Dental Radiology Equipment - Medical Devices Pipeline Assessment, 2018

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 7
2 Introduction 8
2.1 Dental Radiology Equipment Overview 8
3 Products under Development 9
3.1 Dental Radiology Equipment - Pipeline Products by Stage of Development 9
3.2 Dental Radiology Equipment - Pipeline Products by Segment 10
3.3 Dental Radiology Equipment - Pipeline Products by Territory 11
3.4 Dental Radiology Equipment - Pipeline Products by Regulatory Path 12
3.5 Dental Radiology Equipment - Pipeline Products by Estimated Approval Date 13
3.6 Dental Radiology Equipment - Ongoing Clinical Trials 14
4 Dental Radiology Equipment - Pipeline Products under Development by Companies 15
4.1 Dental Radiology Equipment Companies - Pipeline Products by Stage of Development 15
4.2 Dental Radiology Equipment - Pipeline Products by Stage of Development 16
5 Dental Radiology Equipment Companies and Product Overview 17
5.1 Biomedics (NZ) Limited Company Overview 17
5.1.1 Biomedics (NZ) Limited Pipeline Products & Ongoing Clinical Trials Overview 17
5.2 Calcivis Ltd Company Overview 18
5.2.1 Calcivis Ltd Pipeline Products & Ongoing Clinical Trials Overview 18
5.3 DxRay, Inc. Company Overview 21
5.3.1 DxRay, Inc. Pipeline Products & Ongoing Clinical Trials Overview 21
5.4 Farus LLC Company Overview 22
5.4.1 Farus LLC Pipeline Products & Ongoing Clinical Trials Overview 22
5.5 In Veritas Medical Diagnostics Inc. (Inactive) Company Overview 23
5.5.1 In Veritas Medical Diagnostics Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 23
5.6 King's College London Company Overview 24
5.6.1 King's College London Pipeline Products & Ongoing Clinical Trials Overview 24
5.7 LuxRay Dental Systems Inc Company Overview 25
5.7.1 LuxRay Dental Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 25
5.8 Panasonic Healthcare Co Ltd Company Overview 26
5.8.1 Panasonic Healthcare Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 26
5.9 Perio-Imaging Inc. Company Overview 29
5.9.1 Perio-Imaging Inc. Pipeline Products & Ongoing Clinical Trials Overview 29
5.10 Radiation Monitoring Devices Inc Company Overview 30
5.10.1 Radiation Monitoring Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 30
5.11 Raptor Resources Holdings Inc. Company Overview 31
5.11.1 Raptor Resources Holdings Inc. Pipeline Products & Ongoing Clinical Trials Overview 31
5.12 Real Time Imaging Technologies, LLC Company Overview 33
5.12.1 Real Time Imaging Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 33
5.13 S-Ray Incorporated Company Overview 36
5.13.1 S-Ray Incorporated Pipeline Products & Ongoing Clinical Trials Overview 36
5.14 Tribogenics, Inc. Company Overview 37
5.14.1 Tribogenics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 37
5.15 University of California Irvine Company Overview 38
5.15.1 University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 38
5.16 University of Liverpool Company Overview 39
5.16.1 University of Liverpool Pipeline Products & Ongoing Clinical Trials Overview 39
5.17 Varian Medical Systems Inc Company Overview 40
5.17.1 Varian Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 40
5.18 West Virginia University Company Overview 42
5.18.1 West Virginia University Pipeline Products & Ongoing Clinical Trials Overview 42
5.19 Xintek, Inc. Company Overview 43
5.19.1 Xintek, Inc. Pipeline Products & Ongoing Clinical Trials Overview 43
6 Dental Radiology Equipment- Recent Developments 44
6.1 Feb 21, 2018: Orthodontists, Oral Surgeons, Periodontists and Other Specialists Introduced to Teledentistry to Increase the Conversion and Ease of Patient Referrals 44
6.2 Feb 20, 2018: VitalHub Selected to Showcase WellLinc Solution Among 40,000 International Attendees at HIMSS 2018 44
6.3 Feb 20, 2018: Henry Schein Reports Record Fourth Quarter and Full Year 2017 Financial Results 45
6.4 Feb 19, 2018: Henry Schein And Its Dental Laboratory Business, Zahn Dental, To Showcase The Company's Latest Digital Solutions At Chicago Midwinter Dental Meeting And LMT Lab Day 48
6.5 Feb 13, 2018: Henry Schein Denies FTC Anti-Trust Allegations 49
6.6 Feb 12, 2018: Henry Schein Named one of the 2018 World's Most Ethical Companies by The Ethisphere Institute for the Seventh Time 50
6.7 Feb 08, 2018: Align Technology Advanced Treatment Planning Patent Affirmed by Three-Judge Panel 51
6.8 Jan 30, 2018: Danaher Reports Fourth Quarter And Full Year 2017 Results 51
6.9 Jan 30, 2018: Align Technology Reported Gross Profit Of $421.3 Million In Fourth Quarter Of 2017 52
6.10 Jan 24, 2018: Varian Reports Results for First Quarter of Fiscal Year 2018 53
6.11 Jan 24, 2018: CAO Group Protects Its Diode Laser Patent Rights From Infringement By Biolase 54
6.12 Jan 23, 2018: Carestream Wins 36 U.S. Patents In 2017; 43 Additional Patents in Other Countries 55
6.13 Jan 17, 2018: Donald M. Casey Jr. Appointed Chief Executive Officer of Dentsply Sirona 55
6.14 Jan 17, 2018: Dentsply Sirona Announces the Addition of New Board Members 56
6.15 Jan 12, 2018: Planmeca PlanScan intraoral scanner accepted by Orchestrate 3D system 56
6.16 Jan 08, 2018: Air Techniques Welcomes Casey Baldwin as Director of Sales 57
6.17 Jan 04, 2018: LED Medical Diagnostics Announces Appointment of New Director 57
6.18 Jan 02, 2018: Air Techniques Announces Robert Meehan as Digital Product Manager 57
6.19 Jan 02, 2018: Midmark Announces Changes to Executive Leadership Team 58
6.20 Dec 21, 2017: Planmeca Emerald and Planmeca PlanScan intraoral scanners now accepted by the ClearCaps clear aligner system 58
6.21 Dec 20, 2017: Align Technology to Discontinue Acceptance of Digital Scan Submissions From 3Shape TRIOS Scanners in the United States 59
6.22 Dec 19, 2017: 3Shape responds to Align Technology punishing dentists and orthodontists by termination of Invisalign interoperability 60
6.23 Dec 18, 2017: ITC Institutes Section 337 Investigations Based on Align Technology Claims of Scanner-Related 3Shape Patent Infringement 60
6.24 Dec 07, 2017: OraMetrix and suresmile Orthodontic Technology Announce Certification of Carestream Dental's CS 3600 Intraoral Scanner 61
6.25 Nov 28, 2017: Danaher Announced its Leadership Appointment 61
6.26 Nov 27, 2017: LED Medical Diagnostics Reports 2017 Third Quarter Results 61
6.27 Nov 27, 2017: LED Medical Diagnostics Reports 2017 Third Quarter Results November 27, 2017 62
6.28 Nov 20, 2017: Varian Announces Opening of New Facility in Brazil 63
6.29 Nov 15, 2017: 3Shape responds to Align Technology Patent Infringement Lawsuit 64
6.30 Nov 14, 2017: CALCIVIS Announces FDA Filing of the Pre-Market Approval (PMA) Application for its Unique CALCIVIS Imaging System 64
6.31 Nov 14, 2017: Align Technology Files Six Patent Infringement Lawsuits Asserting 26 Patents Against 3Shape 65
6.32 Nov 14, 2017: Midmark Announces New Office for Corporate Headquarters 65
6.33 Nov 10, 2017: J. Morita Becomes Distribution Partner for the 3Shape TRIOS Intraoral Scanner in Japan 66
6.34 Nov 06, 2017: Henry Schein Reports Record Third Quarter Financial Results 66
6.35 Nov 06, 2017: Midmark Technology Center Supported by JobsOhio Grant 69
6.36 Nov 03, 2017: Dentsply Sirona Reports Third Quarter 2017 Results 70
6.37 Nov 01, 2017: CALCIVIS Announces Positive Results from PMA Clinical Study Evaluating its Unique CALCIVIS Imaging System 71
6.38 Nov 01, 2017: BIOLASE Reports 2017 Third Quarter and Nine-Month Results 72
6.39 Oct 31, 2017: BIOLASE Appoints Richard B. Lanman to Board of Directors 74
6.40 Oct 30, 2017: Varian Names New Chief People Officer, SVP HR 75
6.41 Oct 26, 2017: Align Technology Announces Record Third Quarter 2017 Results 75
6.42 Oct 26, 2017: Midmark Showcases New Dental Health Clinic at Sinclair Community College 76
6.43 Oct 25, 2017: Varian Reports Results for Fourth Quarter of Fiscal Year 2017 77
6.44 Oct 19, 2017: Danaher Reports Third Quarter 2017 Results 78
6.45 Oct 16, 2017: Dentsply Sirona Announces Additions to Executive Leadership Team 79
6.46 Oct 11, 2017: Henry Schein Donates More Than $18,000 In Dental Supplies To The Growing Smiles Foundation 79
6.47 Oct 02, 2017: Dentsply Sirona Announces Leadership Changes 80
6.48 Oct 02, 2017: BIOLASE Names John Beaver Senior Vice President, Chief Financial Officer 82
6.49 Sep 22, 2017: CALCIVIS to present at the 5th Annual MedTech & Digital Health Forum in Basel, Switzerland 83
6.50 Sep 13, 2017: Scans from Carestream Dental CS 3600 Compatible with Nutislab 83
6.51 Sep 05, 2017: BIOLASE Names Jonathan T. Lord Chairman of the Board 83
6.52 Sep 05, 2017: CDPQ invests USD 113 million to support the growth of Carestream Dental 84
6.53 Sep 05, 2017: Air Techniques Welcomes Sylvia Rochon as National Sales Manager, Canada 84
6.54 Aug 24, 2017: Air Techniques Introduces ScanX Intraoral View 85
6.55 Aug 22, 2017: Patterson Dental Announces Agreement with 3Shape 85
6.56 Aug 22, 2017: Air Techniques Appoints Patrick Strohkirch as Director of Special Markets 85
6.57 Aug 21, 2017: Vatech Introduces the PaX-i Insight - the Latest Evolution in 2D Imaging 86
6.58 Aug 17, 2017: Straumann Group posts H1 revenue growth of 14% with further margin improvement 87
6.59 Aug 17, 2017: LED Medical Diagnostics Reports Revenue Growth over Prior Quarter 91
6.60 Aug 11, 2017: Henry Schein Launches 2017 Healthy Lifestyles, Healthy Communities Program 92
6.61 Aug 10, 2017: Varian Announces New VP of Investor Relations 93
6.62 Aug 09, 2017: Dentsply Sirona Reports Second Quarter 2017 Results 93
6.63 Aug 08, 2017: Henry Schein Reports Record Second Quarter Financial Results 95
6.64 Aug 07, 2017: Henry Schein Now Accepting Applications For The Third Annual Henry Schein Cares Medal 96
6.65 Aug 07, 2017: BIOLASE Reports 2017 Second Quarter and Six-Month Results 97
6.66 Aug 03, 2017: Align Technology Expands Its Presence in Raleigh, North Carolina With Larger Office to Support Continued Headcount Growth 99
6.67 Aug 02, 2017: SAMHSA announces $6 million in grants to support the International President’s Emergency Plan for AIDS Relief Addiction Technology Transfer Centers 99
6.68 Aug 02, 2017: Carestream Wins Award for Reducing Energy Consumption At Its Colorado Manufacturing Facility 100
6.69 Jul 27, 2017: Align Technology Announces Record Second Quarter 2017 Results 101
6.70 Jul 26, 2017: Varian Medical Systems Reports Third Quarter Fiscal Year 2017 Results Highlighting Growth in Backlog and Improvements in both Gross Margin and Working Capital 102
6.71 Jul 20, 2017: Danaher Reports Second Quarter 2017 Results 103
6.72 Jul 19, 2017: Henry Schein Launches New Medical Website 103
6.73 Jul 05, 2017: Henry Schein Supports Volunteer Endodontists Expanding Oral Health Care In Jamaica 104
6.74 Jun 27, 2017: Henry Schein Settles Litigation 104
6.75 Jun 21, 2017: Air Techniques Announces Expansion of Sales Force 105
6.76 Jun 14, 2017: Latest Study Confirms Accuracy of CS 3600 Intraoral Scanner 105
6.77 Jun 09, 2017: 3Shape TRIOS Now with STL File Export 106
6.78 Jun 08, 2017: Successful pre-launch for CALCIVIS 106
6.79 Jun 05, 2017: CALCIVIS Completes Patient Recruitment of PMA Clinical Study Evaluating its Unique CALCIVIS Imaging System 106
6.80 Jun 02, 2017: Satish Hemachandran Named Carestream Dental’s New General Manager of Practice Management Software 107
6.81 May 24, 2017: Midmark Begins Plans to Build Technology Center in Versailles 108
6.82 May 09, 2017: Henry Schein Reports Record First Quarter Financial Results 108
6.83 May 05, 2017: BIOLASE Announces Management Change 110
6.84 May 03, 2017: BIOLASE Reports 2017 First Quarter Results 111
6.85 Apr 27, 2017: Varian Spotlights World-Leading Systems for Advanced Radiotherapy, Radiosurgery, Brachytherapy and Proton Therapy at ESTRO 36 112
6.86 Apr 27, 2017: Align Technology Announces Record First Quarter 2017 Results 113
6.87 Apr 27, 2017: Strong performance continues as Straumann posts 15% organic growth in Q1 114
6.88 Apr 26, 2017: Varian Medical Systems Reports Results for Second Quarter of Fiscal Year 2017 117
6.89 Apr 21, 2017: Carestream Dental Expands Its CS Solutions for Orthodontics Portfolio 118
6.90 Apr 20, 2017: Danaher Reports First Quarter 2017 Results 119
6.91 Apr 20, 2017: Applications Open for ASRT Foundation and Toshiba Medical Safety FiRsT Grant Program 119
6.92 Apr 19, 2017: Henry Schein Announces New $750 Million Credit Facility 120
6.93 Apr 19, 2017: U.S. Patent Office Grants ClearCorrect's Request to Reopen Align Patent Reexaminations 120
6.94 Apr 10, 2017: Henry Schein Donates More Than $80,000 In Health Supplies And Equipment To Children's Aid Society Community Health Centers In New York City 120
6.95 Apr 05, 2017: Varian Medical Systems Names New CFO 121
6.96 Apr 04, 2017: Varian Medical Systems Establishes Direct Operation in South Africa 121
6.97 Apr 03, 2017: Varian Medical Systems and Elekta Settle Patent Litigation 122
6.98 Mar 28, 2017: Align Technology Prevails In Additional U.S. Patent Office Proceedings Initiated By Clearcorrect 122
6.99 Mar 27, 2017: VOCO at IDS 2017: successful entry into the digital sector 123
6.100 Mar 22, 2017: Straumann Group presents numerous innovations at the 37th International Dental Show in Cologne 124
6.101 Mar 20, 2017: Straumann Group strengthens executive team to sustain dynamic growth in APAC and to lead Global People Management & Development 128
6.102 Mar 17, 2017: Carestream Dental Orthodontic Solutions Validated for Use with OnyxCeph Software 128
6.103 Mar 14, 2017: Susan E. Siegel Joins Align Technology Board of Directors 129
6.104 Mar 13, 2017: BIOLASE Names James D. Surek Vice President Sales, Americas 129
6.105 Mar 08, 2017: BIOLASE Reports 2016 Full Year and Fourth Quarter Results 130
6.106 Mar 01, 2017: BIOLASE Names Mark J. Nelson Chief Financial Officer 132
6.107 Mar 01, 2017: José Baselga and Jean-Luc Butel Appointed to Board of Directors of Varian Medical Systems 133
7 Appendix 135
7.1 Methodology 135
7.2 About GlobalData 138
7.3 Contact Us 138
7.4 Disclaimer 138

List of Tables
1.1 List of Tables
Table 1: Dental Radiology Equipment - Pipeline Products by Stage of Development 9
Table 2: Dental Radiology Equipment - Pipeline Products by Segment 10
Table 3: Dental Radiology Equipment - Pipeline Products by Territory 11
Table 4: Dental Radiology Equipment - Pipeline Products by Regulatory Path 12
Table 5: Dental Radiology Equipment - Pipeline Products by Estimated Approval Date 13
Table 6: Dental Radiology Equipment - Ongoing Clinical Trials 14
Table 7: Dental Radiology Equipment Companies - Pipeline Products by Stage of Development 15
Table 8: Dental Radiology Equipment - Pipeline Products by Stage of Development 16
Table 9: Biomedics (NZ) Limited Pipeline Products & Ongoing Clinical Trials Overview 17
Table 10: X-lite - Product Status 17
Table 11: X-lite - Product Description 17
Table 12: Calcivis Ltd Pipeline Products & Ongoing Clinical Trials Overview 18
Table 13: Calcivis Imaging System - Product Status 18
Table 14: Calcivis Imaging System - Product Description 18
Table 15: Calcivis Ltd - Ongoing Clinical Trials Overview 19
Table 16: Calcivis Imaging System - Monitoring of Caries Lesion Activity in Orthodontic Patients with the Calcivis System 20
Table 17: DxRay, Inc. Pipeline Products & Ongoing Clinical Trials Overview 21
Table 18: Low-Dose High-Resolution Dental Radiography - Product Status 21
Table 19: Low-Dose High-Resolution Dental Radiography - Product Description 21
Table 20: Farus LLC Pipeline Products & Ongoing Clinical Trials Overview 22
Table 21: Imsight Probe - Product Status 22
Table 22: Imsight Probe - Product Description 22
Table 23: In Veritas Medical Diagnostics Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 23
Table 24: Dental Imaging Device - Product Status 23
Table 25: Dental Imaging Device - Product Description 23
Table 26: King's College London Pipeline Products & Ongoing Clinical Trials Overview 24
Table 27: Imaging Device - Dental decay - Product Status 24
Table 28: Imaging Device - Dental decay - Product Description 24
Table 29: LuxRay Dental Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 25
Table 30: LuxRay System - Product Status 25
Table 31: LuxRay System - Product Description 25
Table 32: Panasonic Healthcare Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 26
Table 33: Swept Source Optical Coherence Tomography System - Product Status 26
Table 34: Swept Source Optical Coherence Tomography System - Product Description 26
Table 35: Panasonic Healthcare Co Ltd - Ongoing Clinical Trials Overview 27
Table 36: Swept Source Optical Coherence Tomography System - Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 28
Table 37: Perio-Imaging Inc. Pipeline Products & Ongoing Clinical Trials Overview 29
Table 38: Perio-Imager - Product Status 29
Table 39: Perio-Imager - Product Description 29
Table 40: Radiation Monitoring Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 30
Table 41: High Resolution Dental X-Ray Imager - Product Status 30
Table 42: High Resolution Dental X-Ray Imager - Product Description 30
Table 43: Raptor Resources Holdings Inc. Pipeline Products & Ongoing Clinical Trials Overview 31
Table 44: NIR Imaging System - Product Status 31
Table 45: NIR Imaging System - Product Description 31
Table 46: OCT Dental Imaging System - Product Status 32
Table 47: OCT Dental Imaging System - Product Description 32
Table 48: Real Time Imaging Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 33
Table 49: DDIS & VMS Modular Upgrade - Product Status 33
Table 50: DDIS & VMS Modular Upgrade - Product Description 33
Table 51: Dental Dynamic Imaging System - Product Status 34
Table 52: Dental Dynamic Imaging System - Product Description 34
Table 53: Low-Dose 3D/ Dental Biplanar Upgrade - Product Status 34
Table 54: Low-Dose 3D/ Dental Biplanar Upgrade - Product Description 35
Table 55: View Master System - Product Status 35
Table 56: View Master System - Product Description 35
Table 57: S-Ray Incorporated Pipeline Products & Ongoing Clinical Trials Overview 36
Table 58: ClearView SCAN - Product Status 36
Table 59: ClearView SCAN - Product Description 36
Table 60: Tribogenics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 37
Table 61: MODIS Compact Dental X-Ray Device - Product Status 37
Table 62: MODIS Compact Dental X-Ray Device - Product Description 37
Table 63: University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 38
Table 64: Peridontal Probe - Product Status 38
Table 65: Peridontal Probe - Product Description 38
Table 66: University of Liverpool Pipeline Products & Ongoing Clinical Trials Overview 39
Table 67: iDENTifi - Product Status 39
Table 68: iDENTifi - Product Description 39
Table 69: Varian Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 40
Table 70: 1515D Small Field-Of-View Cone Beam Computed Tomography Panel - Product Status 40
Table 71: 1515D Small Field-Of-View Cone Beam Computed Tomography Panel - Product Description 40
Table 72: 3030D Large Field-Of-View Cone Beam CT Device - Product Status 41
Table 73: 3030D Large Field-Of-View Cone Beam CT Device - Product Description 41
Table 74: West Virginia University Pipeline Products & Ongoing Clinical Trials Overview 42
Table 75: Ultrasonic Gingival Tissue Diagnosis System - Product Status 42
Table 76: Ultrasonic Gingival Tissue Diagnosis System - Product Description 42
Table 77: Xintek, Inc. Pipeline Products & Ongoing Clinical Trials Overview 43
Table 78: TomoD - Product Status 43
Table 79: TomoD - Product Description 43
Table 80: Glossary 137

List of Figures
1.2 List of Figures
Figure 1: Dental Radiology Equipment - Pipeline Products by Stage of Development 9
Figure 2: Dental Radiology Equipment - Pipeline Products by Segment 10
Figure 3: Dental Radiology Equipment - Pipeline Products by Territory 11
Figure 4: Dental Radiology Equipment - Pipeline Products by Regulatory Path 12
Figure 5: Dental Radiology Equipment - Pipeline Products by Estimated Approval Date 13
Figure 6: Dental Radiology Equipment - Ongoing Clinical Trials 14