BARIATRIC SURGERY: GLOBAL MARKETS FOR SERVICES AND DEVICES. HLC153A November Dr. Ritu Thakur Dangi Project Analyst ISBN:

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1 BARIATRIC SURGERY: GLOBAL MARKETS FOR SERVICES AND DEVICES HLC153A November 2013 Dr. Ritu Thakur Dangi Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA , Custom Reports: carol.laverty@bccresearch.com

2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 BARIATRIC SURGERY 2 STUDY BACKGROUND 2 STUDY GOALS AND OBJECTIVES 3 INTENDED AUDIENCE 3 SCOPE OF THE REPORT 4 METHODOLOGY AND INFORMATION SOURCES 4 ANALYST CREDENTIALS 5 RELATED BCC RESEARCH STUDIES 5 BCC RESEARCH ONLINE SERVICES 5 DISCLAIMER 5 CHAPTER 2 EXECUTIVE SUMMARY 7 EXECUTIVE SUMMARY 7 SUMMARY TABLE GLOBAL MARKET FOR BARIATRIC SURGERY BY REGION, THROUGH 2018 ($ MILLIONS) SUMMARY FIGURE GLOBAL MARKET FOR BARIATRIC SURGERY BY REGION, ($ MILLIONS) 7 7 CHAPTER 3 OVERVIEW OF OBESITY 10 DISEASE OVERVIEW 10 COMMON TOOLS TO DIAGNOSE OBESITY 10 BMI 10 TABLE 1 BMI CALCULATION 10 Waist Circumference 10 TYPES OF OBESITY 11 TABLE 2 BMI CATEGORIES BASED ON INCREASING HEALTH RISKS 11 ETIOLOGY AND PATHOPHYSIOLOGY 11 FIGURE 1 ENERGY BALANCE, RISK FACTORS 13 ECONOMIC BURDEN 14 EPIDEMIOLOGY 15 TABLE 3 GLOBAL OBESE POPULATION AND SEVERE OBESE POPULATION VS GENERAL POPULATION, THROUGH 2012 (MILLIONS) FIGURE 2 GLOBAL OBESE POPULATION AND SEVERE OBESE POPULATION, 2008 AND 2012 (% OF GLOBAL GENERAL POPULATION) TABLE 4 U.S. OBESITY AND SEVERE OBESITY VS GENERAL POPULATION, THROUGH 2012 (MILLIONS) OBESITY TREATMENT AND MANAGEMENT 18 GOALS OF WEIGHT LOSS AND MANAGEMENT 18 WEIGHT MANAGEMENT 18 DIETARY THERAPY 19 PHYSICAL ACTIVITY 19 BEHAVIORAL THERAPY 20 COMBINED THERAPY 20 PHARMACOTHERAPY

3 BARIATRIC SURGERY (WEIGHT-LOSS SURGERY) 21 CHAPTER 4 OBESITY AND DIABETES TYPE 2 23 OBESITY AND DIABETES 23 DIABETES MELLITUS (DM) 23 GESTATIONAL DIABETES 23 LATENT AUTOIMMUNE DIABETES IN ADULTS (LADA) 23 FIGURE 3 GLOBAL DIABETES TYPES (% OF TOTAL DIABETES) 24 TYPE 2 DIABETES: ETIOLOGY AND PATHOPHYSIOLOGY 24 DISEASE SYMPTOMS AND RISK FACTORS 25 EPIDEMIOLOGY 26 TABLE 5 GLOBAL DIABETES PREVALENCE, 2012 AND TREATMENT AND MANAGEMENT OPTIONS 27 LIFESTYLE CHANGES 27 ANTIOBESITY MEASURES (PHARMACOLOGIC AGENTS) 28 DIABETES MEDICATIONS AND INSULIN THERAPY 28 BARIATRIC SURGERY 29 MARKET BURDEN 29 CHAPTER 5 OVERVIEW OF BARIATRIC PROCEDURES 32 GENERAL OVERVIEW 32 CRITERIA FOR BARIATRIC SURGERY 32 LAPAROSCOPIC SURGERY VS. OPEN SURGERY 32 FIGURE 4 GLOBAL OPEN VS. LAPAROSCOPIC BARIATRIC SURGERY OCCURRENCE, 2012 (% OF TOTAL BARIATRIC PROCEDURES) BARIATRIC SURGERY PREPARATION 34 DIET MONITORING 34 DIET CONSULTATION 35 PSYCHOLOGICAL CONSULTATION 35 SCREENING BLOOD TESTS 35 INSURANCE COVERAGE 35 TYPES OF BARIATRIC SURGERIES 35 TABLE 6 TYPES OF BARIATRIC SURGERIES 36 MALABSORPTIVE 36 Biliopancreatic Diversion (BPD) 36 Advantages 37 Disadvantages 37 Biliopancreatic Diversion with a Duodenal Switch (BPD-DS) 37 Extended (Distal) Roux-en-Y Gastric Bypass (RYGBP-E) 38 Mini Gastric Bypass 38 Advantages of Malabsorptive Procedures 38 Disadvantages of Malabsorptive Procedures 38 RESTRICTIVE PROCEDURES 39 Sleeve Gastrectomy (SG) 39 Vertical Sleeve Gastrectomy (VSG) 39 Adjustable Gastric Banding (AGB) 40 Gastric Balloons 40 Advantages of Restrictive Procedures 40 34

4 Disadvantages of Restrictive Procedures 41 COMBINED RESTRICTIVE/MALABSORPTIVE 42 Gastric Bypass 42 Roux-en-Y Gastric Bypass (RYGB) 43 Advantages of Gastric Bypass 43 Disadvantages of Gastric Bypass 44 NEW BARIATRIC PROCEDURES 44 PRIMARY OBESITY SURGERY ENDOLUMINAL (POSE) PROCEDURE 44 Procedure Design 45 Clinical Trials 46 RESTORATIVE OBESITY SURGERY ENDOSCOPIC (ROSE) PROCEDURE 46 Procedure 46 Clinical Trials 47 Advantages of ROSE Procedure 47 ROSE Procedure: Procedure Cost 47 BENEFITS OF BARIATRIC SURGERY 47 RISKS AND COMPLICATIONS OF BARIATRIC SURGERY 51 PULMONARY EMBOLISM 51 GASTROINTESTINAL TRACT LEAK 52 BOWEL OBSTRUCTION (BLOCKAGES) 52 STRICTURE 52 BLEEDING 53 ULCER 53 GALLSTONES 53 INFECTIONS 53 CHRONIC NUTRITIONAL PROBLEMS 54 CONVERSION TO OPEN PROCEDURE 55 FAILURE OF WEIGHT LOSS 55 TOO MUCH WEIGHT LOSS 55 BODY IMAGE, EMOTIONAL LOSS AND DEPRESSION 56 NEUROPATHY 56 HYPOGLYCEMIA (LOW BLOOD SUGARS) 56 KIDNEY FAILURE/STONES 57 COMPLICATIONS FROM ANESTHESIA 57 DEATH 57 OTHER COMPLICATIONS 57 BARIATRIC PROCEDURE HISTORIC AND CURRENT TRENDS 58 GLOBAL 58 TABLE 7 GLOBAL BARIATRIC PROCEDURES, THROUGH FIGURE 5 GLOBAL BARIATRIC PROCEDURE TYPES, 2012 (% OF ALL BARIATRIC PROCEDURES) FIGURE 6 GLOBAL BARIATRIC PROCEDURE BY REGION, 2012 (% OF GLOBAL PROCEDURES) NORTH AMERICA 60 TABLE 8 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, THROUGH 2012 FIGURE 7 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, 2012 (% OF ALL BARIATRIC PROCEDURES)

5 AVERAGE PROCEDURE COST OF BARIATRIC SURGERY 61 TABLE 9 AVERAGE COST OF BARIATRIC SURGERY BY PROCEDURE TYPE ($) 62 FACTORS AFFECTING BARIATRIC SURGERY COST 62 BARIATRIC SURGERY: COMPARATIVE ANALYSIS 63 TABLE 10 BARIATRIC SURGERY, COMPARATIVE ANALYSIS 63 HISTORY OF BARIATRIC SURGERY 64 JAW WIRING 65 JEJUNOILEAL BYPASS 65 GASTRIC PARTITIONING 65 VERTICAL BAND GASTROPLASTY (VBG) 66 GASTRIC BALLOONS 66 CHAPTER 6 OVERVIEW OF BARIATRIC SURGERY DEVICES 68 BARIATRIC SURGERY DEVICES 68 GASTRIC BYPASS 68 GASTRIC REMOVAL DEVICES 68 IMPLANTED GASTRIC DEVICES 68 Gastric Bands 68 Intragastric Balloons (IGB) 68 TABLE 11 PRINCIPAL TYPES OF BARIATRIC SURGERY DEVICES 69 REGULATORY STATUS OF BARIATRIC SURGERY DEVICES 70 UNITED STATES 70 EUROPEAN UNION (EU) 73 JAPAN 74 OTHER ASIA 75 China 75 Hong Kong 75 Taiwan 76 India 76 END-USER SEGMENTS 76 CHAPTER 7 UNMET NEED FOR OBESITY AND DIABETES TYPE 2 78 CHAPTER 8 BARIATRIC SURGERY MARKET ASSESSMENT 81 BARIATRIC PROCEDURES AND SERVICES MARKET 81 GLOBAL 81 TABLE 12 GLOBAL BARIATRIC PROCEDURE OCCURRENCE BY TYPES, THROUGH 2018 FIGURE 8 GLOBAL BARIATRIC PROCEDURE OCCURRENCE BY TYPE, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) TABLE 13 BARIATRIC PROCEDURE OCCURRENCE BY REGION, THROUGH FIGURE 9 BARIATRIC PROCEDURE OCCURRENCE BY REGION, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) NORTH AMERICA 84 TABLE 14 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, THROUGH 2018 FIGURE 10 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY)

6 EUROPE 85 TABLE 15 BARIATRIC PROCEDURE OCCURRENCE IN EUROPE, THROUGH FIGURE 11 BARIATRIC PROCEDURE OCCURRENCE IN EUROPE, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) ASIA 87 TABLE 16 BARIATRIC PROCEDURE OCCURRENCE IN ASIA, THROUGH FIGURE 12 BARIATRIC PROCEDURE OCCURRENCE IN ASIA, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) PROJECTED TRENDS IN BARIATRIC SURGERY 89 BARIATRIC SURGERY DEVICES MARKET 89 GLOBAL BARIATRIC SURGERY DEVICE MARKET BY GEOGRAPHY 89 TABLE 17 BARIATRIC SURGERY BY REGION, THROUGH 2018 ($ MILLIONS) 90 FIGURE 13 BARIATRIC SURGERY BY REGION, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) GLOBAL BARIATRIC SURGERY DEVICES MARKET BY PROCEDURE TYPE 91 North America 91 TABLE 18 NORTH AMERICA BARIATRIC SURGERY BY DEVICE, THROUGH 2018 ($ MILLIONS) FIGURE 14 NORTH AMERICA BARIATRIC SURGERY BY DEVICE, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) Asia 92 TABLE 19 ASIA BARIATRIC SURGERY BY TYPE, THROUGH 2018 ($ MILLIONS) 93 FIGURE 15 ASIA BARIATRIC SURGERY BY DEVICE, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) Europe 95 TABLE 20 EUROPE BARIATRIC SURGERY BY DEVICE, THROUGH 2018 ($ MILLIONS) 95 FIGURE 16 EUROPE BARIATRIC SURGERY BY DEVICE, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) GLOBAL IMPLANTED BARIATRIC SURGERY DEVICES MARKET 97 TABLE 21 GLOBAL IMPLANTED DEVICES, THROUGH 2018 ($ MILLIONS) 97 MARKET GROWTH DRIVERS AND RESTRAINTS 97 GROWTH DRIVERS 97 Global Obesity Epidemic 97 Diabetes Prevalence 98 Less Invasive/Noninvasive Procedures 98 Western Food Habits and Sedentary Lifestyles 98 Reimbursement 98 Increasing Awareness in Developed Nations 98 Medical Tourism 99 GROWTH RESTRAINTS 99 Lack of Awareness, Availability and Affordability in Developing Nations High Cost of Bariatric Surgery 99 Long Wait Time 99 Short-Term and Long-Term Complications CHAPTER 9 COMPETITION AND MARKET SHARES 101 TABLE 22 GLOBAL BARIATRIC SURGERY MARKET SHARES BY COMPANY, 2012 ($ MILLIONS/$) 101

7 FIGURE 17 GLOBAL BARIATRIC SURGERY MARKET LEADERS, 2012 (% OF TOTAL MARKET) 101 CHAPTER 10 MARKETED, ABANDONED AND PIPELINE PRODUCTS 104 MARKETED PRODUCTS 104 TABLE 23 BARIATRIC SURGERY DEVICES, KEY MARKETED PRODUCTS (1/2) 104 TABLE 24 BARIATRIC SURGERY DEVICES, KEY MARKETED PRODUCTS (2/2) 105 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 106 REALIZE ADJUSTABLE GASTRIC BAND 106 ORBERA WEIGHT MANAGEMENT SYSTEM 106 ENSEAL 107 PERI-STRIPS DRY WITH VERITAS 107 ENDOPATH XCEL TROCAR 107 ECHELON FLEX POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTERS 108 HARMONIC ACE SHEARS + ADAPTIVE TISSUE TECHNOLOGY 108 ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY 109 Endo GIA Reload 109 ENDO STITCH ENDOSCOPIC SUTURING DEVICE 110 ENDOGASTRIC SOLUTIONS STOMAPHYX DELIVERY DEVICE, FASTENERS AND ACCESSORIES HELIOSPHERE BAG 111 HELIOGAST 111 Heliogast HAGE 111 Heliogast HAGA 111 ENDOCINCH 112 ENDOSURGICAL OPERATING SYSTEM (EOS) 112 ABANDONED PRODUCTS 113 GARREN-EDWARDS GASTRIC BUBBLE (GEGB) 113 TABLE 25 BARIATRIC SURGERY DEVICES, KEY ABANDONED/ DISCONTINUED PRODUCTS EASYBAND 113 PIPELINE PRODUCTS 114 ENDOBARRIER 114 General Description 114 Procedure 114 Clinical Trials 114 TABLE 26 ENDOBARRIER, CLINICAL TRIALS 115 Advantages 117 Disadvantages 117 EndoBarrier: Procedure Cost 117 TABLE 27 BARIATRIC SURGERY DEVICES, KEY PIPELINE PRODUCTS (1/2) 118 TABLE 28 BARIATRIC SURGERY DEVICES, KEY PIPELINE PRODUCTS (2/2) 119 VALENTX 120 General Description 120 Clinical Trials 120 TABLE 29 VALENTX, CLINICAL TRIALS 120 Advantages 121 ASPIREASSIST

8 General Description 122 Clinical Trials 122 TABLE 30 ASPIREASSIST, CLINICAL TRIAL 123 Procedure 123 TANTALUS SYSTEM 123 General Description 123 Clinical Trials 124 TABLE 31 TANTALUS SYSTEM, CLINICAL TRIAL 125 Procedure 126 DEEP BRAIN STIMULATION SYSTEM/TRIGEMINAL NERVE STIMULATION (TNS) OBESITY General Description 127 Clinical Trials 127 TABLE 32 TRIGEMINAL NERVE STIMULATION (TNS), CLINICAL TRIAL 128 ENDORETICS DEVICE 128 General Description 128 Procedure 128 ATTIVA 129 INTRA GASTRIC IMPLANT 129 VBLOC THERAPY/MAESTRO RC SYSTEM 129 General Description 129 Clinical Trials 130 TABLE 33 VBLOC THERAPY/MAESTRO RC SYSTEM, CLINICAL TRIALS 130 Procedure 131 NOBESE DEVICE 131 General Description 131 Procedure 131 SATISPHERE 132 General Description 132 Clinical Trials 132 Procedure 132 SILIMED GASTRIC BALLOON 133 General Description 133 Procedure 133 Clinical Trial 133 TABLE 34 SILIMED GASTRIC BALLOON, CLINICAL TRIAL 133 TRANSPYLORIC SHUTTLE 134 General Description 134 Clinical Trials 134 TABLE 35 TRANSPYLORIC SHUTTLE DEVICE, CLINICAL TRIAL 134 Procedure 134 TOGA SYSTEM 135 General Description 135 Clinical Trials 135 TABLE 36 TOGA SYSTEM, CLINICAL TRIALS 135 Procedure 135 SENSATE ANCHORED GASTRIC DEVICE 136 General Description

9 Procedure 136 Clinical Trial 136 TABLE 37 SENSATE ANCHORED GASTRIC DEVICE, CLINICAL TRIALS 136 ABILITI 137 General Description 137 Clinical Trials 137 TABLE 38 ABILITI SYSTEM, CLINICAL TRIALS 138 CHAPTER 11 REIMBURSEMENT 140 GENERAL REIMBURSEMENT CRITERIA 140 UNITED STATES 140 ICD-9-CM 141 TABLE 39 BARIATRIC SURGERY, INTERNATIONAL CLASSIFICATION OF DISEASES, NINTH REVISION (ICD-9) CODES TABLE 40 COVERED INPATIENT FACILITY ICD-9-CM PROCEDURE CODES 141 ICD EUROPE 142 JAPAN 143 OTHER ASIA CHAPTER 12 CONCLUSIONS: THE OUTLOOK FOR BARIATRIC SURGERY DEVICES 146 MAJOR DEVELOPMENTS THAT WILL INFLUENCE THE BARIATRIC SURGERY MARKET TECHNOLOGICAL DEVELOPMENTS 146 Adaptation of Minimally Invasive Techniques to New Types of Surgical Procedures Endoluminal Procedures 147 Gastric Stimulators 147 New Designs of Gastric Balloons 148 DEMOGRAPHIC AND ECONOMIC TRENDS 148 Growing Obesity Populations Worldwide 148 TABLE 41 TRENDS IN OBESITY COMPOSITION OF THE WORLD'S POPULATION, THROUGH 2018 (MILLIONS) TABLE 42 U.S. OBESITY AND SEVERE OBESITY VS GENERAL POPULATION, THROUGH 2018 (MILLIONS) Income Growth in Developing Markets 149 TABLE 43 PROJECTED TRENDS IN PER CAPITA REAL GDP GROWTH BY REGION, (ANNUAL AVERAGE PERCENTAGE CHANGE) CHANGING STRUCTURE OF THE HEALTH CARE INDUSTRY 150 Hospital Consolidation 150 Medical Tourism 151 Health Insurance Developments 151 LONG-TERM OUTLOOK FOR BARIATRIC SURGERY DEVICES AND SERVICES CHAPTER 13 APPENDIX A: ABBREVIATION(S) 154 CHAPTER 14 APPENDIX B: VENDOR PROFILES 157 ALLERGAN 157 APPLIED MEDICAL 157

10 ASPIRE BARIATRICS 158 BARONOVA 158 BAROSENSE 159 BETA-STIM 159 C.R. BARD 160 COOK GROUP 160 COVIDIEN 161 ENDOGASTRIC SOLUTIONS 161 ENDORETICS 162 ENDOSPHERE 162 ENTEROMEDICS 163 ETHICON ENDO-SURGERY/JOHNSON & JOHNSON 163 GELESIS 164 GI DYNAMICS 164 HELIOSCOPIE 165 INTRAPACE, INC. 165 MEDTRONIC 166 METACURE 167 NEUROSIGMA 167 RESHAPE MEDICAL 168 SATIETY 168 SENSATE 169 SILHOUETTE MEDICAL 169 SLIMEDICS 169 SYNOVIS SURGICAL 170 USGI MEDICAL 170 VALENTX 171 W. L. GORE 171 CHAPTER 15 APPENDIX C: INDUSTRY AND PROFESSIONAL ORGANIZATIONS 173 THE AMERICAN SOCIETY FOR METABOLIC AND BARIATRIC SURGERY (ASMBS) 173 EUROPEAN ASSOCIATION FOR ENDOSCOPIC SURGERY (EAES) 173 INTERNATIONAL ASSOCIATION FOR THE STUDY OF OBESITY 173 INTERNATIONAL DIABETES FEDERATION (IDF) 174 INTERNATIONAL FEDERATION FOR THE SURGERY OF OBESITY AND METABOLIC DISORDERS INTERNATIONAL OBESITY TASK FORCE (IOTF) 174 OBESITY IN AMERICA 175 THE OBESITY SOCIETY 175 SOCIETY OF AMERICAN GASTROINTESTINAL ENDOSCOPIC SURGEONS (SAGES) 175 SOCIETY OF LAPAROENDOSCOPIC SURGEONS (SLS)

11 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL MARKET FOR BARIATRIC SURGERY BY REGION, THROUGH 2018 ($ MILLIONS) TABLE 1 BMI CALCULATION 10 TABLE 2 BMI CATEGORIES BASED ON INCREASING HEALTH RISKS 11 TABLE 3 GLOBAL OBESE POPULATION AND SEVERE OBESE POPULATION VS GENERAL POPULATION, THROUGH 2012 (MILLIONS) TABLE 4 U.S. OBESITY AND SEVERE OBESITY VS GENERAL POPULATION, THROUGH 2012 (MILLIONS) TABLE 5 GLOBAL DIABETES PREVALENCE, 2012 AND TABLE 6 TYPES OF BARIATRIC SURGERIES 36 TABLE 7 GLOBAL BARIATRIC PROCEDURES, THROUGH TABLE 8 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, THROUGH TABLE 9 AVERAGE COST OF BARIATRIC SURGERY BY PROCEDURE TYPE ($) 62 TABLE 10 BARIATRIC SURGERY, COMPARATIVE ANALYSIS 63 TABLE 11 PRINCIPAL TYPES OF BARIATRIC SURGERY DEVICES 69 TABLE 12 GLOBAL BARIATRIC PROCEDURE OCCURRENCE BY TYPES, THROUGH TABLE 13 BARIATRIC PROCEDURE OCCURRENCE BY REGION, THROUGH TABLE 14 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, THROUGH 2018 TABLE 15 BARIATRIC PROCEDURE OCCURRENCE IN EUROPE, THROUGH TABLE 16 BARIATRIC PROCEDURE OCCURRENCE IN ASIA, THROUGH TABLE 17 BARIATRIC SURGERY BY REGION, THROUGH 2018 ($ MILLIONS) 90 TABLE 18 NORTH AMERICA BARIATRIC SURGERY BY DEVICE, THROUGH 2018 ($ MILLIONS) TABLE 19 ASIA BARIATRIC SURGERY BY TYPE, THROUGH 2018 ($ MILLIONS) 93 TABLE 20 EUROPE BARIATRIC SURGERY BY DEVICE, THROUGH 2018 ($ MILLIONS) 95 TABLE 21 GLOBAL IMPLANTED DEVICES, THROUGH 2018 ($ MILLIONS) 97 TABLE 22 GLOBAL BARIATRIC SURGERY MARKET SHARES BY COMPANY, 2012 ($ MILLIONS/$) TABLE 23 BARIATRIC SURGERY DEVICES, KEY MARKETED PRODUCTS (1/2) 104 TABLE 24 BARIATRIC SURGERY DEVICES, KEY MARKETED PRODUCTS (2/2) 105 TABLE 25 BARIATRIC SURGERY DEVICES, KEY ABANDONED/ DISCONTINUED PRODUCTS TABLE 26 ENDOBARRIER, CLINICAL TRIALS 115 TABLE 27 BARIATRIC SURGERY DEVICES, KEY PIPELINE PRODUCTS (1/2) 118 TABLE 28 BARIATRIC SURGERY DEVICES, KEY PIPELINE PRODUCTS (2/2) 119 TABLE 29 VALENTX, CLINICAL TRIALS 120 TABLE 30 ASPIREASSIST, CLINICAL TRIAL 123 TABLE 31 TANTALUS SYSTEM, CLINICAL TRIAL 125 TABLE 32 TRIGEMINAL NERVE STIMULATION (TNS), CLINICAL TRIAL 128 TABLE 33 VBLOC THERAPY/MAESTRO RC SYSTEM, CLINICAL TRIALS 130 TABLE 34 SILIMED GASTRIC BALLOON, CLINICAL TRIAL 133 TABLE 35 TRANSPYLORIC SHUTTLE DEVICE, CLINICAL TRIAL 134 TABLE 36 TOGA SYSTEM, CLINICAL TRIALS 135 TABLE 37 SENSATE ANCHORED GASTRIC DEVICE, CLINICAL TRIALS 136 TABLE 38 ABILITI SYSTEM, CLINICAL TRIALS 138 TABLE 39 BARIATRIC SURGERY, INTERNATIONAL CLASSIFICATION OF DISEASES, NINTH REVISION (ICD-9) CODES

12 TABLE HEADING TABLE 40 COVERED INPATIENT FACILITY ICD-9-CM PROCEDURE CODES 141 TABLE 41 TRENDS IN OBESITY COMPOSITION OF THE WORLD'S POPULATION, THROUGH 2018 (MILLIONS) TABLE 42 U.S. OBESITY AND SEVERE OBESITY VS GENERAL POPULATION, THROUGH 2018 (MILLIONS) TABLE 43 PROJECTED TRENDS IN PER CAPITA REAL GDP GROWTH BY REGION, (ANNUAL AVERAGE PERCENTAGE CHANGE)

13 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL MARKET FOR BARIATRIC SURGERY BY REGION, ($ MILLIONS) FIGURE 1 ENERGY BALANCE, FIGURE 2 GLOBAL OBESE POPULATION AND SEVERE OBESE POPULATION, 2008 AND 2012 (% OF GLOBAL GENERAL POPULATION) FIGURE 3 GLOBAL DIABETES TYPES (% OF TOTAL DIABETES) 24 FIGURE 4 GLOBAL OPEN VS. LAPAROSCOPIC BARIATRIC SURGERY OCCURRENCE, 2012 (% OF TOTAL BARIATRIC PROCEDURES) FIGURE 5 GLOBAL BARIATRIC PROCEDURE TYPES, 2012 (% OF ALL BARIATRIC PROCEDURES) FIGURE 6 GLOBAL BARIATRIC PROCEDURE BY REGION, 2012 (% OF GLOBAL PROCEDURES) FIGURE 7 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, 2012 (% OF ALL BARIATRIC PROCEDURES) FIGURE 8 GLOBAL BARIATRIC PROCEDURE OCCURRENCE BY TYPE, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) FIGURE 9 BARIATRIC PROCEDURE OCCURRENCE BY REGION, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) FIGURE 10 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) FIGURE 11 BARIATRIC PROCEDURE OCCURRENCE IN EUROPE, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) FIGURE 12 BARIATRIC PROCEDURE OCCURRENCE IN ASIA, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) FIGURE 13 BARIATRIC SURGERY BY REGION, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) FIGURE 14 NORTH AMERICA BARIATRIC SURGERY BY DEVICE, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) FIGURE 15 ASIA BARIATRIC SURGERY BY DEVICE, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) FIGURE 16 EUROPE BARIATRIC SURGERY BY DEVICE, 2012 AND 2018 (% OF TOTAL BARIATRIC SURGERY) FIGURE 17 GLOBAL BARIATRIC SURGERY MARKET LEADERS, 2012 (% OF TOTAL MARKET)