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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 outlay If 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.)   ,[object Object],[object Object],[object Object],[object Object],[object Object],Teitelbaum  et al.   PRS ‘07
[object Object],Multi-Center Controlled Clinical Trial  UltraShape ®  Single-Treatment  Teitelbaum  et al.   PRS
[object Object],Multi-Center Controlled Clinical Trial  UltraShape ®  Single-Treatment  Teitelbaum  et al.   PRS
[object Object],Multi-Center Controlled Clinical Trial  UltraShape ®  Single-Treatment  Teitelbaum  et al.   PRS
UltraShape ®   Multi-Center Controlled Clinical Trial  Single-Treatment   Teitelbaum  et al.   PRS Study Results Study Normal Pulse oximetry No treatment-induced change Liver ultrasound No clinically significant change Two-point discrimination
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Multi-Center Controlled Clinical Trial  UltraShape ®  Single-Treatment  Teitelbaum  et al.   PRS ‘07
[object Object],Courtesy of Dr. S. Teitelbaum, Santa Monica, CA UltraShape ®   Single-Treatment  Results Pre-Treatment Post Treatment Reduction    3.5 cm
[object Object],Courtesy of Dr. Jacques Otto, London, England UltraShape ®   Single-Treatment  Results Pre-Treatment 28 Days Post Treatment Reduction    4.0 cm
Position until 2005 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
SCANDINAVIAN AKADEMIKLINIKEN Study 2006  Per Hedén MD, PhD Chairman, Ass. Professor in Plastic Surgery Stockholm, Sweden - London, UK, - Copenhagen, Denmark - Oslo, Norway ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Scandinavian Study Design  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Exclusion Criterion  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Study Timelines  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
Outcome parameters  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Measuring Parameters
UltraShape ™  Non-invasive Lipolysis Using UltraShape™ Focused Ultrasound    Ascher B, Paris, France ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Photos courtesy of Dr. Benjamin Ascher, Paris Pre-Treatment 3 months Post Treatment Reduction    5.0 cm Weight 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 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Baseline Treated Area: Abdomen Circumference measure: 97.0 cm Weight 63.8 Kg  1 Mo FU after 3 Tx Treated Area: Abdomen Circumference measure: 92.5 cm Weight 61.9 Kg Circumference Reduction:  4.5 cm Courtesy of Hector Leal-Silva, MD  Monterrey, Mexico Three Treatment  Results
Baseline Treated Area: Abdomen Fat Layer Thick: 4.9 cm After 1 Tx  Treated Area: Abdomen Fat Layer Thick: 4.5 cm Fat Thickness Reduction: .4 cm Courtesy of Hector Leal-Silva, MD  Monterrey, Mexico One Treatment  Results
Baseline Treated Area: Abdomen Fat Layer Thick: 4.9 cm After 2 Tx  Treated Area: Abdomen Fat 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 Tx Treated Area: Abdomen Fat Layer Thick: 3.8 cm Baseline Treated Area: Abdomen Fat Layer Thick: 4.9 cm Circumference Reduction:  4.5 cm Fat Thickness Reduction:  1.1 cm Courtesy of Hector Leal-Silva, MD  Monterrey, Mexico Three Treatment  Results
Personal  Clinical Experience July 2005 - October 2007 500+ Patient Treatments London Bridge Plastic Surgery
Three Treatment Results – All Sites After Three Treatments -7.5 cm
Treatment Results ,[object Object],[object Object],[object Object],[object Object],[object Object]
Photos courtesy of Dr. Chris Inglefield, London, UK Abdomen Pre-Treatment 1 month Post Treatment UltraShape ™   Single-Treatment  Results Reduction    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
Photos courtesy of Dr. Chris Inglefield, London, UK Lower Abdomen Pre-Treatment Post Treatment UltraShape ™   Two Treatment  Results Reduction    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
Photos courtesy of Dr. Chris Inglefield, London, UK Pre-Treatment 1-month Post Treatment Reduction    6.7 cm Lower Abdomen UltraShape ™   Three Treatment  Results
 
 
 
 
UltraShape ®   CONTOUR 2  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
UltraShape ®   CONTOUR 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
[object Object],[object Object],[object Object],[object Object],[object Object],Patient Positioning CONFIDENTIAL
Taping ,[object Object]
[object Object],[object Object],[object Object],[object Object],Patient Positioning CONFIDENTIAL
[object Object],[object Object],Patient Positioning CONFIDENTIAL
Teitelbaum  et al.   PRS Blood and urine analysis performed:  days 0, 1, 3, 7, 14, 21, 28, 56, and 84 post treatment UltraShape ®   Multi-Center Controlled Clinical Trial  Single-Treatment   Study Results Lab Study No clinically significant changes 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

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UltraShape® clinical evidence shows circumference reduction

  • 2.  
  • 3.  
  • 4. Internationally How big is the problem?
  • 5.  
  • 8. Recent explosion of non-surgical devices
  • 9. 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
  • 10. Surgical procedures are objective with previous defined parameters. Minimal outlay If done in hospital type setting
  • 11. Problem… this has long downtime, higher morbidity and less patient acceptance
  • 12. Key to success in any cosmetic procedure … . a well informed patient with realistic expectations
  • 13. … 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…
  • 15.
  • 16.
  • 17.
  • 18.
  • 19. UltraShape ® Multi-Center Controlled Clinical Trial Single-Treatment Teitelbaum et al. PRS Study Results Study Normal Pulse oximetry No treatment-induced change Liver ultrasound No clinically significant change Two-point discrimination
  • 20.
  • 21.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.  
  • 29.
  • 31.
  • 32. Photos courtesy of Dr. Benjamin Ascher, Paris Pre-Treatment 3 months Post Treatment Reduction  5.0 cm Weight change  -1.0 kg Abdomen UltraShape ™ Three Treatment Results
  • 33.
  • 34. Baseline Treated Area: Abdomen Circumference measure: 97.0 cm Weight 63.8 Kg 1 Mo FU after 3 Tx Treated Area: Abdomen Circumference measure: 92.5 cm Weight 61.9 Kg Circumference Reduction: 4.5 cm Courtesy of Hector Leal-Silva, MD Monterrey, Mexico Three Treatment Results
  • 35. Baseline Treated Area: Abdomen Fat Layer Thick: 4.9 cm After 1 Tx Treated Area: Abdomen Fat Layer Thick: 4.5 cm Fat Thickness Reduction: .4 cm Courtesy of Hector Leal-Silva, MD Monterrey, Mexico One Treatment Results
  • 36. Baseline Treated Area: Abdomen Fat Layer Thick: 4.9 cm After 2 Tx Treated Area: Abdomen Fat Layer Thick: 4.2 cm Fat Thickness Reduction: .7 cm Courtesy of Hector Leal-Silva, MD Monterrey, Mexico Two Treatment Results
  • 37. 1 Mo FU after 3 Tx Treated Area: Abdomen Fat Layer Thick: 3.8 cm Baseline Treated Area: Abdomen Fat Layer Thick: 4.9 cm Circumference Reduction: 4.5 cm Fat Thickness Reduction: 1.1 cm Courtesy of Hector Leal-Silva, MD Monterrey, Mexico Three Treatment Results
  • 38. Personal Clinical Experience July 2005 - October 2007 500+ Patient Treatments London Bridge Plastic Surgery
  • 39. Three Treatment Results – All Sites After Three Treatments -7.5 cm
  • 40.
  • 41. Photos courtesy of Dr. Chris Inglefield, London, UK Abdomen Pre-Treatment 1 month Post Treatment UltraShape ™ Single-Treatment Results Reduction  4.5 cm
  • 42. Photos courtesy of Dr. Chris Inglefield, London, UK Abdomen Pre-Treatment 1 month Post Treatment UltraShape ™ Single-Treatment Results Reduction  1.8 cm
  • 43. Photos courtesy of Dr. Chris Inglefield, London, UK Lower Abdomen Pre-Treatment Post Treatment UltraShape ™ Two Treatment Results Reduction  5.6 cm
  • 44. Photos courtesy of Dr. Chris Inglefield, London, UK Lower Abdomen and Flanks Pre-Treatment Post Treatment UltraShape ™ Two Treatment Results Reduction  4.5 cm
  • 45. Photos courtesy of Dr. Chris Inglefield, London, UK Pre-Treatment 1-month Post Treatment Reduction  6.7 cm Lower Abdomen UltraShape ™ Three Treatment Results
  • 46.  
  • 47.  
  • 48.  
  • 49.  
  • 50.
  • 51. UltraShape ® CONTOUR 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
  • 52.
  • 53.
  • 54.
  • 55.
  • 56. Teitelbaum et al. PRS Blood and urine analysis performed: days 0, 1, 3, 7, 14, 21, 28, 56, and 84 post treatment UltraShape ® Multi-Center Controlled Clinical Trial Single-Treatment Study Results Lab Study No clinically significant changes 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