Sleep Apnea Diagnostic Systems - Medical Devices Pipeline Assessment, 2017

Published : Jul-2017

No. of Pages : 108

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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 Sleep Apnea Diagnostic Systems Overview 7
3 Products under Development 8
3.1 Sleep Apnea Diagnostic Systems - Pipeline Products by Stage of Development 8
3.2 Sleep Apnea Diagnostic Systems - Pipeline Products by Segment 9
3.3 Sleep Apnea Diagnostic Systems - Pipeline Products by Territory 10
3.4 Sleep Apnea Diagnostic Systems - Pipeline Products by Regulatory Path 11
3.5 Sleep Apnea Diagnostic Systems - Pipeline Products by Estimated Approval Date 12
3.6 Sleep Apnea Diagnostic Systems - Ongoing Clinical Trials 13
4 Sleep Apnea Diagnostic Systems - Pipeline Products under Development by Companies 14
4.1 Sleep Apnea Diagnostic Systems Companies - Pipeline Products by Stage of Development 14
4.2 Sleep Apnea Diagnostic Systems - Pipeline Products by Stage of Development 16
5 Sleep Apnea Diagnostic Systems Companies and Product Overview 17
5.1 Advanced Brain Monitoring Inc Company Overview 17
5.1.1 Advanced Brain Monitoring Inc Pipeline Products & Ongoing Clinical Trials Overview 17
5.2 Anaxsys Technology Ltd Company Overview 18
5.2.1 Anaxsys Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 18
5.3 ApneaDx Inc. Company Overview 19
5.3.1 ApneaDx Inc. Pipeline Products & Ongoing Clinical Trials Overview 19
5.4 Apneon, Inc. Company Overview 22
5.4.1 Apneon, Inc. Pipeline Products & Ongoing Clinical Trials Overview 22
5.5 Aspire Medical, Inc. (Inactive) Company Overview 23
5.5.1 Aspire Medical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 23
5.6 Barron Associates, Inc. Company Overview 24
5.6.1 Barron Associates, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24
5.7 Beijing Dehaier Medical Technology Co Ltd Company Overview 25
5.7.1 Beijing Dehaier Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 25
5.8 Ben-Gurion University of the Negev Company Overview 26
5.8.1 Ben-Gurion University of the Negev Pipeline Products & Ongoing Clinical Trials Overview 26
5.9 Biospeech, Inc. Company Overview 27
5.9.1 Biospeech, Inc. Pipeline Products & Ongoing Clinical Trials Overview 27
5.10 BresoTec Inc. Company Overview 28
5.10.1 BresoTec Inc. Pipeline Products & Ongoing Clinical Trials Overview 28
5.11 John Hopkins University Company Overview 29
5.11.1 John Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 29
5.12 K-diagnostics Company Overview 30
5.12.1 K-diagnostics Pipeline Products & Ongoing Clinical Trials Overview 30
5.13 LifeWave Hi-Tech Medical Devices Ltd. Company Overview 31
5.13.1 LifeWave Hi-Tech Medical Devices Ltd. Pipeline Products & Ongoing Clinical Trials Overview 31
5.14 PMD Device Solutions Limited Company Overview 32
5.14.1 PMD Device Solutions Limited Pipeline Products & Ongoing Clinical Trials Overview 32
5.15 Respira Ltd Company Overview 33
5.15.1 Respira Ltd Pipeline Products & Ongoing Clinical Trials Overview 33
5.16 Rice University Company Overview 35
5.16.1 Rice University Pipeline Products & Ongoing Clinical Trials Overview 35
5.17 SleepUp Ltd Company Overview 36
5.17.1 SleepUp Ltd Pipeline Products & Ongoing Clinical Trials Overview 36
5.18 Somnarus Inc. Company Overview 38
5.18.1 Somnarus Inc. Pipeline Products & Ongoing Clinical Trials Overview 38
5.19 TessArae, LLC Company Overview 39
5.19.1 TessArae, LLC Pipeline Products & Ongoing Clinical Trials Overview 39
5.20 University of California Irvine Company Overview 40
5.20.1 University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 40
5.21 University of Texas at Arlington Company Overview 41
5.21.1 University of Texas at Arlington Pipeline Products & Ongoing Clinical Trials Overview 41
5.22 University of Toulon Company Overview 42
5.22.1 University of Toulon Pipeline Products & Ongoing Clinical Trials Overview 42
5.23 VSSB Medical Nanotechnology (Inactive) Company Overview 43
5.23.1 VSSB Medical Nanotechnology (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 43
5.24 Zansors LLC Company Overview 45
5.24.1 Zansors LLC Pipeline Products & Ongoing Clinical Trials Overview 45
6 Sleep Apnea Diagnostic Systems- Recent Developments 48
6.1 Jun 22, 2017: Positional therapy as effective at normalizing sleep apnea in male as compared to female patients with positional OSA 48
6.2 May 22, 2017: Fisher & Paykel Healthcare Reports Record Annual Result, Net Profit Up 18% 48
6.3 May 17, 2017: Statement by ResMed on Plans to Renew Its Patent Infringement Case Against Fisher & Paykel 49
6.4 May 17, 2017: Compumedics: $3 Million In New Orders For China 50
6.5 May 09, 2017: Teijin Reports Revenue Of JPY741.3 Billion In Fiscal 2017 50
6.6 Apr 27, 2017: ResMed Announces Results for the Third Quarter of Fiscal Year 2017 51
6.7 Apr 26, 2017: Natus Medical Announces First Quarter 2017 Financial Results 52
6.8 Apr 24, 2017: Philips' First Quarter Results 2017 53
6.9 Apr 20, 2017: Electrical Geodesics: Results for the year ended 31 December 2016 55
6.10 Mar 20, 2017: Research on Treating Sleep Apnea with Adaptive Servo-ventilation Published in the Journal of the American College of Cardiology (JACC) 56
6.11 Mar 20, 2017: Philips reclassified to STOXX Europe 600 Health Care sector index 57
6.12 Mar 17, 2017: Philips appoints Henk de Jong as Chief of International Markets 57
6.13 Mar 17, 2017: Philips showcases data-driven cardiology solutions at 2017 American College of Cardiology Conference 57
6.14 Mar 16, 2017: An Important Recognition in the US Market for the WatchPAT Device: The American Academy of Sleep Medicine has Formally Endorsed Itamar Medical's WatchPAT Technology to Diagnose Sleep Apnea, Based on Published Evidence 59
6.15 Mar 10, 2017: IXICO presents novel sleep measurement technology at a workshop on Mobile Devices for Clinical Trials in Neurological Diseases in Arizona, US. 60
6.16 Mar 07, 2017: Philips leads the world in filing patents at the European Patent Office for second consecutive year 60
6.17 Mar 07, 2017: Philips expands its award-winning DreamStation platform to treat patients with most complex sleep and breathing needs 61
6.18 Mar 06, 2017: Electrical Geodesics: Business Update 61
6.19 Feb 21, 2017: Philips increases Green Revenues to EUR 10.2 billion, 58% of HealthTech revenues in 2016 62
6.20 Feb 17, 2017: Healthcare Industry Veteran, Jack Stoddard Joins NovaSom's Board of Directors 63
6.21 Feb 14, 2017: Philips announces changes to its Executive Committee 63
6.22 Feb 08, 2017: Oventus Medical grant application successful in latest CRC-P funding round 64
6.23 Feb 06, 2017: TEIJIN:Consolidated Financial Statements For Nine Months Ended December 31 2016 65
6.24 Feb 06, 2017: Teijin Board Elects Akihisa Nabeshima as New President of Teijin Pharma 71
6.25 Feb 01, 2017: Natus Medical Announces Fourth Quarter and Full Year 2016 Financial Results 71
6.26 Jan 25, 2017: Zansors Wins NIH Grant to Advance Wearable At-Home Affordable Sleep Apnea Detection 73
6.27 Jan 24, 2017: Philips' Fourth Quarter and Annual Results 2016 74
6.28 Jan 23, 2017: ResMed and BMC/3B Medical settle global litigation 76
6.29 Jan 23, 2017: ResMed Announces Results for the Second Quarter of Fiscal Year 2017 77
6.30 Jan 19, 2017: Philips appoints Roy Smythe as Chief Medical Officer for Health Informatics 78
6.31 Jan 06, 2017: Lianluo Smart's Presence at 2017 CES 79
6.32 Dec 23, 2016: Philips and leading network of healthcare centers and clinics in Russia to modernize the country's regional healthcare infrastructures 79
6.33 Dec 20, 2016: ResMed Appoints Carlos Nunez, MD, as Chief Medical Officer 80
6.34 Dec 19, 2016: Opto Circuits and its subsidiaries receives orders worth Rs. 910 millions from Philips Health Care 81
6.35 Dec 06, 2016: Winx Sleep Therapy System Now Available Directly to the Millions of Obstructive Sleep Apnea Sufferers Who Can't or Won't Use CPAP 81
6.36 Nov 22, 2016: Record Half Year Result for Fisher & Paykel Healthcare, Earnings Guidance Upgraded 82
6.37 Nov 18, 2016: Dehaier Medical Changed its Name to Lianluo Smart 84
6.38 Oct 26, 2016: Nihon Kohden Announces Consolidation and Relocation of Offices 85
6.39 Oct 25, 2016: ResMed Announces Results for the First Quarter of Fiscal Year 2017 85
6.40 Oct 25, 2016: Dehaier Changes Name to Lianluo Smart Limited, Announces Strategic Personnel Adjustment and Announces Date of Annual Shareholder Meeting 86
6.41 Oct 24, 2016: Philips' Third Quarter Results 2016 88
6.42 Oct 19, 2016: Natus Medical Announces Third Quarter 2016 Financial Results 89
6.43 Sep 22, 2016: Natus Medical Announces Appointment Of Barbara R. Paul, M.d. To Its Board Of Directors 91
6.44 Sep 05, 2016: Teijin Publishes Integrated Report 2016 92
6.45 Sep 01, 2016: Philips appoints Sophie Bechu as Chief of Operations 92
6.46 Aug 29, 2016: Electrical Geodesics Announces Six Month Period of Strong Revenue Growth 93
6.47 Aug 26, 2016: Electrical Geodesics Announces A Period of Strong Revenue Growth 93
6.48 Aug 17, 2016: ResMed Takes Fisher & Paykel to Court over Patents 94
6.49 Jul 28, 2016: Electrical Geodesics Provides Trading Update 94
6.50 Jul 28, 2016: ResMed Announces Results for the Fourth Quarter of Fiscal Year 2016 95
6.51 Jul 27, 2016: FDA Clears Expanded Indication for Itamar Medical's WatchPAT Sleep Apnea Diagnostic Device for Adolescents 98
6.52 Jul 26, 2016: Weinmann is renamed Lowenstein Medical Technology 98
6.53 Jul 25, 2016: Philips' Second Quarter Results 2016 98
6.54 Jul 21, 2016: Strong finish to the financial year for SomnoMed 100
6.55 Jul 20, 2016: Natus Medical Announces Record Second Quarter 2016 Financial Results 101
6.56 Jul 19, 2016: Derek Smith appointed Global CEO of SomnoMed 103
6.57 Jul 12, 2016: Philips and Spanish hospital Campus de la Salud start implementation of multi-year strategic partnership agreement 104
7 Appendix 105
7.1 Methodology 105
;7.2 About GlobalData 108
7.3 Contact Us 108
7.4 Disclaimer 108

1.1 List of Tables
Table 1: Sleep Apnea Diagnostic Systems - Pipeline Products by Stage of Development 8
Table 2: Sleep Apnea Diagnostic Systems - Pipeline Products by Segment 9
Table 3: Sleep Apnea Diagnostic Systems - Pipeline Products by Territory 10
Table 4: Sleep Apnea Diagnostic Systems - Pipeline Products by Regulatory Path 11
Table 5: Sleep Apnea Diagnostic Systems - Pipeline Products by Estimated Approval Date 12
Table 6: Sleep Apnea Diagnostic Systems - Ongoing Clinical Trials 13
Table 7: Sleep Apnea Diagnostic Systems Companies - Pipeline Products by Stage of Development 14
Table 8: Sleep Apnea Diagnostic Systems - Pipeline Products by Stage of Development 16
Table 9: Advanced Brain Monitoring Inc Pipeline Products & Ongoing Clinical Trials Overview 17
Table 10: Apnea Risk Evaluation System - Pediatrics - Product Status 17
Table 11: Apnea Risk Evaluation System - Pediatrics - Product Description 17
Table 12: Anaxsys Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 18
Table 13: Sleep Apnea System - Product Status 18
Table 14: Sleep Apnea System - Product Description 18
Table 15: ApneaDx Inc. Pipeline Products & Ongoing Clinical Trials Overview 19
Table 16: ApneaDx Device - Product Status 19
Table 17: ApneaDx Device - Product Description 19
Table 18: ApneaDx Inc. - Ongoing Clinical Trials Overview 20
Table 19: ApneaDx Device - Home Sleep Study With ApneaDx for the Diagnosis of Obstructive Sleep Apnea: A Pragmatic Randomized Controlled Trial: SIESTA 21
Table 20: Apneon, Inc. Pipeline Products & Ongoing Clinical Trials Overview 22
Table 21: Apnea Monitor - Product Status 22
Table 22: Apnea Monitor - Product Description 22
Table 23: Aspire Medical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 23
Table 24: Aspire Medical Advance System - Product Status 23
Table 25: Aspire Medical Advance System - Product Description 23
Table 26: Barron Associates, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24
Table 27: Soundtrak System - Product Status 24
Table 28: Soundtrak System - Product Description 24
Table 29: Beijing Dehaier Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 25
Table 30: DHR-999 Sleep Diagnostics - Product Status 25
Table 31: DHR-999 Sleep Diagnostics - Product Description 25
Table 32: Ben-Gurion University of the Negev Pipeline Products & Ongoing Clinical Trials Overview 26
Table 33: OSA Detection System - Product Status 26
Table 34: OSA Detection System - Product Description 26
Table 35: Biospeech, Inc. Pipeline Products & Ongoing Clinical Trials Overview 27
Table 36: Sleep Disordered Breathing Detection System - Product Status 27
Table 37: Sleep Disordered Breathing Detection System - Product Description 27
Table 38: BresoTec Inc. Pipeline Products & Ongoing Clinical Trials Overview 28
Table 39: BresoDx - Product Status 28
Table 40: BresoDx - Product Description 28
Table 41: John Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 29
Table 42: Lyra At-Home PSG - Product Status 29
Table 43: Lyra At-Home PSG - Product Description 29
Table 44: K-diagnostics Pipeline Products & Ongoing Clinical Trials Overview 30
Table 45: Sleep ID Monitor - Product Status 30
Table 46: Sleep ID Monitor - Product Description 30
Table 47: LifeWave Hi-Tech Medical Devices Ltd. Pipeline Products & Ongoing Clinical Trials Overview 31
Table 48: CardioConnect - Sleep Apnea - Product Status 31
Table 49: CardioConnect - Sleep Apnea - Product Description 31
Table 50: PMD Device Solutions Limited Pipeline Products & Ongoing Clinical Trials Overview 32
Table 51: RespiraSense - Home Use - Product Status 32
Table 52: RespiraSense - Home Use - Product Description 32
Table 53: Respira Ltd Pipeline Products & Ongoing Clinical Trials Overview 33
Table 54: Digital Snoring Meter - Product Status 33
Table 55: Digital Snoring Meter - Product Description 33
Table 56: Rapid Daytime Test - OSA - Product Status 34
Table 57: Rapid Daytime Test - OSA - Product Description 34
Table 58: Rice University Pipeline Products & Ongoing Clinical Trials Overview 35
Table 59: BabaLung Apnea Monitor - Product Status 35
Table 60: BabaLung Apnea Monitor - Product Description 35
Table 61: SleepUp Ltd Pipeline Products & Ongoing Clinical Trials Overview 36
Table 62: AICOT - Product Status 36
Table 63: AICOT - Product Description 36
Table 64: AirThrough Pacifier - Product Status 37
Table 65: AirThrough Pacifier - Product Description 37
Table 66: STEMA - Product Status 37
Table 67: STEMA - Product Description 37
Table 68: Somnarus Inc. Pipeline Products & Ongoing Clinical Trials Overview 38
Table 69: SomnaPatch - Product Status 38
Table 70: SomnaPatch - Product Description 38
Table 71: TessArae, LLC Pipeline Products & Ongoing Clinical Trials Overview 39
Table 72: SONOSA System - Product Status 39
Table 73: SONOSA System - Product Description 39
Table 74: University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 40
Table 75: Upper Airway Imaging Device - Product Status 40
Table 76: Upper Airway Imaging Device - Product Description 40
Table 77: University of Texas at Arlington Pipeline Products & Ongoing Clinical Trials Overview 41
Table 78: Sleep Disorder Breathing Detection System - Product Status 41
Table 79: Sleep Disorder Breathing Detection System - Product Description 41
Table 80: University of Toulon Pipeline Products & Ongoing Clinical Trials Overview 42
Table 81: Sleep Apnea Contactless Device - Product Status 42
Table 82: Sleep Apnea Contactless Device - Product Description 42
Table 83: VSSB Medical Nanotechnology (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 43
Table 84: VX100 - Product Status 43
Table 85: VX100 - Product Description 43
Table 86: VX200 - Product Status 44
Table 87: VX200 - Product Description 44
Table 88: Zansors LLC Pipeline Products & Ongoing Clinical Trials Overview 45
Table 89: Zerify - Product Status 45
Table 90: Zerify - Product Description 45
Table 91: Zansors LLC - Ongoing Clinical Trials Overview 46
Table 92: Zerify - Wireless Sensor Patch for Educing Barriers to In-home Sleep Apnea Screening, Phase II 47
Table 93: Glossary 107

1.2 List of Figures
Figure 1: Sleep Apnea Diagnostic Systems - Pipeline Products by Stage of Development 8
Figure 2: Sleep Apnea Diagnostic Systems - Pipeline Products by Segment 9
Figure 3: Sleep Apnea Diagnostic Systems - Pipeline Products by Territory 10
Figure 4: Sleep Apnea Diagnostic Systems - Pipeline Products by Regulatory Path 11
Figure 5: Sleep Apnea Diagnostic Systems - Pipeline Products by Estimated Approval Date 12
Figure 6: Sleep Apnea Diagnostic Systems - Ongoing Clinical Trials 13

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