brochure sobre ultra shape (inglés)

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Where Safety and Effectiveness Finally Meet

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Brochure explicativo del método de aplicación y beneficios de UltraShape (Contour I).

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Page 1: Brochure sobre Ultra Shape (Inglés)

Where Safety and Effectiveness Finally Meet

Highlights

The first body contouring solution to combine safety with effectiveness An average reduction of two centimeters in body circumference after a single treatment Lysed adipose tissue cleared via the body's natural mechanisms Tracking and guidance system ensures homogeneous treatment

Non-invasive, focused ultrasound technology Long-term reduction of fat cell population through mechanical effects Selective emulsification of adipose tissue, leaving neighboring tissues unharmed

A measurable difference to more patients' lives “Walk-in, walk-out” office based treatment An effective option when surgery is not desired No disruption to patients’ daily routine No downtime and no need for maintenance treatment

Company Profile

UltraShape, founded in 2000, develops, manufactures and markets innovative, non-invasivesolutions for the aesthetic medical field. The UltraShape expert team of scientists is dedicated to thedevelopment of cutting edge body contouring technology that enhances patients' self image andsense of well being.

First to market - UltraShape offers a unique technology that positions the company as the pioneerin non-invasive body contouring. The revolutionary UltraShape Contour I is the first computer guidednon-invasive body contouring system to emulsify fat cells selectively using focused ultrasoundtechnology.

UltraShape Inc. was established in Delaware by Ami Glicksman M.D., formerly a senior plastic surgeonat the Sheba Medical Center, Tel Aviv, and Yoram Eshel, Ph.D, MBA, a leading expert in medicalphysics with fifteen years experience in high power ultrasound technology. UltraShape Ltd. operatesthrough its fully owned subsidiary in Israel.

The company adheres to the highest scientific and quality standards. UltraShape is ISO 13485: 2003 certified.

System Components

Transducer: Delivers the focused ultrasonic beam Provides real-time feedback on acoustic contact

System Console: Comprised of the ultrasound generator, power unit, cooling system and system computer

Stand: Illumination system and tracking system based on a single video camera System display screen and control panel

List of Patents:This product and its use are protected by one or more ofthe following patents and/or pending patent applications:US 6607498; US 20030083536 A1; US 20040106867 A1;WO 02/054018; WO 04/00011

* Contour I is not yet available in the US© 2006 UltraShape Ltd. All rights reserved.

DBR

-100

04 R

ev. C

30 Habarzel St., Tel Aviv 69710 Israel, Tel:+972-3-6457100 Fax:+972-3-6479321

Toll free number: +800-22557252 [email protected] www.ultrashape.com

Before treatment

Courtesy of: P. Heden, M.D., Stockholm, Sweden

After a single treatment

Before treatment

Courtesy of: J. Burns, M.D., Dallas, TX, USA

After a single treatment

TechnologyKey StandardsCertificationsAcoustic outputUltrasound operation frequencyInput voltageDimensions Cabinet (HxLxW) Light Stand (Height)Weight Cabinet & light stand Transducer

Focused ultrasoundIEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, UL60601-1, CSA 22.2CE Mark, CSA, CB SchemeISPTA= 17.5 W/cm2

200± 30KHz100, 115, 200, 230V, 50-60 Hz, factory set

0.65 x 1.15 x 0.55 meters2.2 meters

150 kg1.85 kg

0344

Specifications

After two treatments

Courtesy of: C. Inglefield, M.D., BSc, London, UK

Before treatment

Page 2: Brochure sobre Ultra Shape (Inglés)

A safe and simple “walk-in, walk-out” office-based

A non-invasive option when surgery is not desired

Treatment areas include abdomen, flanks and thighs

No downtime, no recuperation period and no maintenance

treatments

Minimal training with short learning curveNon-Invasive Focused Ultrasound

The UltraShape technology is based on focused therapeuticultrasound which selectively lyses adipocytes. A predeterminedamount of ultrasound energy is applied to the subcutaneousfat layer where acoustic waves converge in a confined focalvolume causing mechanical disruption of fat cell membranes.Since energy is delivered in pulses, there is no significanttemperature elevation.

Most importantly, the mechanical effect allows for tissueselectivity - only adipose cells within the targeted area aredisrupted while surrounding tissues including blood vessels,nerves, and connective tissue remain unharmed.

An embedded ultrasound imaging system concurrentlyprovides real-time feedback regarding acoustic contact.

Revolutionary Technology

The Contour I system is based on two proprietary technological innovations:

Focused non-invasive ultrasound

Tracking and guidance software

Ultrasound imaging transducer

Focused ultrasound therapeutictransducer

Low energy everywhere exceptin the focal area

Clinical Results

The safety and effectiveness of Contour I is backed byscientifically demonstrated results from multi-center clinicaltrials performed on hundreds of patients worldwide.Results include:

An average reduction of two centimeters in bodycircumference following a single treatment

The majority of patients reported no pain ordiscomfort during or following treatment

Normal blood and urine profiles confirmedphysiologically manageable fat clearance

Histological and clinical evidence of selectivedamage to adipose tissue

No serious adverse effects

Fat Clearance Process

Selective fat cell lysis takes place without causing damage toneighboring blood vessels and nerves. Triglycerides from thedisrupted adipocyte cells are released into the interstitial fluidand gradually transported through the vascular system to theliver. The liver makes no distinction between fat originatingfrom the disrupted adipocytes and fat derived from a consumedmeal. The cell debris is removed through the physiologicalpathways.

Combining Safety with Effectiveness

The only solution to combine non-invasive treatment with measurable results

Safe clearance of lysed adipose tissue via the body's natural mechanisms

An average reduction of two centimeters in body circumference after a single treatment

Advanced Tracking and Guidance Software

The UltraShape treatment is guided by a real-time tracking and guidance system designed to guaranteehomogenous body contouring results. The system includes a software algorithm that maps the threedimensional treatment zone. Precision and safety are reinforced by an optical image guidance devicewhich prevents treatment beyond the pre-marked zone and precludes repeat treatment.

The tracking system addresses the dynamic nature of the treated area, a major challenge in bodycontouring. As the patient breathes and moves, the fat being non-rigid, undergoes spatial deformities.To overcome these obstacles, the system records and synchronizes the body's position in real-time,enabling the patient to move freely or even get up during treatment. When the patient returns, thesystem accurately resumes treatment.

Convenience for You and Your Patients

Contour I - The practical patient-friendly alternative

The UltraShape treatment is the first non-invasive bodycontouring solution to lyse fat cells safely and effectively inboth men and women. The treatment takes an average ofone and a half hours and is carried out in an office environment. Afterward, patients can immediately resume their dailyroutines. Measurable results are evident after a single treatment.The option of additional treatments is available to individualsseeking enhanced results*.

Contour I - Making a measurabledifference to more patients' lives

Designed by plastic surgeons with physiciansin mind, the UltraShape treatment is easilyadministered by physicians or other healthcareprofessionals. Intended for the officeenvironment, it eliminates operating roomand anesthesia expenses. The system providesa user friendly, time-saving and cost effectivetreatment platform that safely delivers ameasurable reduction in body circumference.Patients who previously avoided invasivetreatments will welcome this new bodycontouring option.

Figure 1: Histopathological sample immediately

following the UltraShape treatment (Hematoxylin-

Eosin staining, x50). Image shows disrupted adipose

tissue with no damage to adjacent blood vessels.

Figure 2: Histopathological sample immediately

following the UltraShape treatment (Hematoxylin-Eosin

staining, x25). Image shows damage only to fat cells

while skin and connective tissue remain unharmed.* Still under clinical evaluation. Please refer to theUltraShape website for the latest clinical updates.

Page 3: Brochure sobre Ultra Shape (Inglés)

A safe and simple “walk-in, walk-out” office-based

A non-invasive option when surgery is not desired

Treatment areas include abdomen, flanks and thighs

No downtime, no recuperation period and no maintenance

treatments

Minimal training with short learning curveNon-Invasive Focused Ultrasound

The UltraShape technology is based on focused therapeuticultrasound which selectively lyses adipocytes. A predeterminedamount of ultrasound energy is applied to the subcutaneousfat layer where acoustic waves converge in a confined focalvolume causing mechanical disruption of fat cell membranes.Since energy is delivered in pulses, there is no significanttemperature elevation.

Most importantly, the mechanical effect allows for tissueselectivity - only adipose cells within the targeted area aredisrupted while surrounding tissues including blood vessels,nerves, and connective tissue remain unharmed.

An embedded ultrasound imaging system concurrentlyprovides real-time feedback regarding acoustic contact.

Revolutionary Technology

The Contour I system is based on two proprietary technological innovations:

Focused non-invasive ultrasound

Tracking and guidance software

Ultrasound imaging transducer

Focused ultrasound therapeutictransducer

Low energy everywhere exceptin the focal area

Clinical Results

The safety and effectiveness of Contour I is backed byscientifically demonstrated results from multi-center clinicaltrials performed on hundreds of patients worldwide.Results include:

An average reduction of two centimeters in bodycircumference following a single treatment

The majority of patients reported no pain ordiscomfort during or following treatment

Normal blood and urine profiles confirmedphysiologically manageable fat clearance

Histological and clinical evidence of selectivedamage to adipose tissue

No serious adverse effects

Fat Clearance Process

Selective fat cell lysis takes place without causing damage toneighboring blood vessels and nerves. Triglycerides from thedisrupted adipocyte cells are released into the interstitial fluidand gradually transported through the vascular system to theliver. The liver makes no distinction between fat originatingfrom the disrupted adipocytes and fat derived from a consumedmeal. The cell debris is removed through the physiologicalpathways.

Combining Safety with Effectiveness

The only solution to combine non-invasive treatment with measurable results

Safe clearance of lysed adipose tissue via the body's natural mechanisms

An average reduction of two centimeters in body circumference after a single treatment

Advanced Tracking and Guidance Software

The UltraShape treatment is guided by a real-time tracking and guidance system designed to guaranteehomogenous body contouring results. The system includes a software algorithm that maps the threedimensional treatment zone. Precision and safety are reinforced by an optical image guidance devicewhich prevents treatment beyond the pre-marked zone and precludes repeat treatment.

The tracking system addresses the dynamic nature of the treated area, a major challenge in bodycontouring. As the patient breathes and moves, the fat being non-rigid, undergoes spatial deformities.To overcome these obstacles, the system records and synchronizes the body's position in real-time,enabling the patient to move freely or even get up during treatment. When the patient returns, thesystem accurately resumes treatment.

Convenience for You and Your Patients

Contour I - The practical patient-friendly alternative

The UltraShape treatment is the first non-invasive bodycontouring solution to lyse fat cells safely and effectively inboth men and women. The treatment takes an average ofone and a half hours and is carried out in an office environment. Afterward, patients can immediately resume their dailyroutines. Measurable results are evident after a single treatment.The option of additional treatments is available to individualsseeking enhanced results*.

Contour I - Making a measurabledifference to more patients' lives

Designed by plastic surgeons with physiciansin mind, the UltraShape treatment is easilyadministered by physicians or other healthcareprofessionals. Intended for the officeenvironment, it eliminates operating roomand anesthesia expenses. The system providesa user friendly, time-saving and cost effectivetreatment platform that safely delivers ameasurable reduction in body circumference.Patients who previously avoided invasivetreatments will welcome this new bodycontouring option.

Figure 1: Histopathological sample immediately

following the UltraShape treatment (Hematoxylin-

Eosin staining, x50). Image shows disrupted adipose

tissue with no damage to adjacent blood vessels.

Figure 2: Histopathological sample immediately

following the UltraShape treatment (Hematoxylin-Eosin

staining, x25). Image shows damage only to fat cells

while skin and connective tissue remain unharmed.* Still under clinical evaluation. Please refer to theUltraShape website for the latest clinical updates.

Page 4: Brochure sobre Ultra Shape (Inglés)

A safe and simple “walk-in, walk-out” office-based

treatment

A non-invasive option when surgery is not desired

Treatment areas include abdomen, flanks and thighs

No downtime, no recuperation period and no maintenance

treatments

Minimal training with short learning curveNon-Invasive Focused Ultrasound

The UltraShape technology is based on focused therapeuticultrasound which selectively lyses adipocytes. A predeterminedamount of ultrasound energy is applied to the subcutaneousfat layer where acoustic waves converge in a confined focalvolume causing mechanical disruption of fat cell membranes.Since energy is delivered in pulses, there is no significanttemperature elevation.

Most importantly, the mechanical effect allows for tissueselectivity - only adipose cells within the targeted area aredisrupted while surrounding tissues including blood vessels,nerves, and connective tissue remain unharmed.

An embedded ultrasound imaging system concurrentlyprovides real-time feedback regarding acoustic contact.

Revolutionary Technology

The Contour I system is based on two proprietary technological innovations:

Non-invasive focused ultrasound

Tracking and guidance software

Ultrasound imaging transducer

Focused ultrasound therapeutictransducer

Low energy everywhere exceptin the focal area

Clinical Results

The safety and effectiveness of Contour I is backed byscientifically demonstrated results from multi-center clinicaltrials performed on hundreds of patients worldwide.Results include:

An average reduction of two centimeters in bodycircumference following a single treatment

The majority of patients reported no pain ordiscomfort during or following treatment

Normal blood and urine profiles confirmedphysiologically manageable fat clearance

Histological and clinical evidence of selectivedamage to adipose tissue

No serious adverse effects

Fat Clearance Process

Selective fat cell lysis takes place without causing damage toneighboring blood vessels and nerves. Triglycerides from thedisrupted adipocyte cells are released into the interstitial fluidand gradually transported through the vascular system to theliver. The liver makes no distinction between fat originatingfrom the disrupted adipocytes and fat derived from a consumedmeal. The cell debris is removed through the physiologicalpathways.

Combining Safety with Effectiveness

The only solution to combine non-invasive treatment with measurable results

Safe clearance of lysed adipose tissue via the body's natural mechanisms

An average reduction of two centimeters in body circumference after a single treatment

Advanced Tracking and Guidance Software

The UltraShape treatment is guided by a real-time tracking and guidance system designed to guaranteehomogenous body contouring results. The system includes a software algorithm that maps the threedimensional treatment zone. Precision and safety are reinforced by an optical image guidance devicewhich prevents treatment beyond the pre-marked zone and precludes repeat treatment.

The tracking system addresses the dynamic nature of the treated area, a major challenge in bodycontouring. As the patient breathes and moves, the fat being non-rigid, undergoes spatial deformities.To overcome these obstacles, the system records and synchronizes the body's position in real-time,enabling the patient to move freely or even get up during treatment. When the patient returns, thesystem accurately resumes treatment.

Convenience for You and Your Patients

Contour I - The practical patient-friendly alternative

The UltraShape treatment is the first non-invasive bodycontouring solution to lyse fat cells safely and effectively inboth men and women. The treatment takes an average ofone and a half hours and is carried out in an office environment.Afterward, patients can immediately resume their daily routines.Measurable results are evident after a single treatment. Theoption of additional treatments is available to individualsseeking enhanced results*.

Contour I - Making a measurabledifference to more patients' lives

Designed by plastic surgeons with physiciansin mind, the UltraShape treatment is easilyadministered by physicians or other healthcareprofessionals. Intended for the officeenvironment, it eliminates operating roomand anesthesia expenses. The system providesa user friendly, time-saving and cost effectivetreatment platform that safely delivers ameasurable reduction in body circumference.Patients who previously avoided invasivetreatments will welcome this new bodycontouring option.

Figure 1: Histopathological sample immediately

following the UltraShape treatment (Hematoxylin-

Eosin staining, x50). Image shows disrupted adipose

tissue with no damage to adjacent blood vessels.

Figure 2: Histopathological sample immediately

following the UltraShape treatment (Hematoxylin-Eosin

staining, x25). Image shows damage only to fat cells

while skin and connective tissue remain unharmed.* Still under clinical evaluation. Please refer to theUltraShape website for the latest clinical updates.

Page 5: Brochure sobre Ultra Shape (Inglés)

Where Safety and Effectiveness Finally Meet

Highlights

The first body contouring solution to combine safety with effectiveness An average reduction of two centimeters in body circumference after a single treatment Lysed adipose tissue cleared via the body's natural mechanisms Tracking and guidance system ensures homogeneous treatment

Non-invasive, focused ultrasound technology Long-term reduction of fat cell population through mechanical effects Selective emulsification of adipose tissue, leaving neighboring tissues unharmed

A measurable difference to more patients' lives “Walk-in, walk-out” office based treatment An effective option when surgery is not desired No disruption to patients’ daily routine No downtime and no need for maintenance treatment

Company Profile

UltraShape, founded in 2000, develops, manufactures and markets innovative, non-invasivesolutions for the aesthetic medical field. The UltraShape expert team of scientists is dedicated to thedevelopment of cutting edge body contouring technology that enhances patients' self image andsense of well being.

First to market - UltraShape offers a unique technology that positions the company as the pioneerin non-invasive body contouring. The revolutionary UltraShape Contour I is the first computer guidednon-invasive body contouring system to emulsify fat cells selectively using focused ultrasoundtechnology.

UltraShape Inc. was established in Delaware by Ami Glicksman M.D., formerly a senior plastic surgeonat the Sheba Medical Center, Tel Aviv, and Yoram Eshel, Ph.D, MBA, a leading expert in medicalphysics with fifteen years experience in high power ultrasound technology. UltraShape Ltd. operatesthrough its fully owned subsidiary in Israel.

The company adheres to the highest scientific and quality standards. UltraShape is ISO 13485: 2003 certified.

System Components

Transducer: Delivers the focused ultrasonic beam Provides real-time feedback on acoustic contact

System Console: Comprised of the ultrasound generator, power unit, cooling system and system computer

Stand: Illumination system and tracking system based on a single video camera System display screen and control panel

List of Patents:This product and its use are protected by one or more ofthe following patents and/or pending patent applications:US 6607498; US 20030083536 A1; US 20040106867 A1;WO 02/054018; WO 04/00011

* Contour I is not yet available in the US© 2006 UltraShape Ltd. All rights reserved.

DBR

-100

04 R

ev. C

30 Habarzel St., Tel Aviv 69710 Israel, Tel:+972-3-6457100 Fax:+972-3-6479321

Toll free number: +800-22557252 [email protected] www.ultrashape.com

Before treatment

Courtesy of: P. Heden, M.D., Stockholm, Sweden

After a single treatment

Before treatment

Courtesy of: J. Burns, M.D., Dallas, TX, USA

After a single treatment

TechnologyKey StandardsCertificationsAcoustic outputUltrasound operation frequencyInput voltageDimensions Cabinet (HxLxW) Light Stand (Height)Weight Cabinet & light stand Transducer

Focused ultrasoundIEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, UL60601-1, CSA 22.2CE Mark, CSA, CB SchemeISPTA= 17.5 W/cm2

200± 30KHz100, 115, 200, 230V, 50-60 Hz, factory set

0.65 x 1.15 x 0.55 meters2.2 meters

150 kg1.85 kg

0344

Specifications

After two treatments

Courtesy of: C. Inglefield, M.D., BSc, London, UK

Before treatment

Page 6: Brochure sobre Ultra Shape (Inglés)

Where Safety and Effectiveness Finally Meet

Highlights

The first body contouring solution to combine safety with effectiveness An average reduction of two centimeters in body circumference after a single treatment Lysed adipose tissue cleared via the body's natural mechanisms Tracking and guidance system ensures homogeneous treatment

Non-invasive, focused ultrasound technology Long-term reduction of fat cell population through mechanical effects Selective emulsification of adipose tissue, leaving neighboring tissues unharmed

A measurable difference to more patients' lives “Walk-in, walk-out” office based treatment An effective option when surgery is not desired No disruption to patients’ daily routine No downtime and no need for maintenance treatment

Company Profile

UltraShape, founded in 2000, develops, manufactures and markets innovative, non-invasivesolutions for the aesthetic medical field. The UltraShape expert team of scientists is dedicated to thedevelopment of cutting edge body contouring technology that enhances patients' self image andsense of well being.

First to market - UltraShape offers a unique technology that positions the company as the pioneerin non-invasive body contouring. The revolutionary UltraShape Contour I is the first computer guidednon-invasive body contouring system to emulsify fat cells selectively using focused ultrasoundtechnology.

UltraShape Inc. was established in Delaware by Ami Glicksman M.D., formerly a senior plastic surgeonat the Sheba Medical Center, Tel Aviv, and Yoram Eshel, Ph.D, MBA, a leading expert in medicalphysics with fifteen years experience in high power ultrasound technology. UltraShape Ltd. operatesthrough its fully owned subsidiary in Israel.

The company adheres to the highest scientific and quality standards. UltraShape is ISO 13485: 2003 certified.

System Components

Transducer: Delivers the focused ultrasonic beam Provides real-time feedback on acoustic contact

System Console: Comprised of the ultrasound generator, power unit, cooling system and system computer

Stand: Illumination system and tracking system based on a single video camera System display screen and control panel

List of Patents:This product and its use are protected by one or more ofthe following patents and/or pending patent applications:US 6607498; US 20030083536 A1; US 20040106867 A1;WO 02/054018; WO 04/00011

* Contour I is not yet available in the US© 2006 UltraShape Ltd. All rights reserved.

DBR

-100

04 R

ev. C

30 Habarzel St., Tel Aviv 69710 Israel, Tel:+972-3-6457100 Fax:+972-3-6479321

Toll free number: +800-22557252 [email protected] www.ultrashape.com

Before treatment

Courtesy of: P. Heden, M.D., Stockholm, Sweden

After a single treatment

Before treatment

Courtesy of: J. Burns, M.D., Dallas, TX, USA

After a single treatment

TechnologyKey StandardsCertificationsAcoustic outputUltrasound operation frequencyInput voltageDimensions Cabinet (HxLxW) Light Stand (Height)Weight Cabinet & light stand Transducer

Focused ultrasoundIEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, UL60601-1, CSA 22.2CE Mark, CSA, CB SchemeISPTA= 17.5 W/cm2

200± 30KHz100, 115, 200, 230V, 50-60 Hz, factory set

0.65 x 1.15 x 0.55 meters2.2 meters

150 kg1.85 kg

0344

Specifications

After two treatments

Courtesy of: C. Inglefield, M.D., BSc, London, UK

Before treatment