Ablation Equipments - Medical Devices Pipeline Assessment, 2018

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 7

2 Introduction 9

2.1 Ablation Equipments Overview 9

3 Products under Development 10

3.1 Ablation Equipments-Pipeline Products by Stage of Development 10

3.2 Ablation Equipments-Pipeline Products by Territory 11

3.3 Ablation Equipments-Pipeline Products by Regulatory Path 12

3.4 Ablation Equipments-Pipeline Products by Estimated Approval Date 13

3.5 Ablation Equipments-Ongoing Clinical Trials 14

4 Ablation Equipments-Pipeline Products under Development by Companies 15

4.1 Ablation Equipments Companies-Pipeline Products by Stage of Development 15

4.2 Ablation Equipments-Pipeline Products by Stage of Development 16

5 Ablation Equipments Companies and Product Overview 17

5.1 AngioDynamics Inc Company Overview 17

5.1.1 AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 17

5.2 Avenda Health Inc Company Overview 32

5.2.1 Avenda Health Inc Pipeline Products & Ongoing Clinical Trials Overview 32

5.3 CPSI Biotech Company Overview 33

5.3.1 CPSI Biotech Pipeline Products & Ongoing Clinical Trials Overview 33

5.4 Creo Medical Ltd. Company Overview 35

5.4.1 Creo Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 35

5.5 Deneb Medical SL Company Overview 36

5.5.1 Deneb Medical SL Pipeline Products & Ongoing Clinical Trials Overview 36

5.6 Fractyl Laboratories Inc Company Overview 37

5.6.1 Fractyl Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 37

5.7 Harmonic Medical Inc Company Overview 41

5.7.1 Harmonic Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.8 HistoSonics Inc Company Overview 44

5.8.1 HistoSonics Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.9 Hospital for Special Surgery Company Overview 45

5.9.1 Hospital for Special Surgery Pipeline Products & Ongoing Clinical Trials Overview 45

5.10 Imricor Medical Systems Inc Company Overview 46

5.10.1 Imricor Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.11 Innoblative Designs, Inc. Company Overview 49

5.11.1 Innoblative Designs, Inc. Pipeline Products & Ongoing Clinical Trials Overview 49

5.12 Integra LifeSciences Holdings Corp Company Overview 50

5.12.1 Integra LifeSciences Holdings Corp Pipeline Products & Ongoing Clinical Trials Overview 50

5.13 Intratherm LLC (Inactive) Company Overview 52

5.13.1 Intratherm LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 52

5.14 Massachusetts Institute of Technology Company Overview 53

5.14.1 Massachusetts Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 53

5.15 Medtronic plc Company Overview 54

5.15.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 54

5.16 Memorial Sloan Kettering Cancer Center Company Overview 56

5.16.1 Memorial Sloan Kettering Cancer Center Pipeline Products & Ongoing Clinical Trials Overview 56

5.17 Mirabilis Medical Inc Company Overview 57

5.17.1 Mirabilis Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 57

5.18 Pulse Biosciences Inc Company Overview 60

5.18.1 Pulse Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 60

5.19 Southern Illinois University Carbondale Company Overview 61

5.19.1 Southern Illinois University Carbondale Pipeline Products & Ongoing Clinical Trials Overview 61

5.20 Thermedical Inc Company Overview 62

5.20.1 Thermedical Inc Pipeline Products & Ongoing Clinical Trials Overview 62

5.21 TransEnterix Inc Company Overview 63

5.21.1 TransEnterix Inc Pipeline Products & Ongoing Clinical Trials Overview 63

5.22 University of California San Francisco Company Overview 64

5.22.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 64

5.23 University of Texas at Austin Company Overview 65

5.23.1 University of Texas at Austin Pipeline Products & Ongoing Clinical Trials Overview 65

5.24 University of Wisconsin-Stout Company Overview 66

5.24.1 University of Wisconsin-Stout Pipeline Products & Ongoing Clinical Trials Overview 66

6 Ablation Equipments- Recent Developments 67

6.1 Jul 11, 2018: AngioDynamics Reports Fiscal 2018 Fourth Quarter and Full-Year Financial Results 67

6.2 Jul 10, 2018: Stryker announces organizational changes 68

6.3 Jul 05, 2018: SonaCare reports long-term results of HIFU therapy for prostate cancer 69

6.4 Jun 23, 2018: Fractyl Announces Presentation of Key Scientific Research at ADA 2018 Indicating That Modern Diets Durably Alter Duodenal Lining, Highlighting the Intestine's Role in Type 2 Diabetes and NASH 69

6.5 Jun 14, 2018: HSS Hip and Knee Surgeon Bradford Waddell, MD, Named Chair of Young Arthroplasty Group 71

6.6 Jun 05, 2018: Medtronic Presents Strategic Growth Roadmap at 2018 Investor Day; Outlines Plan to Create Shareholder Value 71

7 Appendix 139

7.1 Methodology 139

7.2 About GlobalData 142

7.3 Contact Us 142

7.4 Disclaimer 142

List of Figure

1.2 List of Figures

Figure 1: Ablation Equipments-Pipeline Products by Stage of Development 11

Figure 2: Ablation Equipments-Pipeline Products by Territory 12

Figure 3: Ablation Equipments-Pipeline Products by Regulatory Path 13

Figure 4: Ablation Equipments-Pipeline Products by Estimated Approval Date 14

Figure 5: Ablation Equipments-Ongoing Clinical Trials 15

List of Table

1.1 List of Tables

Table 1: Ablation Equipments-Pipeline Products by Stage of Development 11

Table 2: Ablation Equipments-Pipeline Products by Territory 12

Table 3: Ablation Equipments-Pipeline Products by Regulatory Path 13

Table 4: Ablation Equipments-Pipeline Products by Estimated Approval Date 14

Table 5: Ablation Equipments-Ongoing Clinical Trials 15

Table 6: Ablation Equipments Companies-Pipeline Products by Stage of Development 16

Table 7: Ablation Equipments-Pipeline Products by Stage of Development 17

Table 8: AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 18

Table 9: NanoKnife 3.0-Product Status 18

Table 10: NanoKnife 3.0-Product Description 19

Table 11: NanoKnife Low Energy Direct Current System-Hepatocellular Carcinoma-Product Status 19

Table 12: NanoKnife Low Energy Direct Current System-Hepatocellular Carcinoma-Product Description 19

Table 13: NanoKnife System-Pancreatic Cancer-Product Status 20

Table 14: NanoKnife System-Pancreatic Cancer-Product Description 20

Table 15: NanoKnife System-Prostate Cancer-Product Status 20

Table 16: NanoKnife System-Prostate Cancer-Product Description 21

Table 17: AngioDynamics Inc-Ongoing Clinical Trials Overview 22

Table 18: NanoKnife System-Prostate Cancer-Efficacy and Safety Assessment of Nanoknife (AngyoDynamics, USA) for Irreversible Electroporation (IRE) of Localized Prostate Cancer 24

Table 19: NanoKnife System-Prostate Cancer-Focal Irreversible Electroporation as Salvage Treatment in Radio-recurrent Prostate Cancer: A Prospective Multicenter Pilot Study 24

Table 20: NanoKnife System-Prostate Cancer-Irreversible Electroporation (IRE) for Unresectable Prostatic Neoplasms: Phase I and Phase II Clinical Trial 24

Table 21: NanoKnife System-Prostate Cancer-Multi-center Randomized Clinical Two Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Localized Prostate Cancer 25

Table 22: NanoKnife System-Prostate Cancer-Registry of Irreversible Electroporation for the Ablation of Prostate Cancer with Use of Nanoknife Device; A Multi-center, International Registry to Evaluate the Treatment of Prostate Cancer in Terms of Recurrence, Functional Outcomes and Safety 25

Table 23: NanoKnife System-Pancreatic Cancer-A Clinical Research about Using Irreversible Electroporation to Treat Locally Advanced Pancreatic Cancer 26

Table 24: NanoKnife System-Pancreatic Cancer-A Pilot Study of Irreversible Electroporation for the Treatment of Upfront Resectable Pancreatic Cancer in the Head of the Pancreas 26

Table 25: NanoKnife System-Pancreatic Cancer-Assessing Optimal Treatment Settings for the Ablation of Locally Advanced Pancreatic Cancer with CT-guided Percutaneous Irreversible Electroporation (ANTILOPE): A Randomized Feasibility Study 26

Table 26: NanoKnife System-Pancreatic Cancer-Crossatlantic Randomized Controlled Trial Comparing Outcome in Survival after Systemic Plus Focal Therapy for Inoperable Pancreatic Carcinoma: Radiotherapy Versus Irreversible Electroporation: CROSSFIRE Trial 27

Table 27: NanoKnife System-Pancreatic Cancer-Evaluation of the Short and Intermediate Term Outcomes of Ablation of Locally Advanced Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation (IRE) System-A Prospective Study 27

Table 28: NanoKnife System-Pancreatic Cancer-Impact of Irreversible Electroporation on Quality of Life for Patients with Locally Advanced Pancreatic Cancer 27

Table 29: NanoKnife System-Pancreatic Cancer-Interest of Irreversible Electroporation in the Treatment of Pancreatic Adenocarcinoma 28

Table 30: NanoKnife System-Pancreatic Cancer-IRE: Anti-tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer 28

Table 31: NanoKnife System-Pancreatic Cancer-Irreversible Electroporation for Locally Advanced Pancreatic Ductal Adenocarcinoma (LEAP TRIAL): A Phase I/II Prospective Trial 28

Table 32: NanoKnife Low Energy Direct Current System-Hepatocellular Carcinoma-A Prospective Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Unresectable Hepatic Carcinoma Close to the Gallbladder 29

Table 33: NanoKnife Low Energy Direct Current System-Hepatocellular Carcinoma-A Prospective Clinical Trial Using Irreversible Electroporation for the Treatment of Liver Cancers 29

Table 34: NanoKnife Low Energy Direct Current System-Hepatocellular Carcinoma-Colorectal Metastatic Liver Disease: Efficacy of Irreversible Electroporation (IRE)-A Phase II Clinical Trial: COLDFIRE-2 Study 29

Table 35: NanoKnife Low Energy Direct Current System-Hepatocellular Carcinoma-Combination of Irreversible Electroporation and NK Immunotherapy for Recurrent Liver Cancer 30

Table 36: NanoKnife Low Energy Direct Current System-Hepatocellular Carcinoma-Comparison Percutaneous Cryosurgery and Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome 30

Table 37: NanoKnife Low Energy Direct Current System-Hepatocellular Carcinoma-Hepatic Carcinoma in Poor Liver Function: Safety and Efficacy of Irreversible Electroporation (IRE) 30

Table 38: NanoKnife Low Energy Direct Current System-Hepatocellular Carcinoma-Irreversible Electroporation (IRE) for Unresectable Portal Venous Tumor Emboli: Phase I and Phase II Clinical Trial 31

Table 39: NanoKnife 3.0-The Safety and Feasibility of Irreversible Electroporation for the Ablation of Small Renal Masses 32

Table 40: Avenda Health Inc Pipeline Products & Ongoing Clinical Trials Overview 33

Table 41: Fiber-Optic Laser-Product Status 33

Table 42: Fiber-Optic Laser-Product Description 33

Table 43: CPSI Biotech Pipeline Products & Ongoing Clinical Trials Overview 34

Table 44: Pressurized Sub-Cooled Nitrogen System-Product Status 34

Table 45: Pressurized Sub-Cooled Nitrogen System-Product Description 34

Table 46: Super-Critical Nitrogen (SCN) Cryoablation Platform-Product Status 34

Table 47: Super-Critical Nitrogen (SCN) Cryoablation Platform-Product Description 35

Table 48: Creo Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 36

Table 49: Flexible Ablation System-Product Status 36

Table 50: Flexible Ablation System-Product Description 36

Table 51: Deneb Medical SL Pipeline Products & Ongoing Clinical Trials Overview 37

Table 52: BoneCut Collaborative Robot-Product Status 37

Table 53: BoneCut Collaborative Robot-Product Description 37

Table 54: Fractyl Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Table 55: Revita DMR System-Product Status 38

Table 56: Revita DMR System-Product Description 38

Table 57: Fractyl Laboratories Inc-Ongoing Clinical Trials Overview 39

Table 58: Revita DMR System-Evaluation of Duodenal Mucosal Resurfacing (DMR) for the Treatment of Non Alcoholic Steatohepatitis (NASH), a Proof of Concept Study 40

Table 59: Revita DMR System-Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes 40

Table 60: Revita DMR System-Evaluation of the Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D) 40

Table 61: Revita DMR System-Multicenter Clinical Trial of Revita DMR Procedure in Patients with Diabetes 41

Table 62: Harmonic Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 42

Table 63: Symphony MRI guided High Intensity Focused Ultrasound-Leiomyomas-Product Status 42

Table 64: Symphony MRI guided High Intensity Focused Ultrasound-Leiomyomas-Product Description 42

Table 65: Harmonic Medical Inc-Ongoing Clinical Trials Overview 43

Table 66: Symphony MRI guided High Intensity Focused Ultrasound-Leiomyomas-MRI-guided High Intensity Focused Ultrasound Ablation of Leiomyomas. Single Arm, Feasibility Study Using the Symphony-MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas. 44

Table 67: HistoSonics Inc Pipeline Products & Ongoing Clinical Trials Overview 45

Table 68: Vortx RX-Product Status 45

Table 69: Vortx RX-Product Description 45

Table 70: Hospital for Special Surgery Pipeline Products & Ongoing Clinical Trials Overview 46

Table 71: Radiofrequency Ablation Device-Product Status 46

Table 72: Radiofrequency Ablation Device-Product Description 46

Table 73: Imricor Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 47

Table 74: Vision MR Ablation Catheter-Product Status 47

Table 75: Vision MR Ablation Catheter-Product Description 47

Table 76: Imricor Medical Systems Inc-Ongoing Clinical Trials Overview 48