Interventional Radiology Devices Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2021

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Interventional Radiology which generates high quality image of tumour by performing simultaneous motion estimation and motion-compensated image reconstruction for cancer patients undergoing radiation therapy. The report provides comprehensive information about the Interventional Radiology Devices pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

What are the market dynamics in the interventional radiology replacement devices pipeline products market?

As of November 2021, 25 pipeline products were in the clinical stage and 17 in the inactive stage. 5 of the pipeline products were in the approval process and 2 in the pre-clinical stage. 14 pipeline products were in the early development stage. The US was found to be the leader in interventional radiology replacement devices pipeline products market followed by Canada, Europe, China, Costa Rica, El Salvador, Mexico, Russia, South Korea, Israel, Ecuador, Chile, Argentina, and Brazil. There were 20 ongoing, recruiting trials of interventional radiology replacement devices pipeline products and 4 were ongoing, not recruiting.

Which are the key players in the interventional radiology replacement devices pipeline products market?

The key players in the market are Accuray Inc, Actuality Medical, Inc. (Inactive), Akesis LLC, Bendit Technologies Ltd, Biocompatibles UK Ltd, Boston Scientific Corp, BrachyFoam LLC, Cornell University, CR Bard Inc and Creo Medical Ltd.

Company overview:

Accuray Inc: Accuray Inc (Accuray) is a medical device company which focuses on the development, manufacture, and sale of personalized treatment solutions for radiosurgery, stereotactic body radiation therapy, intensity modulated radiation therapy, image guided radiation therapy and adaptive radiation therapy. The company’s major products include CyberKnife robotic radiosurgery systems, TomoTherapy system, Radixact delivery treatment platform and Software Solutions. Its flagship product, CyberKnife robotic radiosurgery system is designed to treat tumors anywhere in the body non-invasively with an accuracy of sub-millimeter. TomoTherapy system combines a CT scanner with a radiation treatment delivery system that is used by healthcare professionals in the treatment of a wide range of cancer types. Its major services include post-contract customer support, training, installation services, and other professional services. The company sells its products in the US and through distributors in Latin America, Europe, and Asia. Accuray is headquartered in Sunnyvale, California, the US.

Its product is Linac (Linear Accelerator) that is intended to be used during radiation therapy procedures. It is designed to deliver high-energy x-rays or electrons to the region of the patient’s tumor.

Akesis LLC: Akesis LLC (Akesis) is a contract research organization that provides clinical research services and regulatory affairs consulting. The company offers pharmaceutical development services such as feasibility and protocol development, project and program management, clinical trial monitoring, oversight and conduct of phase i-iv trials, site identification and selection, patient recruitment support, and regulatory document management. It caters its services to therapeutic areas such as dermatology and topical, epilepsy, pediatrics, ophthalmology, osteoarthritis, ulcerative colitis, and women’s and men’s health.

Its product is Akesis Gemini 360 that is intended for stereotactic radiotherapy. It is designed to deliver radiotherapy with integrated real-time imaging with 360° rotation. It is based on Continuous 360° Rotational Technology. It consists of a MV LINAC head and 120 leaf MLC.

Boston Scientific Corp: Boston Scientific Corp (Boston Scientific) is a medical technology company that develops, manufactures, and commercializes devices for a range of interventional medical specialties. The company offers products in the areas of electrophysiology, gastroenterology, gastrointestinal surgery, female pelvic medicine, gynecology, interventional cardiology, interventional radiology, neurological surgery, orthopedic surgery, pain medicine, pulmonology, urology, and vascular surgery. Boston Scientific serves hospitals, clinics, outpatient facilities and medical offices across the world. The company has manufacturing facilities in the US, Ireland, Costa Rica, Brazil, Malaysia, Puerto Rico, and Switzerland. It sells products directly and also through a network of distributors and dealers in Europe, the Middle East, Africa, Asia-Pacific, and the Americas. Boston Scientific is headquartered in Marlborough, Massachusetts, the US.

Its product is, TheraSphere – Brain Cancer is a radioembolization device intended for the treatment of brain cancer. It is designed to deliver a radiotherapeutic agent (yttrium-90) directly to the tumor via blood flow. It consists of millions of microscopic, insoluble glass microspheres being infused into the arteries that feed tumors.  Diameter (mm): 20-30 Delivers Yttrium-90.

Cornell University: Cornell University (CU), subsidiary of State University of New York, is provider of education services. The university offers education and research services. It offers educational services of undergraduates, graduate, and professional courses. CU provides education in the areas environmental engineering and biological engineering, crop and soil sciences, communication, and development sociology departments. The university operates schools and colleges. It offers research services with multidisciplinary partnerships and for graduates and undergraduates. The university has labs, facilities, centers, and institutes for research. It has services in the US, Italy, and Qatar. CU is headquartered at Ithaca, New York, the US.

Its product is, safety catheter that is intended to be used during interventional radiology and endovascular procedures. It is designed to facilitate delivery of guidewires without dilators and/or sheath. It comprises a soft, atraumatic lumen portion and has a temperature-sensitive exoskeleton. 

CR Bard Inc: CR Bard Inc (CR Bard), a subsidiary of Becton Dickinson and Co, is a medical technology company that develops and markets medical devices in the areas of urology, vascular, oncology and surgical specialty. Its offerings include foley catheters, foley trays, irrigation trays, collection systems, intermittent catheters, and trays. CR Bard is headquartered in Murray Hill, New Jersey, the US. Its product is, Loc Wire Replacement that is a signal transmission device designed for breast cancer detection. It is designed to detect the abnormal spot in the breast.

Interventional radiology replacement devices pipeline products, by key players

Interventional radiology replacement devices pipeline products, by key players

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Market report scope

Key countries/regions The US, Canada, Europe, China, Costa Rica, El Salvador, Mexico, Russia, South Korea, Israel, Ecuador, Chile, Argentina, and Brazil
Key players Accuray Inc, Actuality Medical, Inc. (Inactive), Akesis LLC, Bendit Technologies Ltd, Biocompatibles UK Ltd, Boston Scientific Corp, BrachyFoam LLC, Cornell University, CR Bard Inc, Creo Medical Ltd, Elekta AB, GYS Tech LLC, IMRIS, Inc., Intelligent Ultrasound plc, Landauer Inc, MagnetTx Oncology Solutions Inc, Medical Device Investments, Inc., Neuboron Medtech Ltd, Protonvda Inc, Quirem Medical BV, Radiabeam Technologies LLC, Radiaction Ltd, RadiaDyne, LLC, Raysearch Laboratories AB, Siemens Healthineers AG, SpectraCure AB, Standard Imaging Inc, TheraBionic LLC, Theralase Technologies Inc, University Health Network, University of California Los Angeles, University of Florida, University of South Florida, University of Texas Southwestern Medical Center, Varian Medical Systems Inc, Vivos Inc, XL Sci-Tech Inc, Xoft Inc, and ZHealth Documentation LLC.

 Scope

  • Extensive coverage of the Interventional Radiology Devices under development.
  • The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities.
  • The report reviews the major players involved in the development of Interventional Radiology Devices and list all their pipeline projects.
  • The coverage of pipeline products based on various stages of development ranging from Early Development to the Approved/Issued stage.
  • The report provides key clinical trial data of ongoing trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

The report enables you to:

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies.
  • Identify emerging players with potentially strong product portfolio and create effective counter strategies to gain competitive advantage.
  • Identify and understand important and diverse types of Interventional Radiology Devices under development.
  • Develop market-entry and market expansion strategies.
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.
  • In-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Accuray Inc
Actuality Medical, Inc. (Inactive)
Akesis LLC
Bendit Technologies Ltd
Biocompatibles UK Ltd
Boston Scientific Corp
BrachyFoam LLC
Cornell University
CR Bard Inc
Creo Medical Ltd
Elekta AB
GYS Tech LLC
IMRIS, Inc.
Intelligent Ultrasound plc
Landauer Inc
MagnetTx Oncology Solutions Inc
Medical Device Investments, Inc.
Neuboron Medtech Ltd
Protonvda Inc
Quirem Medical BV
Radiabeam Technologies LLC
Radiaction Ltd
RadiaDyne, LLC
Raysearch Laboratories AB
Siemens Healthineers AG
SpectraCure AB
Standard Imaging Inc
TheraBionic LLC
Theralase Technologies Inc
University Health Network
University of California Los Angeles
University of Florida
University of South Florida
University of Texas Southwestern Medical Center
Varian Medical Systems Inc
Vivos Inc
XL Sci-Tech Inc
Xoft Inc
ZHealth Documentation LLC

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 7

|1.2 List of Figures 12

2 Introduction 13

2.1 Interventional Radiology Overview 13

3 Products under Development 14

3.1 Interventional Radiology Devices – Pipeline Products by Stage of Development 14

3.2 Interventional Radiology Devices – Pipeline Products by Territory 15

3.3 Interventional Radiology Devices – Pipeline Products by Regulatory Path 16

3.4 Interventional Radiology Devices – Pipeline Products by Estimated Approval Date 17

3.5 Interventional Radiology Devices – Ongoing Clinical Trials 18

4 Interventional Radiology Devices – Pipeline Products under Development by Companies 19

4.1 Interventional Radiology Companies – Pipeline Products by Stage of Development 19

4.2 Interventional Radiology Devices – Pipeline Products by Stage of Development 21

5 Interventional Radiology Companies and Product Overview 23

5.1 Accuray Inc Company Overview 23

5.1.1 Accuray Inc Pipeline Products & Ongoing Clinical Trials Overview 23

5.2 Actuality Medical, Inc. (Inactive) Company Overview 25

5.2.1 Actuality Medical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 25

5.3 Akesis LLC Company Overview 26

5.3.1 Akesis LLC Pipeline Products & Ongoing Clinical Trials Overview 26

5.4 Bendit Technologies Ltd Company Overview 27

5.4.1 Bendit Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 27

5.5 Biocompatibles UK Ltd Company Overview 28

5.5.1 Biocompatibles UK Ltd Pipeline Products & Ongoing Clinical Trials Overview 28

5.6 Boston Scientific Corp Company Overview 31

5.6.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 31

5.7 BrachyFoam LLC Company Overview 35

5.7.1 BrachyFoam LLC Pipeline Products & Ongoing Clinical Trials Overview 35

5.8 Cornell University Company Overview 36

5.8.1 Cornell University Pipeline Products & Ongoing Clinical Trials Overview 36

5.9 CR Bard Inc Company Overview 38

5.9.1 CR Bard Inc Pipeline Products & Ongoing Clinical Trials Overview 38

5.10 Creo Medical Ltd Company Overview 40

5.10.1 Creo Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 40

5.11 Elekta AB Company Overview 41

5.11.1 Elekta AB Pipeline Products & Ongoing Clinical Trials Overview 41

5.12 GYS Tech LLC Company Overview 46

5.12.1 GYS Tech LLC Pipeline Products & Ongoing Clinical Trials Overview 46

5.13 IMRIS, Inc. Company Overview 48

5.13.1 IMRIS, Inc. Pipeline Products & Ongoing Clinical Trials Overview 48

5.14 Intelligent Ultrasound plc Company Overview 49

5.14.1 Intelligent Ultrasound plc Pipeline Products & Ongoing Clinical Trials Overview 49

5.15 Landauer Inc Company Overview 50

5.15.1 Landauer Inc Pipeline Products & Ongoing Clinical Trials Overview 50

5.16 MagnetTx Oncology Solutions Inc Company Overview 51

5.16.1 MagnetTx Oncology Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 51

5.17 Medical Device Investments, Inc. Company Overview 52

5.17.1 Medical Device Investments, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

5.18 Neuboron Medtech Ltd Company Overview 53

5.18.1 Neuboron Medtech Ltd Pipeline Products & Ongoing Clinical Trials Overview 53

5.19 Protonvda Inc Company Overview 54

5.19.1 Protonvda Inc Pipeline Products & Ongoing Clinical Trials Overview 54

5.20 Quirem Medical BV Company Overview 56

5.20.1 Quirem Medical BV Pipeline Products & Ongoing Clinical Trials Overview 56

5.21 Radiabeam Technologies LLC Company Overview 58

5.21.1 Radiabeam Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 58

5.22 Radiaction Ltd Company Overview 59

5.22.1 Radiaction Ltd Pipeline Products & Ongoing Clinical Trials Overview 59

5.23 RadiaDyne, LLC Company Overview 60

5.23.1 RadiaDyne, LLC Pipeline Products & Ongoing Clinical Trials Overview 60

5.24 Raysearch Laboratories AB Company Overview 61

5.24.1 Raysearch Laboratories AB Pipeline Products & Ongoing Clinical Trials Overview 61

5.25 Siemens Healthineers AG Company Overview 62

5.25.1 Siemens Healthineers AG Pipeline Products & Ongoing Clinical Trials Overview 62

5.26 SpectraCure AB Company Overview 63

5.26.1 SpectraCure AB Pipeline Products & Ongoing Clinical Trials Overview 63

5.27 Standard Imaging Inc Company Overview 67

5.27.1 Standard Imaging Inc Pipeline Products & Ongoing Clinical Trials Overview 67

5.28 TheraBionic LLC Company Overview 68

5.28.1 TheraBionic LLC Pipeline Products & Ongoing Clinical Trials Overview 68

5.29 Theralase Technologies Inc Company Overview 71

5.29.1 Theralase Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.30 University Health Network Company Overview 77

5.30.1 University Health Network Pipeline Products & Ongoing Clinical Trials Overview 77

5.31 University of California Los Angeles Company Overview 79

5.31.1 University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 79

5.32 University of Florida Company Overview 80

5.32.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 80

5.33 University of South Florida Company Overview 81

5.33.1 University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 81

5.34 University of Texas Southwestern Medical Center Company Overview 82

5.34.1 University of Texas Southwestern Medical Center Pipeline Products & Ongoing Clinical Trials Overview 82

5.35 Varian Medical Systems Inc Company Overview 85

5.35.1 Varian Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 85

5.36 Vivos Inc Company Overview 90

5.36.1 Vivos Inc Pipeline Products & Ongoing Clinical Trials Overview 90

5.37 XL Sci-Tech Inc Company Overview 91

5.37.1 XL Sci-Tech Inc Pipeline Products & Ongoing Clinical Trials Overview 91

5.38 Xoft Inc Company Overview 92

5.38.1 Xoft Inc Pipeline Products & Ongoing Clinical Trials Overview 92

5.39 ZHealth Documentation LLC Company Overview 101

5.39.1 ZHealth Documentation LLC Pipeline Products & Ongoing Clinical Trials Overview 101

6 Interventional Radiology- Recent Developments 102

6.1 Nov 18, 2021: IBA announces Business Update Third Quarter 2021 102

6.2 Nov 09, 2021: iCAD Reports Financial Results for the Quarter Ended September 30, 2021 103

6.3 Nov 04, 2021: Invitation to the presentation of Elekta’s second quarter 2021/22 105

6.4 Nov 04, 2021: ViewRay Reports Third Quarter 2021 Results 105

6.5 Nov 03, 2021: HealthHelp and Covera Health announce strategic partnership 107

6.6 Nov 03, 2021: FDA In Brief: FDA provides new draft guidance on premarket submissions for device software functions 107

6.7 Oct 28, 2021: Merit Medical Reports Results For Quarter Ended September 30, 2021 108

6.8 Oct 26, 2021: iCAD to Report Third Quarter 2021 Financial Results on Tuesday, November 9 109

6.9 Oct 20, 2021: Obsidio Expands Clinical Advisory Board With Two New Members 109

6.10 Oct 18, 2021: ViewRay to Host a Virtual Clinical Data Event for Investors and Analysts on October 28, 2021 110

6.11 Oct 14, 2021: ViewRay Announces Conference Call for Third Quarter 2021 Financial Results to be Held After Market on November 4, 2021 110

6.12 Oct 05, 2021: Merit Medical Systems to Announce Third Quarter Results on October 28, 2021 111

6.13 Oct 05, 2021: AI helps rule out cancer in dense breasts 111

6.14 Sep 30, 2021: QIBA-EARL collaboration improves PET/CT conformance 112

6.15 Sep 21, 2021: Isoray Announces Fourth Quarter and Full-Year Fiscal Year End 2021 Financial Results 113

6.16 Sep 16, 2021: ViewRay to Partcipate in the Cantor Global Healthcare Conference 114

6.17 Sep 09, 2021: Merit Medical Systems to Announce First Quarter Results on April 29, 2021 114

6.18 Sep 01, 2021: LucidHealth expands services in Southeastern Ohio through Genesis contract 115

6.19 Aug 25, 2021: Raysearch interim report January 1 – June 30, 2021 115

6.20 Aug 11, 2021: Invitation to the presentation of Elekta’s first quarter 2021/22 116

6.21 Aug 10, 2021: Ion Beam Applications announce Corporate Half Year 2021 results press release and web conference August 25, 2021 116

6.22 Aug 05, 2021: ViewRay Reports Second Quarter 2021 Results 117

6.23 Aug 05, 2021: iCAD Reports Financial Results for the Quarter Ended June 30, 2021 118

6.24 Jul 22, 2021: iCAD to Report Second Quarter 2021 Financial Results on Thursday, August 5 120

6.25 Jul 21, 2021: Notice to the Annual General Meeting of Elekta 120

6.26 Jul 15, 2021: ViewRay Announces Conference Call for Second Quarter 2021 Financial Results to be Held After Market on August 5, 2021 121

6.27 Jul 13, 2021: Obsidio awarded prestigious Fast Track Small Business Innovation Research grant by National Heart, Lung, and Blood Institute 121

6.28 Jul 09, 2021: Merit Medical Systems to Announce Second Quarter Results on July 29, 2021 122

6.29 Jul 09, 2021: Elekta’s Annual Report for 2020/21 available 122

6.30 Jun 24, 2021: Peter Arduini named CEO of GE healthcare 122

6.31 Jun 04, 2021: Elekta Nomination Committee’s proposed Board of Directors for the 2021 Annual General Meeting 123

6.32 May 27, 2021: A long-term partnership as a common goal for C-RAD and Innokas Medical 124

6.33 May 26, 2021: Bulletin from the Annual General Meeting 2021 125

6.34 May 19, 2021: COVID-19 AI detection challenge open for submissions 125

6.35 May 17, 2021: ViewRay to Present at the Jefferies 2021 Virtual Healthcare Conference 126

6.36 May 06, 2021: Accuray Announces New $120 Million Credit Facility 126

6.37 May 04, 2021: C-RAD provides Web Presentation Interim Report Q1 2021 and AGM speech 126

6.38 May 04, 2021: RaySearch establishes local subsidiary for the Australian and New Zealand Market 127

6.39 Apr 29, 2021: iCAD Reports Financial Results for First Quarter Ended March 31, 2021 127

6.40 Apr 29, 2021: Isoray To Announce Third Quarter Fiscal 2021 Financial Results on May 13, 2021 128

6.41 Apr 29, 2021: Accuray customers achieve top scores in AAPM MArkerless Lung Target Tracking CHallenge (MATCH) using Synchrony technology on the Radixact and CyberKnife systems 129

6.42 Apr 28, 2021: Researchers use artificial intelligence (AI) to detect wrist fractures 130

6.43 Apr 27, 2021: 4ways Healthcare embraces cutting edge AI diagnostics-aid tools from Aidoc 131

6.44 Apr 23, 2021: C-RAD Web Presentation Interim Report Q1 2021 and AGM speech 131

6.45 Apr 23, 2021: RaySearch Laboratories Invitation to Annual General Meeting 2021 132

6.46 Apr 23, 2021: The Patent and Market Court of Appeal issues judgement confirming C-RAD’s entitlement to Beamocular’s invention 135

6.47 Apr 20, 2021: iCAD to Report First Quarter 2021 Financial Results on Wednesday, April 28 136

6.48 Apr 16, 2021: Elekta Report Extraordinary General Meeting on Friday 16 April 2021 136

6.49 Apr 15, 2021: China Isotope & Radiation: Entering into investment agreement with the government of Jiajiang County 136

6.50 Apr 13, 2021: Accuray to Report Third Quarter Fiscal 2021 Financial Results on April 27, 2021 136

6.51 Apr 05, 2021: iCAD Announces Estimated Q1 Revenues and Upcoming CFO Transition 137

6.52 Mar 29, 2021: Merit Medical Reports Results for Quarter Ended March 31, 2021 137

6.53 Mar 19, 2021: Notice to the Extraordinary General Meeting of Elekta AB (publ) 139

6.54 Mar 15, 2021: ViewRay announces Departure of Chief Operating Officer 141

6.55 Mar 05, 2021: ViewRay To Participate in the 21st Annual Oppenheimer Healthcare Conference 141

6.56 Mar 04, 2021: ViewRay Reports Fourth Quarter and Full Year 2020 Results 141

6.57 Mar 03, 2021: Isoray to Present at the Oppenheimer 31st Annual Healthcare Conference 143

6.58 Mar 03, 2021: iCAD to Participate in the Cowen 41st Annual Health Care Conference 143

6.59 Feb 23, 2021: Covera Health Expands Leadership Team with New Head of Provider Partnerships 143

6.60 Feb 23, 2021: Will Weatherford elected vice chair of the USF Board of Trustees 144

6.61 Feb 23, 2021: Accuray to Participate in the Cowen 41st Annual Health Care Conference 144

6.62 Feb 19, 2021: ViewRay Announces Conference Call for Fourth Quarter and Full Year 2020 Financial Results to be Held After Market on March 4, 2021 144

6.63 Feb 18, 2021: iCAD to Report Fourth Quarter 2020 Financial Results on Wednesday, February 24 145

6.64 Feb 18, 2021: GenesisCare brings Western North Carolina Cancer patients Elekta Versa HD technology 145

6.65 Feb 17, 2021: St. Petersburg Conference on World Affairs to provide global perspective and insight into historic turmoil 146

6.66 Feb 16, 2021: Isoray Announces the Appointment of Lisa Lauer As Vice President Business Development 147

6.67 Feb 16, 2021: iCAD to Participate in the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference 147

6.68 Feb 15, 2021: Invitation to the presentation of Elekta’s third quarter 2020/21 147

6.69 Feb 15, 2021: Elekta invites analysts and investors to a presentation of the third quarter 2020/21 148

6.70 Feb 12, 2021: Merit Medical Systems to Announce Fourth Quarter and Year End 2020 Results on February 24, 2021 149

6.71 Feb 10, 2021: Merit Medical to Present at 2021 SVB Leerink Global Healthcare Conference 149

6.72 Feb 09, 2021: Isoray Announces Second Quarter Fiscal 2021 Financial Results 149

6.73 Feb 05, 2021: Isoray To Announce Second Quarter Fiscal 2021 Financial Results on February 9, 2021 151

6.74 Feb 03, 2021: C-RAD and WITH-GLOBAL engage in a partnership for the South Korean market 151

6.75 Jan 27, 2021: Accuray to Report Second Quarter Fiscal 2021 Financial Results on January 27, 2021 151

6.76 Jan 15, 2021: ViewRay Announces Participation in the B. Riley Oncology Investor Conference 152

6.77 Jan 08, 2021: Varian Announces First Quarter Fiscal Year 2021 Earnings Release Date 152

6.78 Jan 07, 2021: Isoray to Present at the H.C. Wainwright BioConnect 2021 Conference 152

6.79 Jan 07, 2021: Merit Medical to Participate in Two Upcoming Investor Conferences 152

6.80 Jan 06, 2021: Accuray To Participate at J.P. Morgan”s 39th Annual Healthcare Conference 152

6.81 Dec 28, 2020: Cook Medical launches a new Customer Portal to enhance customer experience 153

6.82 Dec 18, 2020: Made-in-Canada method of producing life-saving radioisotopes receives Health Canada approval 153

6.83 Dec 04, 2020: Digital breast tomosynthesis improves invasive cancer detection 154

6.84 Dec 02, 2020: Single-dose radiation therapy at time of lumpectomy helps breast cancer patients overcome treatment challenges during pandemic 155

7 Appendix 157

7.1 Methodology 157

7.2 About GlobalData 160

7.3 Contact Us 160

Table

Interventional Radiology Devices – Pipeline Products by Stage of Development 14

Interventional Radiology Devices – Pipeline Products by Territory 15

Interventional Radiology Devices – Pipeline Products by Regulatory Path 16

Interventional Radiology Devices – Pipeline Products by Estimated Approval Date 17

Interventional Radiology Devices – Ongoing Clinical Trials 18

Interventional Radiology Companies – Pipeline Products by Stage of Development 19

Interventional Radiology Devices – Pipeline Products by Stage of Development 21

Accuray Inc Pipeline Products & Ongoing Clinical Trials Overview 23

Linac – Product Status 23

Linac – Product Description 23

Radixact System – DIBH – Product Status 24

Radixact System – DIBH – Product Description 24

Actuality Medical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 25

PerspectaSeed 4D – Product Status 25

PerspectaSeed 4D – Product Description 25

Akesis LLC Pipeline Products & Ongoing Clinical Trials Overview 26

Akesis Gemini360 – Product Status 26

Akesis Gemini360 – Product Description 26

Bendit Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 27

Bendit Microcatheter – Interventional Radiology Devices – Product Status 27

Bendit Microcatheter – Interventional Radiology Devices – Product Description 27

Biocompatibles UK Ltd Pipeline Products & Ongoing Clinical Trials Overview 28

TheraSphere – mCRC – Product Status 28

TheraSphere – mCRC – Product Description 28

Biocompatibles UK Ltd – Ongoing Clinical Trials Overview 29

TheraSphere – mCRC – A Prospective, Multicenter, Open-label, Phase II Study to Evaluate Efficacy and Safety of Selective Internal Radiation Therapy Plus Xelox, Bevacizumab and Atezolizumab (Immune Chekpoint Inhibitor) in Patients with Liver-dominant Metastatic Colorectal Cancer 30

TheraSphere – mCRC – Feasibility of a Personalized Dosimetry-based Treatment Planning for Radioembolization in the Treatment of Unresectable Colorectal Metastases in Liver 30

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 31

TheraSphere – Brain Cancer – Product Status 31

TheraSphere – Brain Cancer – Product Description 31

TheraSphere – Glioblastoma – Product Status 32

TheraSphere – Glioblastoma – Product Description 32

TheraSphere – Lung Cancer – Product Status 32

TheraSphere – Lung Cancer – Product Description 33

TheraSphere – Prostate Cancer – Product Status 33

TheraSphere – Prostate Cancer – Product Description 33

TheraSphere – Solid Tumors – Product Status 34

TheraSphere – Solid Tumors – Product Description 34

BrachyFoam LLC Pipeline Products & Ongoing Clinical Trials Overview 35

Hydrogel System – Pelvic Brachytherapy – Product Status 35

Hydrogel System – Pelvic Brachytherapy – Product Description 35

Cornell University Pipeline Products & Ongoing Clinical Trials Overview 36

Safety Catheter – Product Status 36

Safety Catheter – Product Description 36

Safety Guidewire – Product Status 37

Safety Guidewire – Product Description 37

CR Bard Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Loc Wire Replacement – Product Status 38

Loc Wire Replacement – Product Description 38

Next-generation Radiation Therapy Device – Product Status 39

Next-generation Radiation Therapy Device – Product Description 39

RFID Tag Device – Product Status 39

RFID Tag Device – Product Description 39

Creo Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 40

Micro-Optofluidic Lab-On-Chip Device – Product Status 40

Micro-Optofluidic Lab-On-Chip Device – Product Description 40

Elekta AB Pipeline Products & Ongoing Clinical Trials Overview 41

Elekta Unity – Product Status 41

Elekta Unity – Product Description 42

Harmony Pro – Product Status 42

Harmony Pro – Product Description 42

Elekta AB – Ongoing Clinical Trials Overview 43

Elekta Unity – A Study to Evaluate the Efficacy of Elekta Unity in Patients with Localized Prostate Cancer 44

Elekta Unity – Development of Daily Online Magnetic Resonance Imaging for Magnetic Resonance Image Guided Radiotherapy (MRIgRT) 44

Elekta Unity – Feasibility of Imaging and Radiotherapy on a Novel 1.5 T Hybrid Magnetic Resonance Imaging – Linear Accelerator System (MR-Linac) 44

Elekta Unity – Prospective Evaluation of Radiotherapy using Magnetic Resonance Image Guided Treatment (PERMIT) 45

Elekta Unity – Prostate Radiotherapy Integrated with Simultaneous MRI (The PRISM Study) 45

Elekta Unity – The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study 45

GYS Tech LLC Pipeline Products & Ongoing Clinical Trials Overview 46

Navigation System – Interventional Radiology Devices – Product Status 46

Navigation System – Interventional Radiology Devices – Product Description 46

Robot – Interventional Radiology Devices – Product Status 47

Robot – Interventional Radiology Devices – Product Description 47

IMRIS, Inc. Pipeline Products & Ongoing Clinical Trials Overview 48

Second Generation MRgRT System – Product Status 48

Second Generation MRgRT System – Product Description 48

Intelligent Ultrasound plc Pipeline Products & Ongoing Clinical Trials Overview 49

NeedleGuide – Product Status 49

NeedleGuide – Product Description 49

Landauer Inc Pipeline Products & Ongoing Clinical Trials Overview 50

Verifii – Product Status 50

Verifii – Product Description 50

MagnetTx Oncology Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 51

Aurora RT Linac-MR Device – Product Status 51

Aurora RT Linac-MR Device – Product Description 51

Medical Device Investments, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

Brachytherapy Safe Catheter – Product Status 52

Brachytherapy Safe Catheter – Product Description 52

Neuboron Medtech Ltd Pipeline Products & Ongoing Clinical Trials Overview 53

NeuPex – Product Status 53

NeuPex – Product Description 53

Protonvda Inc Pipeline Products & Ongoing Clinical Trials Overview 54

Proton Computed Tomography System – Product Status 54

Proton Computed Tomography System – Product Description 54

The ProtonVDA pRAD System – Product Status 55

The ProtonVDA pRAD System – Product Description 55

Quirem Medical BV Pipeline Products & Ongoing Clinical Trials Overview 56

QuiremSpheres – Brain Tumor – Product Status 56

QuiremSpheres – Brain Tumor – Product Description 56

QuiremSpheres – Pancreatic Tumor – Product Status 57

QuiremSpheres – Pancreatic Tumor – Product Description 57

Radiabeam Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 58

Radiation Therapy Device – Product Status 58

Radiation Therapy Device – Product Description 58

Radiaction Ltd Pipeline Products & Ongoing Clinical Trials Overview 59

Radiation Shield – Product Status 59

Radiation Shield – Product Description 59

RadiaDyne, LLC Pipeline Products & Ongoing Clinical Trials Overview 60

RadiaDyne Endorectal Balloon Device – Product Status 60

RadiaDyne Endorectal Balloon Device – Product Description 60

Raysearch Laboratories AB Pipeline Products & Ongoing Clinical Trials Overview 61

RayStation 10B – Product Status 61

RayStation 10B – Product Description 61

Siemens Healthineers AG Pipeline Products & Ongoing Clinical Trials Overview 62

Treago Robotic Table – Product Status 62

Treago Robotic Table – Product Description 62

SpectraCure AB Pipeline Products & Ongoing Clinical Trials Overview 63

SpectraCure P18 Generation 2 – Product Status 63

SpectraCure P18 Generation 2 – Product Description 63

SpectraCure P18 System – Product Status 63

SpectraCure P18 System – Product Description 64

SpectraCure AB – Ongoing Clinical Trials Overview 65

SpectraCure P18 System – Evaluation of Safety and Clinical Benefit for Photodynamic Therapy (PDT) Treatment: A Phase 2 Trial 66

SpectraCure P18 System – Open-label Clinical Study to Assess the Safety and Adequacy of Effectiveness of the SpectraCure P18 System (Interstitial Multiple Diode Lasers and IDOSE Software) and Verteporfin for Injection (VFI) for the Treatment of Recurrent Prostate Cancer 66

Standard Imaging Inc Pipeline Products & Ongoing Clinical Trials Overview 67

Miniature Radiation Plastic Scintillation Detector System – Product Status 67

Miniature Radiation Plastic Scintillation Detector System – Product Description 67

TheraBionic LLC Pipeline Products & Ongoing Clinical Trials Overview 68

TheraBionic P1 – Product Status 68

TheraBionic P1 – Product Description 68

TheraBionic LLC – Ongoing Clinical Trials Overview 69

TheraBionic P1 – A Phase II Study of Intrabucally Administered Electromagnetic Fields and Regorafenib as Second-line Therapy for Patients with Advanced Hepatocellular Carcinoma 70

TheraBionic P1 – A Randomized Phase II Study of Intrabucally Administered Electromagnetic Fields Versus Placebo as Third-line Therapy for Patients with Advanced Hepatocellular Carcinoma 70

Theralase Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 71

TLC-3000 Photo Dynamic Therapy Laser System – Product Status 71

TLC-3000 Photo Dynamic Therapy Laser System – Product Description 71

TLC-3200 Medical Laser – Product Status 72

TLC-3200 Medical Laser – Product Description 72

TLC-3400 Medical Laser – Product Status 72

TLC-3400 Medical Laser – Product Description 73

Theralase Technologies Inc – Ongoing Clinical Trials Overview 74

TLC-3200 Medical Laser – A Phase II Clinical Study of Intravesical Photodynamic Therapy in Patients with BCG-Unresponsive Non-muscle Invasive Bladder Cancer (“NMIBC”) or Patients who Are Intolerant to BCG Therapy (“Study”) 75

TLC-3000 Photo Dynamic Therapy Laser System – A Phase II Clinical Study of Intravesical Photodynamic Therapy in Patients with BCG-Unresponsive Non-muscle Invasive Bladder Cancer (“NMIBC”) or Patients who Are Intolerant to BCG Therapy (“Study”) 76

University Health Network Pipeline Products & Ongoing Clinical Trials Overview 77

HIFU-Activated Imageable Radiation Sensitizer System – Product Status 77

HIFU-Activated Imageable Radiation Sensitizer System – Product Description 77

Tandem Imaging System – Product Status 78

Tandem Imaging System – Product Description 78

University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 79

Radiation Delivery Device – Bladder cancer – Product Status 79

Radiation Delivery Device – Bladder cancer – Product Description 79

University of Florida Pipeline Products & Ongoing Clinical Trials Overview 80

Mask System – Stereotactic Radiotherapy And Image-Guided Procedures – Product Status 80

Mask System – Stereotactic Radiotherapy And Image-Guided Procedures – Product Description 80

University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 81

MammoSite Cavity Evaluation Device – Product Status 81

MammoSite Cavity Evaluation Device – Product Description 81

University of Texas Southwestern Medical Center Pipeline Products & Ongoing Clinical Trials Overview 82

4D – CBCT – Lung Cancer – Product Status 82

4D – CBCT – Lung Cancer – Product Description 82

Accelerator and Shielding Integrated System – Product Status 83

Accelerator and Shielding Integrated System – Product Description 83

Quantitative Cone-beam CT – Product Status 83

Quantitative Cone-beam CT – Product Description 84

Varian Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 85

MR Guided Radiotherapy Device – Product Status 85

MR Guided Radiotherapy Device – Product Description 85

ProBeam 360° Proton Therapy System – Product Status 86

ProBeam 360° Proton Therapy System – Product Description 86

ProBeam Proton Therapy System – Bone Metastasis – Product Status 86

ProBeam Proton Therapy System – Bone Metastasis – Product Description 87

Varian Medical Systems Inc – Ongoing Clinical Trials Overview 88

ProBeam Proton Therapy System – Bone Metastasis – Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases 89

Vivos Inc Pipeline Products & Ongoing Clinical Trials Overview 90

Y-90 RadioGel – Product Status 90

Y-90 RadioGel – Product Description 90

XL Sci-Tech Inc Pipeline Products & Ongoing Clinical Trials Overview 91

Radioactive Esophageal Stent – Product Status 91

Radioactive Esophageal Stent – Product Description 91

Xoft Inc Pipeline Products & Ongoing Clinical Trials Overview 92

Xoft Axxent Electronic Brachytherapy System – Product Status 92

Xoft Axxent Electronic Brachytherapy System – Product Description 93

Xoft Axxent Electronic Brachytherapy System – Colorectal Cancer – Product Status 93

Xoft Axxent Electronic Brachytherapy System – Colorectal Cancer – Product Description 93

Xoft Axxent Electronic Brachytherapy System – Prostate Cancer – Product Status 94

Xoft Axxent Electronic Brachytherapy System – Prostate Cancer – Product Description 94

Xoft Brain IORT System – Product Status 94

Xoft Brain IORT System – Product Description 95

Xoft Inc – Ongoing Clinical Trials Overview 96

Xoft Axxent Electronic Brachytherapy System – A Phase I/II Study of Intraoperative Radiotherapy for Patients with Large Brain Metastases Treated with Neurosurgical Resection 97

Xoft Axxent Electronic Brachytherapy System – A Pilot Study of Patients with Recurrent Glioblastoma Treated with Maximal Safe Neurosurgical Resection, Intra-operative Radiation Therapy (IORT) Using the Xoft Axxent Electronic Brachytherapy System 97

Xoft Axxent Electronic Brachytherapy System – A Prospective Observational Trial of Xoft Intraoperative Radiotherapy (IORT) as a Component of Breast Conserving Therapy (BCT) in Patients with Early-stage Breast Cancer 97

Xoft Axxent Electronic Brachytherapy System – A Safety and Efficacy Study of Intra-operative Radiation Therapy (IORT) Using the Xoft Axxent eBx System at the Time of Breast Conservation Surgery for Early Stage Breast Cancer 98

Xoft Axxent Electronic Brachytherapy System – An Efficacy Study of Intra-operative Radiation Therapy (IORT) Using the Xoft Axxent eBx System at the Time of Breast Conservation Surgery for Early Stage Breast Cancer “Lite” 98

Xoft Axxent Electronic Brachytherapy System – An Investigator Initiated Study of Intra-Operative Radiation Therapy (IORT) Using the Xoft Axxent eBx System 98

Xoft Axxent Electronic Brachytherapy System – Electronic Brachytherapy (eBx)-Mohs Matched Pair – Cohort Study A Multi-center Retrospective-prospective Matched Pairs Cohort Study to Assess Long-term Clinical Outcomes of Non-melanoma Skin Cancer Patients Treated with eBx Compared to Non-melanoma Skin Cancer Patients Treated with Mohs Surgery 99

Xoft Axxent Electronic Brachytherapy System – Phase II Study of Patients with Recurrent Glioblastoma Multiforme Treated with Maximal Safe Neurosurgical Resection and Intra-operative Radiation Therapy (IORT) Using the Xoft Axxent Electronic Brachytherapy System and Bevacizumab 99

Xoft Axxent Electronic Brachytherapy System – Recurrent Glioblastoma Management with Maximal Safe Resection and Intraoperative Balloon Electronic Brachytherapy: Two Centers Study 99

Xoft Axxent Electronic Brachytherapy System – Xoft Electronic Brachytherapy Clinical Protocol for the Primary Treatment of Non-melanoma Skin Cancer 100

ZHealth Documentation LLC Pipeline Products & Ongoing Clinical Trials Overview 101

Etch – IR – Product Status 101

Etch – IR – Product Description 101

Figures

Interventional Radiology Devices – Pipeline Products by Stage of Development 14

Interventional Radiology Devices – Pipeline Products by Territory 15

Interventional Radiology Devices – Pipeline Products by Regulatory Path 16

Interventional Radiology Devices – Pipeline Products by Estimated Approval Date 17

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