PB73051EN January 2010 PB73051EN VELASMOOTH PRO CLINICAL PRESENTATION

PB73051EN  Superficial plane: <15 mm from skin surface (this area includes dermal and sub-dermal zones) Subcutaneous Tissue Anatomy & Histology VelaSmoothPro II, LipoLite Liposuction LipoLite

PB73051EN Subcutaneous Tissue  A person’s body layout depends on:  Pattern of adipocytes distribution  Increased size of fat cells (hypertrophy)  Enlargement of the number of adipocytes (hyperplasia)  Fat-cell replication by postadipocytes  Eating and exercise habits  Poor lymphatic drainage  Major human fat depots- white adipose tissue Anatomy & Histology

PB73051EN Atrophic degeneration of the hypodermal and dermal zones:  Hypertrophic and hyperplasic changes of the fat cells  Poor blood flow and lymphatic drainage  Glycation of collagen and hypertrophic septae Resulting in  Favorable environment for fat cells having a relatively low metabolism  Cycle of atrophy leading to - Increased circumferences - Bumpy appearance (cellulite) What is the etiology?

PB73051EN  Fat cells swell and push skin upwards as septae are rigid  Blood and lymph vessels are compressed  Accumulation of intercellular fluids and physiological waste Cellulite and Circumference

PB73051EN Factors inducing Cellulite  Heredity  Hormones  Smoking  Lack of exercise  Poor diet  Physiological status

PB73051EN Classification of Cellulite  Class 1 :  No spontaneous dimpling  Pinch test positive for dimpling  Class 2 :  Spontaneous dimpling while standing  Class 3 :  Spontaneous dimpling while standing and lying (morbid obesity or menopausal)

PB73051EN Regulatory Clearance FDA, CE  The VelaSmoothPro II is indicated for:  Temporary reduction in the appearance of cellulite  Temporary reduction of thighs circumferences  Temporary improvement in the local blood circulation  Relief of minor muscle aches and spasms  Body contouring*  Additional treatment programs:  Post-liposuction treatment via circumferential reduction  Post-baby treatment via circumferential reduction Indications For Use * CE only

PB73051EN Features and Benefits

PB73051EN VelaSmoothPro Platform

PB73051EN What is VelaSmoothPro?  More powerful - RF energy increased by 75% to 35 Watts  Higher efficacy  Faster patient’s turnover  Disposable applicator Covers – ‘per patient’- Large: 16H / Small: 4H  Optimize treatment results  Eliminate cross contaminations  Improved quality and reliability  Higher patient comfort  Easier and more comfort for operation  Diagnostic Terminal  Better control of patients treatment protocol  Monitors device’s activity and performance  Intuitive feedback for user  Service diagnostics

PB73051EN The Technologies  Vacuum (Suction)  Infrared (IR)  Radiofrequency (bipolar RF)  Mechanical massage (Rollers)* *Large appl. only

PB73051EN Applicators Specifications Large Small Applicator  RF Power Up to 35WUp to 8W  IR electrical powerUp to 35WUp to 20W  Spot Size 40x40 mm30x30 mm  Penetration 5-20 mm  Wavelength nm (Broad Band IR)  Vacuum Pulsed mbar  Disposable covers16 hrs4 hrs

PB73051EN VelaSmoothPro Applicators  RF  IR  Vacuum  Massage (Rollers) - The Technology Large Small Applicator Applicator

PB73051EN VelaSmooth/ VelaSmoothPro VelaSmoothP ro VelaSmoot h Specs. Applicator 35W 20W RF electrical power Large 35W IR electrical power 420 mbar? Vacuum 16 hrs/10 hrs30 hrs/10 hrs Disposable covers/filters 8W RF electrical power Small 20W IR electrical power 340 mbar? Vacuum 4 hr/4 hr Alternate filter for every treatment 10 hrs (cover with filter) Disposable covers/filters +- Communicatio n Terminal +- Dual Connector

PB73051EN Small covers Large covers Bundle box 5 pack 5 pack 1 large 5pck+ 1 small 5pck Consumables

PB73051EN ButtonTreatment ModeDescription IR modeContinuous infrared light energy is applied RF modeRadio frequency current is applied Vacuum modePressing this button activates the vacuum pump Applicator cover indicators  Green LED: cover is operative and installed properly  Red LED: cover is expired or not installed properly Applicator’s operating panels

PB73051EN Communication Terminal :Communication Terminal Messages Ready – the applicator is connected, the treatment level configured, but the trigger is not yet pressed. Treatment - the applicator is connected, the treatment level configured, and the trigger is pressed. Not Available – the applicator is not connected. Also various Maintenance or Error messages will be displayed, these appear in the troubleshooting guide in User Manual.

PB73051EN  System Type – VelaSmoothPro  VelaSmoothPro - System S/N – the system's factory serial number.  LA/SA S/N – the Large applicator or Small applicator type and factory serial number.  LA/SA Working Hours – the total number of hours already performed by the connected Large or Small applicator.  Disposable Status – how much time remains to operate the disposable covers.  System Freq: 50 or 60 Hz – the system's electrical frequency Communication Terminal – info button

PB73051EN VelaSmooth Treatment Mechanism  Improved blood supply:  90% of vessels are compressed at normal atmospheric pressure  Applying negative pressure → vessel dilation and blood flow ↑↑  Vacuum also enables deeper penetration of RF  Fibroblast stimulation Vacuum Effects

PB73051EN VelaSmoothPro Treatment Mechanism  Mechanical massaging effect enhances drainage of trapped intercellular fluid to lymphatics Mechanical Effect of Rollers – Massage

PB73051EN  IR light heats the tissue down to the deep dermis  RF heats tissue down to the subcutis VelaSmoothPro Treatment Mechanism Deep Heating by IR + RF RF electrodes Lamp Infrared filter Parabolic reflector

PB73051EN Temperature, ˚C Viscosity of H 2 O, centipoises Diffusivity of O 2, cm 2 /s x x x10 -5 VelaSmoothPro Treatment Mechanism Heating Effect On Oxygen Diffusivity Heat increases oxygen diffusivity → delivering more oxygen from capillaries to fat cells Oxygen Diffusivity in Water

PB73051EN VelaSmoothPro Treatment Mechanism  Deep heat is produced by IR/RF in dermal blood vessels  → Oxygen dissociation from Oxy-Hb ↑↑  → Extravasation of nutrients and oxygen ↑↑  Fat metabolic reactions in fat cells ↑↑  Extended use of stored energy from fat cells (lipolysis) results in shrinkage of cells themselves The septae, and consequently the fat chambers, shrink  Stimulation of fibroblasts for collagen synthesis ↑↑  Collagen shrinkage for overall skin surface im provement Heating Effect On Metabolism

PB73051EN The science of Vela – Biological Model

PB73051EN Clinical Procedure  Proper patient selection  Aligning expectations  Pre-treatment :  Exfoliate the skin  Avoid anticoagulants if medical condition permits (advisable)  Shave hair (advisable)  Weigh patient, photograph and measure circumference  Define treated areas, and set treatment parameters Pre-Treatment

PB73051EN Clinical Procedure  Skin type I-VI  No medical contraindications to IR/RF/Vacuum treatment  Not recommended to treat:  Varicosity  BMI > 30  Marginal results with:  Obese patients  Patients with edema due to lymphatic drainage problem  Avoid thyroid area if there are thyroid pathologies Patient Selection

PB73051EN Clinical Procedure  Aligning expectations  Improvement – not elimination  Temporary results – maintenance is essential  Skin tightening by RF may occur  Not for excessive loose skin  Stretch marks may improve – not always  Diet and exercise may improve results – not essential  Weight gain may worsen results Patient Selection

PB73051EN Clinical Procedure Defining Treatment Areas Large:  Treatment area: thighs / buttocks / abdomen  Each area divided into strips  Each strip: ~30 cm long and as wide as the Large applicator Small:  Arms / calf / bra-line / flanks  Curved areas and localized fatty deposits  ~15x20 cm (large hand palm) Possible to combine Large and Small

PB73051EN Clinical Procedure Recommended Treatment Motions Backward & Forward Forward Circular Large Applicator  Work in motion to achieve best contact:  Backward & Forward/ Forward: preferred motion  Possible with Small  Circular, Zig-Zag: reinforcement motions Small Applicator  Stacks: preferred motion  Possible with Large, when movement and seal are difficult, Zig-Zag Stacks

PB73051EN Clinical Procedure  Applying the applicator:  In a perpendicular orientation to the skin  With slight pressure for good contact  10-20% overlap  Release trigger before lifting applicator from skin! Large Applicator& Small Applicator

PB73051EN Clinical Procedure Immediate response:  Persistent radiant heat (>40-42˚C) for at least 5-10 min  Can be felt ~5 mm above the skin or using IR thermometer  Erythema/edema accompany heating but are not the endpoint! Desired Endpoint Skin Surface 40˚C Dermal Skin 45˚C

PB73051EN Clinical Procedure Reaching end-point on an anatomical area:  Treat 1 strip repeatedly until endpoint  Move to adjacent strip and treat similarly  Reinforce: cross-hatched pass on all previous strips, following each new strip, to sustain heat Enhanced mode:  Step 1: reach endpoint in a certain anatomical area (~10 minutes)  Step 2: treat another anatomical area till endpoint (~10 minutes)  Step 3: return to first anatomical area (after ~10 minutes) and repeat procedure till reaching endpoint again Large Applicator Treatment Procedure

PB73051EN Clinical Procedure Reaching end-point on a small area:  Treat the whole area with “Stacking” (up to 15 pulses on each spot)  Reduce number of stacked pulses each successive pass* Enhanced mode:  Step 1: reach endpoint in a certain small area (~5 minutes)  Step 2: treat another area till endpoint (or wait) (~5 minutes)  Step 3: return to first anatomical area (after ~5 minutes) and repeat procedure till reaching endpoint again * According to patient tolerance and skin response Small Applicator Treatment Procedure

PB73051EN Desired TreatmentCellulite Improvement (Upper Hypodermis) Circumference Reduction (Deep Hypodermis) IR2-31 RF33 Vacuum* Treatment Parameters Recommended Parameters IR + Vacuum ≤ 5 (For Safety) For both applicators * * Vacuum levels may be reduced according to patient’s tolerance

PB73051EN Treatment Parameters IR  Reduce for deep treatment (to avoid superficial heating)  Reduce on very dark or tanned skin, or when stacking pulses RF  Set at highest level tolerated Vacuum  Gradually increase in subsequent sessions  Increase for deep treatment  Reduce on sensitive areas (e.g., inner-thigh), or on loose skin  Adjust according to skin response and patient tolerance Selecting And Adjusting

PB73051EN Clinical Procedure Long-term effect:  Circumference reduction improvement (before)  Cellulite improvement (later)  8-12 sessions Short-term effect:  Transient skin texture improvement – after each session

PB73051EN Clinical Protocol  Treatment protocol is individual:  8-12 sessions  Twice a week  Maintenance treatment: One maintenance treatment in the month following the initial series of VelasmoothPro treatments, followed by once in 2–3 months and then with decreasing frequency as needed.

PB73051EN Combination Treatments with Other Modalities  Alternate with mesotherapy (if same session- Vela first)  5 weeks with meso 1/w and Vela 2/w  Other protocols  Combined Vela with deoxycholate treatment  4 sessions 6 weeks apart  For circumference reduction only  4-6 weeks post liposuction for homogeneous healing

PB73051EN Patient Record

PB73051EN

Cellulite and Body Contouring Progressive Results

PB73051EN Before and After Photos Courtesy of J. Shaul, M.D. Post 10 Treatments

PB73051EN Before and After 7 days after 11 treatments BeforeAfter

PB73051EN Before and After 1 week post 4 treatments BeforeAfter

PB73051EN Body Contouring Photos courtesy of Gerald Boey, MD, Canada Post 8 treatmentsBefore

PB73051EN Cellulite Reduction Photos courtesy of Gerald Boey, M.D., Canada Post 7 treatmentsBefore

PB73051EN Skin Tightening via Body Contouring Photos courtesy of Moshe Lapidot, MD, Israel. Post 3 treatmentsBefore

PB73051EN Thank You & Good Luck PB73051EN