficient energy at
40% energy in the 500-600 nm
range (while standard IPL’s only
deliver 10-15%).

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.

Lumecca: Dr. S. Mulholland

Restore hands by clearing away brown age spots.

Contact us to discuss your photofacial needs:

contact@inmodemd.com | www.inmodemd.com |1.855.411.2639
 1 Session
Visible reduction in spider veins.

1 Session
Treats redness, rosacea and spider veins.

Contact us to discuss your photofacial needs:

contact@inmodemd.com | www.inmodemd.com |1.855.411.2639


Case Report:
Skin Rejuvenation

Before 24 Hours 3 Weeks

Applicator: Lumecca IPL 515nm

Number of Sessions: 1
Age: 33 year old female
Area Treated: Full face
Energy: 14 J/cm2
Cooling: Strong-built into hand piece
Number of pulses: 2 passes of 150 short pulses

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

Before After 1 Session

LUMECCA 515NM

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

Before After 1 Session

LUMECCA 580NM

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

LASER HAIR REMOVAL

ULTRA FAST DIODE HAIR REMOVAL FEATURING

SIMULTANEOUS 3PC (PRE, PARALLEL, AND
POST COOLING) TECHNOLOGY AND STATE OF
THE ART PULSING AND POWER.

Diolaze is the new champion of speed in the laser BENEFITS

hair removal arena. Diolaze is the FIRST laser to • Gold standard wavelength, pulsing and power for
combine high peak power and the largest spot size optimal results and maximal safety
simultaneously in the same session. Diode scanning
• Reduction in clinician treatment time from built in
technology and built in safe guards provide a unique diode pulse guide scanner and high pulse repetition
combination of high tech sophistication with efficacy rate at all energy levels
and safety. Clinicians can benefit from this new
• Highest peak pulsing and power for treatment of
efficiency to optimize their hair removal revenue. even the most stubborn hair
• Virtually painless due to strong built in cooling
SPECIFICATIONS
Laser Wavelength
Diode HR Laser 810 nm
Spot Size 50 mm x 8 mm Earn $300 for 15 minutes of high speed
Fluence 10-60 J/cm 2 laser hair removal compared to $300 for 60
minute session for outdated technology.
Pulse Duration Short/Long
Light Cooling Guide 5-15°C
High peak power and large
Repetition Rate Single and 1 pps Auto-Repeat
spot size first time delivered
Scanner Diode Pulse Guide Scanner
simultaneously in the same session

GAME CHANGING LARGE TREATMENT SPOT SIZE (ACTUAL SIZE)

DIOLAZE
TM

Diode Scanning Sapphire Laser NEW

the

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

NON-INVASIVE SOLUTION TARGETING

FAT WITHOUT LEAVING LAX SKIN.
A.C.E. PROVIDES FULL HEAT CONTROL
AND MAXIMUM SAFETY.

BodyFX treatments target problematic fatty tissues for ideal body contouring.

• Radio-Frequency provides precise and optimal heating of the

skin for reduction, contraction and body shaping
• Negative Pressure Massage applies gentle vacuum pressure
allowing for maximal depth treatment
• Clinical studies with histology’s showing volume reduction and contraction
Before After
Dr. S. Mulholland - After 8 BodyFX Treatments

Controlled Heat

A.C.E. TECHNOLOGY BENEFITS Before After

• Acquire. Control. Extend. Technology to safely optimize peak energy Dr. A. Carey - After 8 BodyFX Treatments

• Pre-heating of tissue reduces threshold for selective apoptosis of fat cells

• Sophisticated tissue temperature and impedance monitoring achieves and
maintains optimal temperature end points to prevent atrophic damage
• Active temperature monitoring and control with cut-offs for
unprecedented safety with reduced risk of thermal injury

Most other manufacturers sell body contouring

as a stand alone $80K+ system –BodyFX is one of Before After
your InMode modalities for an all-in-one aesthetic
Dr. D. Duncan – 24 Year Old after 3 Months
solution… with no consumables!

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.

Jannae Beauty Institute

Dr. A. Nelson
Dr. S. Mulholland

Cellulite and body metamorphosis on all skin tones.

6 Sessions Dr. S. Mulholland

Great improvement in abdominal area.

Contact us to discuss your body contouring needs:

contact@inmodemd.com | www.inmodemd.com |1.855.411.2639
 8 Sessions Jannae Beauty Institute

Significant reshaping of body contour and loveDr. S. Mulholland

handles.
Dr. S. Mulholland

Dr. C. Feibleman

Dr. S. Mulholland

Sizeable reduction for problematic fatty tissue.

Contact us to discuss your body contouring needs:

contact@inmodemd.com | www.inmodemd.com |1.855.411.2639


Case Report:
Body Contouring

Before After 6 Weekly Sessions

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.

Treatment Parameters Used For Each Zone:

RF Power Pulse Width 2nd RF
Step 1 40-45 W 4 sec. Level 6 Cover vertically and then horizontally (cross sectional
to sustain heat) a two by four applicator spot size zone
to get the temperature to 41°C.
If the patient feels uncomfortable -> decrease the time to 3-3.5 seconds.
Step 2 40-45 W 2 sec. Level 6 Once at critical temperature, turn pulse width down to
2 seconds to ensure HV pulse for every trigger. Treat
for a few minutes and then move to the next zone.
If the patient feels uncomfortable -> reduce overlap or decrease second RF.
If the patient is comfortable -> turn heat up to 45-50 W, increase energy to 6-10 (try to get to 10 as early
as possible in the series), and overlap for best results.

Physician: S. Mulholland, MD

*BodyFX is Health Canada & CE Cleared. Pending FDA.*

BodyFX_SM_1


Case Report:
Body Contouring

Before After 8 Weekly Sessions

Treatment: Buttocks and Posterior Thighs

Sessions: 8 Weekly Sessions Zone 1 Zone 3
Physician: S. Mulholland, MD

BodyFX was used on a female patient interested in improving

Zone 2 Zone 4
body contour. Improvements in the appearance of cellulite and
skin laxity was noticed post treatment.

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 is Health Canada & CE Cleared. Pending FDA.*

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
Introduction
Non-invasive body contouring is one of the fastest
growing market segments in aesthetic medicine (1).
Non-invasive body contouring technologies have
progressed from non-thermal, mechanical rollers
and suction systems used in the 1990’s, that
enhanced lymphatic drainage in cellulite and fat
deposits, to thermal based suction devices which
combined laser, radio-frequency (RF) and/or
infrared energies with or without mechanical
massage (2-15). These optical or RF systems, with
or without rollers, deliver a thermal stimulus to the
superficial adipose tissue to enhance normal
lipolysis metabolism and decrease the adipocyte
volume (conversion of triglycerides to glycerol and
free fatty acids which egress out of the cell), through
thermal stimulation of epinephrine mediated lipase.
Infrared energy penetrates into the dermis, leading
to a modest tightening effect on the skin and some
improvement in cellulite, while RF systems can
penetrate 5-15mm into the subcutaneous tissue
affording the opportunity to have a direct effect on
adipose tissue. These thermal RF and optical
systems are generally “non-disruptive” in that the
adipocyte cell membrane and cellular functions are
not damaged. Therefore, the disadvantages of these
“non-disruptive” body contour and cellulite systems
is the transient effect on adipose tissue and the
contour enhancements that may be achieved.
Over the past few years there have been several non-
invasive body contouring technologies that have
come to the market that do disrupt the adipocyte.
They damage and permanently injure the fat cell
through: (i) cavitation (the UltraShape focused, high
frequency ultrasound), (ii) thermal disruption
(Liposonix high frequency focused ultrasound) (iii)
freeze the fat cell and induce an adipocyte apoptosis
through cryolipolysis (Zeltiq) and (iv) the creation
of a temporary “pore” in the adipocyte cell
membrane for trigylceride egress (Zerona) (16-30).


The desirable features of a non-invasive body
contouring device include:
(i) some energy effect on the adipocyte that
destroys the cell permanently, or incapacitates
the cellular function leading to apoptosis (cell
death). The final pathway can be thermal (high
temperature or vey low temperature), cavitation
influences or lipid bi-layer membrane
disruption.
(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) Revenue efficient with low disposable costs
We believe that the novel technology described in
this current preliminary study represents a new body
contouring device that offers many of the ideal body
contouring features patients and physicians would
prefer.
Material and Methods
The TiteFX device (Invasix Ltd.) combines, in a
synergistic fashion, the following therapeutic energy
sources:
• Uniform RF heating of the skin and
subcutaneous fat with real time monitoring
of skin temperature using an infrared
thermometer built into the hand piece.
• High-voltage (HV) short RF pulses applied
to the subcutaneous fat to deliver
irreversible electroporation to the adipocyte
leading to delayed apoptosis of the fat cell
and secondary minor muscle stimulation.
The TiteFX applicator has a large suction cavity on
the undersurface of the hand piece with RF
electrodes on each side. The hand piece applies
1
suction pressure to the soft tissue of the convex
contour irregularity, drawing the skin and
subcutaneous tissue up into the cavity. Bipolar RF is
passed between the two electrodes and through the
adipose tissue and skin (Figure 1).
Figure 1 - Hand piece geometry demonstrating RF current
passing through the tissue in the suction cavity
As the RF heats the tissue, the surface temperature
rises. The TiteFX hand piece displays this measured
skin surface temperature on the hand piece. When
the temperature gets to an endpoint that is
established by the physician (the “trigger
temperature”) the device will emit a train of High
Voltage Pulses (HVPs) directly into the adipose
tissue.
The TiteFX allows for very uniform skin heating to
a depth of 15mm due to the vacuum suction and
electrode placement. Figure 2 shows a thermal
image of the skin with uniform temperature
distribution. The uniformity of the skin temperature
means a target “trigger temperature” of 42˚C can be
reached with minimal patient discomfort.
Figure 2 - Uniform temperature distribution on treated skin


Irreversible electroporation is the process of creating
pores in cell membranes under an external electrical
field, leading to apoptotic death of cells in certain
conditions. Preheating of the skin with RF current
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
treated in the abdominal and flanks regions once a
week over a period of 6 weeks. Patients were
observed for 3 months to determine the long-term
adipose tissue effects and body contour changes.
Standard photography and circumferential
measurements were taken prior to treatment and at 3
months following the last treatment.
The protocol during the treatment involved moving
the TiteFX applicator on half of the target zone,
heating the soft tissue every three seconds and then
moving to the next area, overlapping 10-20% with
the previous treatment, rapidly rising the tissue
temperature to 41-43oC. Once the trigger
temperature of 42oC was achieved, HVP energy was
delivered in a pulse of 5-7 seconds with 3-5 passes
of High Voltage Pulses completed in each zone. RF
power of 40-50W was used and the treatments were
completed at an average of 30mins per zone.
Results and Discussion
All patients felt comfortable at tissue temperatures
of 42oC and the majority was able to tolerate 43oC.
At a skin temperature of 44oC the majority of
patients experienced discomfort. No adverse side
effects were observed at any of these three
temperatures.
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

The pilot study on 20 patients provides convincing

Figure 3 - Female before and 3 months following treatment
evidence that a combination of controlled RF
heating and HV pulses offer a long term, non-
invasive body contouring solution with adipocyte
death and permanent contour enhancements.
Synergistic controlled RF heating and HV pulses
results in a consistent circumferential reduction that
may be result of apoptotic death of adipocytes
caused by thermally stimulated Electroporation
effect.
The authors believe that the TiteFX technology is
effective in its current configuration in delivering a
permanent adipocyte apoptotic effect and thus long-
term non-invasive body contour enhancements.

References

1. American Society of Aesthetic Plastic Surgery. Quick

Facts:2009 ASAPS Statistics. Available at
http://www.surgery.org/media/statistics.
2. Sadick NS, Mulholland RS. A prospective clinical study
to evaluate the efficacy and safety of cellulite treatment
using the combination of optical and RF energies for
Figure 4 - Female before and 3 months following treatment subcutaneous tissue heating. J Cosmet Laser Ther
2004;6:187-90.


 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

Non-Surgical Body Contouring: Introduction of a New Non-Invasive

Device for Long-Term Localized Fat Reduction and Cellulite Improvement
Using Controlled, Suction Coupled, Radiofrequency Heating and High
Voltage Ultra-Short Electrical Pulses
R Stephen Mulholland* and Michael Kreindel
University of Toronto, Toronto, Canada

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;
TiteFX; Electroporation; Adipocyte apoptosis; Ultra-short High
Voltage RF Pulsing
Introduction
Ablative therapy for neoplasm, both benign and malignant has
been deployed as an alternative for extirpative surgery for many years
[1]. Reported ablative therapies include low temperature cryotherapy,
focused ultrasound, intra-lesional chemical ablation, interstitial laser
therapy and radiofrequency ablation or RFA [1]. Bio-electrics is a
relatively new player in ablative therapy and apply pulsed, high voltage
electrical currents to cell biology, specifically cell membrane physiology
[2-4].
The integrity and cellular functions of a mammalian cell are, in
part, maintained by trans-membrane potentials that are controlled
by complex cell membrane functions. Exposing a cell to specific
pulsed electrical currents can alter the trans-membrane potential of
mammalian cells and, if the duration of the applied electrical pulses are
less than the “charging time” of the outer cell membrane (approximately
100 nanoseconds), there is a non-thermal interaction with both the
cell membrane and sub-cellular structures [5]. By manipulating the
pulse duration (creating ultra-short pulses), electric field intensity, and
a train, or pulsed sequence of these pulses, it is possible to alter the
cell membrane and affect cell survival [5]. Specifically tailored pulsed
electric fields have the ability to increase the permeability of mammalian
cells, a process known as electroporation, which can be “reversible” or
“irreversible”. Reversible electroporation has been widely deployed in
medicine to facilitate non-permeable chemicals to cross cell membranes
[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,
a sequence of eight, 100 microsecond pulses, with up to 1000 volts,
each pulse separated by 100 millisecond pulse delays are delivered [6].
Reversible electroporation and trans-membrane chemical substance
delivery have had applications in cancer and genotherapy [6]. Ultra-
short nanosecond pulses have demonstrated direct, non-membrane
*Corresponding author: R. Stephen Mulholland, University of Toronto, Toronto,
Canada, E-mail: mulhollandmd@spamedica.com
Received May 15, 2012; Accepted September 01, 2012; Published September
10, 2012
Citation: Mulholland RS, Kreindel M (2012) Non-Surgical Body Contouring:
Introduction of a New Non-Invasive Device for Long-Term Localized Fat Reduction
and Cellulite Improvement Using Controlled, Suction Coupled, Radiofrequency
Heating and High Voltage Ultra-Short Electrical Pulses. J Clin Exp Dermatol Res
3:157. doi:10.4172/2155-9554.1000157
Copyright: © 2012 Mulholland RS, et al. This is an open-access article distributed
under the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the
original author and source are credited.

J Clin Exp Dermatol Res

ISSN:2155-9554 JCEDR, an open access journal Volume 3 • Issue 4 • 1000157
Citation: Mulholland RS, Kreindel M (2012) Non-Surgical Body Contouring: Introduction of a New Non-Invasive Device for Long-Term Localized Fat
Reduction and Cellulite Improvement Using Controlled, Suction Coupled, Radiofrequency Heating and High Voltage Ultra-Short Electrical
Pulses. J Clin Exp Dermatol Res 3:157. doi:10.4172/2155-9554.1000157
intracellular structures, organelles and the nucleus with applications in
cancer, platelet function and gene therapy [2-4].
Irreversible electroporation (IRE) delivers a tailored electrical
pulse configuration specific to the target cell and permanently alters
cell permeability, resulting in an influx of ions, and altering the trans-
membrane potential and intracellular function such that the target
cells stop functioning and dies over time. Industrial applications have
included water sterilization, where the IRE targets and kills bacterial
and yeast cells [7]. More recently, IRE has been shown to ablate tumor
cells, both in vitro and in vivo in mammalian animal studies [7-9].
The therapeutic advantages of IRE in treating tumors are the non-
thermal mechanism and the relative sparing of surrounding structures.
By deploying IRE, the cell membrane electroporation thresholds are
different from the tailored IRE pulsed electric profiles used on the
tumor tissue, creating selectivity [7-10]. Pre-heating of tissue prior
to the train of ultra-short, high voltage pulses appears to reduce the
electroporation threshold and enhance the efficacy of producing
IRE [11]. To date, we are not aware of any published studies on high
voltage, ultra-short, pulsed sequenced IRE on adipocytes. This study
analyzes the cellular effects of a novel basic Radiofrequency and ultra-
short, high voltage pulsed system on adipose tissue and the aesthetic
body contour changes that may result.
Non-invasive body contouring is one of the fastest growing market
segments in aesthetic medicine [12,13]. Non-invasive body contouring
technologies have progressed from non-thermal, mechanical rollers
and suction systems used in the 1990’s, that enhanced lymphatic
drainage in cellulite and fat deposits, to thermal based devices which
combined laser, radio-frequency (RF), hypo- or hyperthermia and/
or infrared energies with or without mechanical massage and/or
suction [14-27]. The most common optical energy sources used in
body contouring devices have been in the near and far Infrared (IR)
spectrum. These optical, IR or RF systems, with or without rollers,
with or without suction, deliver a thermal stimulus to the superficial
adipose tissue to enhance normal lipolysis metabolism. In addition,
these devices decrease, by a reduction of the triglyceride cytosolic
volume, without cell destruction, the adipocyte volume (conversion
of triglycerides to glycerol and free fatty acids which egress out of
the cell and are mobilized and metabolized through normal hepatic
pathways), through thermal stimulation of epinephrine mediated
membrane bound lipase [13,14,27]. Infrared energy penetrates into
the dermis, leading to a modest tightening effect on the skin and
some improvement in cellulite, while RF devices, depending upon the
system, can penetrate 5-25 mm into the subcutaneous tissue affording
the opportunity to have a more direct effect on adipose tissue. Since
the earliest RF non-invasive body contouring systems, the VelaSmooth
and VelaShape which are suction couple IR, RF (Syneron Ltd, Israel)
and Thermage (Solta Medica, USA), there has been proliferation of RF
systems with moving mono-polar, bi-polar, tri-polar and octi-polar
electrode applicators. These thermal RF and optical systems are “non-
disruptive” in that the adipocyte cell membrane and cellular functions
are not damaged. Despite being temporary “metabolic enhancers”
increasing physiological breakdown of triglyceride, most RF systems
for non-surgical body contouring report 2-4 cm circumferential
reductions in abdominal-hip measurements, 2-3 cm in thigh reduction,
with an average 20-60% improvement in the appearance of cellulite
and, when well selected, consistently happy patients [14-27]. However,
the disadvantages of these “non-disruptive” body contour and cellulite
systems is the transient effect on adipose tissue and the contour
enhancements that may be achieved [14-27].
J Clin Exp Dermatol Res
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Page 2 of 9
Over the past few years there have been several non-invasive body
contouring technologies that have come to the market that do disrupt
and permanently damage the adipocyte and provide the potential for
long-term focal fat reduction and body contour improvements. These
“disruptive technologies” damage and permanently injure the fat cell
through: [28-42]
(i) Cavitation (the Ultra shape focused, high frequency ultrasound,
or HIFU)
(ii) Thermal disruption (Liposonix high frequency focused
ultrasound)
(iii) Freeze the fat cell and induce an adipocyte apoptosis through
cryolipolysis (Zeltiq)
(iv) The creation of a temporary “pore” in the adipocyte cell
membrane for triglyceride egress (Zerona)
The Ultra shape uses gentle, non-thermal ultrasound waves to
induce a cavitational disruption of the cytosolic fat droplets and
“non-thermal implosion” of the adipocyte. The Ultra shape protocol
generally calls for 3 treatments, one every two weeks and with the new
vertical depth focus ultrasound (simultaneous ultrasound treatments
at three different layers) and RF applicators, abdominal circumferential
reductions 5-6 cm have been reported after 6 weeks. Advantages of
the Ultra shape are a virtually essentially painless treatment, ease of
use with automated tracking systems for the ultrasound and minimal
treatment edema so results can be seen within a short time. Ultra shape
disadvantages are principally the disposable ultrasound pulse costs [28-
35].
Liposonix uses a thermal HIFU approach and multiple passes
to induce layered adipose thermal necrosis. Liposonix purports
a single treatment protocol, but disadvantages include reports of
significant patient pain (necessitating benzodiazapines and narcotics),
ecchymosis, and edema and swelling following the adipose thermal
necrosis, so often, results are not visible for up to 3-6 months due to
gradual remodeling of the intense thermal necrosis. Circumferential
abdominal reductions of 3-6 cm have been reported using Liposonx
after a single session. Liposonx also has a pulses disposable cost [36,37].
Zeltiq’s “Coolsculpt” uses suction coupled “super-cooling”
applicators applied to the flanks and abdomen. The patient and the
device are left for between 1-4 hours (an hour for each love handle and
one for the lower abdomen). The advantages of cryolipolysis are that it
does not need a technician to perform the procedure and patients can
be left in a side office and the treatment is relatively comfortable. Single
treatment protocols have shown up to 20% of the adipose between
the treatments paddles undergo apoptosis death resulting in a 3-6 cm
average in abdominal circumferential reduction after a single session,
but results are not completed for 4-6 months following the adipocyte
apoptosis. Disadvantages include limited treatment zones as areas
other than the love handle or lower abdomen (you must be able to grab
and retract the adipose tissue and skin) cannot be currently treated
(although new applicators are planned), there is also a high disposable
cost and there have been reports of painful dysaesthesias for several
months after treatment, presumably from a hypothermic injury of the
sensory nerve lipid membrane [38-40,13].
Zerona uses an array of 650 mn diodes strategically placed just
above the skin to induce a cytochrome oxidase induced conformational
alteration in the adipocyte bi-lipid cell membrane and the transient
“pore”. It is through this temporary “fat pore” that triglycerides can
migrate, resulting in a reduction in the adipocyte size and hence
adipose tissue reduction. The protocol for this painless Zerona
Volume 3 • Issue 4 • 1000157
Citation: Mulholland RS, Kreindel M (2012) Non-Surgical Body Contouring: Introduction of a New Non-Invasive Device for Long-Term Localized Fat
Reduction and Cellulite Improvement Using Controlled, Suction Coupled, Radiofrequency Heating and High Voltage Ultra-Short Electrical
Pulses. J Clin Exp Dermatol Res 3:157. doi:10.4172/2155-9554.1000157
procedure can also be performed in a side office, without a technician
and involves 6-12 treatment protocols every second day for 2-3 weeks.
Disadvantages include a relatively modest incidence of non-responders
and a disposable cost [41,42,13].
All of the aforementioned “disruptive” fat contouring technologies
have a disposable component and they are not designed, nor are there
any prospective reports of cellulite reduction.
Although the etiology of cellulite is not completely understood,
there are hereditary, hormonal and perhaps other metabolic multi-
factorial influencers. It is estimated that 70% of post pubertal women
have cellulite and it can be quite independent of BMI, as very thin
woman can develop it and quite obese women may not [13,14-27].
The clinical phenotypic appearance of cellulite is well know, the
“lumpy-bumpy, cottage-cheese” or “orange peel” appearance of the
skin. Anatomically, cellulite occurs most commonly on the posterior
thighs and buttocks, followed by lateral thighs, anterior thighs and
upper abdomen. Cellulite is commonly classified by the modified 7
stage Nurnberger-Muller score [34], according to severity (Table 1).
Histologically, cellulite is characterized by the following [14-27]:
(i) Edematous, swollen lobules of superficial adipose tissue with
poor microcirculation and low tissue oxygenation
(ii) Herniation of the swollen lobule of fat up into the deep reticular
dermis and forming the “nodules”
(iii) Dense, thickened vertical fibrous septae that are congealed,
contracted extensions of the oblique and vertical intra-lobular
septae and result in dermal retraction or “pits”
Although the exact cause of cellulite may be obscure, like the
focal fat reduction technology, many of the RF, suction and massage
devices discussed above have shown some variable improvement in the
appearance of cellulite, with average improvements of 20-70% after a
series of treatments [13,14-27].
The desirable features of a non-invasive body contouring, fat
reduction and cellulite improvement device include [13]:
(i) Some energy medicated thermal, chemical or
electrophysiological effect on the adipocyte that destroys the
cell permanently, or incapacitates the cellular function leading
to apoptosis (cell death). The final pathway can be thermal (high
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
possible mechanism of a novel basic RF and high voltage, ultra-
short pulsed device on the treatment of both focal fat collections and
cellulite. This paper reports a novel technology that represents a new
J Clin Exp Dermatol Res
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Page 3 of 9
body contouring device, the TiteFX (Invasix, Israel) which offers many
of the ideal body contouring features patients and physicians seek.
Materials and Methods
The TiteFX device (Invasix Ltd.) combines, in a synergistic fashion,
the following suction coupled therapeutic energy sources:
• Uniform RF heating of the skin and subcutaneous fat with real
time monitoring of skin temperature using an infrared thermometer
built into the hand piece and a built in “on-line” temperature cut-
off feature that prevents overheating, painful hotspots and ensures
prolonged thermal uniformity at the desired end-points.
• High-voltage (HV), ultra-short RF pulses applied to the
subcutaneous fat are designed to deliver irreversible electroporation
(IRE) effects to the adipocyte leading to delayed apoptosis of the fat cell
and adipocyte cell death. These HV pulse electroporation effects on cell
membranes can be seen in other tissues.
The TiteFX applicator has a large suction cavity on the undersurface
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
contour irregularity, drawing the skin and subcutaneous tissue up
to 1 cm into the cavity. Basic bipolar RF is passed between the two
electrodes and through the adipose tissue and skin resulting in tissue
heating (Figure 1).
Basic RF heating
The skin and subcutaneous tissue is drawn up to 10 mm into the
suction cavity and the RF energy passes between the electrodes, both
directly through the fat drawn up into the suction chamber and down
into the fat below the electrodes, a distance of 50% of the distance of the
two RF electrodes [14]. As the two RF electrodes are 2.5 m apart, the
RF heats fat to a depth of 2.2 cm (1.0 cm of suction coupled elevation
in addition to the 1.2 cm into the uncoupled fat). The suction cavity
and controlled RF bipolar depth distribution allows for a very selective
targeting of only the superficial fat and sparing deeper tissues, such
as motor nerves or muscle from RF heating of the high voltage, ultra-
short pulsing.
As the basic RF heats the tissue, the surface skin and adipose tissue
Figure 1: The TiteFX hand demonstrating RF current passing between the
electrodes through the adipose tissue in the suction cavity and down into the
subcutaneous tissue.
Volume 3 • Issue 4 • 1000157
Citation: Mulholland RS, Kreindel M (2012) Non-Surgical Body Contouring: Introduction of a New Non-Invasive Device for Long-Term Localized Fat
Reduction and Cellulite Improvement Using Controlled, Suction Coupled, Radiofrequency Heating and High Voltage Ultra-Short Electrical
Pulses. J Clin Exp Dermatol Res 3:157. doi:10.4172/2155-9554.1000157

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

J Clin Exp Dermatol Res

ISSN:2155-9554 JCEDR, an open access journal Volume 3 • Issue 4 • 1000157
Citation: Mulholland RS, Kreindel M (2012) Non-Surgical Body Contouring: Introduction of a New Non-Invasive Device for Long-Term Localized Fat
Reduction and Cellulite Improvement Using Controlled, Suction Coupled, Radiofrequency Heating and High Voltage Ultra-Short Electrical
Pulses. J Clin Exp Dermatol Res 3:157. doi:10.4172/2155-9554.1000157
Figure 5: TiteFX applicator with Thermal monitoring display on the top
surface.
throughout the zone. This modulated temperature control process
is called “ACE”, or Acquire (the temperature)-Control (turn the
temperature off-on around the set point)-Extend (prolong the treatment
at the desired temperature to optimize the thermal effect.
With this automated online ACE temperature monitoring and
RF cut-off and HVP protocol, a very homogeneous and uniform
temperature profile and heating of the skin and subcutaneous fat can be
achieved and more importantly, sustained with good patient comfort.
When the epidermal temperature is 43-44°C and the adipose tissue
temperature, to a depth of 2.5 cm is also 43-45°C and these conditions
are sustained for 10 minutes, there is in-vitro and in-vivo evidence that
an RF mediated thermal heating and destruction of the triglyceride
droplets within the cytosol of the adipocyte, which will result in
irreversible damage to the adipocyte and over time fat cell necrosis.
It is the exquisite ACE thermal online regulation and cut-off
features that allow the adipose tissue heating and ultra-short, HV pulses
to be precisely controlled and maintained in this therapeutic adipocyte
thermal necrosis range for the necessary 10 minutes. There are few if
any “heat spikes” possible, ensuring patient comfort and compliance.
When the epidermal endpoint is reach, two things happen:
(i) Basic RF automatically turns off at 44°C and when the
measured epidermal temperature is 43.9°C, the RF comes
back on automatically, maintaining a very uniform superficial
and hence deep adipose tissue temperature profile. The deep
adipose tissue temperature is 2-3°C higher than the skin due
to the directional flow of RF into and through the fat from the
bipolar electrodes and lower fat impedance.
(ii) When the pre-set “trigger temperature” endpoint of 44°C is
reached, a series of HV pulses is emitted into the adipose tissue
to a depth of 2.5 cm. Generally the epidermal thermal endpoint
of 44°C is achieved in each zone within one minute and for
the next 9 minutes, the technician is continually treating with
3 second pulse durations and then overlapping 10-20% percent
J Clin Exp Dermatol Res
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Page 5 of 9
on the next rectangle of adjacent soft tissue throughout the
zone, keeping the epidermal temperature at 44°C and emitting
trains of 10 High Voltage Pulses with each 3 second treatment
cycle.
(iii) The 15×20 cm zone is treated for 1-2 minutes to achieve
critical epidermal end-point temperature with basic RF and
then 9 more minutes at this endpoint with intermittent basic
RF deployed automatically to maintain the uniform 44°C
epidermal and 44°C adipose temperatures and train trains of
High Voltage pulses.
High Voltage, Ultra-Short Pulsed RF
The second mechanism that the TiteFX induces a potentially
permanent cell injury to the adipocyte cell is through a train of
High Voltage, Ultra-Short Pulses (HVP) and fat cell membrane
electroporation. When the temperature gets to the monitored target
epidermal endpoint that is established by the treatment professional
(the “trigger temperature”, generally 44°C), the device will emit a train
of up to 10 High Voltage Pulses directly into the adipose tissue until
that pulse duration is completed.
The TiteFX allows for very uniform skin heating to a depth of
2.5 cm due to the vacuum suction and electrode placement. Figure 6
shows a thermal image of the skin with a very uniform temperature
distribution. The uniformity of the skin temperature means a target
epidermal “trigger temperature” of 43-44°C can be reached with
minimal patient discomfort.
Irreversible electroporation (IRE) is the process of creating pores
and damage in cell membranes under an external electrical field,
leading to an influx of calcium ions and an apoptotic death of cells
under certain physiological conditions. Preheating of the adipocyte
with basic RF current can theoretically allow for a significant reduction
in the electroporation threshold [1-11,43,44] and target selectively, as
the preheated large adipocytes are then potentially more sensitive to
electrical fields [11,43,44]. The TiteFX device uses basic RF and the
uniform adipose heating delivered to induce a delayed thermal necrosis
of a proportion of the adipose tissue in the treatment field, while the
heated adipocytes also become synergistically more sensitized to the
HV pulse. In theory, the addition of basic RF heating of the adipocyte
cytosolic fat droplet, with the HVP adipocyte apoptosis, the fat cells die
over a period of 10 days to 2 weeks and the adipose tissue deflates and
loses volume, thereby improving contour [1-11,43,44].
Figure 6: Uniform temperature distribution on treated skin with temperatures
of 43-44°C through the treatment zone between the two electrodes.
Volume 3 • Issue 4 • 1000157
Citation: Mulholland RS, Kreindel M (2012) Non-Surgical Body Contouring: Introduction of a New Non-Invasive Device for Long-Term Localized Fat
Reduction and Cellulite Improvement Using Controlled, Suction Coupled, Radiofrequency Heating and High Voltage Ultra-Short Electrical
Pulses. J Clin Exp Dermatol Res 3:157. doi:10.4172/2155-9554.1000157
The third mechanism that basic RF in the TiteFX can result in a
body contour improvement and cellulite reduction is skin tightening in
the treatment area. The basic RF energy and HVP results in a controlled
RF heating of the skin, sustained at 44°C epidermal and a similar and
uniform 43-44°C intra-dermal for 10 minutes, which results in heating
of the intra-dermal collagen, elastin and extracellular matrix leading to
non-ablative, inflammatory injury to the dermis and a wound healing
process with enhanced dermal collagen, elastin and ground substance
production [13,45]. The production of new dermal type I collagen,
neo-elastosis and ground substances takes 5-12 weeks to mature and
results in a thicker dermis and a more elastic, or “tighter” dermis.
The enhanced thermally mediated skin contraction also contributes
to improvement in circumferential reduction, body contour and
smoothens the appearance of cellulite by thickening the reticular
dermis and reducing the ability for subcutaneous fat to herniated into
the deep dermis [46].
Patient Studies
In the current study, 24 female and 1 male patients were enrolled.
The age range of the patients was 28 to 62 years old, with an average age
of 41.3 yrs. Patient average BMI was 26, but varied from 18 to 30 and
all of the patients were interested in focal shape correction, without
anticipating any weight reduction. In addition, 14/24 patients also had
posterior or anterior grade 2 or 3 thigh cellulite treated.
The patients underwent a 6-treatment TiteFX protocol where they
were treated on the abdominal and flank regions once a week over
a period of 6 weeks. 14 cellulite patients also had their posterior or
anterior thigh cellulite treated. Therapeutic end points were as outlined
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
for 10 minutes. The protocol during the treatment involved moving
the TiteFX applicator heating the soft tissue for the three second pulse
duration and then moving to the adjacent skin in that zone, overlapping
10-20% with the previous rectangular treatment, rapidly rising the
tissue temperature in the 15×20 cm treatment zone to 43-44°C.
Once the trigger temperature of 44°C epidermal was achieved,
HVP energy was delivered during the 3-second pulse duration and with
4-6 passes of a train of High Voltage, Ultra-Short Pulses completed in
each zone over the 10 minutes. RF power of 40-50 W was used and
the treatments were completed in an average 20 minutes per zone. All
patients and zones were treated once per week for 6 weeks.
Outcome Measurements
Patients were observed for 3 months to determine the long-
term adipose tissue effects and body contour changes. Standard
photography and circumferential measurements were taken prior to
treatment and at 3 months following the last treatment. Photography
was performed using standardized canfield lighting, camera, distances
and was always taken during patient exhalation. Patient’s weights and
exhalation circumferential measurements were recorded weekly with
each visit. 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 TiteFX treatment.
All cellulite patients, in addition to photographic assessment, had
Vectra 3D cellulite analysis performed on the depths and elevations of
the pits and nodules, both pre and post treatment (Figure 7).
J Clin Exp Dermatol Res
ISSN:2155-9554 JCEDR, an open access journal
Page 6 of 9
Results and Discussion
All patients felt acceptable comfort at epidermal tissue
temperatures of 43-44°C and the majority were able to tolerate 44°C. At
a skin temperature of 45°C or higher, even with extreme uniformity a
significant number of patients experienced discomfort when there was
no cooling or topical anesthesia. No adverse side effects were observed
at any of these epidermal target temperatures. The train of ultra-short,
high voltage pulses created an initial electrical “shock” sensation, but
was tolerable in all patients once the patient experience accommodated.
Most patients could tolerate 7-10 HV pulses at a time.
Skin erythema, mild edema and a strong heating sensation were
typical in the treatment zone following the TiteFX and these lasted
up to 6 hours following treatment. The average weight of patients was
stable over the treatment course without a significant reduction.
Circumferential reduction was obvious for most patients 3
months following the completion of their 6 treatments. 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.
The visual analogue 10-point patient assessment score for the
cellulite improvement showed that over 90% of patients felt there
was improvement in the appearance of their cellulite and the average
improvement score was 78%. Before and after cellulite photos were
evaluated by a blinded physician reviewer and subjected to the
modified Nurnberger-Muller 7 stage grading system (Table 1). The
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
average vectra measured improvement in the pit depth or “smoothness
score” was 2.9 mm or 60% (range 1.1 mm-6.3 mm).
The tissue biopsies taken at 72 hours and 14 days after the first
treatment revealed no evidence of fat necrosis in any patient. By 14
days, a substantial percent of adipocytes had undergone a histological
“shrinkage” of the fat cell (Figure 8). It is not certain, if further death
from delayed apoptosis from the HVP would yield further adipose
tissue collapse.
Our clinical findings are supported by other in vitro and in vivo
studies of Radiofrequency heating on cultured and live in situ adipocytes
[45]. Cultured adipocytes show 89% cell viability when subjected
to 45°C for 1 minute and 40% when heated at 45°C for 3 minutes.
Adipocyte cell viability dropped to 20% when subjected to 50°C for one
minute. Other in vivo studies have confirmed that maintaining adipose
tissue at 44-45°C for 15 minutes at depths of 1.5-2.0 cm resulted in loss
Grade I
Skin is Smooth when standing. Cellulite may be induced by pinching
the tissue
Grade II - MILD
Orange Peel or Mattress appearance when standing – MILD
Grade II – MODERATE
Orange Peel or Mattress appearance when standing – MODERATE
Grade II – SEVERE
Orange Peel or Mattress appearance when standing – SEVERE
Grade III – MILD
Cellulite plus raised and depressed areas and nodules when standing
– MILD
Grade III – MODERATE
Cellulite plus raised and depressed areas and nodules when standing
– MODERATE
Grade III – SEVERE
Cellulite plus raised and depressed areas and nodules when standing
– SEVERE
Table 1: The Modified Nurnberger-Muller Cellulite Grading Scale.
Volume 3 • Issue 4 • 1000157
Citation: Mulholland RS, Kreindel M (2012) Non-Surgical Body Contouring: Introduction of a New Non-Invasive Device for Long-Term Localized Fat
Reduction and Cellulite Improvement Using Controlled, Suction Coupled, Radiofrequency Heating and High Voltage Ultra-Short Electrical
Pulses. J Clin Exp Dermatol Res 3:157. doi:10.4172/2155-9554.1000157

Page 7 of 9

of adipocyte viability on biopsy [45]. What is not clear and requires

further study is the mechanism of the fat reduction and adipocyte
death, as there was no evidence of necrotic cell debride, but rather just
fat cell shrinkage, the presumed mechanism was adipocyte apoptosis,
again presumably as a result of sustained basic RF heating, the ultra-
short, high voltage pulses, or a synergy of both.
The TiteFX and its automated on-line thermal control system
allows for a sustained and uniform thermal dose delivery to the
subcutaneous fat that is not possible with most other non-thermally
regulated systems. Further, the efficacy of the HVP and irreversible
electroporation (IRE) is potentially synergized by this sustained deep
adipose heating [1-11,43,44].
With the delayed thermal cellular injury and delayed HPV
adipocyte apoptosis, the potentially deleterious sudden release of
triglycerides by more aggressive disruptive technologies is prevented Figure 7: The Vectra 3D topographic photograph showing the decrease in
with TiteFX and the slow apoptotic “inside out” death of the adipocyte the depth of a cellulite pit following treatment which was calculated through a
by both the RF heating of the triglyceride droplets and the “outside proprietary Canfield algorithm as being lessened by 3.1 mm or 82%.
in” ultra-short HVP cell membrane deactivation through IEE. The
absence of physically disrupted adipocytes on biopsy at 72 hours and
the absence of any lipid spikes on serum blood levels after treatment,
support our hypothesis that the adipocytes undergo removal by
macrophage phagocytosis without acute cell membrane disruption and
significant lipid release.
Our clinical impression is that over time and future studies,
there will emerge a time-dose curve, where longer exposure to the
predetermined “trigger temperatures” and applying trains of more
ultra-short HVP may provide even better results and higher patient
satisfaction, but additional clinical studies are underway to refine and
optimize the treatment protocols.
Most patients reported a high satisfaction level and were able to
detect visible improvement in their body shape. Figures 9-11 show Figure 8: H & E stained superficial adipose tissue showing non-disruptive
female patients before and 3 months following the TiteFX treatment cell adipocyte cell shrinkage at levels up to 2.5 cm deep.
program. Figure 12 shows a patient three months following anterior
thigh cellulite treatment.
The TiteFX cellulite improvements’ were very consistent. This
TiteFX applicator efficacy is likely related to the multiple anti-cellulite
effects consisting of:
(i) Suction causing tensile load on the vertical fibrous septae and a
related stress relaxation and lengthening of the vertical fibrous
septae reducing the depths of the pits
(ii) Suction related vasodilatation of superficial subcutaneous
vessels and mechanical manipulation leading to improved Figure 9: Female before and 3 months following TiteFX treatment.
blood supply, oxygenation and lymphatic drainage
(iii) Thermal necrosis and/or apoptosis and reduction of the
subcutaneous fat, with less fat herniated into the dermis and
smoothening the appearance of the “nodules”
(iv) HVP IRE related apoptosis of the adipocyte population with
less intra-dermal herniation and smaller nodules
(v) RF related thermal thickening of the reticular dermis with more
resistance to re-herniation adipose into the sub-dermal fat
Figure 10: Female before and 3 months following treatment with 4.8 cm
Conclusion reduction off her abdomen and hips and a focal bra line reduction.
The non-invasive treatment of localized deposits of fat and cellulite
is one of the fastest growing segments of cosmetic dermatology and adipocyte reduction capability available to treat focal fat collections,
aesthetic medicine. While there are a number of bodies contouring contour elevations and cellulite, as well as delivering synchronous skin
treatment devices on the market, there are few with proven permanent tightening.

J Clin Exp Dermatol Res

ISSN:2155-9554 JCEDR, an open access journal Volume 3 • Issue 4 • 1000157
Citation: Mulholland RS, Kreindel M (2012) Non-Surgical Body Contouring: Introduction of a New Non-Invasive Device for Long-Term Localized Fat
Reduction and Cellulite Improvement Using Controlled, Suction Coupled, Radiofrequency Heating and High Voltage Ultra-Short Electrical
Pulses. J Clin Exp Dermatol Res 3:157. doi:10.4172/2155-9554.1000157
Figure 11: Female before and 3 months following treatment with a 6.8 cm
reduction off her hip-abdomen circumferential reduction.
Figure 12: Patient with a 81% Canfield vectra measured reduction in the
depth the cellulite pits of the lower anterior thigh.
This study on 25 patients provides strong evidence that a
combination of suction coupled, selective, controlled RF heating
and ultra-short, high voltage RF pulses offers a safe, long term, non-
invasive body contouring solution with adipocyte death and therefore
long-term contour and cellulite enhancements.
Synergistic controlled RF heating and ultra-short HV pulses
appears to result in a consistent circumferential reduction that may
be a result of both adipocyte deaths from uniform and sustained
heating of the adipose tissue at 43-44°C for 10 minutes, over a series
of 6 sessions. In addition, an apoptotic death of adipocytes caused by
trains of ultra-short (nanosecond), high voltages pulses, resulting in
irreversible electroporation (IRE) effects on the fat cell membrane may
also be a major contributor to long-term adipose tissue reduction.
The cellulite improvement was significant and the ability of
the device to treat many of the underlying anatomical alterations in
cellulitic skin may contribute to its efficacy.
The TiteFX is able to treat both focal fat or cellulite zones, each in
20 minutes, making multiple zone body contouring feasible. There is
no disposable costs associated with the use of the device and despite
the thermal mechanism and HVP IRE, is very well tolerated by the
patient with an apparent high index of safety. The authors believe that
the TiteFX technology is effective in delivering a permanent adipocyte
apoptotic effect and thus long-term non-invasive fat reduction, cellulite
improvement and body contour enhancements. Further studies will
help to confirm and position the role of TiteFX in body contouring and
cellulite reduction.
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Volume 3 • Issue 4 • 1000157

A Clinical and Biological Evaluation of a Novel,
Noninvasive Radiofrequency Device for the Long-Term
Reduction of Adipose Tissue
Sylvie Boisnic, MD,1,2 Marc Divaris, MD,2 Andrew A. Nelson, MD,3 Nima M. Gharavi, MD, PhD,4
and Gary P. Lask, MD4

1
Institution GREDECO, Paris, France
2
Department of Plastic and Maxillo-Facial Surgery, University Pitie Salpetriere, Paris, France
3
Department of Dermatology, Tufts University, Boston, Massachusetts
4
Department of Dermatology, University of California, Los Angeles, California
Background and Objective: A novel, noninvasive
technology, utilizing suction-coupled radiofrequency (RF)
heating and ultra-short pulse duration, high-voltage
electrical pulses was studied for its efficacy and safety on
adipose tissue reduction.
Methods: Twenty-one subjects underwent treatment of
their abdominal fat once weekly for 6 weeks. Clinical
outcomes including abdominal circumference, adipose
tissue thickness (measured by ultrasound), adipose tissue
weight, body weight, and clinical photographs were
obtained at visits 1 and 3 months after last treatment.
Adverse events were recorded. Three subjects, who were
undergoing a future elective abdominoplasty, were treated
with the same protocol, but on only one side of the abdomen
before abdominoplasty. Biopsies from the RF-treated and
untreated sides were harvested during abdominoplasty
and cultured; measurements of adipocyte size and shape,
rate of apoptosis, collagen production, and dermal thick-
ness were determined.
Results: Significant clinical improvements (P < 0.05) were
observed for the following clinical outcomes: reduction of
abdominal circumference (113.4–110.7 cm), reduction of
subcutaneous adipose tissue thickness (40.5–38.5 mm),
and reduction in adipose tissue weight (32.2–30.7 kg) at
3-month follow-up visits. Overall patient weight also
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-
cytes were observed to have decreased size and withered
shape, with increased levels of apoptosis; increased
collagen synthesis, with compaction and reorganization
of the dermis was also observed. Only minor, transient side
effects were reported.
Conclusions: This novel, noninvasive RF device
was effective for improving subcutaneous fat, reducing
abdominal circumference and reducing subcutaneous
fat layer thickness. Histologically, these improvements
appear to be partly related to increased adipocyte
apoptosis. Lasers Surg. Med. 46:94–103, 2014.
ß 2014 Wiley Periodicals, Inc.
ß 2014 Wiley Periodicals, Inc.
Lasers in Surgery and Medicine 46:94–103 (2014)
Key words: radiofrequency; adipose tissue; circumfer-
ence reduction; noninvasive fat destruction; apoptosis;
irreversible electroporation; neocollagenosis
INTRODUCTION AND OBJECTIVE
Adipocytes store energy in the form of cytosolic
triglycerides. These fat cells make up adipose tissue in
the body and are held together by an organized lobular
network of collagenous fibrous septae. Adipocytes can
distend dramatically with increased triglyceride content.
Excess adipose tissue can lead to aesthetically displeasing
body contour bulges and convex distensions. Fat lobules
are contained within and partitioned by fibrotic septal
divisions running perpendicular and oblique to the surface
of the skin. In females, these partitions can weaken and the
orientation of the septae be altered, resulting in focal
herniations of fat into the dermis, creating the classic
bulging skin nodules of cellulite [1]. Suction-assisted
Lipoplasty (SAL) performed under tumescent anesthesia
has long been the gold standard treatment to reduce focal
fat excess [2]. Recently, ultrasound, laser, and radio-
frequency (RF) technologies have been added to traditional
lipoplasty, resulting in energy-based liposuction, to im-
prove the soft tissue contraction, and minimize ecchymosis
Conflict of Interest Disclosures: All authors have completed
and submitted the ICMJE Form for Disclosure of Potential
Conflicts of Interest and have disclosed the following: S.B.: A
BodyFX device was provided for her use during this study;
no other disclosures. M.D.: No relevant disclosures. A.A.N.:
Received speaking honoraria from InMode, Inc. and has stock
options with InMode, Inc. N.M.G.: No relevant disclosures.
G.P.L.: Received speaking honoraria from InMode, Inc. and has
stock options with InMode, Inc.


Correspondence to: Gary P. Lask, MD, Department of
Dermatology, University of California Los Angeles, 200 UCLA
Medical Plaza, Suite 450, Los Angeles, CA 90095.
E-mail: glask@mednet.ucla.edu
Accepted 23 December 2013
Published online in Wiley Online Library
(wileyonlinelibrary.com).
DOI 10.1002/lsm.22223
 A CLINICAL AND BIOLOGICAL EVALUATION OF A NOVEL 95

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
controlled by the user, facilitating a safe and effective
treatment at a therapeutic thermal endpoint.
When the preset dermal and adipose therapeutic end
point is reached, typically set at a range between 41 and
438C, the device then begins to emit trains of high-
amplitude, high-voltage, ultra-short (nanosecond) pulse
duration RF pulses into the preheated adipose tissue. The
intensity of these ultra-short pulse duration RF pulses
is controlled and set by the user. The RF is triggered
repeatedly once the preset cut off temperature is reached,
and as long as that temperature is maintained, trains of
high voltage, ultra-short pulse duration RF (second RF)
are emitted. These high-voltage, ultra-short pulse dura-
tion RF pulses selectively target the cell membrane of
adipocytes, resulting in an IRE effect. IRE disrupts the
continuity of the adipocyte cell membrane, hindering its
ability to regulate cell homeostasis. Once the continuity of
the cell membrane is irreversibly disrupted, this starts the
cascade of apoptosis, ultimately resulting in permanent,
programmed cell death of the adipocytes [11,12].
Subjects
Twenty-four subjects between the age of 31 and 59
(average age of 44.7 years), exhibiting clinical indications
of a local excess of adipose tissue were selected and
included in the study. Three of these patients were
scheduled to undergo an elective abdominoplasty, at the
completion of the study. Subjects were asked to maintain
their usual diet and exercise routine so that the device
could be evaluated free from the influence of other
variables.
Only subjects of appropriate age and no adverse medical
conditions were included in the study. Subjects were
excluded from participation if they had gained or lost
weight in the previous three months. General contra-
indications included pacemakers, pregnancy and nursing,
epilepsy, thyroid dysfunction, diabetes, cardiac arrhyth-
mias, heart disease or uncontrolled hypertension, history
of cancer (5 years of remission), liver or kidney disease,
medical conditions causing immunosuppression, use of
isotretinoin (Accutane1) within the previous 6 months, or
any other skin disorders or condition such as abnormal
wound healing. Diuretics and anti-coagulants were also
banned during the study. All participants in the study
signed an Informed Consent Form.
Experimental Procedure
Twenty-four subjects were treated with six weekly
sessions with the device. All patients were treated in
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
immediately following the completion of RF treatments, as
well as 1- and 3-month follow-up visits. The remaining
three subjects were scheduled (at their request) for an
abdominoplasty procedure immediately following the
completion of the series of treatments. These patients
were treated on the right side of the abdomen only, while
the contralateral untreated side served as a control; these
three subjects provided tissue samples for histologic
analysis following their abdominoplasty procedures. Since
abdominoplasty was scheduled immediately following the
RF treatment series, 1- or 3-month clinical follow-up data
were not obtained and only their histologic results were
included in this study. However, as discussed below, the
biopsies were harvested in a validated survival medium
up to 14 days, which has been shown to be the equivalent
to 6–8 weeks in vivo [13–21].
Subjects were bound to prescribed conditions related to
their eating habits 2 hours before and after each session
and were specifically asked to avoid heavy meals, fasting,
carbonated drinks, coffee, or tea. The subjects’ abdomen
was prepped clean before the start of the treatment and the
vacuum chamber of the device was prepped and disinfected
with bleach pads following each session.
Treatment parameters were set at 40 W and 428C,
representing the RF power and the skin surface cut off
temperature, respectively. The basic RF pulse duration
was set at 3–3.5 seconds. The high amplitude, high voltage,
ultra-short pulse duration “second RF” was set at a level as
high as the subject could tolerate, typically ranging from 5
to 10 (correlating to the number of trains of RF pulses
emitted). The surface of the abdomen was divided into two
zones, right and left, with each zone approximately the size
of 6–8 vacuum chambers. Treatments were performed by
applying the device applicator for the entire pulse duration
(3–3.5 seconds) and then moving to the tissue immediately
adjacent with an overlap of the electrode footprint of 20%.
Each zone was treated in a clockwise fashion until that
zone reached the cut-off temperature (428C). Once the cut-
off temperature was attained, usually in about 60 seconds,
the second RF was then automatically emitted in the
treatment zone. The cut off temperature was maintained
in the treatment zone for 5 minutes with a minimum of
10 passes of high-voltage second RF pulse treatments,
resulting in 5 minutes of high amplitude RF pulse treat-
ments. The process was repeated on the other side of
the abdomen. A second treatment pass of both zones was
then performed, resulting in a total tissue treatment time
of 10 minutes for each zone. The three abdominoplasty
subjects, treated on one side only (one treatment zone),
underwent their initial 5-minute treatment pass, then had
a 5-minute rest period, and underwent a second 5-minute
treatment pass. The number of zones treated per subject
depended on the surface area of the person’s abdomen with
greater treatment zones necessary for very large patients.
Total energies ranging from 8.5 to 29 kJ was used per
session per subject on the full abdomen.
Clinical Assessments
The precise circumference of the treatment area before
and after treatment sessions was measured. A tape
measure was used to record circumference on a standing
patient, based on a fixed vertical perpendicular measure-
ment taken from the end of the tape measure at the level of
 A CLINICAL AND BIOLOGICAL EVALUATION OF A NOVEL
the floor; furthermore, the tape measure was kept in
constant contact with the abdomen along the entire
circumference. While there are always limitations with
circumferential measurements, this method allows for a
reproducible method of measurement. These assessments
were performed on day 0 (prior to the first treatment),
immediately following the completion of the series of six
weekly treatments, and 1 and 3 months after the final
treatment session.
A Tefal1 BodySignal2 digital weight scale (REF:
BM3100A9/26A-3810 R) was used to determine both the
weight of the fat tissue (kg) of the subjects, as well as their
overall weight (kg). Jewelry and clothing, except for
undergarments, were removed for the weight measure-
ments. These assessments were performed on day 0
(prior to the first treatment), immediately following the
completion of the series of six weekly treatments, and 1 and
3 months after the final treatment session.
Photographs were taken in standardized conditions in
exhalation before each treatment session in order to
document the appearance of each subject. These assess-
ments were performed on day 0 (prior to the first
treatment), immediately following the completion of the
series of six weekly treatments, and 1 and 3 months after
the final treatment session.
Fat thickness was measured by ultrasound (Philips HD
11 XE) on noncompressible fat, measuring the abdominal
fat layer thickness 5 cm inferior to the umbilicus.
Ultrasound measurements were performed by a single
technician, utilizing uniform pressure on the ultrasound
transducer over noncompressible fat. While there are
inherent limitations in ultrasound measurement of fat
layer due to compression, this method limits this potential
variability. These measurements were performed before
beginning the series of treatments, and 1 month after
completing the treatment series. The initial examination
was completed within 48 hours preceding the first meas-
urements and treatment session.
Cellular and Histologic Assessments
Three patients were scheduled to undergo elective
abdominoplasty at the completion of the treatment series
as described above. Soft tissue composite skin and adipose
biopsies were taken from the treated and untreated
abdominal regions of these three subjects, and the speci-
mens were maintained as next described. Histologic
patient samples were cut into 3 cm2 full-thickness pieces,
with an initial depth of 2.5 cm. The histologic studies
performed immediately after the abdominoplasty included
the full tissue depth, with a depth to 2.5 cm of adipose
tissue analyzed.
Following the initial harvesting and analysis, the
specimens were then maintained following a validated
method of tissue culture, which permits the survival of
normal skin and adipose tissue in ex vivo conditions to keep
skin and adipose samples in survival condition [13–21].
This alternative culture method avoids testing in vivo
biopsy specimens and maintains the model in a validated
97
near in vivo metabolic condition. The elapsed time for the
procedure is artificially accelerated three to four times that
of the normal time needed in vivo [15]. Thus, samples
analyzed after 14 days correspond to in vivo changes seen
6–8 weeks following the completion of the treatment. The
histologic patient samples were maintained in 3 cm2 full-
thickness pieces, and were thinned to a depth of 3 mm of
subcutaneous fat to facilitate tissue culture; as a result, in
the accelerated tissue culture results, the analysis was
based on observation of the superficial adipocytes (up to
3 mm of adipose tissue depth maintained in culture). The
culture specimens were initially washed three times with
an antibiotic solution (300 U/ml penicillin and 300 mg/ml
streptomycin). Skin biopsies were placed with the
epithelium uppermost, at an air/liquid interface, on
culture inserts (filter pore size 12 mm). These inserts
were set on six-well plates and culture medium was added
underneath three times a week. Medium was Dulbecco’s
minimal essential medium (DMEM) containing antibiotics
(100 U/ml penicillin and 100 mg/ml streptomycin), 200 mg/
ml L-glutamine, bovine pituitary extract, growth factors,
and fetal calf serum. All supplements were freshly made
with each medium change every two days and applied at
the epidermal level. Skin biopsies were then put in a
humidified atmosphere of 95% air–5% CO2 at 378C. These
skin cultures were then used as the basis for histologic and
immunohistochemistry studies.
Treated and untreated skin cultures were then com-
pared at day 0 (day of abdominoplasty), day 3, and day 14.
At each of these time points, a portion of the soft tissue
specimen was analyzed for traditional histopathology and
morphometric assessment; a comparison was conducted
between the treated and untreated abdominal skin,
consisting of an analysis of adipocyte architecture and
function, as well as an evaluation of the appearance and
thickness of the hypodermis (measured in microgram at
100 magnification). Photography was used to visualize
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
polyclonal antibody directed against human apoptosis
protease activating factor 1 (APAF-1) (Spring Bioscience,
IgG, 1/300 dilution) was used. The immune-detection was
made with an indirect technique of immunoperoxydase in
four levels, amplified (kit CsA II, DAKO, Les Ulis, France)
and stained in red by 3-amino-9-ethylcarbazole (AEC).
Greater levels of expression of APAF-1 indicate greater
apoptotic activity in the cells.
After 14 days of culture, the remaining soft tissue
specimen was utilized for analyzing collagen synthesis
using a validated collagen assay [13–17]. Skin samples
were enzymatically digested in an acetic acid 0.5 M
solution containing pepsin overnight at 48C. The fibroblas-
tic activity for collagen synthesis was evaluated by a
spectrocolorimetric method (540 nm) measuring the acid-
soluble new collagen synthesized after a specific fixation by
Sirius red staining (Sircoll Collagen Assay, Interchim,
Montlucon, France). The results were expressed in
microgram of collagen per mg protein.
98 BOISNIC ET AL.

Statistical Analyses abdominal circumference decreased further from the

Means, standard deviations (SD), and 95% confidence
interval (CI) for each characteristic were reported. Due to
the substantial variability of the patient’s baseline
characteristics as a result of great variety in patient’s
body types, SD for each measurement vary greatly.
However, since each patient served as a paired baseline
and outcome measurement, Paired Sample T tests could be
utilized to determine the statistical significance of any
improvement. Paired Sample T tests were used to assess
changes in baseline (day 0) and follow-up measures
(immediately after six treatment sessions, 1-month fol-
low-up, and 3-month follow-up) for abdominal circumfer-
ence, fat tissue thickness, fat tissue weight, and body
weight. All analyses were conducted using IBM SPSS 21.0
and significance was set at an a of 0.05.
RESULTS
Clinical Findings
Circumferential measurement. Summary results of
the circumference (cm) of subject’s abdomen are expressed
in Table I. The average circumference of subjects (n ¼ 21)
treated on the abdomen decreased significantly from
113.4 cm (SD ¼ 15.3) pretreatment to 111.5 cm (SD ¼ 15.0)
following the sixth treatment session with the device,
indicating a statistically significant improvement (Paired
Samples T-test t(20) ¼ 6.99, P < 0.001). This clinical
improvement was maintained in the follow-up period.
One month after completing the series of treatments, the
baseline of 113.4 (SD ¼ 15.3) to 111.1 cm (SD ¼ 14.5),
a statistically significant improvement (Paired Sample
T-test, t(20) ¼ 5.73, P < 0.001). At 3 months follow-up, the
average abdominal circumference decreased even further
to 110.7 cm (SD ¼ 14.5), for a total reduction of 2.7 cm from
baseline. Again, this decrease was statistically significant,
with a Paired Sample T-test, t(20) ¼ 5.84, P < 0.001.
Photography allowed for a comparison between pretreat-
ment and follow-up 3 months after completing the series of
treatments (Figs. 2 and 3). Significant improvement in the
appearance of subcutaneous fat, as well as skin tightening,
was directly observed in these photographs.
Echography. Summary results of the fat thickness
(mm) of subject’s target zone, as measured by ultrasound,
are expressed in Table I comparing subcutaneous fat layer
thickness at baseline prior to treatment and 1 month after
completing the series of treatments. The measurement of
subcutaneous fat thickness showed a significant reduction
from an average of 40.5 mm (SD ¼ 11.4) at baseline to an
average of 38.5 mm (SD ¼ 11.0) 1 month following the
series of treatments, representing a statistically signifi-
cant reduction (Paired Sample T-test, t(20) ¼ 5.88,
P < 0.001). An echography example illustrating clinical
improvement is shown in Figure 4 (patient 7), in which a
reduction in the subcutaneous fat layer thickness from 37
to 31 mm was observed at one month following completion
of the treatment series.
Adipose tissue weight. Summary results of subject’s
bodily adipose tissue (kg) are expressed in Table I. The

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

Abdominal Fat tissue Fat tissue Body

circumferencea thicknessb weightc weightd
N (cm) (mm) (kg) (kg)

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

Fig. 2. Clinical improvement in appearance of abdominal

subcutaneous fat following a series of six weekly noninvasive
RF treatments. Before is shown on left, and 3 months following
completion of series of treatments shown on right. Note the
reduction in abdominal circumference, volume of subcutaneous
fat, improved body contour, and tightening of skin in abdominal
treatment area.

average weight of subjects’ (n ¼ 21) adipose tissue signifi-

cantly decreased from 32.2 kg (SD ¼ 8.9) pretreatment to
31.2 kg (SD ¼ 8.4) at the immediate conclusion of the
six treatment sessions (Paired Sample T-test, t(20) ¼ 5.65,
P < 0.001). One month following the completion of the
series of treatments, the average adipose tissue weight
further decreased to 30.8 kg (SD ¼ 8.4) (Paired Sample
T-test, t(20) ¼ 6.80, P < 0.001). Three months following
the completion of the series of treatments, the average
weight of subjects’ adipose tissue stayed stable at 30.7 kg
(SD ¼ 8.2) (Paired Sample T-test, t(20) ¼ 4.72, P < 0.001),
for a total average fat reduction of 1.5 kg.
Body weight. Summary results of the body weight (kg)
for subjects are expressed in Table I. The average weight of
subjects (n ¼ 21) treated with the RF device, was noted to
have decreased from 73.9 (SD ¼ 12.4) to 73.0 kg (SD ¼ 11.8)
immediately following the completion of the series of 6
treatments (Paired Sample T-test, t(20) ¼ 4.31, P < 0.001).
One month after the completion of the series of treatments,
Fig. 3. Clinical improvement in appearance of abdominal
subcutaneous fat following a series of six weekly noninvasive
RF treatments. Before is shown on left, and 3 months following
completion of series of treatments is shown on right. Note the
reduction in abdominal circumference, volume of subcutaneous
fat, improved body contour, and tightening of skin in abdominal
treatment area.
Fig. 4. Ultrasound assessment of subcutaneous fat thickness.
This example demonstrates reduction in subcutaneous fat
thickness from a thickness of 37 mm (before, shown as top image)
to a thickness of 31 mm (after, shown as bottom image) 1 month
following a series of six noninvasive RF treatments.
the average weight of subjects further decreased to 72.7 kg
(SD ¼ 11.9) (Paired Sample T-test, t(20) ¼ 4.99, P < 0.001)
and 3 months following the completion of the series of
treatments, the average weight increased slightly to
73.3 kg (SD ¼ 11.7); at the 3 month postprocedure visit,
there was not a statistically significant change in overall
patient weight (Paired Sample T-test, t(20) ¼ 0.52,
P ¼ 0.609). In all cases at all measurement points, the
total weight change for each subject was less than the
reduction in their adipocyte weight.
Adverse events. Discomfort during the treatment was
a rare occurrence with a report of a pinching feeling under
the area of treatment, or a slight, “shock”-like sensation
combined with surprise at the first discharge of the high
amplitude, ultra-short pulsed RF. Transient and mild post
treatment bruising infrequently occurred following treat-
ment, likely related to the vacuum function of the device.
Bloating, nausea, migraines, diarrhea, nerve spasms,
stomach aches, and frequent urination were reported as
rare side effects of the treatment but may represent
epiphenomena.
100 BOISNIC ET AL.

Cellular and Histologic Findings
Histological evaluation of skin and adipose sam-
ples. After preparation and analysis of the skin samples
from the three subjects, alteration of the fat cells was found
in treated areas of the hypodermis to a depth of 2.5 cm in
the initial histologic analysis. Control, nontreated skin,
contained adipose tissue with normal round adipocytes;
skin treated with the RF device showed altered adipocyte
histology, with a reduction of fat cell size with flattening
and/or elongation of the cells. Fat cell membranes in the
RF-treated adipose appeared shrunken and withered;
occasionally, the adipocyte cell walls were partially
ruptured. No necrosis was observed, and there was no
destruction of adjacent structures (epidermis, blood
vessels, nerves or dermal collagen). These induced changes
to the adipose architecture were noted immediately
following the completion of the series of treatments (at
the time of abdominoplasty). Furthermore, these changes
persisted and became more apparent in superficial adipose
tissue at days 3 and 14 in accelerated culture (Fig. 5).
Immunostaining for adipocyte apoptosis. Within
the adipose tissue of the treated areas, increased levels of
adipocyte apoptosis were observed immediately following
the treatment series, with approximately 20% of all
adipocyte cells staining positive for APAF-1, a validated
marker of apoptosis. In contrast, the control untreated skin
only rarely had adipocytes undergoing apoptosis, with less
than 1% of adipocytes staining positive for APAF-1. At
day 14 of culture, fat cell apoptosis had further increased
(30% of adipocytes staining positive for APAF-1) within
the RF-treated adipose tissue (Fig. 6).
Dermal thickness and neocollagenosis. A signifi-
cant reduction in dermal thickness, with tighter, more
compact collagen, and an apparent decreased spaced
between the collagen fibers, was noted following the RF
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
Fig. 6. Immunohistochemistry staining of APAF-1, a marker of
apoptosis, after 14 days of tissue culture. A: Example of nontreated,
control tissue (200) showing low levels of staining for APAF-1.
B: Example of tissue that underwent a series of six weekly RF
treatments. Note the withered appearance of cell membranes, as
well as the increased staining of APAF-1 in (B), indicating a higher
level of adipocyte apoptosis. Control tissue (200 magnification).
thickness for the three subjects was 1,711.3 mm in the RF-
treated zone versus 2,176.6 mm in the nontreated zone
(measured at 40 magnification). At day 3, the average
dermal thickness measured 1,463.3 mm in the RF-treated
zone versus 1,965.3 mm in the nontreated zone. At day 14,
the average dermal thickness had decreased to 1,452.8 mm
in the RF-treated zone versus 1,646 mm in the nontreated
zone, representing an average dermal compression of
193.2 mm. Additionally, a significant increase in collagen
synthesis (neocollagenosis) was also observed after treat-
ment by the RF device, with a mean collagen level of
57.6 mg/mg in the treated zone versus 49.7 mg/mg in the
nontreated zone, as determined by the spectrocolorimetric
method, representing an average increase of 13.7%.
DISCUSSION
Noninvasive fat reduction is a rapidly expanding field of
cosmetic rejuvenation, as many patients are unwilling to
101
undergo the downtime and healing associated with
traditional invasive suction lipoplasty or newer ultrasound
and laser/RF assisted invasive lipoplasty procedures. To
date, the clinical improvements associated with noninva-
sive fat reduction have been modest at best, may not
address overlying skin laxity, and can be associated with
pain or other adverse effects.
The RF device in this study appears to be a novel, safe,
and effective method for noninvasive fat reduction as well
as synchronous dermal enhancement and skin tightening.
This study, incorporating 24 subjects, has permitted the
visualization and quantification of the statistically signifi-
cant reduction of abdominal fat after treatment by a novel
RF device. Following a series of six weekly, noninvasive RF
treatments, patients were observed to have a significant
reduction in abdominal circumference, reduction in thick-
ness of the subcutaneous fat layer as assessed by
ultrasound, as well as a reduction in adipose tissue weight.
These improvements are noted immediately following the
completion of the series of treatments, and persist with
increased clinical efficacy observed 1 and 3 months after
completing the series of treatments. There was a statisti-
cally significant decrease in patient weight initially
following the series of treatments and at the 1-month
follow-up visit; however, while there was still a decrease in
overall patient weight at the 3-month follow-up visit, this
decrease was not statistically significant. It is notable that
while there was not a statistically significant reduction in
overall patient weight at the 3-month follow-up point,
there was still a maintained statistically significant
reduction in adipose tissue weight at the 3-month follow-
up visit, suggesting increased specificity of the device for
fat. Clinical photographs demonstrated and correlated
with this substantial clinical improvement following the
series of treatments.
Ex vivo human skin cultures following the completion of
the series of RF treatments showed a profound effect on
subcutaneous adipocytes. The adipocyte cells were noted to
have altered morphology, and increased expression of the
apoptosis marker, APAF-1, suggesting that IRE induced
apoptosis is the mechanism of action. Adipocyte apoptosis
results in the release of triglycerides from the disinte-
grated cell membranes, but in a delayed and gradual
manner, enabling a slow and safe removal through the
interstitial space, and subsequent lipid transport systems,
lymphatics and other metabolic functions. There was no
evidence of necrosis or inflammatory changes noted in the
adipocytes following treatments with this novel RF device.
While IRE has been shown to be effective at inducing
cellular apoptosis in other tissues, to our knowledge, this is
the first documentation of IRE in adipose tissue with RF
treatments [22–31].
In addition to the effect on adipocytes, this device was
also noted to have an effect on dermal collagen. As the
dermis was heated, the thickness of the collagen was noted
to decrease indicating more compact, tighter dermal
matrix. Furthermore, increased levels of collagen synthe-
sis were observed following the completion of the series of
RF treatments. This neocollagenosis and remodeled
102 BOISNIC ET AL.

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
dermis. This synchronous dermal enhancement is an
important effect, given that patients who undergo nonin-
vasive fat reduction typically also seek skin tightening
along with fat reduction. While other noninvasive devices
have been able to achieve adipocyte destruction and fat
layer reduction, this novel RF device is unique in its ability
to simultaneously achieve long-term improvement in
subcutaneous fat through apoptosis and skin tightening
with a single technology. This represents a substantial
improvement over currently available technologies.
Only mild and transient adverse events were noted
during the series of treatments. Most of the adverse effects
were related to the device’s thermal mechanism of action
and the mild electrical sensation of the high-voltage
pulsing. Notably, no patients suffered thermal burns to
the skin and there were no reports of cutaneous sensory
changes or painful dysesthesia in any patients. Thus, the
device appears to be a safe and effective option for treating
subcutaneous adipose tissue.
There are, of course, limitations to this study. First, the
study examined only 24 subjects, which may limit the
power of the results; however, the results were statistically
significant with the number of subjects enrolled. Second,
while the study demonstrated significant improvement
immediately following the series of treatments, as well as
3 months after the completion of the series, it remains
unknown whether this clinical improvement will be
maintained over years. Third, the clinical parameters
utilized in this study were conservative, which may have
contributed to a less dramatic clinical improvement;
recently, the authors have utilized higher temperature
cut off values and higher intensity ultra-short pulse
duration RF pulses, with associated greater clinical
improvement, greater reduction in abdominal circumfer-
ence, and increased reduction of adipose tissue weight.
 A CLINICAL AND BIOLOGICAL EVALUATION OF A NOVEL
Lastly, while the histologic and immunohistochemistry
data shown in this study are very promising, they are
based on a limited series of only three patients.
Nonetheless, this device represents a novel treatment
option for patients seeking noninvasive fat reduction. With
the incorporation of two types of RF treatments: (1) a basic
RF pulse in the standard 1 MHz range for thermal heating,
and (2) trains of ultra-short pulse duration, high-ampli-
tude, high-voltage RF pulses to cause IRE, this device
achieves significant reductions in abdominal circumfer-
ence, subcutaneous fat layer thickness, and adipose tissue
weight by inducing adipocyte apoptosis. In addition, this
device also allows for remodeling and tightening of the
existing collagen in the treatment area, and stimulates
neocollagenosis. This combination of skin tightening and
long-term subcutaneous adipose tissue reduction repre-
sents an ideal treatment option for noninvasive fat
reduction. In the future, larger and longer-term studies
may be necessary to further determine the efficacy of this
device and to elucidate the optimal treatment protocols.
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sisted-lipoplasty. Plast Reconstr Surg 2006;118:1032–1045.
6. Dibernardo BE. Randomized, blinded, split abdomen study
evaluating skin shrinkage and skin tightening in laser-
assisted liposuction versus liposuction control. Aesth Surg J
2010;30(4):593–602.
7. Paul MD, Mulholland RS. A new approach for adipose tissue
treatment and body contouring using radiofrequency-assisted
liposuction. Aesth Plast Surg 2009;33(5):687–694.
8. Paul MD, Blugerman G, Kreindel M, Mulholland RS. Three-
dimensional radiofrequency tissue tightening: A proposed
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9. Duncan DI. Improving outcomes in abdominal liposuction:
Comparing skin contraction with radiofrequency assisted
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IMCAS Paris, January 2011.
10. Mulholland RS, Paul MD, Chalfoun C. Non-invasive body
contouring with radiofrequency, ultrasound, cryolysis, and
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11. Mulholland RS. Radio frequency energy for non-invasive and
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38:437–448.
12. Mulholland RS, Kreindel M. Non-Surgical body contouring:
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localized fat reduction and cellulite improvement using
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Res 2012;3(4):157–165.
13. Boisnic S, Branchet-Gumila MC, Benslama L, Le Charpentier
Y, Arnaud-Battandier J. Long term culture of normal skin to
test the efficacy of a hydroxy acid-containing cream. Eur J
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14. Chapman SJ, Walsh A, Beckett E, Vickers CFH. A fully
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16. Branchet-Gumila MC, Boisnic S, Le Charpentier Y, Nonotte I,
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Renault B, Breton L. Eyelid skin explants under neuro-
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Szpirglas H, Dupuy P. Topical retinaldehyde treatment in
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 Expert Roundtable Series:

Important Considerations When

Choosing a Body Shaping
Device for Your Practice
By Jeffrey Frentzen, Executive Editor

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.

THE Aesthetic Guide March/April 2014 www.miinews.com 3

 Important Factors to Consider When Choosing
a Body Shaping System for Your Practice

Z. Paul Lorenc, M.D., F.A.C.S.

Aesthetic Plastic Surgeon For physicians that do not currently offer energy-based body shaping, or are
Manhattan, NY looking to upgrade their existing technology, what criteria should they use
to measure performance?

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.

Douglas J. Key, M.D.
Key Laser Institute for
Aesthetic Medicine
Portland, OR
Jon Perlman, M.D., F.A.C.S.
Cosmetic Plastic Surgeon
Los Angeles and Beverly Hills, CA
Mark B. Taylor, M.D. — When I began my search the first questions I asked were:
What is the technology? How much pain is associated with it? How many treat-
ments will it take to see results? Is it going to be cost-effective for both the patient
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
fat. They’re busy and / or surgery averse, and will be satisfied with minimal im-
provement, no downtime and multiple treatments.

Fredric A. Stern, M.D. — The physician should have a clear understanding of

what specific types of lipodystrophy patients he / she wants to treat, and how
Suzanne L. Kilmer, M.D.
The Skin Surgery Center of Northern effective a totally non-invasive modality would be for each type of patient, as op-
California posed to a surgical, but minimally invasive approach. Some physicians may only
Sacramento, CA
want to use non-invasive devices, which is fine for certain patients with minimal
underlying lipodystrophy. However, this may limit the effectiveness and speed of

4 THE Aesthetic Guide March/April 2014 www.miinews.com

patient results compared to a minimally invasive approach that offers quicker and
more profound results, but requires more expertise.

While all body shaping systems operate on a similar principle of heat or

cold applied to tissue to eliminate fat, many different technologies are used
to achieve results. What are the most popular applications and are they
scientifically sound?

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.

Newer applications that I am observing are high definition liposculpting

and muscle toning. Often, I also combine technologies such as ProLipo™,
CelluSmooth and SkinTyte™ to simultaneously treat excess adiposity, lumpy and
dimpled skin and laxity. I have seen excellent results in these patients.

Radiofrequency (RF)-based systems are proliferating. What must providers con-

After four BodyFx treatments
sider when choosing between monopolar, bi-polar and / or multipolar? Photos courtesy of the Diane Duncan, M.D.

Dr. Perlman — Without making a commitment to a certain technology, I think

it is difficult to know the facts. In marketing their services, both physicians and

THE Aesthetic Guide March/April 2014 www.miinews.com 5

 THE GREAT SUMMER REVEAL. CLEARED
Groundbreaking New Non-Invasive
Body Contouring & Cellulite Treatment

Newly Released Peer Reviewed Article in

Lasers in Surgery & Medicine Journal
Showing Apoptosis

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.

Dr. S. Mulholland Dr. D. Duncan Dr. S. Mulholland

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

“All patients re-epithelialized “The average circumferential “A single full-face Fractora

within 4-7 days. There were no
cases or instances of delayed
healing, no significant adverse
reactions and specifically, no
hypo-pigmentation, PIH and no
hypertrophic/hypotrophic scars.”
Fractional Ablative Radiofrquency
Resurfacing In Asian And
Caucasion Skin: A Novel Method
For Deep Radiofrequency
Fractional Skin Rejuvenation
Journal of Cosmetics, Dermatological
Sciences and Applications, 2012
reduction was 3.58 cm with range
of 1.5 cm-4.4 cm. There were no
non-responders observed in the
study. Average Vectra measured
improvement in the pit depth or
“smoothness score” was 2.9 mm
or 60% (range 1.1 mm-6.3 mm).”
Introduction Of A New Non-Invasive
Device For Long-Term Localized Fat
Reduction And Cellulite Improvement
Using Controlled, Suction Coupled,
Radiofrequency Heating And High
Voltage Ultra-Short Electrical Pulses
Journal of Clinical & Experimental
Dermatology Research, 2012
treatment is able to demonstrate
more than 50% improvement in
an array of indications for the
aging face. Wrinkle and tightening
improvement was slightly better at
the 6 month follow-up than after
3 months, indicating a long process
of collagen remodeling.”
Synchronous Fractional Radio-
Frequency Ablative And Non-Ablative
Treatment For Comprehensive
Rejuvenation Of Aging Skin
Anti-Aging Medical News, 2011

For full access to all clinical papers visit: http://inmodemd.com/results/clinical-results/

IN-DEMAND AESTHETICS IN ONE PLATFORM

IS YOUR PRACTICE READY FOR 15+ REVENUE STREAMS?
InMode offers you the most versatile platform to meet all patient demands.

Fractora Forma Lumecca Diolaze BodyFX

Toll Free: 855.411.2639 | www.inmodemd.com

VIMSB21213
VI
DEO
me
dia I
nMode
 FORMA & BodyFX: EXTRA TV
January 4, 2015
Forma and BodyFX Featured on Extra TV as the Celebrity Secret for a Golden Globes Glow!
The secret is out! Extra TV
reveals Forma & BodyFX as Hollywood’s
A-list celebrities’ favorite non-invasive
treatments. These treatments keep skin
young, tight and glowing! In this video
celebrity skin care facialist, Joanna Vargas,
reveals her methods for getting Julianne
Moore, Naomi Watts, Maggie Gyllenhaal
and Bill Murray red carpet ready for the
Golden Globes.
Forma uses non-invasive radiofrequency
technology to rejuvenate skin and take
years off the face. Forma smoothes crow’s
feet, tightens sagging skin on the jaw
and neck, and diminishes fine lines and
wrinkles. Results can be noticed after just
View Video: http://vimeo.com/116771672
one session. The skin’s elasticity continues
to improve as the therapeutic temperature
from the radiofrequency treatment
stimulates the production of new collagen.
BodyFX is a non-invasive body contouring
and cellulite treatment, using negative
vacuum pressure and radiofrequency
to reduce volume and simultaneously
tighten skin. It can be used to tighten the
abdomen, flanks, thighs and other trouble
areas without surgery or downtime.
Results are progressive and best seen after
a series of treatment sessions.
 FORMA: EXTRA TV
January 8, 2015

Lauren Kitt-Carter Tells Extra TV How She Keeps Her Skin Glowing

31-year-old fitness/fashion model and Forma stimulates the production of new

star of reality show “I Heart Nick Carter”,
Lauren Kitt-Carter reveals her secret to
maintaining younger, tighter skin. Lauren
works hard to keep her body in perfect
shape, but admits that she struggles with
acne and sagging skin on her face.
Extra TV follows Lauren to the cosmetic
dermatologist’s office for a Forma
treatment. This procedure uses
radiofrequency heat to lift and tighten
skin, continuing to improve skin elasticity
for weeks following the treatment.
collagen, restoring youthful volume to
the face. In just 3-5 sessions, patients
can turn back the clock. There is no
anesthesia, no cutting and no downtime.
31 is indeed still young, but experts like
Dr. William Schweitzer say that is never
too early to start taking preventative
measures. Taking care of your skin from
an early age gives you a head start in the
race against time.

View Video: http://vimeo.com/116769279

 FRACTORA FACIAL: EXTRA TV
November 8, 2013

ExtraTV features Fractora RF: the new treatment celebs use to get red carpet ready

Going under the knife is no longer treatment. Dr. Kanodia’s patient,

a requirement for looking like a star.
Celebrity plastic surgeon, Dr. Raj Kanodia
show off his new beauty weapon in the
war on wrinkles.
Fractora RF utilizes radio
frequency energy to even out the face,
jowls, and neck area. Improvement of
skin elasticity, wrinkle reduction, and
skin tone can be seen after just one
Lori, affirms that Fractora has taken
years off her face. Fractora was a
perfect non-invasive treatment to
help tighten her skin and sweep
away signs of aging.
(Extra TV featured Fractora during
sweeps week - reaching a viewership
over 1 millon )

View Video: http://www.youtube.com/watch?v=AoowynYB2xI

 Giuliana & Bill on E!
May 13, 2014

Giuliana contemplates going under wrinkles, acne scars and contraction.

the knife after finding her worst fear: a Giuliana tells Bill about her trip to
wrinkle! She goes in for a consultation the plastic surgeon’s office and admits
with Dr. Raj Kanodia, celebrity plastic that she scheduled a Fractora treatment.
surgeon in Beverly Hills. Giuliana gets hit with her first pulse and
Dr. Kanodia has published doesn’t find it too painful.
numerous medical articles and is often In the end, she is glad that she
a guest lecturer at international medical went through with the treatment and
conferences. Over the years he has even though she dreads getting older, she
developed a worldwide client base among is thankful for being able to celebrate her
entertainers, royalties, models and next birthday.
people alike.
Dr. Raj tells Giuliana that she is too
young to get a facelift. He says that the
slight drooping she is experiencing in her
skin is natural due to aging but that he
can improve the appearance of her skin
with fillers and Fractora.
Fractora is a bipolar radio-
frequency fractional treatment for
superior improvements in texture,
Video: http://vimeo.com/96214201
Fractora Facial: Look 8 Years Younger in 8 Weeks
February 15, 2013
Are you searching for something
that can finally address deep wrinkles,
pigment irregularities, blood vessels, and
acne scars? Or something that can rival
the result of plastic surgery, without all
the downtime and expense of undergoing
surgery? If so, then Fractora may be for
you.
Fractora is now available for those
of us wanting to look years younger in
a relatively short amount of time, with
results lasting several years with little to
no upkeep. So who wouldn’t want to give
this latest and greatest procedure a try?
“It’s like applying 60 tiny
acupuncture needles in a tiny applicator
to the skin,” Dr. Jennifer Walden said in a
recent interview with Todd Boatwright on
Austin’s YNN.
According to Dr. Walden’s website
Video: http://www.youtube.com/watch?v=dEWR-03MF6s
Fractora is several different technologies
rolled into one– radiofrequency sound
waves, not a knife, to help resurface,
smooth, and tighten the facial skin. The
device also has the ability to help reduce
unwanted pockets of fat on different
areas of the body with a switch of the
applicator. Patients have the option of
one big treatment or several smaller ones
over a period of weeks. With no fuss,
mess or downtime, Fractora may be the
perfect fit for you and a solution to those
problem areas you have always tried to
fix.
Viva la Mañana: Fractora Demonstration
October 4, 2013
Dr. Natan Yaker and his assistant,
Maria, demonstrate new radio frequency
technology on Spanish morning show, Viva
la Mañana. Fractora helps to diminish the
appearance of wrinkles caused by aging,
sun damage, and skin deterioration.
Fractora delivers bipolar RF energy
to various depths in the skin through an
array of pin electrodes creating micro
lesion zones of ablation, coagulation
and heating, leading to rejuvenation and
contraction. It also helps to reduce pore
size and pigmentation of the skin. Some
common treatment areas include: face,
jowls, neck, and chest. Dr. Yaker points out
that the chest is often forgotten about but
it sometimes ages even faster than the
face and neck.
Video: http://www.youtube.com/watch?v=b3-CPo68IZQ
One treatment takes from 45
minutes to an hour, and an anesthetic
cream is applied to improve patient
comfort. If a higher energy level is used a
patient might only need 1-2 sessions, but
could experience 3-5 days of downtime.
If the patient can’t take a week off of
work then the treatments can be split up
every 1-2 weeks for 6-8 weeks at a lower
energy level. With this option there is no
downtime and the patient can go back to
work immediately after treatment.
This treatment is not a
replacement for plastic surgery, but
is very effective at treating the earlier
stages of wrinkles and for maintaining
results achieved with plastic surgery.
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
Mulholland at SpaMedica to discuss new non-
surgical procedures, including FaceTite. This new
procedure is performed in physician’s offices which
smoothes away wrinkles caused by weight loss,
dieting, pregnancy, etc.. The internal electrode
goes under the skin, however there is no cutting
or surgery necessary. This is the first device that
safely and effectively heats under the skin, which
is much more effective than on top of the skin.
There is no bruising or down-time. Only a single
treatment is necessary to see the desired results,
and the patient is able to return to work the same
day. Dr. Mulholland has been doing the procedure
for 11 months and has seen impressive results in
the tightening of the skin under the arms, above
the knees, etc. His patient, Jane, felt nothing at all
during the procedure.
Dr. Mulholland introduces TiteFX, which
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
the fat cell in a safe way in which the body can then
metabolize it. There are virtually no risks, and it
takes a series of treatments over several weeks.
3-4 cm is the average reduction. Treatments like
TiteFX are usually half the cost of liposuction, which
comes out to about 1500-2000 dollars. This is
about the same cost as the Jenny Craig or Bernstein
programs. Dr. Mulholland’s patient, Laura, describes
the feeling as a mild electrical shock, which is fairly
comfortable.
Dr. Mulholland shows us the Fractora and
the Fractora Firm. It sends an electrical current
through tiny pores created by microscopic needles.
An antioxidant is applied, which the Firm pushes
into the skin to tighten the skin. It is another
procedure after which the patient can head back to
work on the same day. If the patient goes in once a
week for 4-5 weeks the treatment can take off 4-5
years (a year a week).
 Having It All: Hosted by Niki Taylor
December 13, 2012

Dr. Andrew Nelson, Harvard and
UCLA board certified dermatologist, joins
supermodel Niki Taylor on “Having It All”
to discuss Fractora by Invasix.
Fractora treats multiple signs of
aging by heating the deeper levels of the
skin and allowing collagen to remodel and
resurface itself.
Dr. Nelson points out that the face
is usually the first to get wrinkles from
sun damage and aging. Fractora helps
in fighting that battle by gently applying
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
choose their length of downtime. If the
patient decides that they want a more
aggressive treatment, then downtime
can take up to a few days. Alternatively,
patients can choose a series of mild
treatments that have no downtime at all.
Niki was so excited about Fractora
that Dr. Nelson returned to the studio
after hours to give her an exclusive
treatment. She absolutely loved
the session and calls Fractora a real
breakthrough.

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

NBC News – Miami

Dr. Haideh Hirmand, a New York
board certified plastic surgeon, discusses
different options for people who are
looking into plastic surgery.
“Back in the old days, women
had to go under the knife for a face lift.”
Surgery and non-surgical technologies
are being combined to give the best
results. Rather than replacing one
for the other, the advantages of both
are combined for optimal patient
satisfaction.
She sees big trends in body
tightening, skin tightening, and fat
melting, including radio-frequency
procedures: Fractora Firm and Fractora
Plus for the face and body. These new
innovations go under the skin to create
collagen and firm everything up.

Watch Video: http://www.youtube.com/watch?v=eAybvk6Ntlk

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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
The latest in Non Invasive
skin tightening and
Cellulite Fighters
by dr. ihab matta
We all want to look our best. Thanks to
continuing advances in medical tech-
nology, treatments that were once only
available to the rich and famous are now
accessible to everybody. In the past, one
would have had to have cosmetic plastic
surgery to turn back time, but now years
can be taken off your appearance by
simple in-office lunchtime procedures with
minimal downtime and risk.
Whether it’s getting rid of your wrinkles,
restoring youthful volume to your face,
improving your skin texture and cellulite,
eliminating unwanted hair or reducing that
frustrating “mummy tummy” there
is a non-invasive affordable solution
waiting for you.

Face: Restore volume restoration and lifting. By re-

Face: Eliminate wrinkles.
What to do: Use injectable inflating the area, we actually lift
What to do: Reduce sun exposure,
fillers such as Restylane and the sagging skin and improve
don’t smoke, and get treatment with
Radiesse. everything below. Treatment is
Botulinum toxin A.
done at one sitting with results
How it works: For wrinkles created
How it works: Restylane is a safe lasting 6-18 months. There may
by facial expression, such as frown
non-animal stabilized hyaluronic be some swelling or bruising
lines, crow’s feet or forehead
acid that can be injected into after treatment, but this is easily
creases, Botulinum toxin A (known
the face to restore that lost covered by makeup and usually
as Botox) is the most effective
volume. Common areas treated only lasts a couple of days.
treatment. It works by relaxing the
are hollow temples, lips, chin, Cost can range from $500-
muscles that create the wrinkle, so
marionette lines, smile lines $3000 depending on how much
that it no longer forms when the
(nasolabial folds), tear troughs treatment is carried out per
muscles move. You see results in
and most importantly, cheek session.
2-10 days after getting Botox, and
results can last up to four months,
with the results lasting longer as you
have more treatments. In the hands
of a qualified injector, results look
very natural. There is no downtime
and treatments cost anywhere from
$250-$600 depending on how many
areas are treated.

Jowl/chin/batwing area
What to do: Pollogen Maximus
Radiofrequency treatment to tighten loose skin on the
neck, arms and below the chin.
How it works: Radiofrequency delivers heat to the
skin and subcutaneous tissue below. By reaching and
maintaining a specific temperature, fat is released from
the underlying fat cells and skin tightening is triggered.
The Maximus stimulates collagen production through
deep heating, which helps rebuild the structural
integrity of the skin. Results are seen after the first
treatment with peak results at 6-12 months. Most
patients require 6 sessions for optimal results.
The treatment is pain free and any area with skin
looseness can be treated; common areas include
the jowl, chin, neck, batwings, mummy tummy, hips
and thighs. There is no downtime and clients can
resume their normal daily routine immediately after the
procedure. Cost is usually $200 per session for face or
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

Unwanted Bodyhair Sun damaged areas

What to do: Laser hair removal.
How it works: Laser hair removal works by
“selective photothermolysis”, in other words,
the laser looks for colour in the hair shaft
and targets it, destroying its ability to grow
new hair. Treatment is usually performed
every six weeks or so depending on how
fast the hair grows. When a new crop of hair
starts to grow, it’s time for another session.
Most patients describe the sensation as an
elastic band snapping on the skin, while
some patients (especially those with colour)
may notice a little bit more discomfort.
Most clients require 6-8 sessions to achieve
an 80% or more permanent reduction
in hair. Downtime is usually negligible;
some patients may notice a small sunburn
sensation for a few hours. Cost depends
on how large of an area is treated, ranging
from $50/session for underarms to several
hundred for legs or back.
on face, neck, chest
What to do: Fractora is a new option for patients
with fine wrinkles, brown spots or sun damage,
broken blood vessels and a general drop in skin
quality.
How it works: Fractora is a fractionated
Radiofrequency device that delivers heat 0.6
mm below the skin’s surface to improve the skin
quality. It has a series of either 20 or 60 tiny
pins that provide radiofrequency energy to the
dermal region of the skin. This energy ablates
some of the dermal matrix and stimulates a
collagen response from the body that results in
new, healthy collagen production.
The procedure feels like a heat sensation and
can be administered without anesthetic on a
low setting; but on higher settings, one would
need topical anaesthetic. The procedure is quite
quick and can require between 2-6 sessions
depending on desired outcome, intensity of
treatment and tolerance of downtime. Low
settings have minimal downtime, while higher
settings can be more painful, and have more
swelling. The best areas to treat are crow’s feet,
smoker’s lines, below the eyes, neck, chest
and hands. Cost ranges between $200-500 per
treatment session.

Abdomen, hips, thighs

What to do: TiteFX from Body Tite, targets fat, cellulite and loose skin.

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

Before NEW WAY TO SAY “WRINKLES BE GONE” After

Treatment Diminishes Wrinkles, Scars and Discolorations

Aesthetician and skin care specialist Annette Pennington answers questions about Invasix’ new Fractora and
Fractora Firm treatments, which are creating successful results for patients through a smoother process than
previously available. Perhaps the best part is that there is no daunting recovering time involved.

Q: What are some of the newer
ways to tackle areas that demon-
strate fine or deep wrinkles, scars or
discolored red and brown skin tone?
A: There are now two wonderful
non-invasive treatments for rejuve-
nation, introduced by Invasix. They
are Fractora and Fractora Firm.
Q: What is Fractora and how does it
work?
A: Fractora is a versatile skin resur-
facing treatment providing superior
skin improvements by fractionally
ablating the skin (using tiny ”micro-
points”) and restructuring the
deeper tissue using bipolar radio
frequency. The rF energy is released
into the skin using an array of pin
electrodes, creating zones of
ablation, coagulation and heat. The
gentle heating promotes collagen
restructuring for a deep treatment
effect. The combination of ablation
and deep heat can provide dramatic
improvement of fine and deep lines,
skin tone and texture, as well as skin
tightening and the reduction of red
and brown spots
Fractora Firm uses rF to provide
optimal skin contraction (tightening)
in the deep layers of the skin. radio
frequency energy will stimulate the
new formation of collagen and
elastin, causing lifting, tightening and
an overall improved appearance.
Q: What are the most common areas of
treatment with Fractora?
A: The most common areas to treat
30 • IMAGE • DECEMBER 2013 / JANUARY 2014
are cheeks, mouth, neck, smile
lines, forehead and upper and
lower eyelids.
Q: What are some of the benefits of
using Invasix treatments instead of
some of the other popular ones?
A: The use of fractionated energy
has been proven over the years to
vastly improve the appearance of
aging skin with minimal downtime.
Fractora treatments may be com-
bined with other treatments and
post- procedure care is minimal. It’s
just the use of moisturizer and sun-
screen! There are alternative meth-
ods of treatment, such as lasers,
CO2, IPL for skin rejuvenation, but, as
of today, there is no system on the
market that can address the variety
of issues that Fractora does.
Q: Is this medically-cleared?
A: Yes. It was FDA-approved in 2011.
Q: Who performs the treatments?
A: Specially-trained licensed profes-
sionals perform them.
Q: Are there any risks associated
with use of Invasix?
A: There are some possible side effects
that include local pain, skin redness,
swelling, and change in pigmentation.
These effects are rare and temporary.
Q: What would be the criteria that
a patient should meet in order for
Invasix use to be successful?
A: Patients must be age 18 or over and
cannot be pregnant or nursing. They
must not have a pacemaker or internal
defibrillator, impaired immune system,
severe cardiac disorders, uncontrolled
hypertension, liver or kidney disease.
They cannot have used Accutane for
six months prior to treatment, or have
used superficial injection of Botox or
fillers two weeks prior to treatment.
Q: How long does the treatment
take, and how much downtime is in-
volved?
A: The treatment involves a few ses-
sions (one to five) a few weeks apart
(three to six). Downtime is minimal.
Tiny scabs may appear on the face for
a few days, however make-up may be
applied as soon as one to three days
after a session.
Q: How long do the benefits last? Is
there a way to maintain the benefits
for as long as possible?
A: Treatment is concluded when the
results are satisfactory to the patient,
or according to the physician’s
discretion. One treatment every one to
three months will maintain the
treatment results. IMAGE
______________________________
Annette Pennington is the aesthetician
and skin care specialist at Aesthetic
Plastic Surgery, P.C. in great Neck. She
works in conjunction with plastic
surgeons Dr. Randall Feingold, Dr. Ron
Israeli, Dr. Peter Korn and Dr. David
Light. For more information, call
516-498-8400 or visit
www.aestheticplasticsurgerypc.com.
WWW.IMAGEMAGONLINE.COM
FRACTORA Restore &
TM

Rejuvenate
FRACTIONAL SKIN TREATMENT Your Skin

“ Itto has brought a restorative look

my skin and I feel really good.
I have achieved that youthful glow
that I was hoping to get, and I’m
“
really happy.
RUTH, FRACTORA CLIENT

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

DISCOVER A SUPERIOR SOLUTION TO DECREASE

WRINKLES, IMPROVE SKIN COMPLEXION, REDUCE
SKIN IRREGULARITIES AND PROVIDE A HEALTHIER,
FRACTORA
TM

YOUNGER LOOKING YOU - ALL IN ONE SESSION by

Please speak to your aesthetic provider to see if you are candidate for Fractora.
VFRPO041014
FORMA Discover
TM

Younger
THERMAL CONTRACTION Acting Skin

“ My Forma treatments improved

the look of my face without any pain
or downtime. It is a great alternative
to expensive invasive procedures. “
I love the way my new face looks.
JANE, FORMA CLIENT

Before After
Dr. S. Mulholland

Before After
Dr. A. Nelson

Before After
Dr. S. Mulholland

IMPROVE THE SKIN’S OVERALL

APPEARANCE WITH SMOOTHER
SKIN AND A MORE RADIANT GLOW.
FORMA
TM

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

Photo courtesy: Dr. J. Shaoul

A SAFE AND COMFORTABLE NON-SURGICAL SOLUTION TO REFINE

AND REVERSE THE LAXITY CAUSED BY AGING SKIN.

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

“ II would definitely recommend Lumecca.

like how it brightened my face and
gave me a beatuiful glow. I can really see
“
a difference.
PAMELA, FRACTORA CLIENT

Before After

Before After

Before After

Before After

Before After

Photo Courtesy: Dr. S. Mulholland

DISCOVER A SUPERIOR SOLUTION TO IMPROVE SKIN

COMPLEXION, REDUCE SKIN IRREGULARITIES AND
LOOK YEARS YOUNGER .

Please speak to your aesthetic provider to see if you are candidate for Lumecca.
VLUPO11213
BodyFX Smooth
TM

& Sexy Body

NON-INVASIVE CONTOURING Reshaping
& CELLULITE TREATMENT

“ 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

DISCOVER A SUPERIOR SOLUTION TO IMPROVE THE APPEARANCE

OF CELLULITE, REDUCE DIMPLED SKIN, LOSS OF ELASTICITY
ON THE ABDOMEN, LOVE HANDLES, HIPS, THIGHS
BodyFX
TM

AND OTHER AREAS THAT REQUIRE FAT REDUCTION. by

Please speak to your aesthetic provider to see if you are a candidate for BodyFX.
www.inmodemd.com VBFPO11113