CLINICAL OVERVIEW. Clinical Studies Protocols Before & Afters

Transcription

1 CLINICAL OVERVIEW Clinical Studies Protocols Before & Afters

2 UltraShape Results 3 treatment regimen in use for 3 years Average circumference reduction ranges from 3.3 to 6.3 cm Average response rate ranged from 83% to 100% Average patient satisfaction rate 86% to 94% Note: with UltraShape fat cell destruction is immediate and permanent

3 UltraShape Measurable results in 100% of study patients 1 94% of patients were satisfied with the procedure 1 3 biweekly fat reduction treatment protocol results in average circumference reduction of 3.5cm 2 100% reported very low pain levels 2 Excellent safety profile treatments can be performed every 2 weeks 2 No clinically significant changes in lipid profile, pulse oximetry or liver ultrasound after treatment 3 1. Leal-Silva H. Lipotripsy: Non-invasive Ultrasonic Selective Destruction of Adipocytes using UltraShape. ASLMS 2008, IMCAS Coleman WP, et al. A Multicenter, Randomized, Controlled Study to Evaluate Multiple Treatments with Non-thermal Focused Ultrasound for Noninvasive Fat Reduction. Submitted to Derm Surg (FDA data on file). 3. Teitelbaum et al. Noninvasive body contouring by focused ultrasound: safety and efficacy of the Contour I device in a multicenter, controlled, clinical study. Plast Reconstr Surg 2007;120:

4 1 Published in peer-reviewed journal 2 Presented in scientific conference 3 Data on file submitted for publication Clinical Studies Overview Study Investigator Publication / presented Year Patient Population Avg. Circumference Reduction Results Lipotripsy: Non-invasive Ultrasonic Selective Destruction of Adipocytes using UltraShape Leal H. 2,3 Monterrey, Mexico cm 100% measureable reduction 94% patient satisfaction Non-invasive Ultrasonic Selective Fat Cell Lysis and Body Contouring Inglefield C. 2 London, UK cm 93% patient satisfaction UltraShape New Advancements and Clinical Studies Benchetrit A. 2 Montreal, Canada cm 96% measurable reduction 86% patient satisfaction Reduced Pulse Duration (1.0 second) and Shorter Treatment Intervals using UltraShape Dean Ad El, MD, presented atimcas Asia cm 3 treatments@ 2 week intervals 90%of patients circumference reduction > 2.0 cm 3.95 cmaverage reduction in body circumference Safety and Efficacy of UltraShape Contour I Treatments to Improve the Appearance of Body Contours Multiple Treatments in Shorter Intervals Ascher B. 1 Paris, France cm 90% reported no pain A Multicenter, Randomized, Controlled Study to Evaluate the Contour I V3.1 System for Non-Invasive Reduction in Abdominal Circumference Weiss, Coleman, Kenkel, Ad-El 3 US, Israel cm 100% reported very low pain levels Body Contouring by Non-Invasive Transdermal Focused Ultrasound J. Moreno-Moraga cm 3 tx mean reduction in fat thickness was 2.28 Circumference was reduced by a mean of 3.95 A Multicenter, Randomized, Controlled Study to Evaluate Multiple Treatments with Non-thermal Focused Ultrasound for Noninvasive Fat Reduction William P. Coleman et al cm 3 tx bi-weekly for 22 week mean circumference reduction of 3.5cm

5 Lipotripsy: Non-invasive Ultrasonic Selective Destruction of Adipocytes using UltraShape Dr. Hector Leal-Silva presented at IMCAS 2008 and ASLMS 2008 Method: Thirty six patients between 21 and 60 years old, 33 females and 3 males were treated for localized adiposities in several parts of the body: abdomen, flanks or/and tights in three sequenced sessions of approximately 1000 ultrasonic pulses each one, made one month apart. Diagnostic ultrasound to measure fat tissue thickness in the treatment areas were performed, photographic assessment, weight and measures were registered pre and post treatments in each one of the three procedures and also at the final follow up visit, three months after the last treatment. CT scan to precisely measure fat thickness was preformed in a sample of six cases. Results: The study showed definitive, measurable results in 100 percent of patients including an average of two-inch (5cm) reduction in circumference in the abdomen after a series of three treatments, one month apart. CT scans taken in a subset of study subjects showed objective quantifiable fat thickness reduction. Photographic assessment, weight and circumferential measures were evaluated before and after each treatment and one month after the last treatment. Visual contour improvement was seen in over 85% of patients as assessed by an independent panel of physicians. Ninety-four percent (94%) of patients were satisfied with the procedure. In addition, there were no adverse events reported. Conclusion "UltraShape has addressed a previously unmet patient need in my practice for a safe and effective non-invasive option for the reduction of localized fat deposits," said Leal.

6 Dr. Hector Leal CT Scans- Three Treatments Results Baseline Treated Area: Abdomen Fat Layer Thick: 4.9 cm 1 Mo FU after 3 Tx Treated Area: Abdomen Fat Layer Thick: 3.8 cm Courtesy of Hector Leal-Silva, MD Monterrey, Mexico Circumference Reduction: 4.5 cm Fat Thickness Reduction: 1.1 cm

7 Non-invasive Ultrasonic Selective Fat Cell Lysis and Body Contouring Chris Inglefield, MD presented at ASPRS 2007 Method Study was conducted at London Bridge Plastic Surgery in London 118 women (n=86) and men (n=32) with a mean age of 38 years old, received a series of three treatments, one month apart. Selected patients had a body mass index of less then 30, a healthy, motivated attitude toward exercise and diet, localized fat deposits and a desire for non-invasive fat-reduction and body contouring Results: An average three-inch (7.5cm) reduction in circumference for all body areas An average 2.5-inch (6.3cm) reduction in circumference for the abdomen, hips and lateral thighs. Ninety-three percent (93%) of patients described their results as either "good" or "excellent." No patient-related adverse events. Conclusion: The excellent patient satisfaction that I've seen with the UltraShape procedure over the past two years confirms that this technology is safe and effective, and answers an unmet patient need for non-invasive fat reduction with no pain or downtime," said Inglefield. "The convenient 'walk-in, walk-out' procedure allows patients to see measurable circumference reduction and body contouring without the hassle and risk associated with other, more invasive approaches - they literally receive the treatment and then immediately resume their daily routine.

8 Chris Inglefield, MD presented at ASPRS 2007 Non-invasive Ultrasonic Selective Fat Cell Lysis and Body Contouring Lower Abdomen 3 treatments Pre-Treatment 1-month Post Treatment Photos courtesy of Dr. Chris Inglefield, London, UK Reduction 6.5 cm

9 DMK Rev A UltraShape New Advancements and Clinical Studies Arie Benchetrit, MD, Plastic Surgeon, Montreal, Canada As presented at IMCAS Paris, 2010 Methods: 109 patients received 3 treatments on the abdomen, flanks thighs and/or back rolls. 157 total treatment areas. Results: 96% pf patients experienced measureable circumference reduction. 4.5 cm average circumference reduction Average weight change 0.6 kg

10 DMK Rev A Arie Benchetrit, MD, Plastic Surgeon, Montreal, Canada As presented at IMCAS Paris, 2010 Pre-Treatment 4 Weeks Post Treatment Reduction : 4.7 cm upper abdomen 5.4 cm lower abdomen

11

12

13 A Multicenter, Randomized, Controlled Study to Evaluate the Contour I V3.1 System for Non-Invasive Reduction in Abdominal Circumference Weiss, Coleman, Kenkel, Ad-El US, Israel (IDE study), 2013 Methods: The 22-week long study consisted of a device phase and a follow-up phase, in which 32 patients received a total of 3 treatments on the abdominal region that were performed at baseline and at week-2 and week-4 of the study, and were followed-up at 6, 8, 10, 14, 18 and 22 weeks post-procedure. Patient weight, and abdominal circumferences recorded at the midline, 2 cm above the midline and 2 cm below the midline were measured at enrollment, baseline and at each following visit, and changes in circumferential reduction as well as safety and tolerability of treatment were assessed at the end of the clinical trial. Study participants also completed a questionnaire to help elucidate satisfaction of outcomes and as well as tolerability of treatment. Results: Significant reductions in abdominal circumference could be achieved in all study participants, with results throughout the clinical trial showing a steady decrease in abdominal circumferences recorded at the midline, 2 cm above midline and 2 cm below midline. At the final follow-up assessment, data showed that from baseline, the average reductions in abdominal circumference at the midline, 2 cm above the midline and 2 cm below the midline were -3.5 cm, -3.7 cm and -3.0 cm, respectively. Adverse events recorded throughout the study period were mild and transient in nature, supporting a favorable safety profile for the UltraShape device. Study participants generally tolerated the treatments well, and patient satisfaction questionnaires revealed an overall satisfaction with device treatment during follow-up. Conclusion: The clinical data presented here robustly support both the efficacy and safety of the UltraShape system used for the non-invasive reduction in abdominal circumference.

14 A Multicenter, Randomized, Controlled Study to Evaluate the Contour I V3.1 System for Non- Invasive Reduction in Abdominal Circumference Weiss, Coleman, Kenkel, Ad-El3 US, Israel IDE study Circumference significantly reduced, while subjects weight remained stable along the study course 1 Circumference reduction [cm] Weight change [%] 0 0.0% 0.0% -0.1% -0.5% -0.6% -0.7% -0.5% -0.8% -0.4% Baseline; Tx. 1 2 weeks; Tx. 2 4 weeks; Tx. 3 6 weeks 8 weeks 10 weeks 14 weeks 18 weeks 22 weeks

15

16

17 A Multicenter, Randomized, Controlled Study to Evaluate Multiple Treatments with Non-thermal Focused Ultrasound for Noninvasive Fat Reduction William P. Coleman, III, M.D., William Coleman, III, MD, APMC; Robert A. Weiss, M.D.; Jeffrey M. Kenkel, M.D.; Dean D. Ad-El, M.D. Submitted to Dermatological Surgery Oct Background: Demand for non-surgical aesthetic body procedures has led to the development of non-invasive techniques for reducing localized subcutaneous adipose tissue. Objective: This study assessed multiple treatments with non-thermal focused ultrasound for noninvasive abdominal treatment of excess fat deposits. Methods & Materials: Subjects were randomly assigned to Group 1 for a four-week control phase before undergoing three biweekly abdominal fat reduction treatments or to Group 2 for immediate treatment Weight, abdominal circumference, tolerability to treatment, subject satisfaction and adverse events were recorded. Results: Weight remained stable in the 126 participants. Mean reduction in midline circumference was 2.5±2.1 cm in Group 1 and 3.5±2.7 cm in Group 2 at week 22. The effect of multiple treatments was cumulative with a steady decrease in abdominal circumferences during the study. Erythema was observed in 28% of treatments, but was mild and transient in nature. Subjects tolerated the treatments well and were satisfied with treatment outcome. Conclusion: The study demonstrated efficacy and safety of multiple non-thermal focused ultrasound treatments of excess abdominal fat deposits. Although the remodeling effect is minor compared to traditional surgical procedures, successive focused ultrasound treatments significantly reduced treatment area circumference, while avoiding invasive techniques and their associated disadvantages.

18 A Multicenter, Randomized, Controlled Study to Evaluate Multiple Treatments with Non-thermal Focused Ultrasound for Noninvasive Fat Reduction William P. Coleman, III, M.D., William Coleman, III, MD, APMC; Robert A. Weiss, M.D.; Jeffrey M. Kenkel, M.D.; Dean D. Ad-El, M.D. Submitted to Dermatological Surgery Oct Figure 1. Mean abdominal circumference by visit in Group 1 and Group 2. (TX/FU). TX = Treatment and FU = Follow-up.