1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 16
2 Introduction 17
2.1 Continuous Glucose Monitoring Systems Overview 17
3 Products under Development 18
3.1 Continuous Glucose Monitoring Systems – Pipeline Products by Stage of Development 18
3.2 Continuous Glucose Monitoring Systems – Pipeline Products by Territory 19
3.3 Continuous Glucose Monitoring Systems – Pipeline Products by Regulatory Path 20
3.4 Continuous Glucose Monitoring Systems – Pipeline Products by Estimated Approval Date 21
3.5 Continuous Glucose Monitoring Systems – Ongoing Clinical Trials 22
4 Continuous Glucose Monitoring Systems – Pipeline Products under Development by Companies 23
4.1 Continuous Glucose Monitoring Systems Companies – Pipeline Products by Stage of Development 23
4.2 Continuous Glucose Monitoring Systems – Pipeline Products by Stage of Development 27
5 Continuous Glucose Monitoring Systems Companies and Product Overview 31
5.1 A. Menarini Diagnostics S.r.l. Company Overview 31
5.2 Abbott Diabetes Care, Inc. Company Overview 33
5.3 Advanced Biosensors-Ohio, Llc Company Overview 35
5.4 Advanced Medical Electronics Corporation Company Overview 36
5.5 Alcon Inc Company Overview 38
5.6 Arkal Medical, Inc. Company Overview 39
5.7 Azurite Technologies, Inc. Company Overview 41
5.8 Bar-Ilan University Company Overview 42
5.9 Bellco Srl Company Overview 43
5.10 Bio-Impedance General Ltd. Company Overview 44
5.11 Biorasis, Inc. Company Overview 45
5.12 BioTex Inc Company Overview 46
5.13 Biovotion AG Company Overview 47
5.14 Brigham and Women’s Hospital Company Overview 49
5.15 CALISTO MEDICAL, INC. (Inactive) Company Overview 50
5.16 Cardiff University Company Overview 51
5.17 CGM3 Ltd Company Overview 52
5.18 ConvaTec Healthcare B Sarl Company Overview 53
5.19 Cyber Medical Ltd. Company Overview 54
5.20 Debiotech SA Company Overview 56
5.21 DexCom Inc Company Overview 58
5.22 DirectSens GmbH Company Overview 70
5.23 Eccrine Systems Inc Company Overview 71
5.24 Echo Therapeutics Inc Company Overview 72
5.25 Ecole Polytechnique Federale de Lausanne Company Overview 76
5.26 eLutions Integrated Systems, Inc. Company Overview 77
5.27 EyeSense GmbH Company Overview 78
5.28 Flowsion A/S Company Overview 82
5.29 Globe Medical Tech Inc Company Overview 84
5.30 GlucoLight Corporation Company Overview 85
5.31 Glucometrics, Inc. Company Overview 86
5.32 Glucometrix AG Company Overview 87
5.33 Glucosense Diagnostics Ltd Company Overview 88
5.34 GlucoSet AS Company Overview 89
5.35 Glucovation Inc Company Overview 90
5.36 GluMetrics Inc Company Overview 91
5.37 Glusense Ltd Company Overview 92
5.38 GlySens Inc Company Overview 93
5.39 GlySure Ltd Company Overview 97
5.40 G-Sense Ltd. Company Overview 100
5.41 Guided Therapeutics Inc Company Overview 101
5.42 Hypo-Safe A/S Company Overview 103
5.43 iGlyko, Inc. Company Overview 106
5.44 Institute of Biomedical Engineering (ISIB-CNR) (Inactive) Company Overview 108
5.45 Insulet Corp Company Overview 109
5.46 Integrity Applications Ltd Company Overview 111
5.47 Invivomon Inc. Company Overview 114
5.48 Invivosense ASA Company Overview 115
5.49 iSense Corporation (Inactive) Company Overview 116
5.50 Luminous Medical Inc Company Overview 117
5.51 Massachusetts Institute of Technology Company Overview 119
5.52 MASTInc Company Overview 120
5.53 Medella Health Inc. Company Overview 121
5.54 Medical Wireless Sensing Ltd Company Overview 122
5.55 Medtronic plc Company Overview 124
5.56 Mellitor Ltd. Company Overview 132
5.57 Microchips Biotech Inc Company Overview 133
5.58 mobiLIFE Company Overview 134
5.59 Nemaura Medical Inc Company Overview 135
5.60 Northwestern University Company Overview 137
5.61 NovioSense B.V. Company Overview 139
5.62 Optiscan Biomedical Corp Company Overview 141
5.63 Pignolo SpA Company Overview 144
5.64 PositiveID Corp Company Overview 145
5.65 Prediktor AS Company Overview 147
5.66 Profusa, Inc. Company Overview 149
5.67 Roche Diagnostics International Ltd Company Overview 150
5.68 San Meditech (Huzhou) Co., Ltd. Company Overview 152
5.69 Senseonics, Incorporated Company Overview 153
5.70 SensiVida Medical Technologies, Inc. (Inactive) Company Overview 156
5.71 Senzime AB Company Overview 157
5.72 Singapore Biomicro Pte Ltd Company Overview 159
5.73 Stanford University Company Overview 160
5.74 Tenax Therapeutics Inc Company Overview 161
5.75 Terumo Corp Company Overview 162
5.76 The Charles Stark Draper Laboratory Inc Company Overview 164
5.77 Ultradian Diagnostics LLC Company Overview 166
5.78 University of Bari Aldo Moro Company Overview 168
5.79 University of Bath Company Overview 169
5.80 University of California Berkeley Company Overview 170
5.81 University of California San Diego Company Overview 172
5.82 University of South Florida Company Overview 174
5.83 University of Strathclyde Company Overview 175
5.84 University of Texas at Arlington Company Overview 176
5.85 Vytrace, Inc. Company Overview 177
5.86 Zyvex Corporation Company Overview 178
6 Continuous Glucose Monitoring Systems- Recent Developments 179
6.1 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 179
6.2 Nov 21, 2016: PositiveID Reports Revenue of $4.6 Million for First Nine Months of 2016, Up 70% from $2.7 Million for First Nine Months of 2015 181
6.3 Nov 18, 2016: Abbott Labs Prices Public Offering of 2.35% Notes due 2019 for USD2.9 Billion 182
6.4 Nov 18, 2016: Abbott Labs Prices Public Offering of 2.9% Notes due 2021 for USD2.85 Billion 182
6.5 Nov 18, 2016: Abbott Labs Prices Public Offering of 3.4% Notes due 2023 for USD1.5 Billion 183
6.6 Nov 18, 2016: Abbott Labs Prices Public Offering of 3.75% Notes due 2026 for USD3 Billion 183
6.7 Nov 18, 2016: Abbott Labs Prices Public Offering of 4.9% Notes due 2046 for USD3.3 Billion 184
6.8 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 184
6.9 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 184
6.10 Nov 14, 2016: Diabetes Management Leader Dexcom Expands Presence in EMEA Markets with new Edinburgh HQ 185
6.11 Nov 11, 2016: Presentation of PRECISE II U.S. Pivotal Trial Data of the Eversense CGM System at the 16th Annual Diabetes Technology Meeting 186
6.12 Nov 11, 2016: GlucoTrack Maker to Present Updated Scientific Data Demonstrating Increased Accuracy 187
6.13 Nov 10, 2016: Tenax Therapeutics Announces Third Quarter 2016 Financial Results and Provides Corporate Update 187
6.14 Nov 07, 2016: GlucoTrack Maker Announces Receipt of Final Regulatory Approval in South Korea 188
6.15 Nov 03, 2016: Insulet Reports Third Quarter 2016 Financial Results 189
6.16 Nov 02, 2016: Henry Schein Reports Record Third Quarter Financial Results 190
6.17 Nov 01, 2016: DexCom Reports Third Quarter 2016 Financial Results 192
6.18 Nov 01, 2016: Tandem Diabetes Care Reports Third Quarter 2016 Financial Results 193
6.19 Oct 27, 2016: Senseonics submits Eversense Continuous Glucose Monitoring system PMA to FDA 194
6.20 Oct 26, 2016: ConvaTec Raises USD1.8 Billion in IPO 195
6.21 Oct 25, 2016: Edwards Lifesciences Reports Third Quarter Results 195
6.22 Oct 24, 2016: NovioSense Raises Funds in Venture Financing 197
6.23 Oct 19, 2016: PositiveID to Present at RedChip’s Global Online Growth Conference on October 20th 197
6.24 Oct 19, 2016: Abbott Reports Third-Quarter 2016 Results 197
6.25 Sep 28, 2016: Abbott Receives FDA Approval for the FreeStyle Libre Pro System, a Revolutionary Diabetes Sensing Technology for Healthcare Professionals to Use with Their Patients 200
6.26 Sep 27, 2016: PositiveID Announces Highlights for Third Quarter 2016 201
6.27 Sep 15, 2016: PositiveID to Present at the 2016 Aegis Growth Conference on September 22nd 202
6.28 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 202
6.29 Sep 07, 2016: Completed The First Subject in Clinical Study for Continuous Glucose Monitoring System in Hong Kong 203
6.30 Sep 07, 2016: Reimbursement of Dexcom CGM Technology for Patients with Type 1 and Type 2 Insulin-Dependent Diabetes is Now Available in Germany 204
6.31 Sep 06, 2016: Insulet Raises Private Placement of Senior Notes for USD300 Million 204
6.32 Sep 06, 2016: Insulet to Establish Highly-Automated Manufacturing Operation in the United States 205
6.33 Sep 06, 2016: Insulet Announces Executive Appointments 205
6.34 Sep 01, 2016: Medtronic Announces Approval Of Enlite Sensor For iPro2 Professional Continuous Glucose Monitoring System In The U.S. 205
6.35 Aug 25, 2016: M Pharma Raises USD1.5 Million in First Tranche of Private Placement of 10% Debentures Due 2019 206
6.36 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 206
6.37 Aug 25, 2016: Lee’s Pharmaceutical Holdings: Interim Results For The Six Months Ended 30 June 2016 209
6.38 Aug 17, 2016: Guided Therapeutics Reports Second Quarter 2016 Financial Results; Year to Date Revenue Up 71% Over Same Period Last Year 211
6.39 Aug 15, 2016: PositiveID Reports Q2 2016 Revenue of $1.8 Million, Up from $51 Thousand in Q2 2015 212
6.40 Aug 12, 2016: Echo Therapeutics Announces Second Quarter 2016 Financial Results 213
6.41 Aug 11, 2016: Tenax Therapeutics Announces Second Quarter 2016 Financial Results and Provides Corporate Update 214
6.42 Aug 09, 2016: Senseonics Reports Topline Accuracy Results from U.S. Pivotal Study of Eversense CGM System 215
6.43 Aug 04, 2016: Nemaura Medical, Completes Second FDA Pre-submission Meeting And Appoints Navigant To Submit IDE For Nemauras SugarBEAT System 216
6.44 Aug 04, 2016: Henry Schein Reports Second Quarter Financial Results 216
6.45 Aug 03, 2016: Insulet Reports Second Quarter 2016 Financial Results 218
6.46 Aug 02, 2016: DexCom Reports Second Quarter 2016 Financial Results 219
6.47 Jul 28, 2016: Tandem Diabetes Care Reports Second Quarter 2016 Financial Results 219
6.48 Jul 26, 2016: Edwards Lifesciences Reports Second Quarter Results 221
6.49 Jul 20, 2016: Abbott Reports Second-Quarter 2016 Results 222
6.50 Jul 19, 2016: FDA Posts Briefing Documents Ahead of Advisory Committee Meeting 224
6.51 Jul 19, 2016: Medtronic Expands Continuous Glucose Monitoring Solutions for People with Diabetes Using Insulin Injections with CE Mark Receipt 225
6.52 Jul 12, 2016: PositiveID Announces Highlights for First Half of 2016 226
6.53 Jul 08, 2016: Ossen Innovation to Acquire 90.27% Stake in San MediTech from America-Asia Diabetes Research Foundation 226
7 Appendix 259
7.1 Methodology 259
7.2 About GlobalData 262
7.3 Contact Us 262
7.4 Disclaimer 262