Neurosurgical Products Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies

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Neurosurgical Products Pipeline Market Report Overview

The neurosurgical products pipeline market research report provides comprehensive information about the neurosurgical products pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Key Segments ·       Dura Substitutes

·       Neuroendoscopes

·       Neurosurgical Drills

·       Synthetic Dura Substitutes

·       Neurosurgical Drills

·       Biological Dura Substitutes

Key Territories ·       The US

·       Europe

·       Canada

·       Israel

·       Japan

·       Philippines

·       Turkey

Key Regulatory Paths ·       510(k)

·       CE

·       PMA

·       MDL

·       Ninsho

Leading Companies ·       Alcyone Lifesciences Inc

·       Aleva Neurotherapeutics SA

·       Augusta University

·       Axion BioSystems Inc

·       Biocircuit Technologies Inc

·       C2C Development LLC

·       Carnegie Mellon University

·       Carthera SAS

·       Cizeta Surgical

·       Cornell University

·       Elite Surgical Supplies (Pty) Ltd.

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Neurosurgical Products Pipeline Market Segments

Some of the key segments in neurosurgical products pipeline market are dura substitutes, neuroendoscopes, neurosurgical drills, synthetic dura substitutes, neurosurgical drills, and biological dura substitutes. As of May 2023, Dura substitutes has the highest number of pipeline products.

Neurosurgical Products Pipeline Market Analysis, by Segments, 2023 (%)

Neurosurgical Products Pipeline Market Analysis, by Segments, 2023 (%)

For more segment insights into the neurosurgical products pipeline market, download a free report sample

Neurosurgical Products Pipeline Market Segmentation by Territories

Some of the territories in the neurosurgical products pipeline market are the US, Europe, Canada, Israel, Japan, Philippines, and Turkey. As of May 2023, the US has the highest number of products in the pipeline out of them all.

Neurosurgical Products Pipeline Market Analysis, by Territories, 2023 (%)

Neurosurgical Products Pipeline Market Analysis, by Territories, 2023 (%)

For more territory insights into neurosurgical products pipeline market, download a free report sample

Neurosurgical Products Pipeline Market Segmentation by Regulatory Paths

Some of the key regulatory paths followed by the neurosurgical products pipeline products market are 510(k), CE, PMA, MDL, and Ninsho among others. As of May 2023, most of the products follow the 510(k) pathway to enter the market.

Neurosurgical Products Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

Neurosurgical Products Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

For more regulatory path insights into neurosurgical products pipeline market, download a free report sample

Neurosurgical Products Pipeline Market – Competitive Landscape

Some of the leading companies in neurosurgical products pipeline products market are Alcyone Lifesciences Inc, Aleva Neurotherapeutics SA, Augusta University, Axion BioSystems Inc, Biocircuit Technologies Inc, C2C Development LLC, Carnegie Mellon University, Carthera SAS, Cizeta Surgical, Cornell University, and Elite Surgical Supplies (Pty) Ltd.

Alcyone Lifesciences Inc: Alcyone Therapeutics Inc (Alcyone Therapeutics) formerly Alcyone Lifesciences Inc, is a biotechnology company developing precision gene-based therapeutics (CNS) medicines for the treatment of severe neurological disorders. The company is headquartered in Lowell, Massachusetts, the US.

Segments Covered in the Report

Neurosurgical Products Pipeline Market Segments Outlook

  • Dura Substitutes
  • Neuroendoscopes
  • Neurosurgical Drills
  • Synthetic Dura Substitutes
  • Neurosurgical Drills
  • Biological Dura Substitutes

Neurosurgical Products Pipeline Market Territories Outlook

  • The US
  • Europe
  • Canada
  • Israel
  • Japan
  • Philippines
  • Turkey

Neurosurgical Products Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • CE
  • PMA
  • MDL
  • Ninsho

Scope

  • Extensive coverage of the neurosurgical products under development
  • Reviews details of major pipeline products which include, product description, licensing and collaboration details, and other developmental activities
  • Reviews the major players involved in the development of neurosurgical products and list all their pipeline projects
  • The coverage of pipeline products based on various stages of development ranging from Early Development to 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 portfolios and create effective counter strategies to gain a competitive advantage
  • Identify and understand important and diverse types of neurosurgical products 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

Alcyone Therapeutics Inc
Aleva Neurotherapeutics SA
Anatomics Pty Ltd
Augusta University
Axion BioSystems Inc
AxoGen Corp
Beijing Biosis Healing Biological Technology Co Ltd
Bendit Technologies Ltd
Biocircuit Technologies Inc
C2C Development, LLC
Carnegie Mellon University
Carthera SAS
Cizeta Surgical
Cornell University
Elite Surgical Supplies (Pty) Ltd
Harvard University
Imperial College London
InSightec Ltd
Integra LifeSciences Holdings Corp
International HIFU
InVivo Therapeutics Corp
JetGuide Ltd
Johns Hopkins University
KARL STORZ SE & Co KG
Kerecis ehf
Kuros Biosciences AG
LeMaitre Vascular Inc
Lumendo AG
Massachusetts Institute of Technology
Mayo Clinic
Medtronic Plc
Microsurgical Innovations Inc
MRC Systems GmbH
Nanonerve Inc.
Neuraptive Therapeutics Inc
NeuroOne Medical Technologies Corp
Nurami Medical Ltd
Orthocell Ltd
PediaWorks Inc
Replication Medical Inc
Resultados y Calidad del Sistema Sanitario Publico de Andalucia
Scivita Medical Technology Co Ltd
Senzime AB
Skull Base Institute
Sree Chitra Tirunal Institute for Medical Sciences & Technology
The Swedish Neuroscience Institute
U.S. Department of Veterans Affairs
University of Colorado
University of Maryland Baltimore
University of South Florida
University of Texas Medical Branch at Galveston
University of Utah
Vanderbilt University
Xylos Corporation

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 Neurosurgical Products Overview 13

3 Products under Development 14

3.1 Neurosurgical Products – Pipeline Products by Stage of Development 14

3.2 Neurosurgical Products – Pipeline Products by Segment 15

3.3 Neurosurgical Products – Pipeline Products by Territory 16

3.4 Neurosurgical Products – Pipeline Products by Regulatory Path 17

3.5 Neurosurgical Products – Pipeline Products by Estimated Approval Date 18

3.6 Neurosurgical Products – Ongoing Clinical Trials 19

4 Neurosurgical Products – Pipeline Products under Development by Companies 20

4.1 Neurosurgical Products Companies – Pipeline Products by Stage of Development 20

4.2 Neurosurgical Products – Pipeline Products by Stage of Development 23

5 Neurosurgical Products Companies and Product Overview 25

5.1 Alcyone Therapeutics Inc Company Overview 25

5.1.1 Alcyone Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 25

5.2 Aleva Neurotherapeutics SA Company Overview 27

5.2.1 Aleva Neurotherapeutics SA Pipeline Products & Ongoing Clinical Trials Overview 27

5.3 Anatomics Pty Ltd Company Overview 28

5.3.1 Anatomics Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 28

5.4 Augusta University Company Overview 29

5.4.1 Augusta University Pipeline Products & Ongoing Clinical Trials Overview 29

5.5 Axion BioSystems Inc Company Overview 30

5.5.1 Axion BioSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 30

5.6 AxoGen Corp Company Overview 31

5.6.1 AxoGen Corp Pipeline Products & Ongoing Clinical Trials Overview 31

5.7 Beijing Biosis Healing Biological Technology Co Ltd Company Overview 32

5.7.1 Beijing Biosis Healing Biological Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

5.8 Bendit Technologies Ltd Company Overview 33

5.8.1 Bendit Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

5.9 Biocircuit Technologies Inc Company Overview 35

5.9.1 Biocircuit Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 35

5.10 C2C Development, LLC Company Overview 36

5.10.1 C2C Development, LLC Pipeline Products & Ongoing Clinical Trials Overview 36

5.11 Carnegie Mellon University Company Overview 37

5.11.1 Carnegie Mellon University Pipeline Products & Ongoing Clinical Trials Overview 37

5.12 Carthera SAS Company Overview 38

5.12.1 Carthera SAS Pipeline Products & Ongoing Clinical Trials Overview 38

5.13 Cizeta Surgical Company Overview 44

5.13.1 Cizeta Surgical Pipeline Products & Ongoing Clinical Trials Overview 44

5.14 Cornell University Company Overview 45

5.14.1 Cornell University Pipeline Products & Ongoing Clinical Trials Overview 45

5.15 Elite Surgical Supplies (Pty) Ltd Company Overview 46

5.15.1 Elite Surgical Supplies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

5.16 Harvard University Company Overview 47

5.16.1 Harvard University Pipeline Products & Ongoing Clinical Trials Overview 47

5.17 Imperial College London Company Overview 48

5.17.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 48

5.18 InSightec Ltd Company Overview 49

5.18.1 InSightec Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

5.19 Integra LifeSciences Holdings Corp Company Overview 61

5.19.1 Integra LifeSciences Holdings Corp Pipeline Products & Ongoing Clinical Trials Overview 61

5.20 International HIFU Company Overview 63

5.20.1 International HIFU Pipeline Products & Ongoing Clinical Trials Overview 63

5.21 InVivo Therapeutics Corp Company Overview 64

5.21.1 InVivo Therapeutics Corp Pipeline Products & Ongoing Clinical Trials Overview 64

5.22 JetGuide Ltd Company Overview 65

5.22.1 JetGuide Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

5.23 Johns Hopkins University Company Overview 66

5.23.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 66

5.24 KARL STORZ SE & Co KG Company Overview 68

5.24.1 KARL STORZ SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 68

5.25 Kerecis ehf Company Overview 69

5.25.1 Kerecis ehf Pipeline Products & Ongoing Clinical Trials Overview 69

5.26 Kuros Biosciences AG Company Overview 70

5.26.1 Kuros Biosciences AG Pipeline Products & Ongoing Clinical Trials Overview 70

5.27 LeMaitre Vascular Inc Company Overview 71

5.27.1 LeMaitre Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.28 Lumendo AG Company Overview 72

5.28.1 Lumendo AG Pipeline Products & Ongoing Clinical Trials Overview 72

5.29 Massachusetts Institute of Technology Company Overview 73

5.29.1 Massachusetts Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 73

5.30 Mayo Clinic Company Overview 75

5.30.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 75

5.31 Medtronic Plc Company Overview 76

5.31.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 76

5.32 Microsurgical Innovations Inc Company Overview 77

5.32.1 Microsurgical Innovations Inc Pipeline Products & Ongoing Clinical Trials Overview 77

5.33 MRC Systems GmbH Company Overview 78

5.33.1 MRC Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 78

5.34 Nanonerve Inc. Company Overview 79

5.34.1 Nanonerve Inc. Pipeline Products & Ongoing Clinical Trials Overview 79

5.35 Neuraptive Therapeutics Inc Company Overview 80

5.35.1 Neuraptive Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 80

5.36 NeuroOne Medical Technologies Corp Company Overview 82

5.36.1 NeuroOne Medical Technologies Corp Pipeline Products & Ongoing Clinical Trials Overview 82

5.37 Nurami Medical Ltd Company Overview 83

5.37.1 Nurami Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

5.38 Orthocell Ltd Company Overview 84

5.38.1 Orthocell Ltd Pipeline Products & Ongoing Clinical Trials Overview 84

5.39 PediaWorks Inc Company Overview 86

5.39.1 PediaWorks Inc Pipeline Products & Ongoing Clinical Trials Overview 86

5.40 Replication Medical Inc Company Overview 87

5.40.1 Replication Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 87

5.41 Resultados y Calidad del Sistema Sanitario Publico de Andalucia Company Overview 88

5.41.1 Resultados y Calidad del Sistema Sanitario Publico de Andalucia Pipeline Products & Ongoing Clinical Trials Overview 88

5.42 Scivita Medical Technology Co Ltd Company Overview 89

5.42.1 Scivita Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

5.43 Senzime AB Company Overview 91

5.43.1 Senzime AB Pipeline Products & Ongoing Clinical Trials Overview 91

5.44 Skull Base Institute Company Overview 92

5.44.1 Skull Base Institute Pipeline Products & Ongoing Clinical Trials Overview 92

5.45 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 93

5.45.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 93

5.46 The Swedish Neuroscience Institute Company Overview 95

5.46.1 The Swedish Neuroscience Institute Pipeline Products & Ongoing Clinical Trials Overview 95

5.47 U.S. Department of Veterans Affairs Company Overview 96

5.47.1 U.S. Department of Veterans Affairs Pipeline Products & Ongoing Clinical Trials Overview 96

5.48 University of Colorado Company Overview 97

5.48.1 University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 97

5.49 University of Maryland Baltimore Company Overview 98

5.49.1 University of Maryland Baltimore Pipeline Products & Ongoing Clinical Trials Overview 98

5.50 University of South Florida Company Overview 99

5.50.1 University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 99

5.51 University of Texas Medical Branch at Galveston Company Overview 100

5.51.1 University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 100

5.52 University of Utah Company Overview 101

5.52.1 University of Utah Pipeline Products & Ongoing Clinical Trials Overview 101

5.53 Vanderbilt University Company Overview 103

5.53.1 Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 103

5.54 Xylos Corporation Company Overview 105

5.54.1 Xylos Corporation Pipeline Products & Ongoing Clinical Trials Overview 105

6 Neurosurgical Products- Recent Developments 106

6.1 May 11, 2023: Medtronic to announce financial results for its fourth quarter and full fiscal year 2023 106

6.2 May 04, 2023: Cardinal Health reports third quarter fiscal year 2023 results and raises fiscal year 2023 non-gaap eps guidance 106

6.3 May 01, 2023: FAU and Insightec partner to use focused ultrasound to treat neurological disorders 108

6.4 Apr 28, 2023: Japan Medical Dynamic Marketing announces summary of consolidated financial results for the fiscal year ended March 2023 109

6.5 Apr 27, 2023: OssDsign notice to attend the annual general meeting 110

6.6 Apr 19, 2023: BioArctic’s Invitation to presentation of first quarter report for January – March 2023 on April 27 114

6.7 Apr 12, 2023: Medtronic has a layoff in California 114

6.8 Mar 28, 2023: Stryker announces Annual Meeting of Shareholders 114

6.9 Mar 24, 2023: American Shared Hospital Services Reports Fourth Quarter and Year End 2022 Financial Results 115

6.10 Mar 16, 2023: Surgalign to Host its 2023 Annual Meeting of Shareholders on June 1, 2023 118

6.11 Mar 16, 2023: Medtronic joins in $25M funding round for home monitoring company 118

6.12 Mar 08, 2023: UCSF Health Appoints Two Prominent Healthcare Executives to Senior Leadership Positions 118

6.13 Mar 06, 2023: Oonpoint to present its augmented reality platform technology at the 2023 Canaccord Genuity Musculoskeletal Conference 118

6.14 Mar 03, 2023: Nation’s first pediatric hybrid intraoperative MRI neurosurgery suite opens at Children’s Minnesota 119

6.15 Feb 10, 2023: Carl Zeiss Meditec achieves further revenue growth in First quarter 2022/23 119

6.16 Feb 02, 2023: Cardinal Health Reports Second Quarter Fiscal Year 2023 Results and Raises Fiscal Year 2023 Non-GAAP EPS Guidance 121

6.17 Jan 31, 2023: Japan Medical Dynamic Marketing Announces Summary of Consolidated Financial Results for the Third Quarter of the Fiscal Year Ending March 2023 122

6.18 Jan 10, 2023: OssDsign Catalyst 1cc is now launched and available in the U.S. market 123

6.19 Jan 09, 2023: NeuroPace Announces Preliminary Unaudited Fourth Quarter and Full-Year 2022 Revenue and Appoints Dr. Uri Geiger to Board of Directors 123

6.20 Dec 19, 2022: Cardinal Health Names Aaron Alt Chief Financial Officer 125

6.21 Dec 07, 2022: Cook Medical welcomes Dr. John A. Kaufman as Chief Medical Officer 125

6.22 Nov 23, 2022: Medtronic Reports Quarterly Earnings 126

6.23 Nov 22, 2022: OssDsign publishes Q3 2022 Interim Report 126

6.24 Nov 22, 2022: Medtronic reports second quarter fiscal 2023 financial results 127

6.25 Nov 22, 2022: Mayo Clinic surgeon takes the wheel as Kwik Trip’s new CEO 133

6.26 Nov 15, 2022: Medtronic Set to Announce Earnings on Tuesday 133

6.27 Nov 10, 2022: Surgalign aims to slash $30M from 2023 spending with planned layoffs 133

6.28 Oct 19, 2022: Renishaw full-year results reports record revenue increase 133

6.29 Oct 06, 2022: Integra LifeSciences appoints Harvinder Singh as Executive Vice President, President Of Co.”s International Business 133

6.30 Oct 06, 2022: Integra LifeSciences Announces Key Executive Appointment 133

6.31 Sep 30, 2022: Renishaw Annual Report 2022 133

6.32 Sep 30, 2022: Natalie Caine named chief administrative officer at Mayo Clinic in Rochester 136

6.33 Sep 16, 2022: Renishaw Preliminary announcement of results for the year ended 30 June 2022 136

6.34 Sep 08, 2022: Cardinal Health Announces Pharmaceutical Segment Organizational Changes 137

6.35 Sep 07, 2022: Medtronic to appear at September investor conferences 138

6.36 Sep 05, 2022: Renishaw Register for the 2022 full-year results webcast 138

6.37 Sep 01, 2022: American Shared Hospital Services Strengthens Management Team with Appointment of Peter Gaccione as Chief Operating Officer 138

6.38 Aug 23, 2022: Medtronic reports first quarter fiscal 2023 financial results 139

6.39 Aug 23, 2022: NeuroPace to Present at the Morgan Stanley 20th Annual Global Healthcare Conference 141

6.40 Aug 23, 2022: Medtronic Announces Quarterly Earnings Results 142

6.41 Aug 12, 2022: American Shared Hospital Services Reports

12.5% Period-over-Period Increase in Second Quarter 2022 Revenue 144

6.42 Aug 11, 2022: Cardinal Health Reports Fourth Quarter and Full Year Results for Fiscal Year 2022 147

6.43 Aug 11, 2022: NeuroPace Reports Second Quarter 2022 Financial Results and Provides a Business Update 148

6.44 Aug 11, 2022: Precipio Reports Earnings Results for the Second Quarter and Six Months Ended June 30, 2022 150

6.45 Aug 08, 2022: ClearPoint Neuro Announces Appointment of Mary McNamara-Cullinane as Vice President of Regulatory Affairs 150

6.46 Aug 08, 2022: Precipio Announces Second Quarter Shareholder Update Call 150

6.47 Aug 08, 2022: InVivo Therapeutics Holdings Announces Quarterly Report For the quarterly period ended June 30, 2022 151

6.48 Aug 01, 2022: Cardinal Health Names Michelle Greene as Chief Information Officer 151

6.49 Jul 28, 2022: Smith+Nephew Second Quarter and First Half 2022 Results 152

6.50 Jul 21, 2022: NeuroPace to Report Second Quarter 2022 Financial Results on August 11, 2022 153

6.51 Jul 12, 2022: Aspire & USF Pass $10M in ticket & donation revenue 154

6.52 Jul 07, 2022: Cardinal Health to Announce Fourth-Quarter and Year-End Results for Fiscal Year 2022 on August 11 154

6.53 Jun 27, 2022: Medtronic Board appoints Lidia Fonseca as a new director 154

6.54 Jun 20, 2022: MicroTransponder Appoints New CEO 155

6.55 Jun 13, 2022: Keith Meadors Joins Precipio To Lead Its Products Division 155

6.56 Jun 08, 2022: OssDsign announces that SEB has initiated research coverage of the company 156

6.57 Jun 06, 2022: Altus Spine heads to Prague, Czech Republic, as Platinum Sponsors of the Society of University Neurosurgeons Annual Meeting 156

7 Appendix 158

7.1 Methodology 158

7.2 About GlobalData 161

7.3 Contact Us 161

7.4 Disclaimer 161

Table

Neurosurgical Products – Pipeline Products by Stage of Development 14

Neurosurgical Products – Pipeline Products by Segment 15

Neurosurgical Products – Pipeline Products by Territory 16

Neurosurgical Products – Pipeline Products by Regulatory Path 17

Neurosurgical Products – Pipeline Products by Estimated Approval Date 18

Neurosurgical Products – Ongoing Clinical Trials 19

Neurosurgical Products Companies – Pipeline Products by Stage of Development 20

Neurosurgical Products – Pipeline Products by Stage of Development 23

Alcyone Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 25

Next-Gen Chronic AMC – Product Status 25

Next-Gen Chronic AMC – Product Description 25

ThecaFlex DRx System – Product Status 26

ThecaFlex DRx System – Product Description 26

Aleva Neurotherapeutics SA Pipeline Products & Ongoing Clinical Trials Overview 27

spiderSTIM – Product Status 27

spiderSTIM – Product Description 27

Anatomics Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 28

DuraShield – Product Status 28

DuraShield – Product Description 28

Augusta University Pipeline Products & Ongoing Clinical Trials Overview 29

Surgical Instrument – Neurological Procedures – Product Status 29

Surgical Instrument – Neurological Procedures – Product Description 29

Axion BioSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 30

Microhook Based Nerve Tape Device – Product Status 30

Microhook Based Nerve Tape Device – Product Description 30

AxoGen Corp Pipeline Products & Ongoing Clinical Trials Overview 31

Axoguard HA+ Nerve Protector – Product Status 31

Axoguard HA+ Nerve Protector – Product Description 31

Beijing Biosis Healing Biological Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

Dura Repair Mesh – Product Status 32

Dura Repair Mesh – Product Description 32

Bendit Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

Bendit21 Microcatheter – Product Status 33

Bendit21 Microcatheter – Product Description 34

Biocircuit Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 35

Nerve Tape – Product Status 35

Nerve Tape – Product Description 35

C2C Development, LLC Pipeline Products & Ongoing Clinical Trials Overview 36

NAViTECH Streamlined Device – Product Status 36

NAViTECH Streamlined Device – Product Description 36

Carnegie Mellon University Pipeline Products & Ongoing Clinical Trials Overview 37

Hydrosurgery System – Product Status 37

Hydrosurgery System – Product Description 37

Carthera SAS Pipeline Products & Ongoing Clinical Trials Overview 38

SonoCloud – 9 – Product Status 38

SonoCloud – 9 – Product Description 38

SonoCloud System – Product Status 39

SonoCloud System – Product Description 39

SonoProbe – Product Status 39

SonoProbe – Product Description 40

Carthera SAS – Ongoing Clinical Trials Overview 41

SonoCloud System – Safety and Efficacy of Blood Brain Barrier Opening with Implantable Device Sonocloud Combined with Nivolumab Used Alone or an Association with Ipilimumab in Brain Metastases from Patients with Malignant Melanoma 42

SonoCloud – 9 – Multisite Open-label Randomized Phase II Clinical Trial in Newly Diagnosed Glioblastoma Treated by Concurrent Temoradiation and Adjuvant Temozolomide +/- Ultrasound-induced Blood Brain Barrier Opening 43

SonoCloud – 9 – Phase 1 / 2 Trial of Blood-brain Barrier Opening With an Implantable Ultrasound Device SonoCloud-9 and Treatment with Albumin-bound Paclitaxel and Carboplatin in Patients With Recurrent Glioblastoma 43

SonoCloud – 9 – Phase I Trial Assessing the Safety of the Repeated Ultrasound-induced Opening of the Blood-brain Barrier in Pediatric Patients With Refractory Supra-tentorial Malignant Brain Tumors Before Chemotherapy Administration 43

Cizeta Surgical Pipeline Products & Ongoing Clinical Trials Overview 44

Skull Grip – Product Status 44

Skull Grip – Product Description 44

Cornell University Pipeline Products & Ongoing Clinical Trials Overview 45

Tightly-Focused Femtosecond Laser – Product Status 45

Tightly-Focused Femtosecond Laser – Product Description 45

Elite Surgical Supplies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

CRANIAL SYSTEM – Product Status 46

CRANIAL SYSTEM – Product Description 46

Harvard University Pipeline Products & Ongoing Clinical Trials Overview 47

Safe Cranial Drilling Device – Product Status 47

Safe Cranial Drilling Device – Product Description 47

Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 48

Catheter System – Product Status 48

Catheter System – Product Description 48

InSightec Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

ExAblate Neuro – Product Status 49

ExAblate Neuro – Product Description 49

Exablate Neuro – Alzheimer’s Disease – Product Status 50

Exablate Neuro – Alzheimer’s Disease – Product Description 50

InSightec Ltd – Ongoing Clinical Trials Overview 51

ExAblate Neuro – A Clinical Study to Investigate the Safety and Efficacy of Exablate Neuro for glioblastoma treatment 53

ExAblate Neuro – A Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor 53

ExAblate Neuro – A Feasibility Clinical Trial of Exablate for Low Intensity Focused Ultrasound Neuromodulation in Patients with Opioid Use Disorder (OUD) 53

ExAblate Neuro – A Feasibility Study of MRgFUS in the Treatment of Therapy-Resistant Tremor-Related Patients with Low SDR Value 54

ExAblate Neuro – A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using the ExAblate Transcranial System to Treat the Cardinal Motor Features of Parkinson’s Disease 54

ExAblate Neuro – A Feasibility Study to Evaluate Safety and Initial Effectiveness of MR-Guided Focused Ultrasound Ablation Therapy in the Treatment of Focal Epilepsy 54

ExAblate Neuro – A Pilot Study for Brain Delivery of Cerezyme in Patients with Parkinson’s Disease Using MR-guided Focused Ultrasound Induced Opening of the Blood-brain Barrier 55

ExAblate Neuro – A Pivotal Clinical Trial of the Management of the Medically-refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Idiopathic Parkinson’s Disease with Unilateral Lesioning of the Globus Pallidum Using the ExAblate Neuro System 55

ExAblate Neuro – A Pivotal Study Evaluating the Efficacy of Exablate Neuro System in the Treatment of Patients with Primary Non-small Cell Lung Cancer: LIMITLESS 55

ExAblate Neuro – Assessment of Safety and Feasibility of Exablate Blood-brain Barrier Disruption (BBBD) with Microbubbles for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy 56

ExAblate Neuro – Assessment of Safety and Feasibility of ExAblate Blood-brain Barrier Disruption for the Treatment of High Grade Glioma in Patients Undergoing Standard Chemotherapy 56

ExAblate Neuro – Assessment of Safety and Feasibility of Exablate Blood-brain Barrier Disruption for the Treatment of High-grade Glioma in Patients Undergoing Standard Chemotherapy 56

ExAblate Neuro – Assessment of Safety and Feasibility of Exablate Blood-brain Barrier Open (BBB Open) with Microbubble Resonators for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy (Clinical Research for BBB Open) 57

ExAblate Neuro – Assessment of Safety and Feasibility of ExAblate Neuro System to Perform Auto-focusing Echo Imaging in Patients with Idiopathic Essential Tremor with Medication Refractory Tremor 57

ExAblate Neuro – Assessment of Safety and Feasibility of Exablate Neuro System to Perform Echo-Focusing Echo Imaging in Patients with Treatment-Resistant Neurologic and Psychiatric Indications 57

ExAblate Neuro – Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Thalamotomy of Central Lateral Thalamic Nucleus for the Treatment of Medication-refractory Trigeminal Neuralgia 58

ExAblate Neuro – Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy for Pain Palliation in Head & Neck Cancer 58

ExAblate Neuro – Transcranial Ultrasound Therapy of Essential Tremor 59

Exablate Neuro – Alzheimer’s Disease – A Phase IIa Study to Evaluate the Safety and Efficacy of Blood-Brain Barrier (BBB) Opening Using Transcranial MR-guided Focused Ultrasound in Patients with Alzheimer’s Disease 60

Exablate Neuro – Alzheimer’s Disease – Assessment of Safety and Efficacy of ExAblate Blood-brain Barrier Disruption for the Treatment of Patients with Probable Alzheimer’s Disease 60

Integra LifeSciences Holdings Corp Pipeline Products & Ongoing Clinical Trials Overview 61

MAYFIELD Composite – Product Status 61

MAYFIELD Composite – Product Description 61

Next Generation DuraSeal – Product Status 62

Next Generation DuraSeal – Product Description 62

International HIFU Pipeline Products & Ongoing Clinical Trials Overview 63

High Intensity Focused Ultrasound System – Product Status 63

High Intensity Focused Ultrasound System – Product Description 63

InVivo Therapeutics Corp Pipeline Products & Ongoing Clinical Trials Overview 64

Dural Graft – Product Status 64

Dural Graft – Product Description 64

JetGuide Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

JetGuide System – Neuro – Product Status 65

JetGuide System – Neuro – Product Description 65

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 66

Minimally Invasive Focused Ultrasound Device – Product Status 66

Minimally Invasive Focused Ultrasound Device – Product Description 66

Radiex – Product Status 67

Radiex – Product Description 67

KARL STORZ SE & Co KG Pipeline Products & Ongoing Clinical Trials Overview 68

Video Neuro-Endoscope – Product Status 68

Video Neuro-Endoscope – Product Description 68

Kerecis ehf Pipeline Products & Ongoing Clinical Trials Overview 69

Kerecis Omega3 Dura – Product Status 69

Kerecis Omega3 Dura – Product Description 69

Kuros Biosciences AG Pipeline Products & Ongoing Clinical Trials Overview 70

Neuroseal – Cranial – Product Status 70

Neuroseal – Cranial – Product Description 70

LeMaitre Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 71

DuraSure – Product Status 71

DuraSure – Product Description 71

Lumendo AG Pipeline Products & Ongoing Clinical Trials Overview 72

Micro-Surgical Instrument – Product Status 72

Micro-Surgical Instrument – Product Description 72

Massachusetts Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 73

Magnetically Steerable Robot – Product Status 73

Magnetically Steerable Robot – Product Description 73

Ultrathin Endoscope – Product Status 74

Ultrathin Endoscope – Product Description 74

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 75

Minimally Invasive Neurology/Neurosurgery Device – Product Status 75

Minimally Invasive Neurology/Neurosurgery Device – Product Description 75

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 76

Duratech BioRegeneration Matrix – Product Status 76

Duratech BioRegeneration Matrix – Product Description 76

Microsurgical Innovations Inc Pipeline Products & Ongoing Clinical Trials Overview 77

Biodegradable Nerve Conduit – Product Status 77

Biodegradable Nerve Conduit – Product Description 77

MRC Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 78

Multilas – Product Status 78

Multilas – Product Description 78

Nanonerve Inc. Pipeline Products & Ongoing Clinical Trials Overview 79

Nanofibrous Dural Substitute – Product Status 79

Nanofibrous Dural Substitute – Product Description 79

Neuraptive Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 80

AxoBond – Product Status 80

AxoBond – Product Description 80

AxoTrim – Product Status 81

AxoTrim – Product Description 81

NeuroOne Medical Technologies Corp Pipeline Products & Ongoing Clinical Trials Overview 82

Percutaneous Paddle Lead Placement System – Product Status 82

Percutaneous Paddle Lead Placement System – Product Description 82

Nurami Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

Artifascia – Product Status 83

Artifascia – Product Description 83

Orthocell Ltd Pipeline Products & Ongoing Clinical Trials Overview 84

Remplir – Product Status 84

Remplir – Product Description 85

PediaWorks Inc Pipeline Products & Ongoing Clinical Trials Overview 86

Neurosurgery Resector – Product Status 86

Neurosurgery Resector – Product Description 86

Replication Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 87

Neural Implant – Product Status 87

Neural Implant – Product Description 87

Resultados y Calidad del Sistema Sanitario Publico de Andalucia Pipeline Products & Ongoing Clinical Trials Overview 88

Craniotomy Suture Passer – Product Status 88

Craniotomy Suture Passer – Product Description 88

Scivita Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

Single-Use Neuro Videoscope – Product Status 89

Single-Use Neuro Videoscope – Product Description 89

Single-Use Neurosurgical Videoscope – Product Status 90

Single-Use Neurosurgical Videoscope – Product Description 90

Senzime AB Pipeline Products & Ongoing Clinical Trials Overview 91

TetraSens Pediatric – Product Status 91

TetraSens Pediatric – Product Description 91

Skull Base Institute Pipeline Products & Ongoing Clinical Trials Overview 92

MARVEL – Product Status 92

MARVEL – Product Description 92

Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 93

Bovine Pericardium – Dura Substitute – Product Status 93

Bovine Pericardium – Dura Substitute – Product Description 93

Intracranial Electrode – Epilepsy Surgery – Product Status 94

Intracranial Electrode – Epilepsy Surgery – Product Description 94

The Swedish Neuroscience Institute Pipeline Products & Ongoing Clinical Trials Overview 95

MR-guided Focused Ultrasound System – Product Status 95

MR-guided Focused Ultrasound System – Product Description 95

U.S. Department of Veterans Affairs Pipeline Products & Ongoing Clinical Trials Overview 96

Implantable Device – Product Status 96

Implantable Device – Product Description 96

University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 97

Denver Surgical Corridor – Product Status 97

Denver Surgical Corridor – Product Description 97

University of Maryland Baltimore Pipeline Products & Ongoing Clinical Trials Overview 98

Minimally Invasive Neurosurgical Intracranial Robot – Product Status 98

Minimally Invasive Neurosurgical Intracranial Robot – Product Description 98

University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 99

Dural Knife With Protective Foot-Plate – Product Status 99

Dural Knife With Protective Foot-Plate – Product Description 99

University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 100

Endoscope With Stimulating Electrode – Product Status 100

Endoscope With Stimulating Electrode – Product Description 100

University of Utah Pipeline Products & Ongoing Clinical Trials Overview 101

Computer-Controlled Surgical Cutting Tool – Product Status 101

Computer-Controlled Surgical Cutting Tool – Product Description 101

Hollow Artificial Conduit – Product Status 102

Hollow Artificial Conduit – Product Description 102

Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 103

Flat-Cut Bit For Cranial Perforator – Product Status 103

Flat-Cut Bit For Cranial Perforator – Product Description 103

PosiSeat – Product Status 104

PosiSeat – Product Description 104

Xylos Corporation Pipeline Products & Ongoing Clinical Trials Overview 105

Dura Replacement Device – Product Status 105

Dura Replacement Device – Product Description 105

Glossary 160

Figures

Neurosurgical Products – Pipeline Products by Stage of Development 14

Neurosurgical Products – Pipeline Products by Segment 15

Neurosurgical Products – Pipeline Products by Territory 16

Neurosurgical Products – Pipeline Products by Regulatory Path 17

Neurosurgical Products – Pipeline Products by Estimated Approval Date 18

Neurosurgical Products – Ongoing Clinical Trials 19

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