Ophthalmic Lasers - Medical Devices Pipeline Assessment, 2017

2017-06-14
Price :
Published : Jun-2017
No. of Pages : 124
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 6
2 Introduction 7
2.1 Ophthalmic Lasers Overview 7
3 Products under Development 8
3.1 Ophthalmic Lasers - Pipeline Products by Stage of Development 8
3.2 Ophthalmic Lasers - Pipeline Products by Segment 9
3.3 Ophthalmic Lasers - Pipeline Products by Territory 10
3.4 Ophthalmic Lasers - Pipeline Products by Regulatory Path 11
3.5 Ophthalmic Lasers - Pipeline Products by Estimated Approval Date 12
3.6 Ophthalmic Lasers - Ongoing Clinical Trials 13
4 Ophthalmic Lasers - Pipeline Products under Development by Companies 14
4.1 Ophthalmic Lasers Companies - Pipeline Products by Stage of Development 14
4.2 Ophthalmic Lasers - Pipeline Products by Stage of Development 15
5 Ophthalmic Lasers Companies and Product Overview 16
5.1 3D-Micromac AG Company Overview 16
5.1.1 3D-Micromac AG Pipeline Products & Ongoing Clinical Trials Overview 16
5.2 Alcon Inc Company Overview 17
5.2.1 Alcon Inc Pipeline Products & Ongoing Clinical Trials Overview 17
5.3 Bausch & Lomb Inc Company Overview 18
5.3.1 Bausch & Lomb Inc Pipeline Products & Ongoing Clinical Trials Overview 18
5.4 Bausch + Lomb Technolas Company Overview 21
5.4.1 Bausch + Lomb Technolas Pipeline Products & Ongoing Clinical Trials Overview 21
5.5 Belkin Laser Ltd Company Overview 23
5.5.1 Belkin Laser Ltd Pipeline Products & Ongoing Clinical Trials Overview 23
5.6 Biolase, Inc. Company Overview 25
5.6.1 Biolase, Inc. Pipeline Products & Ongoing Clinical Trials Overview 25
5.7 Carl Zeiss Meditec AG Company Overview 26
5.7.1 Carl Zeiss Meditec AG Pipeline Products & Ongoing Clinical Trials Overview 26
5.8 CV Laser Pty Ltd Company Overview 27
5.8.1 CV Laser Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 27
5.9 Ellex Medical Lasers Limited Company Overview 28
5.9.1 Ellex Medical Lasers Limited Pipeline Products & Ongoing Clinical Trials Overview 28
5.10 IOPtima Ltd. Company Overview 30
5.10.1 IOPtima Ltd. Pipeline Products & Ongoing Clinical Trials Overview 30
5.11 Lensar Inc Company Overview 31
5.11.1 Lensar Inc Pipeline Products & Ongoing Clinical Trials Overview 31
5.12 LumiThera, Inc. Company Overview 32
5.12.1 LumiThera, Inc. Pipeline Products & Ongoing Clinical Trials Overview 32
5.13 Massachusetts Eye and Ear Infirmary Company Overview 34
5.13.1 Massachusetts Eye and Ear Infirmary Pipeline Products & Ongoing Clinical Trials Overview 34
5.14 Michigan State University Company Overview 35
5.14.1 Michigan State University Pipeline Products & Ongoing Clinical Trials Overview 35
5.15 MRC Systems GmbH Company Overview 36
5.15.1 MRC Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 36
5.16 Nidek Co Ltd Company Overview 37
5.16.1 Nidek Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 37
5.17 Princeton University Company Overview 38
5.17.1 Princeton University Pipeline Products & Ongoing Clinical Trials Overview 38
5.18 Rowiak GmbH Company Overview 39
5.18.1 Rowiak GmbH Pipeline Products & Ongoing Clinical Trials Overview 39
5.19 Spire Corp Company Overview 40
5.19.1 Spire Corp Pipeline Products & Ongoing Clinical Trials Overview 40
5.20 Stroma Medical Corp Company Overview 41
5.20.1 Stroma Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 41
5.21 University of Bern Company Overview 42
5.21.1 University of Bern Pipeline Products & Ongoing Clinical Trials Overview 42
5.22 University of Calgary Company Overview 43
5.22.1 University of Calgary Pipeline Products & Ongoing Clinical Trials Overview 43
5.23 Visioneering Technologies Inc Company Overview 44
5.23.1 Visioneering Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 44
6 Ophthalmic Lasers- Recent Developments 45
6.1 May 30, 2017: The German Court has Granted a Preliminary Injunction in Favour of VSY Biotechnology BV and Against Carl Zeiss Meditec 45
6.2 May 11, 2017: ZEISS: Significant Growth in Revenue and Earnings 45
6.3 May 10, 2017: LENSAR Awards Teleon Surgical European Distributor Contract 46
6.4 May 10, 2017: Carl Zeiss Meditec accelerates growth in the first six months of 2016/17 47
6.5 May 08, 2017: ZEISS Appoints New Fellow 48
6.6 May 08, 2017: Dr. Stephen S. Lane joins Alcon as Chief Medical Officer and Global Head Franchise Clinical Strategy 49
6.7 May 05, 2017: LENSAR Receives FDA Clearances for Laser Cataract Platform Integration With OCULUS Pentacam Tomographers 50
6.8 May 05, 2017: BIOLASE Announces Management Change 51
6.9 May 04, 2017: IRIDEX Announces Presentation Of Data Demonstrating Safety And Efficacy Of Micropulse Technology At Upcoming Industry Conferences 51
6.10 May 03, 2017: IRIDEX Announces First Quarter 2017 Financial Results 52
6.11 May 03, 2017: BIOLASE Reports 2017 First Quarter Results 53
6.12 Apr 25, 2017: Novartis delivered sales growth across all divisions as growth drivers, including Cosentyx and Entresto, more than offset generic erosion; innovation momentum continued 54
6.13 Apr 04, 2017: Carl Zeiss Meditec Group achieves first half 2016/17 revenue of approximately EUR 588 million 59
6.14 Mar 21, 2017: Dr. Tom Tooma Performs ReLEx SMILE Procedures for Correction of Myopia in Orange County 59
6.15 Mar 21, 2017: Dieter Kurz Confirmed as Chairman of the Supervisory Boards at SCHOTT and ZEISS 59
6.16 Mar 13, 2017: BIOLASE Names James D. Surek Vice President Sales, Americas 60
6.17 Mar 08, 2017: BIOLASE Reports 2016 Full Year and Fourth Quarter Results 60
6.18 Mar 08, 2017: IRIDEX Announces Fourth Quarter and 2016 Financial Results and Provides Full Year 2017 Financial Outlook 63
6.19 Mar 01, 2017: BIOLASE Names Mark J. Nelson Chief Financial Officer 64
6.20 Feb 28, 2017: Novartis shareholders approve all resolutions proposed by Board of Directors at the Annual General Meeting 65
6.21 Feb 27, 2017: Ellex Medical Lasers: Financial Report for Half-Year Ended 31 December 2016 66
6.22 Feb 10, 2017: Carl Zeiss Meditec Off to A Solid Start Into Business Year 2016/17 67
6.23 Feb 02, 2017: Ellex Trading Update for the Six Months Ended 31 December 2016 68
6.24 Jan 26, 2017: LENSAR Launches Streamline III to Assist Cataract Surgeons in Managing and Improving Astigmatism Treatment for Optimal Visual Outcomes 70
6.25 Jan 26, 2017: Novartis highlights progress towards access and environmental goals in 2016 Corporate Responsibility Performance Report 70
6.26 Jan 26, 2017: Achievement of sales milestone for COPD products 71
6.27 Jan 25, 2017: Novartis delivered solid 2016 performance, with Growth Products absorbing Gleevec US LOE; innovation momentum continued; announces share buyback 72
6.28 Jan 17, 2017: Visioneering Technologies Announces Jeff Babbe as New Executive Territory Manager for Chicago, IL 79
6.29 Jan 09, 2017: BIOLASE Announces Management Change 79
6.30 Jan 09, 2017: IRIDEX Announces Preliminary Unaudited Revenues for 2016 Fourth Quarter and Full Year 79
6.31 Jan 06, 2017: NIDEK launches the YLC-500 Vixi Yellow Scan Laser Photocoagulator / YLC-500 Yellow Laser Photocoagulator 80
6.32 Dec 21, 2016: Visioneering Technologies Announces Brian Atkinson as Territory Manager for the Dallas/Ft. Worth Market 80
6.33 Dec 19, 2016: Lensar Strategic Restructure In Partnership With Pdl Biopharma 81
6.34 Dec 16, 2016: ZEISS Achieves Record Revenue and Earnings 81
6.35 Dec 13, 2016: Visioneering Technologies Announces Ken Gold as New Executive Territory Manager for the Baltimore-Washington, DC Area 83
6.36 Dec 09, 2016: Carl Zeiss Meditec continues its growth trend 83
6.37 Dec 07, 2016: VTI names executive director of manufacturing and engineering 84
6.38 Dec 07, 2016: Visioneering Technologies Announces Ms. Rosa Lee as New Executive Director of Manufacturing & Engineering 85
6.39 Dec 01, 2016: Compact Navilas Laser System 577s Receives U.S. FDA Clearance 85
6.40 Nov 29, 2016: Novartis Access shares one-year learnings and announces memorandum of understanding with Rwanda 86
6.41 Nov 16, 2016: New Head of the ZEISS Semiconductor Manufacturing Technology Business Group 87
6.42 Nov 09, 2016: Daniel B. Polley, Ph.D., appointed Director of Lauer Tinnitus Research Center at Mass. Eye and Ear 88
6.43 Nov 08, 2016: BIOLASE Reports 2016 Third Quarter and Nine-Month Results 89
6.44 Nov 03, 2016: IRIDEX Reports 2016 Third Quarter, Nine-Month Results 91
6.45 Oct 25, 2016: Novartis delivered solid third quarter with Growth Products offsetting Gleevec patent expiration; several positive readouts for potential blockbusters 92
6.46 Oct 18, 2016: New laser eye procedure receives FDA approval - something to SMILE about! 99
6.47 Oct 13, 2016: Carl Zeiss Meditec appoints Steven C. Schallhorn, MD as Chief Medical Officer 100
6.48 Oct 12, 2016: Bausch + Lomb Booth to Feature Wet Lab During the Annual Meeting of the American Academy of Ophthalmology in Chicago 101
6.49 Oct 11, 2016: IRIDEX Announces Preliminary Revenues for 2016 Third Quarter 103
6.50 Oct 04, 2016: Zecotek Announces Preliminary Revenue for Fiscal 2016 103
6.51 Sep 14, 2016: ZEISS receives US FDA Approval for VisuMax SMILE vision correction procedure, the latest advancement in laser eye surgery 104
6.52 Sep 13, 2016: FDA approves VisuMax Femtosecond Laser to surgically treat nearsightedness 105
6.53 Aug 26, 2016: Ellex awarded $2.5m Federal Government Grant 106
6.54 Aug 26, 2016: Ellex Reports Full Year FY16 Audited Results 106
6.55 Aug 12, 2016: Carl Zeiss Meditec Grows in Ophthalmology and Microsurgery 107
6.56 Aug 04, 2016: IRIDEX Reports 2016 Second Quarter, Six-Month Results 108
6.57 Aug 01, 2016: BIOLASE Reports 2016 Second Quarter and Six-Month Results 108
6.58 Jul 28, 2016: Ellex Reports Trading Update for the Year Ended 30 June 2016 111
6.59 Jul 27, 2016: Carl Zeiss Meditec Recruits James V. Mazzo to Lead Its Newly Consolidated Ophthalmology Organization 112
6.60 Jul 20, 2016: Carl Zeiss Meditec announces change to Management Board 112
6.61 Jul 19, 2016: Novartis delivered solid Q2 despite full quarter of US Gleevec generic impact; significant positive innovation news strengthens future growth prospects 112
6.62 Jul 11, 2016: IRIDEX Announces Atabak Mokari Will Be Chief Financial Officer And VP Corporate Development 119
6.63 Jul 06, 2016: U.S. patent trial and appeal board grants ZEISS' petition and institutes IPR against NPE patent holder AMI 119
6.64 Jun 30, 2016: Merck Welcomes ZEISS and Hamilton Thorne as New Members of the Global Fertility Alliance 120
7 Appendix 121
7.1 Methodology 121
7.2 About GlobalData 124
7.3 Contact Us 124
7.4 Disclaimer 124

1.1 List of Tables
Table 1: Ophthalmic Lasers - Pipeline Products by Stage of Development 8
Table 2: Ophthalmic Lasers - Pipeline Products by Segment 9
Table 3: Ophthalmic Lasers - Pipeline Products by Territory 10
Table 4: Ophthalmic Lasers - Pipeline Products by Regulatory Path 11
Table 5: Ophthalmic Lasers - Pipeline Products by Estimated Approval Date 12
Table 6: Ophthalmic Lasers - Ongoing Clinical Trials 13
Table 7: Ophthalmic Lasers Companies - Pipeline Products by Stage of Development 14
Table 8: Ophthalmic Lasers - Pipeline Products by Stage of Development 15
Table 9: 3D-Micromac AG Pipeline Products & Ongoing Clinical Trials Overview 16
Table 10: Excimer Laser System - Product Status 16
Table 11: Excimer Laser System - Product Description 16
Table 12: Alcon Inc Pipeline Products & Ongoing Clinical Trials Overview 17
Table 13: ALLEGRETTO EX-400 Laser - Product Status 17
Table 14: ALLEGRETTO EX-400 Laser - Product Description 17
Table 15: Bausch & Lomb Inc Pipeline Products & Ongoing Clinical Trials Overview 18
Table 16: TECHNOLAS TENEO 317 Excimer Laser - Product Status 18
Table 17: TECHNOLAS TENEO 317 Excimer Laser - Product Description 19
Table 18: Bausch & Lomb Inc - Ongoing Clinical Trials Overview 20
Table 19: TECHNOLAS TENEO 317 Excimer Laser - A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser Using LASIK 20
Table 20: Bausch + Lomb Technolas Pipeline Products & Ongoing Clinical Trials Overview 21
Table 21: Customlens - Product Status 21
Table 22: Customlens - Product Description 21
Table 23: Customshape - Product Status 22
Table 24: Customshape - Product Description 22
Table 25: Belkin Laser Ltd Pipeline Products & Ongoing Clinical Trials Overview 23
Table 26: BELKIN Laser - Glaucoma - Product Status 23
Table 27: BELKIN Laser - Glaucoma - Product Description 23
Table 28: Belkin Laser Ltd - Ongoing Clinical Trials Overview 24
Table 29: BELKIN Laser - Glaucoma - Direct Selective Laser Trabeculoplasty (DSLT) in Open Angle Glaucoma (OAG): A Randomized Controlled Trial 24
Table 30: Biolase, Inc. Pipeline Products & Ongoing Clinical Trials Overview 25
Table 31: YSGG Waterlase Laser - Presbyopia - Product Status 25
Table 32: YSGG Waterlase Laser - Presbyopia - Product Description 25
Table 33: Carl Zeiss Meditec AG Pipeline Products & Ongoing Clinical Trials Overview 26
Table 34: IRay Stereotactic Radiotherapy System - Product Status 26
Table 35: IRay Stereotactic Radiotherapy System - Product Description 26
Table 36: CV Laser Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 27
Table 37: Multipurpose Ophthalmic Laser - Product Status 27
Table 38: Multipurpose Ophthalmic Laser - Product Description 27
Table 39: Ellex Medical Lasers Limited Pipeline Products & Ongoing Clinical Trials Overview 28
Table 40: Integre Pro Scan - Product Status 28
Table 41: Integre Pro Scan - Product Description 29
Table 42: IOPtima Ltd. Pipeline Products & Ongoing Clinical Trials Overview 30
Table 43: IOPtiMate - Product Status 30
Table 44: IOPtiMate - Product Description 30
Table 45: Lensar Inc Pipeline Products & Ongoing Clinical Trials Overview 31
Table 46: LensAR Laser System - Presbyopia - Product Status 31
Table 47: LensAR Laser System - Presbyopia - Product Description 31
Table 48: LumiThera, Inc. Pipeline Products & Ongoing Clinical Trials Overview 32
Table 49: LT-300 LED - Product Status 32
Table 50: LT-300 LED - Product Description 32
Table 51: LumiThera, Inc. - Ongoing Clinical Trials Overview 33
Table 52: LT-300 LED - A Double-masked, Randomized, Sham-controlled, Parallel Group, Single-center Study to Assess the Safety and Efficacy of Photobiomodulation in Subjects with Dry Age-related Macular Degeneration 33
Table 53: Massachusetts Eye and Ear Infirmary Pipeline Products & Ongoing Clinical Trials Overview 34
Table 54: Corneal Flap Slicer - Product Status 34
Table 55: Corneal Flap Slicer - Product Description 34
Table 56: Michigan State University Pipeline Products & Ongoing Clinical Trials Overview 35
Table 57: Adaptive Laser System - Product Status 35
Table 58: Adaptive Laser System - Product Description 35
Table 59: MRC Systems GmbH Pipeline Products & Ongoing Clinical Trials Overview 36
Table 60: FLIM - Product Status 36
Table 61: FLIM - Product Description 36
Table 62: Nidek Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 37
Table 63: NAVEX Quest - Product Status 37
Table 64: NAVEX Quest - Product Description 37
Table 65: Princeton University Pipeline Products & Ongoing Clinical Trials Overview 38
Table 66: Presbyopia Correction Device - Product Status 38
Table 67: Presbyopia Correction Device - Product Description 38
Table 68: Rowiak GmbH Pipeline Products & Ongoing Clinical Trials Overview 39
Table 69: LenSurgeon - Presbyopia Reversal - Product Status 39
Table 70: LenSurgeon - Presbyopia Reversal - Product Description 39
Table 71: Spire Corp Pipeline Products & Ongoing Clinical Trials Overview 40
Table 72: Fiber Laser Instrument - Eye Surgery - Product Status 40
Table 73: Fiber Laser Instrument - Eye Surgery - Product Description 40
Table 74: Stroma Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 41
Table 75: Stroma Ophthalmic Device - Eye Color - Product Status 41
Table 76: Stroma Ophthalmic Device - Eye Color - Product Description 41
Table 77: University of Bern Pipeline Products & Ongoing Clinical Trials Overview 42
Table 78: Integrated Computer Assisted Retinal Laser Photocoagulation System - Product Status 42
Table 79: Integrated Computer Assisted Retinal Laser Photocoagulation System - Product Description 42
Table 80: University of Calgary Pipeline Products & Ongoing Clinical Trials Overview 43
Table 81: Opthalmic Laser Device - Product Status 43
Table 82: Opthalmic Laser Device - Product Description 43
Table 83: Visioneering Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 44
Table 84: LASIK Device - Product Status 44
Table 85: LASIK Device - Product Description 44
Table 86: Glossary 123

1.2 List of Figures
Figure 1: Ophthalmic Lasers - Pipeline Products by Stage of Development 8
Figure 2: Ophthalmic Lasers - Pipeline Products by Segment 9
Figure 3: Ophthalmic Lasers - Pipeline Products by Territory 10
Figure 4: Ophthalmic Lasers - Pipeline Products by Regulatory Path 11
Figure 5: Ophthalmic Lasers - Pipeline Products by Estimated Approval Date 12
Figure 6: Ophthalmic Lasers - Ongoing Clinical Trials 13
Filed in: Medical Device
Publisher : GlobalData