BodyTite™ of Invasix - Presentation

featuring RFAL™ Technology

Deutschland - Distribution

i-CosMed Ltd & Co.KGSchloßstrasse 14

D-82031 GrünwaldFon: +49-(0)89-37 41 21 72Fax: +49-(0)89-430 21 69

www.icosmed.de


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?

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

Obesity Trends in USA:


Why The Growth?

The average American man has a 5 inch increase in waist size (now 40 inches).

Statistics Courtesy American Heart Association

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


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– Little to no skin tightening

• PAL (Power Assisted Liposuction)– Fast treatment– Very aggressive and no blood vessel coagulation– Little to no skin tightening

• LAL (Laser Assisted Liposuction)– Slow treatment – requires separate aspiration– Has tightening effect– Blood vessel coagulation

Now …. RFAL


An ideal Liposuction

solution should

address the following:

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

Immediate Post-treatment Benefits• Less pain• Less swelling• Less bruising

Long-term Objectives•Uniform re-contouring• Soft-tissue contraction & Tightening


Ideal Liposuction Criteria

Physiological/Medical Criteria:1. Coagulate vessels = less bruising2. Liquefy fat = gentle extraction = less swelling3. Skin contraction4. Uniform body contouring5. Continuous thermal monitoring & safety6. Treat individuals with larger BMI


Ideal Liposuction Criteria

Economic Criteria:1. Perform under local anesthesia2. Side office procedure3. Treat a variety of treatment zones/sizes4. 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

RF Internal ElectrodeCoagulation of Adipose, Vascular and Fibrous TissueAND ASPIRATES = ONLY FAST ONE STAGE TECHNOLOGY

RF External Electrode

Controlled Depth of Penetration

5mm extension

50mm extension


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

Fat

Muscle

Skin

RF Laser


Comparison with Laser Assisted Liposuction

RFAL LAL


BodyTite Physiological Effect< Click image to start animation >


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


RFAL Features & BenefitsSpeed 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 SpeedRFAL SAL

Cannula Size 3.7mm aspirating cannula

3.7mm blunt nose Mercedes cannula

Aspirated in 21 minutes

490 ml (23.3 ml/min) 440 ml (20.9 ml/min)

RFAL

SAL

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 aggregates


RFAL Features & BenefitsSkin 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

0

5

10

15

20

25

30

35

23,5 26 28,5 31 33,5 36 38,5 41 43,5 46 48,5 51

% o

f tot

al

Temperature, oC

LAL RFAL

Researcher 2.9 software was used for thermal images quantiattive analysis

RFAL LAL


0

5

10

15

20

25

30

35

23,5 26 28,5 31 33,5 36 38,5 41 43,5 46 48,5 51

% o

f tot

al

Temperature, oC

LAL RFAL

Larger treatment area uniformity


Uniformity of RFAL

Flir A320 Thermal CameraFlir A320 Thermal Camera


Histological Study

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

Untreated fat.

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


Histological Study

Collagen after RFAL treatment

Blood vessel coagulated after RFAL treatment

Untreated collagen


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

RFALSAL


Adipose Tissues Coagulation

• Adipose liquefaction = gentle extraction

• Reduced extraction forces

• Less edema, less pain

RFALSAL


Sp

Skin Contraction with RFAL


RFAL Skin Contraction

Normal Untreated Collagen

RFAL Treated CollagenDenaturization


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


Before

After

BodyTite Effects


Immediate ContractionBefore -70mm After tumescent – 82mm

After RF but prior suction – 70mm


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o C

ourt

esy:

Ste

phen

Mul

holla

nd M

D

21% vertical contraction

Analysis of Tightening Results


10.3% vertical contraction


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nd M

D


10% vertical contraction


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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


“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

Physician Testimonial


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


Before & 6 Weeks After

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enni

s H

urw

itz,

MD

Absolute waist circumferential contraction of 9cm (118-109=9cm)

Massive Weight Loss: Dr. Hurwitz



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MD



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Patient: Analysis of Tightening Results


Before & After

Hips, Flanks and Abdomen Treatment

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esy:

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phen

Mul

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nd M

D


Before & After

Post Mummy Tummy – Mother of 9 and 4 year old

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Mul

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nd M

D


Before & 3 mos After – 28F

Weight 133 lbs; Cir. 83 cm Weight 122 lbs; Cir. 71 cm

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esy:

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llerm

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luge

rman

, MD


Before & 3mos After – 28F


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llerm

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luge

rman

, MD


Before & After

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Den

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, MD




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llerm

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, MD


Before & 3mos After – 20M

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

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esy:

Gui

llerm

o B

luge

rman

, MD


Before & After – 58F

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

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Ste

phen

Mul

holla

nd M

D


Before & After – 34F

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

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esy:

Ste

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Mul

holla

nd M

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Before & After

Abdomen Treatment

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Photo Courtesy: Guillermo Blugerman, MD

Arm treatment showing significant skin contraction.


Before & 6W After – 57F

Inner & Outer Thigh Treatment with Cellulite Reduction

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Ste

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Mul

holla

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Before & After

Flank and Back Treatment

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Before & After

Abdomen Treatment

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Before & After

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Den

nis

Hur

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, MD



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Den

nis

Hur

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, MD


Before & 3mos After

Abdomen Treatment

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Mal

colm

Pau

l, M

D


Before & After

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Mal

colm

Pau

l, M

D

Back and Abdomen Treatment




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Gui

llerm

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luge

rman

, MD


Before & After

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Gui

llerm

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luge

rman

, MD


“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 yearsAreas Treated: Hips, flanks, bra line (wants abdomen next)

Profile: Single mother of 3 year old child

Patient Testimonial


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

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

Direct MailPostcard

Patient Education Brochure


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 AdvantagesErgonomic design• Small foot print• Light weight• Simple use• Intuitive interface

Most advanced technology• Higher power• Faster treatment• Single Stage• Uniform heating• Directional heating• Lipolysis/Tightening/Coagulatio

n• BEST in class Skin Contraction

Fully Controlled Procedure• Skin temperature monitoring• Anti-carbonization

monitoring• Controlled penetration depth• Skin contact monitoring• Output power monitoring• Skin impedance monitoring


Thank you

Questions?Please Call - +49-89-37412172


Deutschland - Distribution

i-CosMed Ltd & Co.KGSchloßstrasse 14

D-82031 GrünwaldFon: +49-(0)89-37 41 21 72Fax: +49-(0)89-430 21 69

www.icosmed.de

BodyTite™ of Invasix - Presentation

Health & Medicine

Transcript of BodyTite™ of Invasix - Presentation