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Respiratory Measurement Devices - Pipeline Review, 2015 Reference Code: GDME0005EPD

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Respiratory Measurement Devices - Pipeline Review, 2015

Reference Code: GDME0005EPD

Publication Date: April 2015

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Table of Contents

Table of Contents ............................................................................................................................................................................... 2

List of Tables .................................................................................................................................................................................. 8

List of Figures ............................................................................................................................................................................... 11

Introduction ....................................................................................................................................................................................... 12

Respiratory Measurement Devices Overview ............................................................................................................................... 12

Products under Development ........................................................................................................................................................... 13

Respiratory Measurement Devices - Pipeline Products by Stage of Development ....................................................................... 13

Respiratory Measurement Devices - Pipeline Products by Segment ............................................................................................ 14

Respiratory Measurement Devices - Pipeline Products by Territory ............................................................................................. 15

Respiratory Measurement Devices - Pipeline Products by Regulatory Path................................................................................. 16

Respiratory Measurement Devices - Pipeline Products by Estimated Approval Date ................................................................... 17

Respiratory Measurement Devices - Ongoing Clinical Trials ........................................................................................................ 18

Respiratory Measurement Devices - Pipeline Products under Development by Companies............................................................ 19

Respiratory Measurement Devices Companies - Pipeline Products by Stage of Development .................................................... 19

Respiratory Measurement Devices - Pipeline Products by Stage of Development ....................................................................... 21

Respiratory Measurement Devices Companies and Product Overview ........................................................................................... 23

Advanced Circulatory Systems, Inc. Company Overview ................................................................................................................. 23

Advanced Circulatory Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview......................................................... 23

Aerocrine AB Company Overview .................................................................................................................................................... 25

Aerocrine AB Pipeline Products & Ongoing Clinical Trials Overview ............................................................................................ 25

Anaxsys Technology Ltd Company Overview .................................................................................................................................. 27

Anaxsys Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview .......................................................................... 27

Arizona State University Company Overview ................................................................................................................................... 29

Arizona State University Pipeline Products & Ongoing Clinical Trials Overview ........................................................................... 29

Biospeech, Inc. Company Overview ................................................................................................................................................. 31

Biospeech, Inc. Pipeline Products & Ongoing Clinical Trials Overview ........................................................................................ 31

Cambridge Consultants Limited Company Overview ....................................................................................................................... 32

Cambridge Consultants Limited Pipeline Products & Ongoing Clinical Trials Overview ............................................................... 32

CAS Medical Systems, Inc. Company Overview .............................................................................................................................. 33

CAS Medical Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview ...................................................................... 33

City University London Company Overview ..................................................................................................................................... 35

City University London Pipeline Products & Ongoing Clinical Trials Overview ............................................................................. 35

Dartmouth College Company Overview ........................................................................................................................................... 36

Dartmouth College Pipeline Products & Ongoing Clinical Trials Overview ................................................................................... 36

Ecole Polytechnique de Montreal Company Overview ..................................................................................................................... 37

Ecole Polytechnique de Montreal Pipeline Products & Ongoing Clinical Trials Overview ............................................................. 37

Feather Sensors, LLC Company Overview ...................................................................................................................................... 38

Feather Sensors, LLC Pipeline Products & Ongoing Clinical Trials Overview .............................................................................. 38

Flashback Technologies, Inc. Company Overview ........................................................................................................................... 39

Flashback Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview ................................................................... 39

Fluorometrix Corporation Company Overview .................................................................................................................................. 40

Fluorometrix Corporation Pipeline Products & Ongoing Clinical Trials Overview ......................................................................... 40

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GE Global Research Company Overview ........................................................................................................................................ 41

GE Global Research Pipeline Products & Ongoing Clinical Trials Overview ................................................................................ 41

iHealth Lab Inc Company Overview ................................................................................................................................................. 42

iHealth Lab Inc Pipeline Products & Ongoing Clinical Trials Overview ......................................................................................... 42

Koronis Biomedical Technologies Corporation Company Overview ................................................................................................. 43

Koronis Biomedical Technologies Corporation Pipeline Products & Ongoing Clinical Trials Overview ........................................ 43

Lionsgate Technologies Inc. Company Overview ............................................................................................................................. 46

Lionsgate Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview .................................................................... 46

Masimo Corporation Company Overview ......................................................................................................................................... 47

Masimo Corporation Pipeline Products & Ongoing Clinical Trials Overview ................................................................................. 47

NanoVation-GS Company Overview ................................................................................................................................................ 52

NanoVation-GS Pipeline Products & Ongoing Clinical Trials Overview ........................................................................................ 52

Neetour Medical Ltd Company Overview ......................................................................................................................................... 53

Neetour Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview ................................................................................. 53

Nicrem S.r.l. Company Overview ..................................................................................................................................................... 54

Nicrem S.r.l. Pipeline Products & Ongoing Clinical Trials Overview ............................................................................................. 54

North Carolina State University Company Overview ........................................................................................................................ 57

North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview ................................................................ 57

Oxitone Medical Ltd Company Overview.......................................................................................................................................... 59

Oxitone Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview ................................................................................. 59

PneumaCare Ltd. Company Overview ............................................................................................................................................. 60

PneumaCare Ltd. Pipeline Products & Ongoing Clinical Trials Overview ..................................................................................... 60

Thora-3DI Ongoing Clinical Trial Details ................................................................................................................................... 63

Princeton University Company Overview ......................................................................................................................................... 64

Princeton University Pipeline Products & Ongoing Clinical Trials Overview ................................................................................. 64

Sheffield Hallam University Company Overview .............................................................................................................................. 65

Sheffield Hallam University Pipeline Products & Ongoing Clinical Trials Overview ...................................................................... 65

Sparo Labs Company Overview ....................................................................................................................................................... 67

Sparo Labs Pipeline Products & Ongoing Clinical Trials Overview ............................................................................................... 67

Stellenbosch University Company Overview .................................................................................................................................... 68

Stellenbosch University Pipeline Products & Ongoing Clinical Trials Overview ............................................................................ 68

Thoracic Medical Systems Inc. Company Overview ......................................................................................................................... 71

Thoracic Medical Systems Inc. Pipeline Products & Ongoing Clinical Trials Overview ................................................................ 71

Tufts University Company Overview ................................................................................................................................................ 72

Tufts University Pipeline Products & Ongoing Clinical Trials Overview ........................................................................................ 72

University of British Columbia Company Overview .......................................................................................................................... 73

University of British Columbia Pipeline Products & Ongoing Clinical Trials Overview .................................................................. 73

University of California, Berkeley Company Overview ..................................................................................................................... 74

University of California, Berkeley Pipeline Products & Ongoing Clinical Trials Overview ............................................................. 74

University of California, Davis Company Overview .......................................................................................................................... 75

University of California, Davis Pipeline Products & Ongoing Clinical Trials Overview .................................................................. 75

University of California, San Diego Company Overview ................................................................................................................... 76

University of California, San Diego Pipeline Products & Ongoing Clinical Trials Overview .......................................................... 76

University of Nebraska Omaha Company Overview ........................................................................................................................ 77

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University of Nebraska Omaha Pipeline Products & Ongoing Clinical Trials Overview ................................................................ 77

University of Oxford Company Overview .......................................................................................................................................... 78

University of Oxford Pipeline Products & Ongoing Clinical Trials Overview .................................................................................. 78

University of Washington Company Overview .................................................................................................................................. 79

University of Washington Pipeline Products & Ongoing Clinical Trials Overview ......................................................................... 79

Wipox LLC Company Overview ........................................................................................................................................................ 80

Wipox LLC Pipeline Products & Ongoing Clinical Trials Overview ............................................................................................... 80

Xhale, Inc. Company Overview ........................................................................................................................................................ 81

Xhale, Inc. Pipeline Products & Ongoing Clinical Trials Overview ................................................................................................ 81

Respiratory Measurement Devices- Recent Developments ............................................................................................................. 83

Mar 19, 2015: Studies Show Inadequate Monitoring of Patient Respiratory Status by Capnography and Pulse Oximetry .......... 83

Mar 19, 2015: Masimo to Showcase Root Solutions for the OR and ICU at the International Anesthesia Research Society's 2015 Annual Meeting and International Science Symposium ................................................................................................................ 83

Mar 09, 2015: Mortara Instrument Acquires Property For Business Expansion ............................................................................ 84

Mar 06, 2015: Aerocrine Receives FDA Clearance for NIOX VERO BlueTooth Wireless Enhancement ..................................... 85

Mar 06, 2015: Otsuka Pharmaceutical Appoints Board Members, Statutory Auditors .................................................................. 85

Mar 05, 2015: ndd Medical Technologies' Mobile Pulmonary Function Testing Helps Combat Pulmonary Fibrosis .................... 85

Mar 04, 2015: CASMED Announces 2014 Fourth Quarter and Full Year Financial Results ......................................................... 86

Mar 03, 2015: Cardinal Health Named One of the "Top 50 Companies for Executive Women" by NAFE .................................... 88

Mar 02, 2015: PharMerica Announces Wholesale Drug Distribution Agreement with Cardinal Health ......................................... 88

Feb 26, 2015: Korean Regulators Clear Masimo PVI for Clinical Use .......................................................................................... 89

Feb 25, 2015: LGTmedical Announces Issuance of U.S. Patent for Kenek Core Audio Waveform Technology .......................... 89

Feb 25, 2015: Patented Canadian Technology that Measures Heart Rate and Blood Oxygen Levels through Smartphones and Other Mobile Devices Approved by Health Canada ...................................................................................................................... 90

Feb 25, 2015: Compumedics Announces Business Update 31 Dec 2014 .................................................................................... 91

Feb 20, 2015: Aerocrine Achieves Record Sales for the 4th Quarter and Full Year ..................................................................... 92

Feb 17, 2015: Capnia Announces First U.S. Commercial Sales of CoSense ............................................................................... 93

Feb 04, 2015: Nonin Medical Joins Lineup of Pulse Oximetry Options for Next Generation Welch Allyn Vital Signs Monitoring Device ........................................................................................................................................................................................... 94

Jan 29, 2015: Aerocrine Receives Japanese Health Authority Clearance For NIOX VERO ......................................................... 94

Jan 29, 2015: Cardinal Health Reports Fiscal 2015 Second-Quarter Results .............................................................................. 95

Jan 29, 2015: UTMD Reports Financial Performance for Fourth Quarter ..................................................................................... 96

Jan 29, 2015: Utah Medical Products Reports Financial Performance for Fourth Quarter and Year 2014 ................................... 99

Jan 28, 2015: Capnia Announces Publication of CoSense Scientific Data in the Journal Blood Cells, Molecules and Diseases103

Jan 27, 2015: Otsuka Australia Pharmaceutical Opens in Australia ........................................................................................... 103

Jan 22, 2015: Covidien Reports First-Quarter 2015 Results ....................................................................................................... 104

Jan 22, 2015: RESMED Announces Results for the First Quarter of Fiscal Year 2015 .............................................................. 104

Jan 07, 2015: Taiwan Biophotonic Introducing the Industry's First Reflective Optical Sensor for Fingerless Wrist-Worn Pulse Oximeter ..................................................................................................................................................................................... 105

Jan 07, 2015: CASMED Reports Preliminary Sales for the 2014 Fourth Quarter and Full Year ................................................. 106

Jan 07, 2015: MGC Diagnostics Reports Fiscal 2014 Fourth Quarter and Full Year Results ..................................................... 107

Jan 07, 2015: Aerocrine Reports Record Sales for the 4th Quarter and Full Year 2014 ............................................................ 108

Dec 23, 2014: ALung Releases its 2014 Year in Review Summary ........................................................................................... 109

Dec 22, 2014: New Funding Arrangements Leverage Compumedics into Key Export Markets ................................................. 110

Dec 17, 2014: Cardinal Health urEssential Award to Recognize Medical Laboratory Professional ............................................ 110

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Dec 11, 2014: Smiths Medical Announces Plans to Move to New Corporate Headquarters ...................................................... 111

Dec 08, 2014: University of Iowa Hospital and Clinics Boosts Patient Safety: Upgrades Patient Monitoring to Innovative Pulse Oximetry Technology .................................................................................................................................................................. 112

Dec 04, 2014: Masimo iSpO2 Pulse Oximeter Featured in Fitness Book by Tour de France Champion Greg LeMond ............. 112

Nov 27, 2014: Aerocrine Interim Report January – September 2014 ......................................................................................... 113

Nov 27, 2014: Interim report January September 2014 .............................................................................................................. 114

Nov 21, 2014: Cardinal Health and Henry Schein Enter into Long-term Strategic Agreement to Serve Physician Offices ......... 114

Nov 21, 2014: Nutrition & Sante Inaugurates New Factory Expanding Production Base of the French Leader in Functional and Dietetic Foods ............................................................................................................................................................................. 115

Nov 20, 2014: Covidien's Nellcor Bedside SpO2 Patient Monitoring System Gets CE Mark Approval ....................................... 115

Nov 18, 2014: Prominent Japanese Med Device Provider to be Respiratory Motion's Exclusive Partner for World's #2 Medical Market ......................................................................................................................................................................................... 116

Nov 14, 2014: Otsuka Group Establishes New Company in Order to Strengthen Presence in Vending Machine Market .......... 117

Nov 10, 2014: Hospital Demo Suggests Respiratory Motion Patient Monitor May be Key Safety Tool in Caring for Ebola Patients .................................................................................................................................................................................................... 117

Nov 06, 2014: Aerocrine's Niox Vero Device Gets FDA Marketing Clearance............................................................................ 118

Nov 05, 2014: New Clinical Study Shows Accuracy of Masimo Noninvasive Spot-Check Hemoglobin (SpHb(R)) in Trauma Patients ....................................................................................................................................................................................... 119

Nov 05, 2014: Covidien Reports Fourth-Quarter and Fiscal 2014 Results ................................................................................. 119

Nov 04, 2014: CASMED Announces Third Quarter 2014 Financial Results ............................................................................... 121

Oct 23, 2014: Arkansas Heart Hospital Upgrades to Masimo SET Pulse Oximetry, Resulting in Significant Reduction in False Alarms and Improved Patient Care and Satisfaction .................................................................................................................. 123

Oct 23, 2014: RESMED Announces Results for the First Quarter of Fiscal Year 2015 .............................................................. 124

Oct 23, 2014: Utah Medical Products Reports Financial Performance for Third Quarter 2014 ................................................... 125

Oct 14, 2014: Retrospective Study of Enhanced Recovery After Surgery Program for Patients Undergoing Colorectal Surgery, Which Included Fluid Therapy Tailored to Masimo's PVI, Showed Reduced Length of Stay and Cost Savings ......................... 127

Oct 10, 2014: Covidien To Lay off About 160 Employees........................................................................................................... 128

Oct 09, 2014: Covidien Secures FDA 510(k) Approval For Nellcor Portable SpO2 Patient Monitoring System ......................... 128

Oct 09, 2014: Covidien Announces U.S. Food and Drug Administration 510(k) Clearance for Nellcor Portable SpO2 Patient Monitoring System ...................................................................................................................................................................... 129

Oct 02, 2014: Philips to appeal verdict in patent infringement lawsuit in the US ......................................................................... 129

Sep 29, 2014: Aerocrine and Microsoft collaborate to test secure, cloud-based remote medical device monitoring .................. 130

Sep 29, 2014: ResMed and Brightree Strengthen Integrated Sleep Compliance Management Capabilities .............................. 130

Sep 25, 2014: Masimo Announces MX-5 OEM Circuit Board, Offering Breakthrough rainbow Pulse CO-Oximetry Measurements at 250mW ................................................................................................................................................................................... 131

Sep 25, 2014: Phoenix Grants AccessClosure Emerging Growth Company Award ................................................................... 132

Sep 23, 2014: Terumo Cardiovascular Group to Distribute Nonin Medical‘s SenSmart Model X-100 Universal Oximetry System in U.S. Cardiovascular Hospitals ................................................................................................................................................ 132

Sep 19, 2014: Masimo PVI Helped Assess Fluid Responsiveness in Clinical Study of Adult, Noncardiac Patients ................... 133

Sep 11, 2014: Michael C. Kaufmann to Become Chief Financial Officer of Cardinal Health; Jon Giacomin to Lead Pharmaceutical Segment ............................................................................................................................................................ 134

Sep 09, 2014: MGC Diagnostics Reports 2014 Third Quarter Operating Results ...................................................................... 134

Sep 04, 2014: Yale-New Haven Hospital Upgrades to Masimo SET Pulse Oximetry for Improved Patient Outcomes .............. 136

Sep 02, 2014: Canada's Lawson Health Research Institute Investigates Groundbreaking New Technology to Monitor Cerebral Blood Flow in Cardiac Surgery Patients...................................................................................................................................... 137

Aug 28, 2014: Nonin Medical Announces FDA Clearance of Nonin Model 3231 USB Pulse Oximeter ...................................... 137

Aug 22, 2014: New Clinical Study Evaluates Masimo RAM Technology for Tracking Changes in Respiratory Rate in Anesthetized Patients ................................................................................................................................................................. 138

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Aug 20, 2014: OBS Medical Awarded a SBRI Healthcare Development Contract ..................................................................... 138

Aug 20, 2014: Covidien Opens Advanced Medical Technology Center in Brazil ........................................................................ 139

Aug 18, 2014: ResMed's New AirSense 10 CPAP and APAP Devices Deliver Superior Patient Comfort and Cost-Saving Efficiency for Healthcare Providers ............................................................................................................................................. 140

Aug 12, 2014: FDA Issues Warning Letter To Masimo ............................................................................................................... 141

Aug 11, 2014: Fred's And Cardinal Health Announce Primary Supply Agreement ..................................................................... 141

Aug 06, 2014: CASMED Announces Second Quarter 2014 Financial Results ........................................................................... 141

Aug 05, 2014: Otsuka Welfare Clinic for Refugees in Pakistan Awarded Foreign Minister‘s Commendation ............................. 143

Aug 04, 2014: Cardinal Health Reports Fourth-Quarter And Fiscal Year Results, Provides Fiscal 2015 Outlook ...................... 143

Jul 31, 2014: RESMED Announces Results for the Fourth Quarter and Fiscal Year 2014 ......................................................... 144

Jul 25, 2014: Covidien Reports Third-Quarter Fiscal 2014 Results ............................................................................................ 146

Jul 24, 2014: Aerocrine Interim report January– June 2014 ....................................................................................................... 147

Jul 24, 2014: Utah Medical Products Reports Financial Performance for Second Quarter 2014 ................................................ 148

Jul 24, 2014: 'Women in Pharmacy' Program Seeks to Expand Pharmacy Ownership .............................................................. 151

Jul 23, 2014: Nonin Medical Announces that Mark VanderWerf has been Elected Chairman of the American Telemedicine Association's Industry Council .................................................................................................................................................... 151

Jul 02, 2014: New clinical review gives practising physicians‘ recommendations for how to use Aerocrine‘s FeNO-test in routine clinical practice ........................................................................................................................................................................... 152

Jul 01, 2014: Two Longtime Leaders in Home Care Announce New Parent Holding Company ................................................. 153

Jun 27, 2014: Masimo Announces Support for the Every Newborn Action Plan to Reduce Global Newborn Mortality .............. 153

Jun 25, 2014: Cardinal Health Introduces New Tools to Help Community Pharmacies Prevent Heart Disease, Improve Patients‘ Cardiovascular Health................................................................................................................................................................. 154

Jun 18, 2014: New Study of Masimo Noninvasive and Continuous SpHb Monitoring Demonstrates Accuracy and Utility in Double-Jaw Surgery ................................................................................................................................................................... 155

Jun 15, 2014: Clinical Trials Success Drives Growth .................................................................................................................. 156

Jun 12, 2014: Aerocrine Announces Leadership Changes ......................................................................................................... 156

Jun 12, 2014: MGC Diagnostics Reports 2014 Second Quarter Operating Results ................................................................... 156

Jun 12, 2014: Covidien To Move Positions From Boulder To Indiana In US .............................................................................. 158

Jun 11, 2014: Cardinal Health CFO Jeffrey Henderson To Retire At End Of Fiscal Year 2015 .................................................. 158

Jun 11, 2014: Humana and UC San Diego Health System Partner to Launch Accountable Care Agreement in Southern California ..................................................................................................................................................................................... 158

Jun 11, 2014: Aerocrine Announces Management Changes ...................................................................................................... 159

Jun 04, 2014: Cardinal Health Launches Medication Therapy Management Solution to Make it Easier for Retail Pharmacies to Improve Patient Medication Adherence and Outcomes .............................................................................................................. 160

Jun 04, 2014: ITC Judge Rules APEX Infringes ResMed Patents .............................................................................................. 161

May 29, 2014: Masimo Announces CE Mark of iSpO2 Rx Pulse Oximeter for Mobile Devices .................................................. 161

May 22, 2014: Covidien Releases Two-Year Study Results Demonstrating Sustained Effectiveness of Drug-Coated Angioplasty Balloon Technology .................................................................................................................................................................... 162

May 20, 2014: MGC Diagnostics Announces Executive Management Changes ........................................................................ 163

May 19, 2014: Pulmonx Announces First Comprehensive Report of Collateral Ventilation Assessed by the Chartis Endobronchial Catheter in Late Stage Emphysema ................................................................................................................... 164

May 19, 2014: Covidien Teams with National Association of Community Health Centers on Grants to Organizations in Medically Underserved Communities ......................................................................................................................................................... 164

May 15, 2014: New Study Shows Masimo SET Pulse Oximetry Helps Yale-New Haven Children's Hospital Significantly Reduce Retinopathy of Prematurity in Newborns..................................................................................................................................... 165

May 07, 2014: Covidien Opens Advanced Medical Training and Research Center in Turkey .................................................... 166

May 01, 2014: CASMED Announces First Quarter 2014 Financial Results ................................................................................ 167

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May 01, 2014: Cardinal Health Reports Fiscal 2014 Third-Quarter Results ............................................................................... 168

Apr 30, 2014: U.S. Veteran's Administration Selects Nonin Medical's PalmSAT 2500A Handheld Pulse Oximeter for VA Hospitals ..................................................................................................................................................................................... 169

Apr 25, 2014: Covidien Reports Second-Quarter Fiscal 2014 Results ....................................................................................... 169

Apr 24, 2014: Utah Medical Products Reports Financial Performance for First Quarter 2014 .................................................... 171

Apr 24, 2014: Cardinal Health Expands Lab Portfolio to include Hematology Capital Equipment .............................................. 173

Apr 23, 2014: Resmed Announces Record Financial Results For The Quarter Ended And Nine Months Ended March 31, 2014 .................................................................................................................................................................................................... 173

Apr 23, 2014: BMC Wins in a Patent Invalidity Case Against ResMed ....................................................................................... 174

Apr 08, 2014: ResMed Drops Infringement Allegations Against BMC and 3B ............................................................................ 174

Apr 07, 2014: New Clinical Study Shows Masimo PVI Helps Clinicians Optimize Fluid Administration in Patients Under Combined General and Epidural Anesthesia .............................................................................................................................. 175

Appendix ........................................................................................................................................................................................ 176

Methodology ................................................................................................................................................................................... 176

About GlobalData ........................................................................................................................................................................... 178

Disclaimer ....................................................................................................................................................................................... 178

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List of Tables

Respiratory Measurement Devices - Pipeline Products by Stage of Development .......................................................................... 13

Respiratory Measurement Devices - Pipeline Products by Segment ............................................................................................... 14

Respiratory Measurement Devices - Pipeline Products by Territory ................................................................................................ 15

Respiratory Measurement Devices - Pipeline Products by Regulatory Path .................................................................................... 16

Respiratory Measurement Devices - Pipeline Products by Estimated Approval Date ...................................................................... 17

Respiratory Measurement Devices - Ongoing Clinical Trials ............................................................................................................ 18

Respiratory Measurement Devices Companies - Pipeline Products by Stage of Development ....................................................... 19


Advanced Circulatory Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview ............................................................ 23

CirQlator Intrathoracic Pressure Regulator - Pediatric Version - Product Status .............................................................................. 23

CirQlator Intrathoracic Pressure Regulator - Pediatric Version - Product Description ...................................................................... 24

Aerocrine AB Pipeline Products & Ongoing Clinical Trials Overview ............................................................................................... 25

NIOX VERO - Product Status ........................................................................................................................................................... 25

NIOX VERO - Product Description ................................................................................................................................................... 26

NIOX VERO - Home-treatment Monitoring Device - Product Status ................................................................................................ 26

NIOX VERO - Home-treatment Monitoring Device - Product Description......................................................................................... 26

Anaxsys Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview .............................................................................. 27

respiR8 - Product Status .................................................................................................................................................................. 27

respiR8 - Product Description ........................................................................................................................................................... 28

Arizona State University Pipeline Products & Ongoing Clinical Trials Overview .............................................................................. 29

Wireless Capnography Device - Product Status ............................................................................................................................... 29

Wireless Capnography Device - Product Description ....................................................................................................................... 30

Biospeech, Inc. Pipeline Products & Ongoing Clinical Trials Overview ............................................................................................ 31

Sleep Disordered Breathing Detection System - Product Status ...................................................................................................... 31

Sleep Disordered Breathing Detection System - Product Description .............................................................................................. 31

Cambridge Consultants Limited Pipeline Products & Ongoing Clinical Trials Overview ................................................................... 32

Breathe - Product Status .................................................................................................................................................................. 32

Breathe - Product Description .......................................................................................................................................................... 32

CAS Medical Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview ......................................................................... 33

FORE-SIGHT ELITE - Pediatric And Neonatal Patients - Product Status ........................................................................................ 33

FORE-SIGHT ELITE - Pediatric And Neonatal Patients - Product Description ................................................................................ 34

City University London Pipeline Products & Ongoing Clinical Trials Overview ................................................................................. 35

Fibre-Optic Sensor - Product Status ................................................................................................................................................. 35

Fibre-Optic Sensor - Product Description ......................................................................................................................................... 35

Dartmouth College Pipeline Products & Ongoing Clinical Trials Overview ....................................................................................... 36

Non-Invasive pO2 Measurement Device - Product Status ............................................................................................................... 36

Non-Invasive pO2 Measurement Device - Product Description ........................................................................................................ 36

Ecole Polytechnique de Montreal Pipeline Products & Ongoing Clinical Trials Overview ................................................................ 37

Microsystem – Respiratory Parameters - Product Status ................................................................................................................. 37

Microsystem – Respiratory Parameters - Product Description ......................................................................................................... 37

Feather Sensors, LLC Pipeline Products & Ongoing Clinical Trials Overview .................................................................................. 38

Breath Gauge - Product Status ........................................................................................................................................................ 38

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Breath Gauge - Product Description ................................................................................................................................................. 38

Flashback Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview ...................................................................... 39

CipherOx - Product Status ................................................................................................................................................................ 39

CipherOx - Product Description ........................................................................................................................................................ 39

Fluorometrix Corporation Pipeline Products & Ongoing Clinical Trials Overview ............................................................................. 40

tcpO2/tcpCO2 Respiration Monitor - Product Status ........................................................................................................................ 40

tcpO2/tcpCO2 Respiration Monitor - Product Description ................................................................................................................ 40

GE Global Research Pipeline Products & Ongoing Clinical Trials Overview .................................................................................... 41

EIT Lung Function Monitoring System - Product Status ................................................................................................................... 41

EIT Lung Function Monitoring System - Product Description ........................................................................................................... 41

iHealth Lab Inc Pipeline Products & Ongoing Clinical Trials Overview ............................................................................................. 42

Wristworn Pulse Oximeter Device - Product Status ......................................................................................................................... 42

Wristworn Pulse Oximeter Device - Product Description .................................................................................................................. 42

Koronis Biomedical Technologies Corporation Pipeline Products & Ongoing Clinical Trials Overview ............................................ 43

Home-Based Spirometer Device - Product Status ........................................................................................................................... 43

Home-Based Spirometer Device - Product Description .................................................................................................................... 44

Low Power Wireless Pulse Oximeter Sensor - Product Status ......................................................................................................... 44

Low Power Wireless Pulse Oximeter Sensor - Product Description ................................................................................................. 44

Ultrasonic Spirometer - Home Monitoring of Asthma - Product Status ............................................................................................. 45

Ultrasonic Spirometer - Home Monitoring of Asthma - Product Description ..................................................................................... 45

Lionsgate Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview ........................................................................ 46

Kenek O2 Pulse Oximeter - Product Status ..................................................................................................................................... 46

Kenek O2 Pulse Oximeter - Product Description .............................................................................................................................. 46

Masimo Corporation Pipeline Products & Ongoing Clinical Trials Overview .................................................................................... 47

iSpO2 - Professional Version - Product Status ................................................................................................................................. 47

iSpO2 - Professional Version - Product Description ......................................................................................................................... 48

O3 Regional Oximetry - Product Status ........................................................................................................................................... 48

O3 Regional Oximetry - Product Description .................................................................................................................................... 48

Rainbow Universal ReSposable SuperSensor - Product Status ....................................................................................................... 49

Rainbow Universal ReSposable SuperSensor - Product Description ............................................................................................... 49

RRp - Product Status ....................................................................................................................................................................... 50

RRp - Product Description ................................................................................................................................................................ 50

SpfO2 - Product Status..................................................................................................................................................................... 50

SpfO2 - Product Description ............................................................................................................................................................. 51

NanoVation-GS Pipeline Products & Ongoing Clinical Trials Overview ........................................................................................... 52

Stick-on Patch - Product Status ........................................................................................................................................................ 52

Stick-on Patch - Product Description ................................................................................................................................................ 52

Neetour Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview .................................................................................... 53

Capno-Pulse - Product Status .......................................................................................................................................................... 53

Capno-Pulse - Product Description .................................................................................................................................................. 53

Nicrem S.r.l. Pipeline Products & Ongoing Clinical Trials Overview ................................................................................................. 54

NICRem Baby - Product Status ........................................................................................................................................................ 54

NICRem Baby - Product Description ................................................................................................................................................ 54

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Respiratory Holter - COPD - Product Status .................................................................................................................................... 55

Respiratory Holter - COPD - Product Description ............................................................................................................................. 55

Respiratory Holter - Heart Disease - Product Status ........................................................................................................................ 55

Respiratory Holter - Heart Disease - Product Description ................................................................................................................ 56

SERIES 100 - Product Status ........................................................................................................................................................... 56

SERIES 100 - Product Description ................................................................................................................................................... 56

North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview ................................................................... 57

VitalFlo - Product Status ................................................................................................................................................................... 57

VitalFlo - Product Description ........................................................................................................................................................... 58

Wearable Sleep Monitoring Device - Product Status ........................................................................................................................ 58

Wearable Sleep Monitoring Device - Product Description ................................................................................................................ 58

Oxitone Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview ..................................................................................... 59

OxiTone Device - Product Status ..................................................................................................................................................... 59

OxiTone Device - Product Description ............................................................................................................................................. 59

PneumaCare Ltd. Pipeline Products & Ongoing Clinical Trials Overview......................................................................................... 60

PneumaScan - Product Status ......................................................................................................................................................... 60

PneumaScan - Product Description ................................................................................................................................................. 61

Thora-3DI - Product Status ............................................................................................................................................................... 61

Thora-3DI - Product Description ....................................................................................................................................................... 62

PneumaCare Ltd. - Ongoing Clinical Trials Overview ...................................................................................................................... 63

Thora-3DI - Thora-3Di Respiratory Rate Validation .......................................................................................................................... 63

Princeton University Pipeline Products & Ongoing Clinical Trials Overview ..................................................................................... 64

Exhaled Nitric Oxide Analyzer - Product Status ............................................................................................................................... 64

Exhaled Nitric Oxide Analyzer - Product Description ........................................................................................................................ 64

Sheffield Hallam University Pipeline Products & Ongoing Clinical Trials Overview .......................................................................... 65

4FA Respiration Monitor - Product Status ........................................................................................................................................ 65

4FA Respiration Monitor - Product Description ................................................................................................................................ 66

Sparo Labs Pipeline Products & Ongoing Clinical Trials Overview .................................................................................................. 67

Sparo Spirometer - Product Status ................................................................................................................................................... 67

Sparo Spirometer - Product Description ........................................................................................................................................... 67

Stellenbosch University Pipeline Products & Ongoing Clinical Trials Overview ............................................................................... 68

Artificial Pulse Oximeter - Product Status ......................................................................................................................................... 68

Artificial Pulse Oximeter - Product Description ................................................................................................................................. 68

Flow Volume Meter - Product Status ................................................................................................................................................ 69

Flow Volume Meter - Product Description ........................................................................................................................................ 69

Mobile Spirometer - Product Status .................................................................................................................................................. 69

Mobile Spirometer - Product Description .......................................................................................................................................... 70

Thoracic Medical Systems Inc. Pipeline Products & Ongoing Clinical Trials Overview .................................................................... 71

tremoFlo C-100 - Product Status ...................................................................................................................................................... 71

tremoFlo C-100 - Product Description .............................................................................................................................................. 71

Tufts University Pipeline Products & Ongoing Clinical Trials Overview ............................................................................................ 72

Noninvasive Absolute Brain Tissue Oximeter - Product Status ........................................................................................................ 72

Noninvasive Absolute Brain Tissue Oximeter - Product Description ................................................................................................ 72

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University of British Columbia Pipeline Products & Ongoing Clinical Trials Overview ...................................................................... 73

Camera Oximeter - Product Status .................................................................................................................................................. 73

Camera Oximeter - Product Description ........................................................................................................................................... 73

University of California, Berkeley Pipeline Products & Ongoing Clinical Trials Overview ................................................................. 74

Pulse Oximeter Sensor - Product Status .......................................................................................................................................... 74

Pulse Oximeter Sensor - Product Description .................................................................................................................................. 74

University of California, Davis Pipeline Products & Ongoing Clinical Trials Overview ...................................................................... 75

Pediatric Asthma Monitor - Product Status ....................................................................................................................................... 75

Pediatric Asthma Monitor - Product Description ............................................................................................................................... 75

University of California, San Diego Pipeline Products & Ongoing Clinical Trials Overview .............................................................. 76

Portable Hand Held Alveolar Oxygen And Carbon Dioxide Meter - Product Status ......................................................................... 76

Portable Hand Held Alveolar Oxygen And Carbon Dioxide Meter - Product Description ................................................................. 76

University of Nebraska Omaha Pipeline Products & Ongoing Clinical Trials Overview .................................................................... 77

COPD Detection Platform - Product Status ...................................................................................................................................... 77

COPD Detection Platform - Product Description .............................................................................................................................. 77

University of Oxford Pipeline Products & Ongoing Clinical Trials Overview ..................................................................................... 78

Breath-by-breath Respiratory Gas Analyser - Product Status .......................................................................................................... 78

Breath-by-breath Respiratory Gas Analyser - Product Description .................................................................................................. 78

University of Washington Pipeline Products & Ongoing Clinical Trials Overview ............................................................................. 79

SpiroSmart - Product Status ............................................................................................................................................................. 79

SpiroSmart - Product Description ..................................................................................................................................................... 79

Wipox LLC Pipeline Products & Ongoing Clinical Trials Overview ................................................................................................... 80

WiPOX - Product Status ................................................................................................................................................................... 80

WiPOX - Product Description ........................................................................................................................................................... 80

Xhale, Inc. Pipeline Products & Ongoing Clinical Trials Overview .................................................................................................... 81

Assurance Multi-sense Sensor - Product Status .............................................................................................................................. 81

Assurance Multi-sense Sensor - Product Description ...................................................................................................................... 81

Respiratory Oximeter - Product Status ............................................................................................................................................. 82

Respiratory Oximeter - Product Description ..................................................................................................................................... 82

Glossary ......................................................................................................................................................................................... 177

List of Figures


Respiratory Measurement Devices - Pipeline Products by Segment ............................................................................................... 14

Respiratory Measurement Devices - Pipeline Products by Territory ................................................................................................ 15

Respiratory Measurement Devices - Pipeline Products by Regulatory Path .................................................................................... 16

Respiratory Measurement Devices - Pipeline Products by Estimated Approval Date ...................................................................... 17

Respiratory Measurement Devices - Ongoing Clinical Trials ............................................................................................................ 18

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Introduction

Respiratory Measurement Devices Overview

This category includes devices that are used to measure pressure, flow and volume in a patient's airway and lungs. The category

also covers devices used to measure oxygen saturation in the blood. These are further segmented into pulse oximeter systems,

capnographs and spirometers. The category does not include peak flow meters.

• Capnograph

Capnography devices monitor and record the carbon dioxide concentration in exhaled respiratory gases by analysing the

extent of Infrared absorption. Capnographs include monitors and sensors. One unit is one Capnograph.

• Pulse Oximeter Systems

The pulse oximeter system is a photoelectric instrument for measuring the oxygen saturation of blood. Hand held pulse

oximeters, table top pulse oximeters and pulse oximeter sensors are included here.

Hand Held Pulse Oximeters

A hand held pulse oximeter is a portable, light weight pulse oximeter for point of care checking of blood oxygen saturation.

It works on a battery and electronically displays results. One unit is one handheld oximeter.

Pulse Oximeter Sensors

A pulse oximeter sensor is an integral part of the pulse oximeter used to detect oxygen saturation in the patient's blood. It

consists of a sensor and a lead, usually attachable to the patient‘s finger tip. One unit is one oximeter sensor.

Table Top Pulse Oximeters

The table top pulse oximeter is a bulky version of the portable system. Its main features include audio and visual alarms

for oxygen saturation and pulse rate monitoring, a pulse tone with variable pitch and digital signal processing for accurate

reading. One unit is one Table top Oximeter.

• Spirometers

A spirometer is a device used to assess lung function in terms of the rate and amount of air that is breathed in and out

over a specified period of time. These devices usually come in various sizes like portable and table top spirometers. This

category covers only table top spirometers. One unit is one spirometer.

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Products under Development

Respiratory Measurement Devices - Pipeline Products by Stage of Development


Source: Primary and Secondary Research, GlobalData

As of April, 2015


Stage Of Development Number of Products

Early development

Pre-Clinical

Clinical

Approved

In Approval Process

Source: Primary / Secondary Research, GlobalData

As of April, 2015

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Respiratory Measurement Devices - Pipeline Products by Segment


Pipeline Products by Segment n=54


As of April, 2015


Category Name Number of Products

Pulse Oximeter Systems

Spirometers

Pulse Oximeter Sensors

Hand Held Pulse Oximeters

Capnograph


As of April, 2015

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Respiratory Measurement Devices - Pipeline Products by Territory



As of April, 2015


Territory Number of Products

United States

Global

Europe

China

Japan


As of April, 2015

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Respiratory Measurement Devices - Pipeline Products by Regulatory Path



As of April, 2015


Regulatory Path Number of Products

510(k)

CE

IMDRC

Ninsho


As of April, 2015

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Appendix

The data and analysis within this report is driven by GlobalData.

GlobalData gives you key information to drive sales, investment and deal making activity in your business.

Our coverage includes 200,000 + reports on 185,000+ companies (including 150,000+ private) across 200+ countries and 29

industries. The key industries include Alternative Energy, Oil & Gas, Clean Technology, Technology and Telecommunication,

Pharmaceutical and Healthcare, Power, Financial Services, Chemical and Metal & Mining.

Methodology

GlobalData company reports are based on a core set of research techniques which ensure the best possible level of quality and

accuracy of data. The key sources used include:

• Company Websites

• Company Annual Reports

• SEC Filings

• Press Releases

• Proprietary Databases

Taxonomy:

GlobalData has developed an industry-leading four tier (market, category, segment, subsegment) medical devices taxonomy. The

taxonomy is both comprehensive and constantly updated ensuring data quality. The report published is a category based report

where the product taxonomy vary from category level to sub-segment level.

Origination:

GlobalData‘s pipeline products and clinical trials data is built using information and data from a number of important sources based

on both internal and external sources to develop a comprehensive and robust view of the medical devices market.

Secondary Research:

Extensive secondary research is done to gather data specific to the pipeline products and clinical trials. We track medical devices

that are in development related to nearly 18 markets (ie, cardiovascular devices, dental devices etc) that we cover.

GlobalData conducts extensive research to gather data specific to pipeline products (product status, current stage of development,

product description, technology and estimation timelines of medical devices) and clinical trials. Hundreds of medical specific live

news sources are monitored on a daily basis.

Primary Research:

Primary research is conducted to validate the product status, stage of development and estimated timelines.

GlobalData‘s pool of primary research candidates for the pipeline products enquiries includes marketing / product managers, R&D

director, sales director and key person involving with regulatory process.

Updates:

All pipeline products are updated at least once in a quarter. Products are updated through secondary research sources such as

live news, press releases, company websites, presentations, sec filings, transcripts etc.

GlobalData uses an in house template to estimate product approval date and product launch date in case if data is not obtained

either through secondary or primary research. The template uses various parameters (pipeline territory (region), device class,

stage of development, product source date) to analyze and estimate the product approval/launch date.

A wide range of factors are considered while estimating timelines for the medical devices.

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Notes

• Financial information for the company is taken from the most recently published annual reports or SEC filings

• The number of products mentioned in various graphs can be inconsistent due to plotting of different fields

• Pipeline Products by Stage of Development Graph - Displays exact count of pipeline products

• Pipeline Products by Segment Graph - Products tagged directly to sector is not included but its sub-level tagging is shown

• Pipeline Products by Territory Graph - Displays count of all multiple territories tagged to pipeline products

• Pipeline Products by Regulatory Path Graph - Displays only count of territories for which Regulatory Path is defined

• Pipeline Products by Estimated Approval Date Graph - Displays count of all estimated approval dates tagged to multiple

territories

• Only the below mentioned status of Clinical trials are included in the report specific to the pipeline products:

Ongoing, Recruiting

Ongoing, not Recruiting

Ongoing, Recruiting by invitation

Ongoing, not yet recruiting

• Recent Development section covers news posted during last six months

• GlobalData considers regulatory approved (Approved and Issued) products as pipeline in case products are yet to launch in the

market.

Glossary

Field Name Definition

Product Name Indicates product name

Developed By Provides information of the company which develops the

product

Product Description Provides information on product (What is the condition, where

it will be used, benefits, technical specifications etc)

Indication Provides information on the therapeutic or diagnostic

conditions where the product is used

Application Indicates the procedure or intervention for which the selected

product is used

Device Class Provides product class information based on their design

complexity, characteristics and risk factors i.e. Class I, II and

III

Highest Stage of Development/Development stage Provides information on the developmental status e.g. early

development, pre-clinicals, clinical, in approval process

Territory A geographic region where the product is currently in pipeline

or will be commercially launched

Estimated Approval Date Provides information on expected product approval date

Market Category/Equipment Type Indicates the classification of a medical device based on

therapy area and application

Regulatory Path Regulatory process through which the product gets marketing

approval by respective regulatory agency

Technology Indicates the core technology used in product

Function Provides information about the mechanism of action of the

device

Early Development Defined when a product is in prototype or design stage of

development

Pre Clinical Defined when a product is tested in animals

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Clinical Defined when a product is tested in humans for the safety and

efficacy of the device

In Approval Process Defined when a product is filed for approval with regulatory

body for approval of the product

Issued Defined when a product receives regulatory approval from

European Union

Approved Defined when a product receives regulatory approval from a

country other than Europe

Planned (Ongoing, not yet Recruiting) The participants are not yet to be recruited or enrolled for the

study

Ongoing, Recruiting The participants are currently being recruited or enrolled for

the study

Ongoing, not Recruiting The study is still ongoing. The patients are being treated or

examined or study results are being analyzed for its

endpoints. But enrollment for the study stands completed

Ongoing, Recruiting by invitation The participants are being (or will be) selected from a

predetermined population (as decided in advance by the

researchers)

Global (Pipeline territory) If source does not indicate any specific country as pipeline

region, then Global is added as the pipeline territory


As of April, 2015

About GlobalData

GlobalData is one of the world‘s leading providers of company operational data and strategic analysis, providing detailed

information on tens of thousands of companies globally. Our highly qualified team of Analysts, Researchers, and Solution

Consultants use proprietary data sources and various tools and techniques to gather, analyze and represent the latest and the

most reliable information essential for businesses to sustain a competitive edge. Data is continuously updated and revised by large

teams of research experts, so that it always reflects the latest events and information. With a large dedicated research and

analysis capability, GlobalData employs rigorous primary and secondary research techniques in developing unique data sets and

research material for this series and its other reports. GlobalData offers comprehensive geographic coverage across world‘s most

important sectors, focusing particularly on energy and healthcare.

Disclaimer

All Rights Reserved

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic,

mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData

The data and analysis within this report is driven by GlobalData from its own primary and secondary research of public and

proprietary sources and does not necessarily represent the views of the company profiled SAMPLE

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