Infusion Pumps - 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 4

2 Introduction 5

2.1 Infusion Pumps Overview 5

3 Products under Development 6

3.1 Infusion Pumps-Pipeline Products by Stage of Development 6

3.2 Infusion Pumps-Pipeline Products by Territory 7

3.3 Infusion Pumps-Pipeline Products by Regulatory Path 8

3.4 Infusion Pumps-Pipeline Products by Estimated Approval Date 9

4 Infusion Pumps-Pipeline Products under Development by Companies 10

4.1 Infusion Pumps Companies-Pipeline Products by Stage of Development 10

4.2 Infusion Pumps-Pipeline Products by Stage of Development 11

5 Infusion Pumps Companies and Product Overview 12

5.1 ClearLine MD Company Overview 12

5.2 Fluonic, Inc. Company Overview 13

5.3 Hospira Inc Company Overview 14

5.4 Innovfusion Pte. Ltd. Company Overview 16

5.5 Lynntech Inc Company Overview 19

5.6 Massachusetts Institute of Technology Company Overview 20

5.7 Palyon Medical Corp (Inactive) Company Overview 21

5.8 SteadyMed Therapeutics Inc Company Overview 22

5.9 Terumo Corp Company Overview 23

5.10 Turnpoint Medical Devices Inc Company Overview 24

6 Infusion Pumps- Recent Developments 25

6.1 Jun 01, 2018: Fresenius Kabi opens new laboratory and office areas at its Innovation & Development Center in Graz, Austria 25

6.2 May 28, 2018: New EU Commission's initiative SPC manufacturing waiver” 25

6.3 May 18, 2018: Fresenius on track to continue strong growth, 25th straight dividend increase approved 25

6.4 May 17, 2018: Fresenius Medical Care forecasts continued strong growth 26

6.5 May 16, 2018: B. Braun to Showcase its Innovative Synchronized Intelligence Infusion Platform at AACN 26

6.6 May 14, 2018: Baxter Announces U.S. FDA Clearance of New Spectrum IQ Infusion System 27

6.7 May 09, 2018: Fresenius holds topping-out ceremony for new 'EK3' building at headquarters in Bad Homburg 28

6.8 May 03, 2018: Fresenius makes excellent start to 2018, with strong sales and net income growth in constant currency 29

6.9 May 03, 2018: Fresenius Medical Care remains on track for another record year after solid first quarter 2018 34

6.10 May 02, 2018: Fresenius Medical Care Announces Leadership Change in EMEA 37

6.11 Apr 30, 2018: IRadimed Reports First Quarter 2018 Financial Results 37

6.12 Mar 22, 2018: Fresenius starts work on new RD building in Bad Homburg 38

6.13 Feb 26, 2018: Akorn Issues Statement on Investigation 38

6.14 Feb 26, 2018: Fresenius remains on growth course after 14 straight record years 39

6.15 Feb 06, 2018: IRADIMED Reports Revenue Of USD6.7 Million In The Fourth Quarter Ended December 31, 2017 44

6.16 Feb 05, 2018: Zyno Solutions Names Steve Watkins As General Manager And Executive Vice President 46

6.17 Jan 29, 2018: Terumo Integrates Two R&D Facilities in Silicon Valley to Accelerate Development of Innovative Medical Devices 47

6.18 Jan 29, 2018: HES solutions should remain on the market 47

6.19 Jan 22, 2018: IRADIMED Announces 2018 Annual and First Quarter Financial Guidance 48

6.20 Jan 08, 2018: MicroPort Lifesciences Displayed La Fenice Hypophyseal Hormone Infusion Pump at CDS2017 48

6.21 Dec 11, 2017: Cardiome Highlights Partner SteadyMed's Agreement With FDA On Pathway To Trevyent NDA Resubmission 49

6.22 Dec 08, 2017: SteadyMed Announces FDA Agreed Pathway to Trevyent NDA Resubmission 50

6.23 Dec 08, 2017: Medfusion Syringe Pump Model 4000 V1.6.1 Firmware Update Notice 50

6.24 Dec 08, 2017: ICU Medical's LifeCare PCA is the First PCA Pump to Integrate with Cerner Millennium EHR 51

6.25 Dec 01, 2017: Fresenius Kabi opens extension at production plant in Mihla, eastern Germany 52

6.26 Nov 15, 2017: ICU Medical Receives the 2017 Cerner Innovation Award for Industry Leadership in IV-EHR Interoperability 52

6.27 Nov 13, 2017: SteadyMed Reports Third Quarter 2017 Financial Results and Provides Corporate Update 53

6.28 Nov 02, 2017: Fresenius reports another strong quarter and confirms guidance 54

6.29 Oct 30, 2017: IRADIMED Announces Third Quarter 2017 Financial Results 56

6.30 Oct 12, 2017: SteadyMed Receives Notice of Allowance for its European Patent Relating to Enhanced Reduction of Infusion-Site Pain 57

6.31 Oct 10, 2017: Fresenius Kabi's Generic Drugs Business Unit Head elected as president of Medicines for Europe 57

6.32 Sep 29, 2017: Fresenius lays cornerstone for new building at headquarters in Bad Homburg 57

6.33 Sep 08, 2017: Fresenius Kabi marks 20-year anniversary of Friedberg production site-Logistics center expansion planned 58

6.34 Aug 24, 2017: Tandem Diabetes Care Announces Issuance of Patent Related to Remote Bolus Feature for Medical Infusion Pumps 59

6.35 Aug 14, 2017: MicroPort Lifesciences Hosts GnRH Pump Treatment Symposium 59

6.36 Aug 11, 2017: SteadyMed Reports Second Quarter 2017 Financial Results and Provides Corporate Update 60

6.37 Aug 01, 2017: Fresenius confirms its guidance after a strong second quarter with double-digit sales and earnings growth 62

6.38 Jul 31, 2017: SteadyMed Appoints Jeff Myers M.D. Ph.D. Vice President of Medical Affairs 64

6.39 Jul 28, 2017: IRADIMED Announces Second Quarter 2017 Financial Results 65

6.40 Jul 24, 2017: MicroPort Lifesciences Attends 2017 CEA Annual Meeting 66

6.41 Jul 21, 2017: Fresenius appoints Rachel Empey as Chief Financial Officer 67

6.42 Jul 12, 2017: Fresenius Medical Care successfully amends and extends its credit agreement, ahead of schedule 68

6.43 Jul 06, 2017: Fresenius Kabi expands production site in Portugal 68

6.44 Jul 03, 2017: Cardiome's Partner SteadyMed Submits U.S. New Drug Application for TREVYENT for the Treatment of Pulmonary Arterial Hypertension 68

7 Appendix 69

7.1 Methodology 69

7.2 About GlobalData 72

7.3 Contact Us 72

7.4 Disclaimer 72

List of Figure

1.2 List of Figures

Figure 1: Infusion Pumps-Pipeline Products by Stage of Development 6

Figure 2: Infusion Pumps-Pipeline Products by Territory 7

Figure 3: Infusion Pumps-Pipeline Products by Regulatory Path 8

Figure 4: Infusion Pumps-Pipeline Products by Estimated Approval Date 9

List of Table

1.1 List of Tables

Table 1: Infusion Pumps-Pipeline Products by Stage of Development 6

Table 2: Infusion Pumps-Pipeline Products by Territory 7

Table 3: Infusion Pumps-Pipeline Products by Regulatory Path 8

Table 4: Infusion Pumps-Pipeline Products by Estimated Approval Date 9

Table 5: Infusion Pumps Companies-Pipeline Products by Stage of Development 10

Table 6: Infusion Pumps-Pipeline Products by Stage of Development 11

Table 7: ClearLine MD Pipeline Products & Ongoing Clinical Trials Overview 12

Table 8: FloStat Infusion Pump System-Product Status 12

Table 9: FloStat Infusion Pump System-Product Description 12

Table 10: Fluonic, Inc. Pipeline Products & Ongoing Clinical Trials Overview 13

Table 11: SURE+-Product Status 13

Table 12: SURE+-Product Description 13

Table 13: Hospira Inc Pipeline Products & Ongoing Clinical Trials Overview 14

Table 14: Lifecare PCA Restart-Product Status 14

Table 15: Lifecare PCA Restart-Product Description 14

Table 16: Smart Infusion Pump Integrated With Accelero Connect Software-Product Status 15

Table 17: Smart Infusion Pump Integrated With Accelero Connect Software-Product Description 15

Table 18: Innovfusion Pte. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 16

Table 19: DIVA-Product Status 16

Table 20: DIVA-Product Description 16

Table 21: EPIVA-Product Status 17

Table 22: EPIVA-Product Description 17

Table 23: INTRAVA-Product Status 17

Table 24: INTRAVA-Product Description 18

Table 25: Lynntech Inc Pipeline Products & Ongoing Clinical Trials Overview 19

Table 26: Disposable Drug Infusion Pump-Product Status 19

Table 27: Disposable Drug Infusion Pump-Product Description 19

Table 28: Massachusetts Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 20

Table 29: Compact Self-Powered Actuator-Product Status 20

Table 30: Compact Self-Powered Actuator-Product Description 20

Table 31: Palyon Medical Corp (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 21

Table 32: Palyon Implantable Drug Delivery System-Product Status 21

Table 33: Palyon Implantable Drug Delivery System-Product Description 21

Table 34: SteadyMed Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 22

Table 35: Trevyent-Product Status 22

Table 36: Trevyent-Product Description 22

Table 37: Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 23

Table 38: Next Generation SmartPump-Product Status 23

Table 39: Next Generation SmartPump-Product Description 23

Table 40: Turnpoint Medical Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 24

Table 41: Breeze Infusion Pump-Product Status 24

Table 42: Breeze Infusion Pump-Product Description 24

Table 43: Glossary 71