Powered by VDF™ Pulsed Focused Ultrasound
V3 by
THE ULTIMATE SOLUTION FOR NON-INVASIVE BODY SCULPTING
DELIVERING THE SYNERGY OF PULSED FOCUSED ULTRASOUND
AND VACUUM-ASSISTED RADIO FREQUENCY
FAT CELL DESTRUCTIONINSTANT • SELECTIVE • PERMANENT
About UltraShape UltraShape redefines aesthetic medicine by developing, manufacturing and marketing innovative non-invasive technologies for fat cell destruction and body sculpting. The company develops and markets clinically proven safe and effective solutions that enhance the lives of patients. The UltraShape proprietary technology employs pulsed (non-thermal) focused ultrasound that instantly, selectively and permanently destroys fat cells without affecting surrounding structures. Founded in 2000, UltraShape has sold Contour I devices in more than 50 countries, demonstrating safety and efficacy.
The Contour I system is not FDA cleared for sale in the United States.
Contour I V3 Technical Specifications
• Key Standards
• IEC 60601-1
• IEC 60601-1-2
• Certifications
• CE (0344) mark
• CSA
• CB Scheme
• Focused ultrasound technology
• Ultrasound operation frequency: 200 ± 30 KHz
• Input voltage: Set by technician during installation: 110-120 V or 200-240
V, 50/60 Hz
• RF - Vacuum
• Frequency: 0.8, 2 MHz
• Power: up to 50W
• Dimensions (H × L × W): 200 × 98 × 65 cm
• Weight
• System Console: 130 kg
• Ultrasound Transducer: Less than 2.5 kg
• RF-Vacuum applicator: Less than 1 kg
Copyrighting © 2008-2012 UltraShape Ltd. All right reserved. No part of this publication may be reproduced, stored in a retrieval system, transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without written permission of Ultrashape Ltd. This product
and its use are protected by one or more patents and pending patent applications. Ultrashape, the Ultrashape “wave”, its logo, Contour I and “The Shape of Things to Come” are trademarks or registered trademarks of Ultrashape Ltd. Other trademarks are the property of their respective owners.
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Email: [email protected]: www.ultrashape.com
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Results that Measure Up
Addressing the Unmet Needs of Physicians and Patients
The UltraShape procedure delivers a safe and effective non-invasive option for the reduction of fat, even in stubborn localized unwanted fatty deposits (those areas that are hard to reduce even with diet and exercise) and smooth, uniform body sculpture with high patient satisfaction. Both men and women experience impressive long-lasting results in the abdomen, flanks and thighs.
UltraShape® Contour I V3 is the ultimate solution for non-invasive body sculpting. It uses Vertical Dynamic Focus™ (VDF) pulsed (non-thermal) focused ultrasound to instantly and permanently destroy fat cells providing your patients a convenient non-invasive no-downtime solution to reduce localized fat deposits and body circumference.
The UltraShape system is scientifically validated to target and selectively destroy only fat cells (adipocytes), leaving critical surrounding structures such as blood vessels, nerves and connective tissue unharmed.1
It is the first clinically proven non-invasive solution that offers measurable lasting body sculpting results with no need for maintenance treatments. The UltraShape system has been shown to be safe and effective in a multi-center controlled trial and numerous other peer-reviewed published independent clinical studies. Patients experience an average circumference reduction of four centimeters and as much as ten centimeters after three treatments with high patient satisfaction.2
1 Characterization of Nonthermal Focused Ultrasound for Noninvasive Selective Fat Cell Disruption (Lysis): Technical and Preclinical Assessment. Brown Spencer et al. Plastic and Reconstructive Surgery. July 2009
2 Data collected from several company controlled, sponsored and non company controlled studies.3 Noninvasive Body Contouring by Focused Ultrasound: Safety and Efficacy of the Contour I Device in a Multicenter, Controlled, Clinical Study.Teitelbaum Steven A et al. Plastic and Reconstructive Surgery. September 2007
Powered by VDF™ Pulsed Focused Ultrasound
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Proven pulsed (non-thermal) focused ultrasound for instant, selective and permanent •fat cell destruction
Integrated vacuum-assisted RF and Vertical Dynamic Focus™ (VDF) focused ultrasound •deliver synergistic effects to enhance fat cell destruction and tighten tissue
Comfortable treatment•
Homogeneous fat reduction throughout the entire targeted treatment area – no irregularities •
No bruising, swelling or downtime with focused ultrasound•
Safe, simple, “walk-in, walk-out” procedure•
Long-lasting measurable results within just a few weeks• 3
Addressing Your Practice Needs
Attracts a new and significant patient population seeking non-invasive alternatives •for targeted fat reduction
100% delegable procedure – easy to train your staff•
Independent revenue and profit generator – high profitability per treatment•
Upgradeable platform: VDF™ multi-focus ultrasound technology designed to treat •more fat volume at multiple depths using higher peak acoustic pressure
High patient satisfaction rate ensures business growth by repeat visits and also •“word of mouth” marketing
How It Works
Patented Pulsed (Non-thermal) Focused Ultrasound
The pulsed acoustic waves of ultrasonic energy converge in a confined focal volume at controlled depths causing an instant mechanical (non-thermal) destruction of fat cells. Histology from UltraShape’s peer-reviewed published research confirms immediate fat cell destruction while surrounding critical structures exposed to these effects remain intact.1 The UltraShape system is the only non-invasive technology scientifically proven to instantly and selectively destroy fat cells.
Precision and safety are reinforced by an integrated acoustic contact sensor, which provides real-time feedback to the system ensuring proper transducer-to-skin contact and efficient energy delivery to the targeted treatment area. In addition, the system’s proprietary computerized real-time tracking and guidance software ensures complete and homogeneous energy delivery providing smooth, uniform body sculpting results.
Natural Fat Clearance2
The UltraShape procedure is based on a natural fat clearance process where triglycerides and cell debris from the immediately destroyed fat cells are processed by the body’s natural physiological and metabolic pathways. These pathways are the same that handle fat during weight loss. Results from UltraShape’s peer-reviewed published multi-center controlled clinical trial and other independent clinical studies show that the released triglycerides do not accumulate to a clinically significant extent in the blood or liver.3
The UltraShape® Contour I V3 body sculpting system meets your patients’ need for an effective and convenient non-invasive alternative to reduce localized fatty deposits and body circumference. The UltraShape system is the only scientifically and clinically proven non-invasive solution to instantly, selectively and permanently destroy unwanted fat cells in the most problematic areas such as abdomen, flanks and thighs.
Focused ultrasound: • high acoustic energy targets only subcutaneous fat tissue at controlled depths within a precise focal volume
Pulsed (non-thermal) ultrasound: • no temperature increase within or around focal point (less than 0.5°C increase)
Selective, mechanical acoustic effects: • only fat cells are targeted and instantly and permanently destroyed while skin, blood vessels, nerves and connective tissues remain unharmed
1 Characterization of Nonthermal Focused Ultrasound for Noninvasive Selective Fat Cell Disruption (Lysis): Technical and Preclinical Assessment. Brown Spencer et al. Plastic and Reconstructive Surgery. July 2009
2 Body Contouring by Non-invasive Transdermal Focused Ultrasound. J. Moreno-Moraga et al. Lasers in Surgery and Medicine. 2007
3 Noninvasive Body Contouring by Focused Ultrasound: Safety and Efficacy of the Contour I Device in a Multicenter, Controlled, Clinical Study.Teitelbaum Steven A et al. Plastic and Reconstructive Surgery. September 2007
“With UltraShape finally there is a nearly painless, non-invasive, no downtime body contouring option that gives durable results. The system precisely delivers focused ultrasound energy powerful enough to destroy fat cells but leave neighboring tissue unharmed.”
Steven Teitelbaum, M.D., Assistant Clinical Professor of Plastic Surgery at the David Geffen School of Medicine at UCLA and lead investigator for UltraShape’s multi-center controlled clinical trial Plastic and Reconstructive Surgery, Journal of the American Society of Plastic Surgeons. PRS 120: 779, 2007Immediate and permanent fat cell
destruction at a controlled depth leaving skin, blood vessels, nerves, and connective tissue intact
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Blue dot confirms correct placement of transducer and allows energy delivery
Yellow dot guides operator to the precise location to deliver each pulse of energy
Highlighted treatment area is acquired and mapped by tracking and guidance software
End of treatment showing complete and uniform energy delivery throughout the entire treatment area
New Advanced Tracking & Guidance System
The UltraShape procedure is guided by an improved proprietary real-time tracking and guidance system. The system delivers optimized 3D mapping of the body’s curvature, guaranteeing adherence to a pre-programmed treatment algorithm to deliver smooth, uniform body sculpting results. This algorithm ensures complete and uniform energy delivery over the entire treatment area, minimizing the risk of contour irregularities, a common side effect of liposuction.
Treatment only within marked treatment area•
Each point is treated only once•
Homogeneous energy delivery over entire treatment area•
Uniform results with no irregularities•
The tracking system, by addressing the dynamic nature of the treatment area as it monitors and synchronizes patient position in real-time, enables the patient to move freely without affecting the treatment.
New “Freestyle” Treatment Mode
The Freestyle mode enables the operator to deliver energy freely over the treatment area while the software tracks each pulse of energy to ensure complete and uniform energy delivery throughout the entire treatment area – for easier faster treatments.
New Patient Data Management Software
The new V3 software comes with a comprehensive patient database application providing a powerful tool for treatment data management.
Proven Tissue EffectsIn-vivo Porcine Model: Immediate Acute Micro Effects
The UltraShape system has been used to treat hundreds of thousands of patients in over 50 countries. The safety and effectiveness of the UltraShape procedure is supported by a peer-reviewed, published multi-center controlled clinical trial and independent clinical studies of over 600 patients.
Clinically Proven Safe and Effective
Effectiveness Histological evidence of immediate fat cell destruction •without damage to surrounding blood vessels, nerves and connective tissue, both in and around the focal volume
Pre-clinical gross pathology shows immediate fat •destruction
CT scans demonstrate fat thickness reduction•
Average circumference reduction ranges from •3.5 to 6.3 cm1
Satisfaction86%-94% average patient satisfaction rate in •independent clinical studies1
SafetyThe vast majority of patients reported no pain or •discomfort during or following treatment
Normal blood and urine profiles in peer-reviewed •published studies confirmed safe fat clearance
No reported serious treatment-related adverse effects •in over 200,000 patient treatments
Control (40x) Selective fat cell destruction (40x)
Fat cell destruction
Fat cell destruction
Selective fat cell destruction (100x)
Intactblood vessels Intact
connective tissue
Selective fat cell destruction (100x)
Intactblood vessels
Fat cell destruction
Intact nerves
Histology from peer-reviewed published research demonstrating immediate and selective fat cell destruction and intact surrounding structures such as blood vessels, nerves and connective tissue after a single UltraShape treatment
1 Data collected from several company sponsored clinical studies, details in table on page 7
Immediate fat destruction•
Rapid Tissue Recovery•
Multiple treatments at •two week intervals enable greater cumulative fat layer thinning
Fat destruction after one treatment
Tissue recovery two weeks post first treatment
Fat destruction after third treatment
Tissue recovery two weeks post third treatment
In-vivo Porcine Model: Immediate Acute Effects
Gross pathology shows treatment with pulsed (non-thermal) focused ultrasound causes immediate fat tissue destruction and full tissue recovery was observed as soon as 2 weeks post-treatment.
Holes in fat lead to collapsing and thinning of the fat layer •
Each treatment shows new cavitation-associated fat specific •destruction resulting in greater cumulative fat layer thinning
Full tissue recovery at two weeks confirms efficient fat •clearance from localized area resulting in rapid visible results
CT Scans Demonstrating Fat Layer Thickness Reduction After Three UltraShape Treatments
UltraShape Clinical Studies - Abdomen, Flanks and Thighs
“My clinical study demonstrated measurable circumference reduction in all patients. These results were further supported by CT scans in a subset of patients showing a sustained reduction in fat thickness. In addition, 94% of patients reported satisfaction with the UltraShape procedure confirming that it is meeting patient expectations and the high demand for safe and effective non-invasive fat reduction in today’s aesthetic practice.”
Hector Leal-Silva, M.D., Dermatologic Surgeon, Monterrey, Mexico
Pre-treatment One month after 3 treatments
Investigator YearPatientPopulation
Average Circumference Reduction
Results
Teitelbaum S. et al1, US, UK, Japan 2004-05 164 2.0 cm (Single Treatment) 82% > 0.5 cm circumference reduction
Leal H.1 Monterrey, Mexico 2009 24 3.0-3.4 cm (1 combo therapy Tx)96% > 1.5 cm circumference reduction 100% patient satisfaction
Moreno-Moraga J2 Madrid, Spain 2006 30 3.95 cm 100% measurable and visual improvement
Ascher B.2 Paris, France 2007-08 25 3.58 cm 83% > 1.0 cm circumference reduction
Leal-Silva H.1 Monterrey, Mexico 2007-08 36 5.0 cm 100% measureable reduction, 94% patient satisfaction
Ad El D.1, Beilinson Med, Israel 2008 26 3.96 cm 90% > 2.0 cm circumference reduction
Mulholland S.2, Toronto, Canada 2008 21 3.48 cm 86% patient satisfaction
Inglefield C.2, London, UK 2005-06 148 6.3 cm 93% patient satisfaction
de Almeida G.2 Sao Paulo, Brazil 2007-08 20 5.4 cm 100% measurable reduction, 86% patient satisfaction
Benchetrit A.2 Montreal, Canada 2007-09 109 4.5 cm 96% measurable reduction, 86% patient satisfaction
1 Company controlled sponsored clinical studies
2 Other publications, peer reviewed and/or presented at scientific conferences
3 All of the studies were performed with single focused ultrasound
Contour I V3 Multi-Application PlatformV3 - You Asked, We Delivered
Upgradeable platform •
Ergonomic transducer design with gel comfort pad for improved operator treatment •experience
“Freestyle” treatment mode for easier faster treatments while facing patient•
Intuitive “TOUCH-Screen” for improved user interface•
New software for shorter set-up and treatment time•
3-D treatment mapping for improved treatment area coverage •and enhanced efficacy
Robust patient management database•
Advancements for Improved Efficacy and Reproducibility
Digital Ultrasound Pulser •
Delivers higher energy consistently•
Enables future ultrasound technology advancements•
Two Integrated Synergistic Energy-Based Technologies•
Advanced pulsed (non-thermal) focused ultrasound•
RFVac™ vacuum-assisted radio frequency •
Patented Vertical Dynamic Focus™ (VDF) Pulsed Ultrasound Technology
Software-driven VDF technology enables the use of a customized vector array of acoustic parameters to deliver higher energy (peak acoustic pressure) to a single or multiple focal depths in a single pulse.
VDF™ Multi-Focus Ultrasound
Designed to treat multiple depths •in a single pulse
Flexibility to treat a range of depths from •superficial to deep
Delivers • higher peak acoustic pressure and treats more fat volume per pulse
Acoustic Sensor
VDF™ Single-Focus Ultrasound
The VDF Single-Focus ultrasound is designed to treat more fat volume at 25% higher power (peak acoustic pressure)
Skin
Fat Layer
Muscle
Skin
Fat Layer
Muscle
Combination Therapy for a Complete Body Sculpting Solution1
Step 2: UltraShape Pulsed (Non-thermal) Focused Ultrasound Treatment using single focus or VDF™ single-focus ultrasound mode
Immediate, selective and •permanent fat cell destruction
Step 1: UltraShape RFVac™ Treatmentusing UltraShape RFVacTM vacuum-assisted RF applicator
Increasing circulation and •dissolved micro-bubbles in the tissue prepare the tissue for the focused ultrasound treatment Increasing cavitation effect
Step 3: UltraShape RFVac™ Treatmentusing UltraShape RFVacTM vacuum-assisted RF applicator
Accelerating circulation and •lymphatic activity Better and faster fat clearance and tissue tightening
RFVac™ Bi-polar Radio Frequency and Integrated Vacuum
The system combines two bi-polar RF modes (0.8 & 2.0 MHz) into one device, to enable volumetric RF thermotherapy at different tissue depths within the body. The vacuum draws the skin into the treatment head as RF energy is delivered to enable effective heating of underlying tissue. The vacuum massage can be performed without RF energy
Illustration of RF energy RF power levels: 1-6 delivers 8-50W at both 0.8 and 2.0 MHz
Deep
Superficial
RF Frequency [MHz] Vacuum Level Depth (mm)
0.8 6 (highest) 18
0.8 1 (lowest) 11
2.0 6 (highest) 13
2.0 1 (lowest) 7
2.0MHz
0.8MHz
1 The above single-session combination therapy protocol was used by Dr. Hector Leal-Silva, Monterrey, Mexico in a clinical study that showed an average circumference
reduction of 3.0 cm after a single-pass UltraShape treatment and 3.4 cm after a double-pass UltraShape treatment.
1
2
3
Clinically Proven Safe and Effective
Before
After
Courtesy of Dr. Arie Benchetrit, Montreal, Quebec
Courtesy of Dr. Moreno-Moraga et al, Madrid Spain
Courtesy of Dr. Mark Lupin, Victoria, British Columbia
Courtesy of Dr. Chris Inglefield, London, UK
Pulsed Focused Ultrasound – Two-Three Treatment Results1
“I have been using UltraShape for non-invasive fat reduction and body shaping in my cosmetic plastic surgery practice for the past three years. The UltraShape procedure has attracted a significant and new surgery-adverse patient population into my practice and consistently delivers good results with high patient satisfaction. Patient demand for this type of procedure was such that the device paid for itself in full after six months of use. Six months ago, I upgraded to the new UltraShape V3 and results thus far indicate even better and more consistent localized fat reduction as well as some skin tightening in the same procedure. UltraShape continues to be one of the most popular and successful non-invasive procedures in my practice.”
Arie Benchetrit, MD FRCS(C) Plastic Surgeon
Montreal, Canada
Before
After
Courtesy of Hector Leal-Silva, MD Monterrey, Mexico
Same-session combination therapy using pulsed focused ultrasound and vacuum-assisted RF – Single Treatment Results1
1 The above treatments were performed with single focused ultrasound
1 The above treatments were performed with single focused ultrasound
Same-session combination therapy using VDF™ pulsed focused ultrasound and vacuum-assisted RF – Three Treatment Results 1
“The UltraShape V3 is in a class of its own. Having reviewed all the other presently available technologies for non-invasive body sculpting, UltraShape remains the only choice. It is remarkable to have a method to remove fat that is virtually painless, shows smooth and even results in as little as 2-4 weeks and has results as long lasting as liposuction. Truly a smart device, its non-thermal cavitational effect for fat removal means no downtime, no bruising, and no soreness after the procedure. A testament to the success of any technology is the balance of good to high patient satisfaction with return on investment. Now with the V3, I have seen a greater than 95% patient satisfaction rate and a technology that continues to be an asset to my practice. UltraShape has stood the test of time and is a proven leader in its field.”
Mark Lupin, MD FRCPC Dermatologist and Laser Specialist
Victoria, BC, Canada
About the UltraShape ProcedureUltraShape is a comfortable, “walk-in, walk-out” procedure for non-invasive fat cell destruction that requires no downtime, no recuperation and no ongoing maintenance treatments. Destroyed fat cells are cleared from the body naturally and as with liposuction the effects are long lasting when combined with a healthy lifestyle that includes diet and exercise. To optimize results, patients are recommended to undergo a series of three UltraShape treatments.
Before
A fter
Courtesy of Hector Leal-Silva, MD Monterrey, Mexico
1 The above treatments were performed with single focused ultrasound
Powered by VDF™ Pulsed Focused Ultrasound
V3 by
THE ULTIMATE SOLUTION FOR NON-INVASIVE BODY SCULPTING
DELIVERING THE SYNERGY OF PULSED FOCUSED ULTRASOUND
AND VACUUM-ASSISTED RADIO FREQUENCY
FAT CELL DESTRUCTIONINSTANT • SELECTIVE • PERMANENT
About UltraShape UltraShape redefines aesthetic medicine by developing, manufacturing and marketing innovative non-invasive technologies for fat cell destruction and body sculpting. The company develops and markets clinically proven safe and effective solutions that enhance the lives of patients. The UltraShape proprietary technology employs pulsed (non-thermal) focused ultrasound that instantly, selectively and permanently destroys fat cells without affecting surrounding structures. Founded in 2000, UltraShape has sold Contour I devices in more than 50 countries, demonstrating safety and efficacy.
The Contour I system is not FDA cleared for sale in the United States.
Contour I V3 Technical Specifications
• Key Standards
• IEC 60601-1
• IEC 60601-1-2
• Certifications
• CE (0344) mark
• CSA
• CB Scheme
• Focused ultrasound technology
• Ultrasound operation frequency: 200 ± 30 KHz
• Input voltage: Set by technician during installation: 110-120 V or 200-240
V, 50/60 Hz
• RF - Vacuum
• Frequency: 0.8, 2 MHz
• Power: up to 50W
• Dimensions (H × L × W): 200 × 98 × 65 cm
• Weight
• System Console: 130 kg
• Ultrasound Transducer: Less than 2.5 kg
• RF-Vacuum applicator: Less than 1 kg
Copyrighting © 2008-2012 UltraShape Ltd. All right reserved. No part of this publication may be reproduced, stored in a retrieval system, transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without written permission of Ultrashape Ltd. This product
and its use are protected by one or more patents and pending patent applications. Ultrashape, the Ultrashape “wave”, its logo, Contour I and “The Shape of Things to Come” are trademarks or registered trademarks of Ultrashape Ltd. Other trademarks are the property of their respective owners.
DBR-17406 Rev.B
STUD
IO D
ALIA
INB
AR
Email: [email protected]: www.ultrashape.com
0344 C US
THE
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