Continuous Glucose Monitoring Systems-Medical Devices Pipeline Assessment, 2017

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 8

1.2 List of Figures 13

2 Introduction 14

2.1 Continuous Glucose Monitoring Systems Overview 14

3 Products under Development 15

3.1 Continuous Glucose Monitoring Systems-Pipeline Products by Stage of Development 15

3.2 Continuous Glucose Monitoring Systems-Pipeline Products by Territory 16

3.3 Continuous Glucose Monitoring Systems-Pipeline Products by Regulatory Path 18

3.4 Continuous Glucose Monitoring Systems-Pipeline Products by Estimated Approval Date 19

3.5 Continuous Glucose Monitoring Systems-Ongoing Clinical Trials 20

4 Continuous Glucose Monitoring Systems-Pipeline Products under Development by Companies 21

4.1 Continuous Glucose Monitoring Systems Companies-Pipeline Products by Stage of Development 21

4.2 Continuous Glucose Monitoring Systems-Pipeline Products by Stage of Development 24

5 Continuous Glucose Monitoring Systems Companies and Product Overview 27

5.1 A. Menarini Diagnostics S.r.l. Company Overview 27

5.2 Abbott Diabetes Care, Inc. Company Overview 29

5.3 Advanced Biosensors-Ohio, Llc Company Overview 35

5.4 Advanced Medical Electronics Corporation Company Overview 36

5.5 Arkal Medical, Inc. Company Overview 37

5.6 Bio-Impedance General Ltd. Company Overview 38

5.7 Biorasis, Inc. Company Overview 39

5.8 Biovotion AG Company Overview 40

5.9 CALISTO MEDICAL, INC. (Inactive) Company Overview 42

5.10 Cardiff University Company Overview 43

5.11 City, University of London Company Overview 44

5.12 Columbia University Company Overview 45

5.13 ConvaTec Group Plc Company Overview 46

5.14 Cyber Medical Ltd. Company Overview 47

5.15 Debiotech SA Company Overview 48

5.16 DexCom Inc Company Overview 49

5.17 DirectSens GmbH Company Overview 52

5.18 Echo Therapeutics Inc Company Overview 53

5.19 Ecole Polytechnique Federale de Lausanne Company Overview 56

5.20 eLutions Integrated Systems, Inc. Company Overview 57

5.21 EyeSense GmbH Company Overview 58

5.22 Flowsion A/S Company Overview 62

5.23 Gili Medical Ltd Company Overview 64

5.24 Globe Medical Tech Inc Company Overview 65

5.25 GlucoLight Corporation (Inactive) Company Overview 66

5.26 Glucometrix AG Company Overview 67

5.27 Glucosense Diagnostics Ltd Company Overview 68

5.28 GlucoSet AS Company Overview 69

5.29 Glucovation Inc Company Overview 70

5.30 GluMetrics Inc Company Overview 71

5.31 GlySens Inc Company Overview 72

5.32 GlySure Ltd Company Overview 75

5.33 G-Sense Ltd. Company Overview 77

5.34 Guided Therapeutics Inc Company Overview 78

5.35 iGlyko, Inc. Company Overview 79

5.36 Indigo Diabetes NV Company Overview 80

5.37 Institute of Biomedical Engineering (ISIB-CNR) (Inactive) Company Overview 81

5.38 Insulet Corp Company Overview 82

5.39 Integrated Medical Group of Irvine Company Overview 84

5.40 Integrity Applications Ltd Company Overview 85

5.41 Invivomon Inc (Inactive) Company Overview 87

5.42 Invivosense ASA (Inactive) Company Overview 88

5.43 iSense Corporation (Inactive) Company Overview 89

5.44 Massachusetts Institute of Technology Company Overview 90

5.45 MASTInc Company Overview 91

5.46 Medella Health Inc. Company Overview 92

5.47 Medical Wireless Sensing Ltd Company Overview 93

5.48 Medtronic plc Company Overview 95

5.49 Mellitor Ltd. Company Overview 104

5.50 Microchips Biotech Inc Company Overview 105

5.51 mobiLIFE Company Overview 106

5.52 Nemaura Medical Inc Company Overview 107

5.53 Northwestern University Company Overview 109

5.54 NovioSense BV Company Overview 110

5.55 Optiscan Biomedical Corp Company Overview 111

5.56 PositiveID Corp Company Overview 114

5.57 Prediktor AS Company Overview 116

5.58 Profusa, Inc. Company Overview 118

5.59 San Meditech (Huzhou) Co., Ltd. Company Overview 119

5.60 Senseonics, Incorporated Company Overview 120

5.61 SensiVida Medical Technologies, Inc. (Inactive) Company Overview 123

5.62 Sentek Group, Inc. Company Overview 124

5.63 Senzime AB Company Overview 125

5.64 Singapore Biomicro Pte Ltd Company Overview 127

5.65 Tenax Therapeutics Inc Company Overview 128

5.66 Terumo Corp Company Overview 129

5.67 Texas A&M University Company Overview 131

5.68 Ultradian Diagnostics LLC Company Overview 132

5.69 University of Bath Company Overview 133

5.70 University of California Berkeley Company Overview 134

5.71 University of California Irvine Company Overview 135

5.72 University of California San Diego Company Overview 136

5.73 University of South Florida Company Overview 137

5.74 University of Texas at Arlington Company Overview 138

5.75 Vytrace, Inc. Company Overview 139

5.76 Zyvex Corporation Company Overview 140

6 Continuous Glucose Monitoring Systems- Recent Developments 141

6.1 Mar 30, 2017: ConvaTec Expands Unomedical Manufacturing Technology Partnership with Medtronic Diabetes to Meet Growing Demand 141

6.2 Mar 29, 2017: ConvaTec Group: Directorate changes 141

6.3 Mar 28, 2017: Novo Acquires 19.95% Stake in Convatec from Nordic Capital and Avista for USD1.22 Billion 142

6.4 Mar 28, 2017: ConvaTec: Proposed Directorate Changes 142

6.5 Mar 27, 2017: Integrity Applications Board Appoints John Graham CEO and Chairman, Angela Strand Vice Chairman 142

6.6 Mar 24, 2017: Medicare Announces Criteria Covering Dexcom G5 Mobile CGM for All People with Diabetes on Intensive Insulin Therapy 144

6.7 Mar 21, 2017: Medtronic Prices Public Offering of 1.7% Notes Due 2019 for USD1 Billion 144

6.8 Mar 21, 2017: Medtronic Prices Public Offering of 3.35% Notes Due 2027 for USD850 Million 145

6.9 Mar 21, 2017: Medtronic Prices Public Offering of 4.625% Notes Due 2045 for USD150 Million 145

6.10 Mar 21, 2017: Tenax Therapeutics Announces Year-End 2016 Financial Results and Provides Corporate Update 146

6.11 Mar 14, 2017: PositiveID's E-N-G Mobile Systems' 2017 Bookings Through February Total $1.7 Million, Up More than 200% from Prior Quarter 147

6.12 Mar 13, 2017: DexCom Appoints Richard Collins to Board of Directors 147

6.13 Mar 08, 2017: Tandem Diabetes Care Reports 2016 Financial Results 148

6.14 Feb 28, 2017: DexCom Reports Fourth Quarter and Fiscal Year 2016 Financial Results 150

6.15 Feb 27, 2017: Insulet Reports Fourth Quarter and Full Year 2016 Financial Results 151

6.16 Feb 23, 2017: Henry Schein Launches Newly Designed Website For A Greater Customer Experience 152

6.17 Feb 21, 2017: Henry Schein Reports Record Fourth Quarter And Full Year 2016 Financial Results 153

6.18 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 155

6.19 Feb 21, 2017: PositiveID Announces 2016 Highlights 158

6.20 Feb 16, 2017: GlucoTrack Maker Presents Scientific Data Demonstrating Reliable Accuracy and Precision 158

6.21 Feb 16, 2017: Clinical Study Confirms Continuous Glucose Monitoring is as Safe and Effective as Blood Glucose Monitoring 160

6.22 Feb 15, 2017: Real-World Data From Abbott's Freestyle Libre Show Association Between Higher Frequency Of Glucose Monitoring And Improved Glucose Control For People With Diabetes 161

6.23 Feb 15, 2017: Nemaura Medical to present sugarBEAT Poster at the Advanced Technologies and Treatments for Diabetes Symposium in Paris, February 16th 2017 163

6.24 Feb 15, 2017: GluSense Raises USD1.9 Million in Financing Round 163

6.25 Feb 15, 2017: Data Presented at ATTD 2017 Demonstrate Clinical Advantages of Tandem Diabetes Care Sensor-augmented Pump over Medtronic MiniMed SAPs 163

6.26 Feb 09, 2017: Henry Schein Names Bridget A. Ross To Lead Global Medical Group 164

6.27 Feb 09, 2017: Terumo Announces Change of Executive Officers 165

6.28 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 166

6.29 Feb 06, 2017: GlucoTrack Maker Appoints New Chief Financial Officer 167

6.30 Feb 01, 2017: Edwards Lifesciences Reports Fourth Quarter Results 168

6.31 Jan 31, 2017: Terumo Opens a Branch in Yangon 169

6.32 Jan 30, 2017: Henry Schein Joins Takara Belmont To Support Oral Health Of At-Risk Youth In Israel By Donating State-Of-The-Art Equipment 170

6.33 Jan 25, 2017: Novartis Plans to Spin-Off Alcon 170

6.34 Jan 24, 2017: Dexcom announces publication of key study in the Journal of the American Medical Association demonstrating the value of CGM in reducing A1C and hypoglycemia in diabetes patients on injection therapy 171

6.35 Jan 24, 2017: Henry Schein Disaster Relief Hotline Is Open To Support Customers Affected By Tornadoes In The South 172

6.36 Jan 12, 2017: Centers for Medicare & Medicaid Services Classify Therapeutic Continuous Glucose Monitors as "Durable Medical Equipment" under Medicare Part B 172

6.37 Jan 12, 2017: JDRF Encouraged by Medicare Decision to Take First Step Toward Coverage of Continuous Glucose Monitors for People with Type 1 Diabetes 172

6.38 Jan 11, 2017: The launch of Dexcom Canada will reshape how Canadians living with diabetes access and use continuous glucose monitoring 174

6.39 Jan 10, 2017: DexCom Reports Record Preliminary, Unaudited Revenue for the Fourth Quarter and Fiscal Year 2016 and Provides Initial 2017 Outlook 175

6.40 Jan 09, 2017: OptiScan Biomedical Receives CE Mark for OptiScanner 6000 Automated Device for Monitoring Multiple Key Analytes in ICU Patients 175

7 Appendix 264

7.1 Methodology 264

7.2 About GlobalData 267

7.3 Contact Us 267

7.4 Disclaimer 267

List of Figure

1.2 List of Figures

Figure 1: Continuous Glucose Monitoring Systems-Pipeline Products by Stage of Development 16

Figure 2: Continuous Glucose Monitoring Systems-Pipeline Products by Territory 17

Figure 3: Continuous Glucose Monitoring Systems-Pipeline Products by Regulatory Path 19

Figure 4: Continuous Glucose Monitoring Systems-Pipeline Products by Estimated Approval Date 20

Figure 5: Continuous Glucose Monitoring Systems-Ongoing Clinical Trials 21

List of Table

1.1 List of Tables

Table 1: Continuous Glucose Monitoring Systems-Pipeline Products by Stage of Development 16

Table 2: Continuous Glucose Monitoring Systems-Pipeline Products by Territory 17

Table 3: Continuous Glucose Monitoring Systems-Pipeline Products by Regulatory Path 19

Table 4: Continuous Glucose Monitoring Systems-Pipeline Products by Estimated Approval Date 20

Table 5: Continuous Glucose Monitoring Systems-Ongoing Clinical Trials 21

Table 6: Continuous Glucose Monitoring Systems Companies-Pipeline Products by Stage of Development 22

Table 7: Continuous Glucose Monitoring Systems-Pipeline Products by Stage of Development 25

Table 8: A. Menarini Diagnostics S.r.l. Pipeline Products & Ongoing Clinical Trials Overview 28

Table 9: GlucoMen Day-Product Status 28

Table 10: GlucoMen Day-Product Description 29

Table 11: Abbott Diabetes Care, Inc. Pipeline Products & Ongoing Clinical Trials Overview 30

Table 12: FreeStyle Libre Flash Glucose Monitoring System-Product Status 30

Table 13: FreeStyle Libre Flash Glucose Monitoring System-Product Description 31

Table 14: FreeStyle Libre Glucose Monitoring System-Consumer Version-Product Status 31

Table 15: FreeStyle Libre Glucose Monitoring System-Consumer Version-Product Description 32

Table 16: Abbott Diabetes Care, Inc.-Ongoing Clinical Trials Overview 33

Table 17: FreeStyle Libre Flash Glucose Monitoring System-Accuracy of Flash Glucose Monitoring Freestyle Libre (Abbott) in Home Setting and In-patient Setting During Hypo-Hyperglycemia 34

Table 18: FreeStyle Libre Flash Glucose Monitoring System-An Evaluation of Self-management of Diabetes Using FreeStyle Libre Flash Glucose Monitoring System in Young People 34

Table 19: FreeStyle Libre Flash Glucose Monitoring System-Frequency of Hypoglycemia in Patients with Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life 34

Table 20: FreeStyle Libre Flash Glucose Monitoring System-The Impact on Quality of Life of Novel Glucose -sensing Technology Used by Individuals with Type 2 Diabetes on Intensive-insulin Therapy 35

Table 21: Advanced Biosensors-Ohio, Llc Pipeline Products & Ongoing Clinical Trials Overview 36

Table 22: Continuous Glucose Monitor-Product Status 36

Table 23: Continuous Glucose Monitor-Product Description 36

Table 24: Advanced Medical Electronics Corporation Pipeline Products & Ongoing Clinical Trials Overview 37

Table 25: Continuous Glucose Monitor-Product Status 37

Table 26: Continuous Glucose Monitor-Product Description 37

Table 27: Arkal Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 38

Table 28: GlucoPod CGM System-Product Status 38

Table 29: GlucoPod CGM System-Product Description 38

Table 30: Bio-Impedance General Ltd. Pipeline Products & Ongoing Clinical Trials Overview 39

Table 31: MD Watch-Product Status 39

Table 32: MD Watch-Product Description 39

Table 33: Biorasis, Inc. Pipeline Products & Ongoing Clinical Trials Overview 40

Table 34: Glucowizzard-Product Status 40

Table 35: Glucowizzard-Product Description 40

Table 36: Biovotion AG Pipeline Products & Ongoing Clinical Trials Overview 41

Table 37: Multisensor Glucose Monitoring System-Product Status 41

Table 38: Multisensor Glucose Monitoring System-Product Description 41

Table 39: VSM 3 Glucose Monitoring System-Product Status 42

Table 40: VSM 3 Glucose Monitoring System-Product Description 42

Table 41: CALISTO MEDICAL, INC. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 43

Table 42: Glucoband-Product Status 43

Table 43: Glucoband-Product Description 43

Table 44: Cardiff University Pipeline Products & Ongoing Clinical Trials Overview 44

Table 45: Non-Invasive Blood Glucose Meter-Product Status 44

Table 46: Non-Invasive Blood Glucose Meter-Product Description 44

Table 47: City, University of London Pipeline Products & Ongoing Clinical Trials Overview 45

Table 48: Non-Invasive Glucose Monitor-Product Status 45

Table 49: Non-Invasive Glucose Monitor-Product Description 45

Table 50: Columbia University Pipeline Products & Ongoing Clinical Trials Overview 46

Table 51: Wearable Continuous Blood Glucose Monitoring Device-Product Status 46

Table 52: Wearable Continuous Blood Glucose Monitoring Device-Product Description 46

Table 53: ConvaTec Group Plc Pipeline Products & Ongoing Clinical Trials Overview 47

Table 54: Closed Loop Continuous Glucose Monitoring System-Product Status 47

Table 55: Closed Loop Continuous Glucose Monitoring System-Product Description 47

Table 56: Cyber Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 48

Table 57: Cybersensors Continuous Glucose Sensor-Product Status 48

Table 58: Cybersensors Continuous Glucose Sensor-Product Description 48

Table 59: Debiotech SA Pipeline Products & Ongoing Clinical Trials Overview 49

Table 60: Integrated iSense CGM And JewelPUMP-Product Status 49

Table 61: Integrated iSense CGM And JewelPUMP-Product Description 49

Table 62: DexCom Inc Pipeline Products & Ongoing Clinical Trials Overview 50

Table 63: DexCom CGM With Accu-Chek Insulin Delivery System-Product Status 50

Table 64: DexCom CGM With Accu-Chek Insulin Delivery System-Product Description 50

Table 65: Dexcom G5x-Product Status 51

Table 66: Dexcom G5x-Product Description 51

Table 67: G6 Continuous Glucose Monitor-Product Status 51

Table 68: G6 Continuous Glucose Monitor-Product Description 52

Table 69: DirectSens GmbH Pipeline Products & Ongoing Clinical Trials Overview 53

Table 70: Continuous Blood Glucose Monitoring System-Product Status 53

Table 71: Continuous Blood Glucose Monitoring System-Product Description 53

Table 72: Echo Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 54

Table 73: Gen 2 Symphony CGM System-Product Status 54

Table 74: Gen 2 Symphony CGM System-Product Description 54

Table 75: NextGen System-Product Status 55

Table 76: NextGen System-Product Description 55

Table 77: Symphony tCGM System-Home-Product Status 55

Table 78: Symphony tCGM System-Home-Product Description 56

Table 79: Symphony tCGM System-Hospital Critical Care-Product Status 56

Table 80: Symphony tCGM System-Hospital Critical Care-Product Description 56

Table 81: Ecole Polytechnique Federale de Lausanne Pipeline Products & Ongoing Clinical Trials Overview 57

Table 82: Viscosimetric Glucose Sensor-Product Status 57

Table 83: Viscosimetric Glucose Sensor-Product Description 57

Table 84: eLutions Integrated Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 58

Table 85: Optically-Efficient Miniaturized Raman Optical System-Product Status 58

Table 86: Optically-Efficient Miniaturized Raman Optical System-Product Description 58

Table 87: EyeSense GmbH Pipeline Products & Ongoing Clinical Trials Overview 59

Table 88: Eye Sensor-Product Status 59

Table 89: Eye Sensor-Product Description 59

Table 90: Fiber Optic Sensor-Product Status 60

Table 91: Fiber Optic Sensor-Product Description 60

Table 92: EyeSense GmbH-Ongoing Clinical Trials Overview 61

Table 93: Fiber Optic Sensor-Effectiveness and Safety Study of the Percutaneous Optical Fibre Glucose Sensor (FiberSense) for Home Use in Diabetic and Prediabetic Individuals 62

Table 94: Fiber Optic Sensor-Evaluation of a Percutaneous Optical Fibre Glucose Sensor (FiberSense) Across the Glycemic Range with Rapid Glucose Excursions Using the Glucose Clamp 62

Table 95: Flowsion A/S Pipeline Products & Ongoing Clinical Trials Overview 63

Table 96: Diramo System-Product Status 63

Table 97: Diramo System-Product Description 64

Table 98: Gili Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

Table 99: Diawatch-Product Status 65

Table 100: Diawatch-Product Description 65

Table 101: Globe Medical Tech Inc Pipeline Products & Ongoing Clinical Trials Overview 66

Table 102: Continuous Glucose Monitoring Device-Product Status 66

Table 103: Continuous Glucose Monitoring Device-Product Description 66

Table 104: GlucoLight Corporation (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 67

Table 105: SENTRIS-100-Product Status 67

Table 106: SENTRIS-100-Product Description 67

Table 107: Glucometrix AG Pipeline Products & Ongoing Clinical Trials Overview 68

Table 108: Non-Invasive Blood Glucose Monitoring Device-Product Status 68

Table 109: Non-Invasive Blood Glucose Monitoring Device-Product Description 68

Table 110: Glucosense Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

Table 111: Non-Invasive Blood Glucose Monitor-Product Status 69

Table 112: Non-Invasive Blood Glucose Monitor-Product Description 69

Table 113: GlucoSet AS Pipeline Products & Ongoing Clinical Trials Overview 70

Table 114: GlucoSet Sensor-Product Status 70

Table 115: GlucoSet Sensor-Product Description 70

Table 116: Glucovation Inc Pipeline Products & Ongoing Clinical Trials Overview 71

Table 117: SugarSenz Continuous Glucose Monitor-Product Status 71

Table 118: SugarSenz Continuous Glucose Monitor-Product Description 71

Table 119: GluMetrics Inc Pipeline Products & Ongoing Clinical Trials Overview 72

Table 120: GluCath Intravascular Continuous Glucose Monitor-Product Status 72

Table 121: GluCath Intravascular Continuous Glucose Monitor-Product Description 72

Table 122: GlySens Inc Pipeline Products & Ongoing Clinical Trials Overview 73

Table 123: GlySens ICGM System-Product Status 73

Table 124: GlySens ICGM System-Product Description 73

Table 125: Second Generation ICGM System-Product Status 74

Table 126: Second Generation ICGM System-Product Description 74

Table 127: GlySens Inc-Ongoing Clinical Trials Overview 75

Table 128: GlySens ICGM System-Function of Implanted Glucose Sensor 2 75

Table 129: GlySure Ltd Pipeline Products & Ongoing Clinical Trials Overview 76

Table 130: GlySure Continuous Glucose Monitoring System-Product Status 76

Table 131: GlySure Continuous Glucose Monitoring System-Product Description 76

Table 132: GlySure Ltd-Ongoing Clinical Trials Overview 77

Table 133: GlySure Continuous Glucose Monitoring System-A Clinical Study to Evaluate the Safety of the GlySure Continuous Intra-vascular Glucose Monitoring System and Its Performance in Comparison to Intermittent Blood Glucose Monitoring in Adult Intensive Care Unit Patients 77

Table 134: G-Sense Ltd. Pipeline Products & Ongoing Clinical Trials Overview 78

Table 135: G-Sense Device-Product Status 78

Table 136: G-Sense Device-Product Description 78

Table 137: Guided Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 79

Table 138: Altea MicroPor Laser-Product Status 79

Table 139: Altea MicroPor Laser-Product Description 79

Table 140: iGlyko, Inc. Pipeline Products & Ongoing Clinical Trials Overview 80

Table 141: iGlyko System-Product Status 80

Table 142: iGlyko System-Product Description 80

Table 143: Indigo Diabetes NV Pipeline Products & Ongoing Clinical Trials Overview 81

Table 144: Needle-Free Glucose Sensor-Product Status 81

Table 145: Needle-Free Glucose Sensor-Product Description 81

Table 146: Institute of Biomedical Engineering (ISIB-CNR) (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 82

Table 147: Electrical Impedance Spectroscopy-Glucose Monitoring-Product Status 82

Table 148: Electrical Impedance Spectroscopy-Glucose Monitoring-Product Description 82

Table 149: Insulet Corp Pipeline Products & Ongoing Clinical Trials Overview 83

Table 150: Integrated CGM With Next Gen OmniPod System PDM-Product Status 83

Table 151: Integrated CGM With Next Gen OmniPod System PDM-Product Description 84

Table 152: Integrated Medical Group of Irvine Pipeline Products & Ongoing Clinical Trials Overview 85

Table 153: Implantable Continuous Glucose Monitor-Product Status 85

Table 154: Implantable Continuous Glucose Monitor-Product Description 85

Table 155: Integrity Applications Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

Table 156: GlucoTrack-DF-C-Product Status 86

Table 157: GlucoTrack-DF-C-Product Description 86