BodyTite(TM) Presentation

Deutschland - Distribution

i-CosMed Ltd & Co.KG
Schloßstrasse 14
D-82031 Grünwald
Fon: +49-(0)89-37 41 21 72
Fax: +49-(0)89-430 21 69
www.icosmed.de

featuring RFAL™ Technology

A new approach to minimally
invasive aesthetic surgery

Presenter:


Who is Invasix?
• Privately held Israeli company - www.invasix.com
• Dedicated to minimally invasive technologies through the
development of innovative body contouring device,
– facial technology in R&D
• World wide distribution with dedicated offices in North America,
Asia Pacific and Europe
• ISO, CE approved, FDA pending
• Dedicated and growing North American service structure
• Experienced and seasoned management team with ESC, Lumenis,
Syneron and Sciton experience


The Body Contouring Market
• 350,000 liposuctions performed by plastics
• Total estimated number of procedures is close
to 1,000,000 in US
• Representing 4% of all elective surgeries


Why The Growth?
Obesity Trends in USA:

In 1990 not a single state had a BMI over 15%
By 2007 two-thirds of US had BMI over 25%

Statistics Courtesy Center of Disease Control


Why The Growth?
In the last 40 years …
The average American man has The average American woman has
a 5 inch increase in waist size a 7 inch increase in waist size
(now 40 inches). (now 37 inches).

Statistics Courtesy American Heart Association


The Growth of Liposuction
• Estimated body contouring market will double
in the next 4 years
• Significant part of growth due to Energy
Assisted Liposuction market
• Growth will be driven by liposuction
technologies perceived as being gentle, out-
patient and proven to induce contraction


Liposuction Popularity


Available Liposuction Options:
• Traditional Liposuction
– Requires hard work
– No blood vessel coagulation
– Little to no skin tightening
• WAL (Water Assisted Liposuction)
– Less bleeding and trauma than SAL, been available 5 years
– Little or no skin tightening
• UAL (Ultrasound Assisted Liposuction)
– Good for fibrotic tissue
– Requires separate aspiration
– No blood vessel coagulation Now …. RFAL
• PAL (Power Assisted Liposuction)
– Fast treatment
– Very aggressive and no blood vessel coagulation
• LAL (Laser Assisted Liposuction)
– Slow treatment – requires separate aspiration
– Has tightening effect
– Blood vessel coagulation


Procedure Benefits
• Speed
• Less bleeding
• Monitoring and Safety
• Thermal uniformity

An ideal
Liposuction Immediate Post-treatment Benefits

solution • Less pain
• Less swelling

should • Less bruising

address the
following: Long-term Objectives
• Uniform re-contouring
• Soft-tissue contraction & Tightening


Ideal Liposuction Criteria
Physiological/Medical Criteria:
1. Coagulate vessels = less bruising
2. Liquefy fat = gentle extraction = less swelling
3. Skin contraction
4. Uniform body contouring
5. Continuous thermal monitoring & safety
6. Treat individuals with larger BMI


Ideal Liposuction Criteria
Economic Criteria:
1. Perform under local anesthesia
2. Side office procedure
3. Treat a variety of treatment zones/sizes
4. Speed; one stage coagulation & aspiration


BodyTite System RFAL Specifications
• 75W RF output system
• Treatment depth control from 5mm to
50mm
• Real time skin temperature monitoring
• Real time power and tissue impedance
monitoring
• Tip anti-carbonization control
• Directional energy delivery
• Low weight – 10 kg
• Small footprint – 30 X 30 X 100 cm


RFAL Technology
• Radio Frequency Assisted Liposuction
• Heating the skin by the RF current which flows from the
internal to the external electrode placed on the skin above
the internal electrode.


Internal Electrode = Cannula
• Internal electrode is also a cannula
• For simultaneous coagulation & aspiration
• One Stage coagulation and aspiration
• Unprecedented speed, uniformity & safety


BodyTite Handpiece
Controlled Depth of
Penetration

5mm extension

RF External Electrode

RF Internal Electrode
Coagulation of Adipose, Vascular and Fibrous Tissue 50mm extension
AND ASPIRATES = ONLY FAST ONE STAGE TECHNOLOGY


Thermal Directionality and Uniformity


Thermal Profile Computer Simulation

External electrode

Internal electrode


Comparison with Laser Assisted Liposuction
• RF Assisted Liposuction (RFAL) & LipoTightening
– Better localization and concentration of energy
– Uniform heating
– Exponential thermal zone size
– Safe RF enabled tightening of skin
RF Laser

Skin

Fat

Muscle


Comparison with Laser Assisted Liposuction

RFAL LAL


< Click image to start animation >

BodyTite Physiological Effect


RFAL Features & Benefits
Sophisticated Handpiece
• Treatment depth adjustment
• Directional and controlled RF
• Constant monitoring & safety feedback
control
• Simultaneous aspiration-coagulation
handpiece
• Aspiration speed greater than traditional
liposuction


Speed of Treatment:
• Sample area of 5x5cm and thickness of 20mm with initial
temperature of 26oC were treated at depth of 10mm until skin
surface was heated uniformly up to 42oC. Power of 50W was
used.
• Measured treatment time was 37sec representing treatment
speed of 1.5 sec/cm2.
• Typical site 25x25cm can be treated during about 10min.
• SmartLipo MPX requires more than hour to treat identical area
• Faster at higher wattages


RFAL vs SAL Aspiration Speed
RFAL SAL
Cannula Size 3.7mm aspirating 3.7mm blunt nose
cannula Mercedes cannula
Aspirated in 490 ml (23.3 ml/min) 440 ml (20.9 ml/min)
21 minutes

Conclusions:
• RFAL12% faster aspiration than SAL
• RFAL visibly less hematocrit than SAL
• RFAL has visible liquification of the
aspirated fat vs SAL more lobular fat SAL
aggregates
RFAL


Skin Temperature Monitoring & Limit Control
• A sensor embedded in the handpiece provides real time surface
temperature; only device to monitor epidermal temperature
• Temperature cut-off above an adjustable target level and energy is
automatically reactivated when the hand piece/temperature falls
below the cut-off level
• This closed-loop feedback avoids overtreatment and thermal hot
spots to ensure a safe and uniform treatment.
• Allows operator to maintain
target temp at any give location


Impedance Monitoring
• Contact Impedance:
– Energy cut off if one of the electrodes does not have contact
with the skin’s surface or is too close to the skin’s surface
• Anti-Carbonization Protection:
– Automatically cuts off energy during treatment if carbonization
builds on the internal electrode.


Audible Feedback
• For both temperature measurements and impedance feedback
• Physicians can focus on treatment
• Audible monitors sound when approaching and then achieved
target temp
• Impedance errors (too close or too far) sound as well


User Friendly Interface

50 W


Quantified Comparison of Heating Uniformity
RFAL LAL

LAL RFAL
35
30
Researcher 2.9 software was
25
used for thermal images
% of total
20
quantiattive analysis 15
10
5
0
23,5 26 28,5 31 33,5 36 38,5 41 43,5 46 48,5 51
Temperature, oC


Larger treatment
area uniformity

LAL RFAL

35
30
25
% of total

20
15
10
5
0
23,5 26 28,5 31 33,5 36 38,5 41 43,5 46 48,5 51
Temperature, oC


Uniformity of RFAL

Flir A320 Thermal Camera Flir A320 Thermal Camera


Histological Study

Untreated fat.

Fat after SAL/ PAL treatment. Adipose tissue
is separated to clusters. Space between
adipocytes is filled with hemoglobin.

Fat after RFAL treatment. Channel in the fat
is observed. Fat cells are disrupted around
the channel.


Histological Study

Blood vessel coagulated after RFAL treatment

Untreated collagen

Collagen after RFAL treatment


Sp
Blood Vessel Coagulation with RFAL


Vessel Coagulation


Blood Vessel Coagulation

Untreated Fat LAL Treated Fat RFAL Treated Fat


No bleeding in
fat area

normal bleeding
in sub-dermal
area


Blood Vessel Coagulation Histology
• RF coagulates vessels


RFAL Coagulative Effect
• RFAL followed by PAL faster than PAL alone
• Lower Hematocrit in Aspirate than SAL/PAL
• Higher Lipocrit in Aspirate than SAL/PAL

SA RFAL
L


Adipose Tissues Coagulation
• Adipose liquefaction = gentle extraction
• Reduced extraction forces
• Less edema, less pain

SA RFAL
L


Sp
Skin Contraction with RFAL


RFAL Skin Contraction

Normal Untreated Collagen

RFAL Treated Collagen
Denaturization


20-30% More Contraction @ 3-6 mons


RFAL Skin Contraction
Sub Dermal RFAL Contraction

+
Fibrous Septae Contraction

=
X, Y, Z Soft Tissue Contraction


Pre-Abdominalplasty Patient

CONTROL

Patient was treated with three technologies, Smartlipo MPX 46W,
BodyTite 50W and BodyTite 75W


BodyTite Effects

Before

After


Immediate Contraction
Before -70mm After tumescent – 82mm

After RF but prior suction – 70mm


Analysis of Tightening Results

Photo Courtesy: Stephen Mulholland MD
21% vertical contraction



10.3% vertical contraction



10% vertical contraction


Summary of Skin Contraction
• SAL/UAL maximum linear contraction of 5% reported (11% surface
contraction)
• LAL 8% linear corresponding to 17% area contraction verified
• Initial RFAL skin contraction studies show:
• - linear 14%-40%
• - area contraction 24%-60% for high volume patient
• - depending on treated volume and energy deposited
• RFAL is about twice more effective on skin contraction than LAL
• Objective 3D Vector Analysis in progress


Physician Testimonial: Skin Contraction
“For skin tightening, nothing other than BodyTite really works. With
competing systems, you may attain as much as 10% improvement in skin
tightening. But BodyTite truly causes skin contraction, if used correctly.
With BodyTite, you can actually measure skin contraction. With one
treatment, I am seeing up to 40% skin retraction.”

“Every single patient of mine has been ecstatically happy with treatment.”

--- Dr. Diane Duncan, Fort Collins CO


Physician Testimonial
“I consider BodyTite the next-generation in non-excisional skin-tightening
devices – more evolutionary than revolutionary. … The ability to modulate the
skin surface temperature is better than any other system on the market.”

“This should be an easy procedure to market to patients because I feel it fills a
need. We’ll be able to achieve more skin tightening in a lipo patient with loose
skin compared to other existing modalities. These patients may no longer
require a tummy tuck. Plus, practices should be able to charge a premium for
that benefit.”

--- Dr. Jason Pozner, Boca Raton FL


Physician Testimonial
This morning I saw this 35 year old 5' 4" 150 pound woman 2 weeks after her
limited abdominoplasty and RF abdominal liposuction as marked. She has no
pain and no problem healing and I feel an incredible early result not
previously achievable by any means.
-- Dr. Dennis Hurwitz, Pittsburgh PA


IRB Clinical Sites
Multiple centered IRB clinical site
• Malcolm Paul, USA
• Diane Duncan, USA
• Dennis Hurwitz, USA
• Gerald Pitman, USA
• Roy Geronomous & Lori Brightman, USA
• Stephen Mulholland, Canada
• Guillermo Blugerman, Argentina

Overall results show uniformity, consistency
and safe results.


Sp
Before and After Photos


Massive Weight Loss: Dr. Hurwitz

Before & 6 Weeks After

Photo Courtesy: Dennis Hurwitz, MD
Absolute waist circumferential contraction of 9cm (118-109=9cm)



Patient: Analysis of Tightening Results


Before & After

Hips, Flanks and Abdomen Treatment


Before & After

Post Mummy Tummy – Mother of 9 and 4 year old


Before & 3 mos After – 28F

Photo Courtesy: Guillermo Blugerman, MD
Weight 133 lbs; Cir. 83 cm Weight 122 lbs; Cir. 71 cm


Before & 3mos After – 28F



Before & After


Before & 3mos After – 20M

Weight 178 lbs ; Cir. 105 cm Weight 172 lbs; Cir. 100 cm


Before & After – 58F

Inner & Outer Thigh, Hips & Abdomen Treatment with Cellulite Reduction


Before & After – 34F

Inner & Outer Thigh, Bra Line, Hips, Buttocks & Abdomen Treatment


Before & After

Abdomen Treatment



Arm treatment showing significant skin contraction.



Before & 6W After – 57F

Inner & Outer Thigh Treatment with Cellulite Reduction


Before & After

Flank and Back Treatment


Before & 3mos After

Photo Courtesy: Malcolm Paul, MD
Abdomen Treatment


Before & After

Photo Courtesy: Malcolm Paul, MD
Back and Abdomen Treatment


Before & After


Patient Testimonial
“My results are amazing! BodyTite has totally re-contoured my figure and
changed my body type completely. It feels like my skin has tightened and
formed back to my body and I can see I don’t have saggy skin or rolls
anymore. Three years after having my baby, I feel like I have a new body
image and my shape back.”

“I was treated a month ago and already I feel more active and lighter, with a
much better figure. I am a new person with a totally new shape and outlook
about my body image.”

“During and after my treatment I never felt any pain. I would describe it as a
general soreness, but not painful at all.”

L.M., 24 years
Areas Treated: Hips, flanks, bra line (wants abdomen next)
Profile: Single mother of 3 year old child


Marketing
• Liposuction is a big market ($341,144 procedures performed by
ASAPS members in 2008)
• Consumers are losing interest in traditional liposuction (down 25%
since 2007) in the same time, Energy Assisted Liposuction market is
booming and overall body contouring market is growing
• Consumes are demanding
- skin contraction
- less bruising, pain, etc
- out-patient
• To maintain practice growth physicians need to incorporate Energy
Assisted Liposuction
Statistics courtesy ASAPS


Marketing Materials
Patient Education Direct Mail
Brochure Postcard

And More:
•Patient Education Flip Book
•Advertising Templates
•Table Top Display
•Posters
•Consumer Website


BodyTite ROI Benefits:
• Increased market demand
• Adds new patients in your practice interested in a gentle, less
downtime procedure
• New patients who are not ready for excisional procedures but
interested in RFAL contraction
• Treat multiple zones achieving coagulation and contraction faster
than SAL , UAL, LAL
• Safest most reliable way of achieving thermal treatment
• More patient candidates (high BMI, loose skin, previous
liposuction)
• Side-office and local anesthesia to reduce overhead
• between $1500-$4000 facility/staffing in cost savings


BodyTite Competitive Advantages
Ergonomic design Fully Controlled Procedure
• Small foot print • Skin temperature monitoring
• Light weight • Anti-carbonization
• Simple use monitoring
• Intuitive interface • Controlled penetration depth
Most advanced technology • Skin contact monitoring
• Higher power • Output power monitoring
• Faster treatment • Skin impedance monitoring
• Single Stage
• Uniform heating
• Directional heating
• Lipolysis/Tightening/Coagulatio
n
• BEST in class Skin Contraction


Thank you

Questions?
Please Call - +49-89-37412172

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