Non-invasive Fat Reduction Using Focused Ultrasound There are Two Major Types of Fat What is Fat? Fat cells store excess lipids that are not used as energy. Stubborn Fat Is Resistant to Diet & Exercise 70% of women say they worry about developing a tummy bulge1 1 in 3 women say they have considered more than just dieting and exercise to get rid of their fat2 91% of women say there are Most people have tried diet & exercise But they still feel it’s not enough2 things about their body they want to change or reduce2 What is the UltraShape Procedure? UltraShape is the first and only FDA cleared procedure that uses focused pulsed ultrasound to: Precisely destroy fat cells protecting surrounding tissue, nerves and muscle For immediate, long-lasting body contouring With no downtime, no discomfort and no side effects UltraShape targets problem areas of stubborn SUBCUTANEOUS FAT Why Patients Love UltraShape Non Surgical Fast Results No Heat No Cold Just Comfort No Downtime Affordable Visible Results How UltraShape Gets Rid of Your Stubborn Fat How UltraShape Gets Rid of Your Stubborn Fat • Ultrasound energy is delivered precisely to stubborn subcutaneous fat 1.5 cm below the skins surface • Rapidly changing pressure waves create vapor cavities in fat cells • The mechanical stress caused by pressure stresses fat cell membranes causing them to break – releasing lipids (fat) • Fat cells are destroyed while skin, nerves, blood vessels and connective tissue are unharmed • Effect is purely mechanical, which means no discomfort or heating Where Does the Fat Go? Once fat cells are fractured: • Freed triglycerides (fat) are safely cleared from the local area Transported to the liver and used as energy Fat Cells UltraShape • • They are processed by the body’s natural metabolic pathways and transported to the liver to be used as energy Clinical studies have proven that there are no clinically significant changes in lipid profiles Release of Triglycerides 3 Free Fatty Acids Glycerol Fat [from the UltraShape procedure] is ultimately processed by the body’s natural physiological and metabolic pathways that handle fat during weight loss.” Spencer A. Brown, PhD, Director of Plastic Surgery Research UT Southwestern Medical Center Is the UltraShape Procedure Safe? • The UltraShape procedure has an excellent safety record • Over 250,000 patient treatments have been safely performed worldwide • Over 600 patients have been the subject of clinical studies on the UltraShape Procedure • As with any medical procedure there is always some risk • Ask your doctor if you would like additional information on the safety of the UltraShape procedure A Selection of Clinical Studies on UltraShape Investigator Leal H.2,3 Monterrey, Mexico Moreno-Moraga J1 Madrid, Spain Ascher B.1 Paris, France Leal H.2,3 Monterrey, Mexico Ad El D.2,3 Beilinson Med, Israel Inglefield C.2 London, UK de Almeida G.2 Sao Paulo, Brazil Benchetrit A.2 Montreal, Canada Ascher B.1 Paris, France S.-L. Chang1,2 Taiwan 1Published Year Patient Population Avg. Circumference Reduction 2009 24 3.0-3.4 cm (1 combo tx) 2006 30 3.95 cm 100% measurable and visual improvement 2007-08 25 3.58 cm 83% > 1.0 cm circumference reduction 2007-08 36 5.0 cm 100% measureable reduction 94% patient satisfaction 2008 26 3.96 cm 90% > 2.0 cm circumference reduction 2005-06 148 6.3 cm 93% patient satisfaction 2007-08 20 5.4 cm 100% measurable reduction 86% patient satisfaction 2007-09 109 4.5 cm 96% measurable reduction 86% patient satisfaction 2010 25 3.58 cm (3 tx) 90% reported no pain 2013 32 3.91 cm (3 tx) 21.4 and 25% reduction in fat thickness measured by MRI in peer-reviewed journal 2Presented in scientific conference 3Data on file Results 96% > 1.5 cm circumference reduction 100% patient satisfaction What to Expect Am I A Candidate? The UltraShape procedure is for: • • • Reduction of localized fat deposits Reduction of abdominal circumference Improving body shape and contour A good UltraShape candidate: • • • • Has a BMI under 30 Can pinch an inch of soft subcutaneous fat Maintains a healthy lifestyle and diet Has realistic expectations UltraShape is not a treatment for weight loss, obesity, severe skin laxity, cellulite, or a replacement for liposuction UltraShape May Not Be Right For You If: • Pacemaker, implanted cardiac defibrillator, or other electromagnetic implanted devices • Pregnant, or breast feeding or anticipated pregnancy during the treatment phase • Metabolic disorders or are currently taking any medication that could affect fat metabolism • Hepatitis or other liver diseases • Immune system disease or connective tissue disorders • History of poor wound healing, an open wound or rash in the treatment area • Keloids, hypertrophic scars, or depressed scars in the treatment area • Blood or bleeding disorders What Does An UltraShape Treatment Feel Like? How long does the UltraShape procedure take? • An UltraShape treatment lasts between 45 minutes – 1 hour • For best results, we recommend a series of three treatments 2 weeks apart Is the UltraShape procedure painful? • The UltraShape procedure is performed during a convenient, “walk-in, walk-out” session performed at an authorized UltraShape treatment center • The UltraShape procedure uses pulsed ultrasound, so there is no discomfort caused by cold or heat • Some patients report a slight-to-moderate tingling sensation • The vast majority of patients report a comfortable treatment experience Preparing For Your UltraShape Procedure Step I : Treatment Consultation Your trained UltraShape treatment provider will : 1. Discuss the treatment with you and answer any questions you have 2. Medically evaluate you to confirm you are a good candidate 3. Check if you have enough fat thickness (over 3 cm) in the treatment area by using a finger pinch test or caliper pinch test. 4. Identify and mark area to be treated 5. Determine treatment pricing based on area to the treated Step II: Recording Measurements 1. Record measurements of the area to be treated to track circumferential reduction 2. Measurements will be taken and recorded before each treatment 3. A specially designed belt will be placed around your abdomen to isolate the area to be treated Step III: The UltraShape Treatment 1. Markers will be placed around the treatment area for the system to outline the treatment area 2. A special ultrasound gel will be applied on the treatment area 3. Treatment will begin and your entire marked “problem area” will be treated 4. Once treatment is completed, the gel will be wiped from the treatment area 5. Your next appointment will be scheduled in 2 weeks Post-Treatment Instructions • Resume daily routine • Avoid weight gain • Eat a healthy diet • Get routine exercise • Reveal your UltraShape! Treated fat cells are permanently destroyed. But remember that the key to maintaining your good results is to eat a good diet and have an active, healthy lifestyle. Patient Results When Will I See Results? • Results are often visible within 10-14 days after the 1st treatment* • You will see continued reduction up to 3 months after the completion of your 3rd treatment • Clinical studies show average reduction of 3.4 cm - 6.3 cm after 3 treatments • Maintaining a healthy lifestyle, good diet and exercise program are key to optimizing your results Results may vary. Not everyone will experience similar results, each individual will respond differently to the treatment. UltraShape Results Abdomen Before UltraShape After 3 Treatments 4.0 cm reduction Photos courtesy of D. Ad El, MD UltraShape Results Abdomen Before UltraShape After 3 Treatments 7.9 cm reduction Photos courtesy of D. Ad El, MD UltraShape Results Upper/Lower Abdomen Before UltraShape After 3 Treatments 4.7 cm reduction upper abdomen 5.4 cm reduction lower abdomen Photos courtesy of A. Benchetrit, MD UltraShape Results Abdomen Before UltraShape After 2 Treatments 3.1 cm reduction Photos courtesy of M. Lupin, MD 1Data on file UltraShape Results Abdomen Before UltraShape After 2 Treatments 7.7 cm reduction Photos courtesy of D. Ad El, MD UltraShape Results Abdomen Before UltraShape After 1 Treatment 6.8 cm reduction Photos courtesy of H. Leal-Silva UltraShape Results Lower Abdomen Before UltraShape After 3 Treatments 6.5 cm reduction Photos courtesy of C. Inglefield, MD, London, UK UltraShape Results Abdomen Before UltraShape After 3 Treatments 5.0 cm reduction Photos courtesy of B. Ascher, MD Non-invasive Fat Reduction Using Focused Ultrasound PB85591EN-NA