london ultrashape 2008

UltraShape®

the evidence

Internationally How big is the problem?

SURGICAL +118% in 7 years

NON-SURGICAL +763% in 7 years

Recent explosion of non-surgical devices

Non-SURGICAL

• Continue to grow quicker than surgical

• >4 x more common than surgical

– (ASAPS - USA 2004 12 million cosmetic

procedures - 2,1 Surgical and 9,7 nonsurgical)

• No or limited downtime

• High patient acceptance

Surgical procedures are objective with previous defined parameters. Minimal outlayIf done in hospital type setting

Problem… this has long downtime, higher morbidity and less patient acceptance

Key to success in any cosmetic procedure

…. a well informed patient with realistic expectations

… to be able to inform patients correctly we have to know the potentials and limitations of a non surgical aesthetic procedure. Thus carefully controlled and monitored studies are needed regarding UltraShape…

UltraShape®The clinical evidence

UltraShape® Multi-Center Controlled Clinical Trial Single-Treatment S.Teitelbaum (U.S.), J.Burns (U.S.), J.Otto (England), J.Kubota (Japan), Y.Shirakabe (Japan), S. Brown (U.S.) Enrolled: 164 Patients

Treated: Single treatment: abdomen, flanks, and thighs

Endpoint: Circumference reduction (standardized measuring

system) Fat thickness (ultrasonography-constant

pressure device)

Safety: Blood and urine analysis (including lipid profile),

liver ultrasound, pulse oximetry, 2-point

discrimination

Controls: Untreated control group

Internal controls: thigh circumference & weightTeitelbaum et al. PRS ‘07

Single treatment reduced circumference by 2 cm on avg.

Multi-Center Controlled Clinical Trial Multi-Center Controlled Clinical Trial UltraShapeUltraShape®® Single-Treatment Single-Treatment

Teitelbaum et al. PRS

Significant reduction in treatment area vs. internal control area

Multi-Center Controlled Clinical Trial Multi-Center Controlled Clinical Trial UltraShapeUltraShape®® Single-Treatment Single-Treatment

Teitelbaum et al. PRS

No significant weight change

Multi-Center Controlled Clinical Multi-Center Controlled Clinical Trial Trial UltraShapeUltraShape®® Single-Treatment Single-Treatment

Teitelbaum et al. PRS

Study Study Results

Pulse oximetry Normal

Liver ultrasound No treatment-induced change

Two-point discrimination No clinically significant change

UltraShape® Multi-Center Controlled Clinical Trial Single-Treatment

Teitelbaum et al. PRS

Efficacy82% demonstrated measurable circumference reduction 2.0 cm avg. reduction at 84 days (P value <0.01)

SafetyNo clinically significant elevation in lipid profilesNo clinically significant changes in blood or urine tests, liver ultrasoundNo serious adverse events

Patient Satisfaction 76% rated moderate-to-excellent satisfaction with single Rx 92% reported no pain or discomfort96% reported treatment time was acceptable

Teitelbaum et al. PRS ‘07

Multi-Center Controlled Clinical Trial UltraShape® Single-Treatment

Courtesy of Dr. S. Teitelbaum, Santa Monica, CA

UltraShape® Single-Treatment Results

Lower Abdomen

Pre-Treatment Post Treatment

Reduction 3.5 cm 3.5 cm

Courtesy of Dr. Jacques Otto, London, England

UltraShape® Single-Treatment Results

Lateral Thighs

Pre-Treatment 28 Days Post Treatment

Reduction 4.0 cm 4.0 cm

Position until 2005Available Information– Multi center study– Single treatment only– Subjects BMI = 26.5– Safety (blood test, urinalysis, liverultrasonography, skin and fat evaluation etc..)– Circumference reduction• Gaps– No data regarding multiple treatments– Insufficient data regarding patient satisfaction

SCANDINAVIAN AKADEMIKLINIKEN Study

2006 Per Hedén MD, PhD Chairman, Ass. Professor in Plastic SurgeryStockholm, Sweden - London, UK, - Copenhagen, Denmark - Oslo, Norway

Primary:To establish the safety and the efficacy of theUltraShape Contour I system multiple treatmentregimen.SecondaryTo evaluate the subjects tolerance and satisfactionrate to the Contour I multiple treatmentsTo evaluate the additive affect of multiple

treatmentsby the Contour I system

Scandinavian Study Design • Healthy Subjects• Age 18-45• Fat thickness of at least 2.5 cm prior 1sttreatment• Hairless Skin (or willing to shave prior thetreatment)• Commitment to adhere to the study

timeline

Exclusion Criterion • Pregnancy• Cardiac pacemaker//defibrillators• Skin diseases• Fat-soluble drug regimen within the last 30

days• History of blood coagulation problems• Depressed scars within the treatment area

Study Timelines • 24 Subjects• Three (3) treatment sessions, one month apart• Treatment area – abdomen• BMI normal – mostly deformations//bulges• FU period – every 2 weeks (Weeks 0, 2, 4, 6, 8,

10,12)• Last visit – 3 months after the last treatment

(week20)

Outcome parameters Safety Parameters• Adverse Events• Skin and fat evaluation• Pain during or following the treatmentsEfficacy Parameters• Circumference reduction• Photos• Patient satisfaction questionnaires (prior 1sttreatment and at weeks 4, 8, 12 and 20)

Measuring Parameters

UltraShape™

Non-invasive Lipolysis Using UltraShape™ Focused Ultrasound Ascher B, Paris, France

American Society for Aesthetic Plastic Surgery (2007) International Masters Course of Aging Skin (2007)

130 patients: abdomen, flanks, thighs 3 Treatments @ 30 day intervals 92% experienced measurable circumference reduction 73% 2-7cm circumference reduction Well tolerated with no patient related serious adverse events

• 1 blister, no sequela 88% rated moderate-to-very good satisfaction

Photos courtesy of Dr. Benjamin Ascher, Paris

Pre-Treatment 3 months Post Treatment

Reduction 5.0 cmWeight change -1.0 kg

Abdomen

UltraShape™ Three Treatment Results

“Lipotripsy” Non-invasive Ultrasonic Selective Destruction of Adipocytes using UltraShape™ Focused Ultrasound” Leal-Silva H, Monterrey, Mexico

American Society of Dermatologic Surgeons (2007) World Congress of Dermatology (2007)

36 patients: abdomen, flanks, thighs 3 Treatments @ 30 day intervals

100% experienced measurable circumference reduction 2 inch (5 cm) average reduction in body circumference CT scans (n=6) showed objective quantifiable fat thickness

reduction in 100% of cases No adverse events 94% rated satisfied-to-excellent satisfaction

BaselineTreated Area: AbdomenCircumference measure: 97.0 cmWeight 63.8 Kg

1 Mo FU after 3 TxTreated Area: AbdomenCircumference measure: 92.5 cmWeight 61.9 Kg

Circumference Reduction: 4.5 cm

Courtesy of Hector Leal-Silva, MD Monterrey, Mexico

Three Treatment Results

BaselineTreated Area: AbdomenFat Layer Thick: 4.9 cm

After 1 Tx Treated Area: AbdomenFat Layer Thick: 4.5 cm

Fat Thickness Reduction: .4 cm

Courtesy of Hector Leal-Silva, MD Monterrey, Mexico

One Treatment Results

BaselineTreated Area: AbdomenFat Layer Thick: 4.9 cm

After 2 Tx Treated Area: AbdomenFat Layer Thick: 4.2 cm

Fat Thickness Reduction: .7 cm

Courtesy of Hector Leal-Silva, MD Monterrey, Mexico

Two Treatment Results

1 Mo FU after 3 TxTreated Area: AbdomenFat Layer Thick: 3.8 cm

BaselineTreated Area: AbdomenFat Layer Thick: 4.9 cm

Circumference Reduction: 4.5 cmFat Thickness Reduction: 1.1 cm

Courtesy of Hector Leal-Silva, MD Monterrey, Mexico

Three Treatment Results

Personal Clinical Experience

July 2005 - October 2007500+ Patient Treatments

London Bridge Plastic Surgery

Three Treatment Results – All Sites

After Three Treatments

-8

-7

-6

-5

-4

-3

-2

-1

0

Treat 1 Treat 2 Treat 3

All Sites

-7.5 cm

Treatment ResultsCircumference reduction (mean)

Abdomen 8.5 cmLateral thighs 5.2 cmHips 4.5 cm

Average 6.3 cm

Photos courtesy of Dr. Chris Inglefield, London, UK

Abdomen

Pre-Treatment 1 month Post Treatment

UltraShape™ Single-Treatment Results

Reduction 4.5 cm 4.5 cm

Photos courtesy of Dr. Chris Inglefield, London, UK

Abdomen

Pre-Treatment 1 month Post Treatment

UltraShape™ Single-Treatment Results

Reduction 1.8 cm 1.8 cm

Photos courtesy of Dr. Chris Inglefield, London, UK

Lower Abdomen

Pre-Treatment Post Treatment

UltraShape™ Two Treatment Results

Reduction 5.6 cm 5.6 cm

Photos courtesy of Dr. Chris Inglefield, London, UK

Lower Abdomen and Flanks

Pre-Treatment Post Treatment

UltraShape™ Two Treatment Results

Reduction 4.5 cm 4.5 cm

Photos courtesy of Dr. Chris Inglefield, London, UK

Pre-Treatment 1-month Post Treatment

Reduction 6.7 cm 6.7 cm

Lower Abdomen

UltraShape™ Three Treatment Results

UltraShapeUltraShape®® CONTOUR 2 CONTOUR 2

New Illumination system: Video camera integrated into the

system Optimal illumination of treatment

zone Improved tracking Software controlled camera and

illumination systems

LED based technology Softer light for superior working

environment

State of the art design

UltraShapeUltraShape®® CONTOUR 2CONTOUR 2

Patient Info Screen

(Data Base)

Zebra Cross

(Determining the Shape of the

Treatment Area)

Selection of Boundaries of the Treatment Area

Once area is detected, the

number of nodes is

displayed

Markers Selection

Treatment

Blue indicates overlap of target and

the center of the transducer;

White X indicates good acoustic

contact

New Software and GUI

Patient positioning is important for:

Stability of the tracking system

Maintaining a flat treatment area. This allows full

transducer contact and assures ideal acoustic contact

Minimizing the interaction with adjacent bony areas

Lowering the probability of adverse events

Patient Positioning

CONFIDENTIALCONFIDENTIAL

Taping

To “re-gather” the fat into a

central treatment area, surgical

tape may be used to lift and

gather the tissue

Flank Area (small):

Position the patient so that he/she is lying on their side (lateral)

In order to improve treatment conditions, place a pillow underneath the other flank so that it will push the flank to be treated up to the same height as the pelvis

For the comfort of the patient, place an additional pillow between the patient's legs

Patient Positioning

CONFIDENTIALCONFIDENTIAL

Patient Positioning

Thigh Area:Patient in “frog”

position; customized pillows for better positioning

CONFIDENTIALCONFIDENTIAL

Teitelbaum et al. PRS

Blood and urine analysis performed: days 0, 1, 3, 7, 14, 21, 28, 56, and 84 post treatment

Lab Study Study Results

CBC No clinically significant changes

PT, PTT, INR No clinically significant changes

Electrolytes, BUN/Cr No clinically significant changes

LFT’s, Bilirubin, Albumin No clinically significant changes

Serum Lipids No clinically significant changes

CPK, calcium No clinically significant changes

Urinalysis No clinically significant changes

UltraShapeUltraShape®® Multi-Center Controlled Clinical Trial Multi-Center Controlled Clinical Trial Single-Single-

TreatmentTreatment