Coagulation Analyzers - Medical Devices Pipeline Assessment, 2018

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 5

2 Introduction 6

2.1 Coagulation Analyzers Overview 6

3 Products under Development 7

3.1 Coagulation Analyzers-Pipeline Products by Stage of Development 7

3.2 Coagulation Analyzers-Pipeline Products by Territory 8

3.3 Coagulation Analyzers-Pipeline Products by Regulatory Path 9

3.4 Coagulation Analyzers-Pipeline Products by Estimated Approval Date 10

4 Coagulation Analyzers-Pipeline Products under Development by Companies 11

4.1 Coagulation Analyzers Companies-Pipeline Products by Stage of Development 11

4.2 Coagulation Analyzers-Pipeline Products by Stage of Development 12

5 Coagulation Analyzers Companies and Product Overview 13

5.1 Analyticon Biotechnologies AG Company Overview 13

5.2 BioMedica USA LLC (Inactive) Company Overview 18

5.3 Braun Biosystems, Inc. Company Overview 19

5.4 Hansjorg Wyss Institute for Biologically Inspired Engineering Company Overview 20

5.5 Helena Laboratories Corp Company Overview 21

5.6 HemoSonics, LLC Company Overview 22

5.7 Nexus Medical, LLC Company Overview 29

5.8 SonoMedix, Inc. Company Overview 30

5.9 Universal Biosensors Inc Company Overview 31

5.10 University of Michigan Company Overview 32

5.11 University of Texas Health Science Center at Houston Company Overview 33

6 Coagulation Analyzers- Recent Developments 34

6.1 Jun 12, 2018: Change at the top of the Segment Advanced Therapies at Siemens Healthineers 34

6.2 Jun 05, 2018: Medtronic Presents Strategic Growth Roadmap at 2018 Investor Day; Outlines Plan to Create Shareholder Value 34

6.3 May 25, 2018: Groundbreaking POC hemostasis diagnostic to be presented at Major European Meetings 35

6.4 May 25, 2018: Grifols culminates a year of growth and approves the distribution of a record EUR 265 million in dividends 36

6.5 May 25, 2018: Siemens appoints new CEO of Siemens Mexico, Central America, and Caribbean 38

6.6 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 38

6.7 May 23, 2018: Grifols publishes its 2017 Corporate Responsibility Report as part of its commitment to transparency 40

6.8 May 15, 2018: Proposed nominations of future Siemens Alstom Board of Directors completed 41

6.9 May 09, 2018: Siemens Announces Earnings Release and Financial Results Q2 FY 2018 42

6.10 May 09, 2018: Sysmex Group Formulates New Long-Term Management Goals 44

6.11 May 09, 2018: Sysmex Announces Summary of Consolidated Financial Results for the Fiscal Year Ended March 31, 2018 46

6.12 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 49

6.13 May 07, 2018: Instrumentation Laboratory Worldwide Sales Top USD970 M In 2017 50

6.14 May 03, 2018: Siemens Healthineers fully on track to meet the targets 51

6.15 May 03, 2018: Grifols increases its net profit by 7% to Euros 143 million and delivers significant growth in organic sales 52

6.16 May 01, 2018: Trinity Biotech announces Results for Q1, 2018 55

6.17 May 01, 2018: Predicting side effects before they happen 57

7 Appendix 117

7.1 Methodology 117

7.2 About GlobalData 120

7.3 Contact Us 120

7.4 Disclaimer 120

List of Figure

1.2 List of Figures

Figure 1: Coagulation Analyzers-Pipeline Products by Stage of Development 8

Figure 2: Coagulation Analyzers-Pipeline Products by Territory 9

Figure 3: Coagulation Analyzers-Pipeline Products by Regulatory Path 10

Figure 4: Coagulation Analyzers-Pipeline Products by Estimated Approval Date 11

List of Table

1.1 List of Tables

Table 1: Coagulation Analyzers-Pipeline Products by Stage of Development 8

Table 2: Coagulation Analyzers-Pipeline Products by Territory 9

Table 3: Coagulation Analyzers-Pipeline Products by Regulatory Path 10

Table 4: Coagulation Analyzers-Pipeline Products by Estimated Approval Date 11

Table 5: Coagulation Analyzers Companies-Pipeline Products by Stage of Development 12

Table 6: Coagulation Analyzers-Pipeline Products by Stage of Development 13

Table 7: Analyticon Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 14

Table 8: Coagulyzer 1-Product Status 14

Table 9: Coagulyzer 1-Product Description 15

Table 10: Coagulyzer 100-Product Status 15

Table 11: Coagulyzer 100-Product Description 16

Table 12: Coagulyzer 2-Product Status 16

Table 13: Coagulyzer 2-Product Description 17

Table 14: Coagulyzer 4-Product Status 17

Table 15: Coagulyzer 4-Product Description 18

Table 16: BioMedica USA LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 19

Table 17: Portable Diagnostic System-Hemostasis-Product Status 19

Table 18: Portable Diagnostic System-Hemostasis-Product Description 19

Table 19: Braun Biosystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 20

Table 20: Bio6-Product Status 20

Table 21: Bio6-Product Description 20

Table 22: Hansjorg Wyss Institute for Biologically Inspired Engineering Pipeline Products & Ongoing Clinical Trials Overview 21

Table 23: Hemostasis Monitoring Microfluidic Device-Product Status 21

Table 24: Hemostasis Monitoring Microfluidic Device-Product Description 21

Table 25: Helena Laboratories Corp Pipeline Products & Ongoing Clinical Trials Overview 22

Table 26: Cascade Abrazo Analyzer-Product Status 22

Table 27: Cascade Abrazo Analyzer-Product Description 22

Table 28: HemoSonics, LLC Pipeline Products & Ongoing Clinical Trials Overview 23

Table 29: HemoSonics Global Hemostasis Analyzer-Chronic Liver Disease-Product Status 23

Table 30: HemoSonics Global Hemostasis Analyzer-Chronic Liver Disease-Product Description 24

Table 31: HemoSonics Global Hemostasis Analyzer-Intensive Care-Product Status 24

Table 32: HemoSonics Global Hemostasis Analyzer-Intensive Care-Product Description 24

Table 33: HemoSonics Global Hemostasis Analyzer-Neurosurgery-Product Status 25

Table 34: HemoSonics Global Hemostasis Analyzer-Neurosurgery-Product Description 25

Table 35: HemoSonics Global Hemostasis Analyzer-Oral Contraception-Product Status 25

Table 36: HemoSonics Global Hemostasis Analyzer-Oral Contraception-Product Description 26

Table 37: HemoSonics Global Hemostasis Analyzer-Orthopedic Surgery-Product Status 26

Table 38: HemoSonics Global Hemostasis Analyzer-Orthopedic Surgery-Product Description 26

Table 39: HemoSonics Global Hemostasis Analyzer-Perinatal Care-Product Status 27

Table 40: HemoSonics Global Hemostasis Analyzer-Perinatal Care-Product Description 27

Table 41: HemoSonics Global Hemostasis Analyzer-Trauma-Product Status 27

Table 42: HemoSonics Global Hemostasis Analyzer-Trauma-Product Description 28

Table 43: HemoSonics Global Hemostasis Analyzer HS-GHA-Product Status 28

Table 44: HemoSonics Global Hemostasis Analyzer HS-GHA-Product Description 28

Table 45: Quantra Hemostasis Analyzer-Product Status 29

Table 46: Quantra Hemostasis Analyzer-Product Description 29

Table 47: Nexus Medical, LLC Pipeline Products & Ongoing Clinical Trials Overview 30

Table 48: ProTime InRhythm-Product Status 30

Table 49: ProTime InRhythm-Product Description 30

Table 50: SonoMedix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 31

Table 51: NanoAcoustic Blood Analyzer-Product Status 31

Table 52: NanoAcoustic Blood Analyzer-Product Description 31

Table 53: Universal Biosensors Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Table 54: Handheld POC Coagulation Testing System-Ambulatory Care-Product Status 32

Table 55: Handheld POC Coagulation Testing System-Ambulatory Care-Product Description 32

Table 56: University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 33

Table 57: mHemoRetractoMeter-Product Status 33

Table 58: mHemoRetractoMeter-Product Description 33

Table 59: University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 34

Table 60: MEMS Based Blood Coagulometer-Product Status 34

Table 61: MEMS Based Blood Coagulometer-Product Description 34

Table 62: Glossary 120