Opportunities in U.S. Pulmonary Device Markets

Companies Covered

AirSep Corporation

Covidien Ltd

DeVilbiss Healthcare

Fisher & Paykel Healthcare Corporation Ltd

Flaga Group hf

Hill-Rom (Hillenbrand Industries, Inc.)

Invacare Corporation

Medical Graphics Corporation/Angeion

nSpire Health, Inc

Olympus America, Inc

ResMed, Inc

Respironics, Inc

Viasys Healthcare, Inc

Table of Contents

Executive Summary

Major Pulmonary Diseases

Non-Sleep Pulmonary Diagnostic Technologies

Non-Sleep Device-Based Pulmonary Therapeutics

Traditional Products

Emerging Technologies

Sleep Apnea Products

Diagnostic Segment

Therapeutics Segment

Suppliers

Summary Exhibit 1: Pulmonary Device Markets by Major Category, 2005-2011

Summary Exhibit 2: Overview of Major Pulmonary Conditions

Summary Exhibit 3: Non-Sleep Pulmonary Diagnostic Technologies, 2005-2011

Summary Exhibit 4: Non-Sleep Pulmonary Therapy Technologies, 2005-2011

Summary Exhibit 5: Emerging Pulmonary Device Therapies, 2008-2015

Summary Exhibit 6: Sleep Apnea Technologies by Category, 2005-2011

1.0 Overview and Epidemiology

1.1 Major Obstructive Pulmonary Diseases

1.1.1 Chronic Obstructive Pulmonary Disease

1.1.1.1 Risk Factors

1.1.1.2 Symptoms

1.1.1.3 Diagnosis and Staging

1.1.1.4 Heterogenous versus Homogenous Emphysema

1.1.1.5 Treatment

1.1.1.6 Prevalence

1.1.1.7 Morbidity and Mortality

1.1.2 Asthma

1.1.2.1 Risk Factors

1.1.2.2 Symptoms

1.1.2.3 Types

1.1.2.4 Diagnosis

1.1.2.5 Severity

1.1.2.6 Treatment

1.1.2.7 Statistics

1.2 Lung Cancer

1.2.1 Risk Factors

1.2.2 Symptoms

1.2.3 Diagnosis

1.2.4 Staging

1.2.5 Treatment

1.2.6 Prognosis

1.2.7 Incidence

1.3 Mechanical Ventilation Patients

1.3.1 Complete Quadriplegia

1.3.2 Amyotrophic Lateral Sclerosis

1.3.3 Intensive Care Patients

1.4 Sleep Apnea

1.4.1 Mechanics of Nocturnal Breathing

1.4.2 Types of Sleep Apnea

1.4.2.1 Obstructive Sleep Apnea

1.4.2.1.1 Pathophysiology

1.4.2.1.2 Diagnosis and Staging

1.4.2.1.3 Risk Factors

1.4.2.2 Central Sleep Apnea

1.4.2.2.1 Pathophysiology

1.4.2.2.2 Risk Factors

1.4.2.3 Complex Sleep Apnea

1.4.3 Prevalence of Sleep Apnea

1.4.4 Associated Comorbidities

1.4.4.1 Diabetes

1.4.4.2 Hypertension

1.4.4.3 Other Cardiovascular Disorders

1.4.4.4 Daytime Sleepiness and Cognitive Dysfunction

1.4.5 Diagnosis

1.4.6 Treatment

1.4.6.1 Positive Airway Pressure Devices

1.4.6.2 Oral Appliances

1.4.6.3 Surgery and Surgical Implants

Exhibit 1-1: Overview of Chronic Obstructive Pulmonary Disease

Exhibit 1-2: Characteristics of Patients Dying with COPD

Exhibit 1-3: Staging of COPD Severity

Exhibit 1-4: Prevalence of COPD by Disease Severity, Patient Forecast, 2005-2011

Exhibit 1-5: Staging of Asthma Severity

Exhibit 1-6: Selected Asthma Statistics

Exhibit 1-7: Overview of Lung Cancer

Exhibit 1-8: Stage Distribution of Lung Cancer by Type at Diagnosis, 1996-2002

Exhibit 1-9: Five-Year Survival Rates by Lung Cancer Type and Stage, 1996-2002

Exhibit 1-10: States With Highest Incidence of Lung Cancer by Sex, 1999-2003

Exhibit 1-11: Ventilator-Dependent Quadriplegics, Patient Forecast, 2005-2011

Exhibit 1-12: Amyotrophic Lateral Sclerosis, New Diagnoses, 2005-2011

Exhibit 1-13: Intensive Care Mechanical Ventilation, Patient Forecast, 2005-2011

Exhibit 1-14: Types of Sleep Apnea

Exhibit 1-15: Risk Factors for Obstructive Sleep Apnea

Exhibit 1-16: Selected Studies of OSA in the General Population

Exhibit 1-17: Obstructive Sleep Apnea (OSA) Prevalence by Severity, 2005-2011

Exhibit 1-18: Central Sleep Apnea (CSA) Prevalence, 2006-2011

Exhibit 1-19: Complex Sleep Apnea (CompSA) Prevalence, 2006-2011

Exhibit 1-20: Selected Studies of Obstructive Sleep Apnea and Type 2 Diabetes

Exhibit 1-21: Selected Studies of Hypertension and Obstructive Sleep Apnea

Exhibit 1-22: Selected Studies of Cardiovascular Disease in OSA Patients

Exhibit 1-23: Selected Studies of OSA and Cognitive Impairment

Exhibit 1-24: Treatment of Sleep Apnea by Type

2.0 Pulmonary Diagnostic Technologies

2.1 Pulmonary Screening Recommendations

2.1.1 Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial

2.1.2 National Lung Screening Trial

2.2 Current Diagnostic Technologies

2.2.1 Spirometry

2.2.1.1 Variables Measured

2.2.1.2 Sensing Methods

2.2.1.3 Sites of Use

2.2.1.4 Configurations

2.2.1.4 Technology Trends

2.2.1.5 Suppliers and Products

2.2.1.5 Market Analysis

2.2.2 Pulmonary Function Testing Systems

2.2.2.1 Tests and Measurements

2.2.2.3 Technology Trends

2.2.2.4 Products and Supliers

2.2.2.5 Market Analysis

2.2.3 Bronchoscopy

2.2.3.1 Physicians and Labs

2.2.3.2 Products

2.2.3.3 Technology Trends

2.2.3.3.1 Autofluorescence Bronchoscopy

2.2.3.3.2 Optical Coherence Tomography

2.2.3.3.3 Endobronchial Ultrasonography

2.2.3.3.4 Electromagnetic Navigation Bronchoscopy

2.2.3.4 Procedures

2.2.3.5 Market Analysis

2.3 Emerging Diagnostic Technologies

2.3.1 Digital Chest X-Rays

2.3.2 Computer-Aided Detection

2.3.2.1 Clinical Goals

2.3.2.2 Protocols

2.3.2.3 Current Barriers to Use

2.3.2.4 Clinical Experience

2.3.2.5 Suppliers

2.3.2.5.1 CAD Sciences/Saphenia LLC

2.3.2.5.2 EDDA Technology

2.3.2.5.3 GE Healthcare

2.3.2.5.4 Hologic/R2 Technology

2.3.2.5.5 Infinnitt

2.3.2.5.6 Kodak Health Group

2.3.2.5.7 Median Technologies

2.3.2.5.8 Merge Healthcare

2.3.2.5.9 MGT Capital/Medicsight

2.3.2.5.10 Philips Medical Systems

2.3.2.5.11 Riverain Medical

2.3.2.5.12 Siemens Medical Solutions

2.3.2.6 Market Analysis

2.3.3 New Imaging Technologies

2.3.3.1 Deep Breeze Medical

2.3.3.2 Vital Images

2.3.3.3 Market Analysis

2.4 Sleep Apnea Diagnosis

2.4.1 Referral Pathways

2.4.2 Evaluations

2.4.3 Diagnostic Protocol

2.4.3.1 Scoring the Severity of Sleep Apnea

2.4.3.2 Titration, Split-Night Sleep & Follow-Up Studies

2.4.3.3 Home-Based Diagnosis and Unattended Studies

2.4.4 Diagnostic Technologies

2.4.4.1 PSG Technologies

2.4.4.2 Non-PSG Technologies

2.4.5 Trends in Sleep Diagnostics

2.4.5.1 Home Diagnosis

2.4.5.2 Sleep Labs

2.4.6 Products and Suppliers

2.4.6.1 Advanced Brain Monitoring

2.4.6.2 Bio-Logic Systems (Natus Medical)

2.4.6.3 Compumedics

2.4.6.4 Covidien

2.4.6.5 Embla (Flaga Group)

2.4.6.6 Grass Technologies (Astro-Med)

2.4.6.7 Nihon Kohden America

2.4.6.8 Respironics

2.4.6.9 Viasys Healthcare

2.4.7 Market Analysis

2.4.7.1 PSG Technologies

2.4.7.2 Non-PSG Technologies

2.4.7.3 Supplier Shares

Exhibit 2-1: Selected Diagnostic Spirometers, 2007

Exhibit 2-2: Spirometry Products, Market Forecast, 2005-2011

Exhibit 2-3: Spirometry Products, Market Forecast by Segment, 2005-2011

Exhibit 2-4: Spirometry Products, Supplier Shares, 2006

Exhibit 2-5: Comparison of Obstructive and Restrictive Pulmonary Disease

Exhibit 2-6: Selected Pulmonary Function Testing Systems, 2007

Exhibit 2-7: Pulmonary Function Testing Systems, Market Forecast, 2005-2011

Exhibit 2-8: Pulmonary Function Testing Products, Supplier Shares, 2006

Exhibit 2-9: Rigid and Flexible Bronchoscopy

Exhibit 2-10: Selected Flexible Bronchoscopes, 2007

Exhibit 2-11: Selected Emerging Adjunctive Bronchoscopic Technologies, 2007

Exhibit 2-12: Selected Autofluorescence Bronchoscopy Systems, 2007

Exhibit 2-13: Olympus Endobronchial Ultrasound Products

Exhibit 2-14: Comparison of Lung Biopsy Methods

Exhibit 2-15: superDimension Bronchus Electromagnetic Navigation Technology

Exhibit 2-16: Bronchoscopy, Procedure Forecast, 2005-2011

Exhibit 2-17: Flexible Bronchoscopes, Market Forecast, 2005-2011

Exhibit 2-18: Flexible Bronchoscopes, Supplier Shares, 2006

Exhibit 2-19: Selected Approaches to Optimizing Pulmonary Diagnosis, 2007

Exhibit 2-20: Benefits and Limitations of Digital X-Ray Technology

Exhibit 2-21: Major Drivers and Barriers to Adoption of Lung CAD Technology

Exhibit 2-22: Selected Lung Computer-Aided Detection Systems, 2007

Exhibit 2-23: Lung CAD Systems, Market Forecast, 2005-2011

Exhibit 2-24: Lung CAD Systems, Supplier Shares, 2006

Exhibit 2-25: Selected New Lung Imaging Technologies, 2007

Exhibit 2-26: Deep Breeze Medical VRIxp Technology

Exhibit 2-27: Vibration Response Imaging, Market Forecast, 2007-2011

Exhibit 2-28: Epworth Sleepiness Scale

Exhibit 2-29: Severity of Disease by Apnea-Hypopnea Index (AHI)

Exhibit 2-30: Reimbursement for Sleep Studies

Exhibit 2-31: Overview of Sleep Diagnostic Technologies

Exhibit 2-32: Sleep Labs and Beds, Facility Forecast, 2005-2011

Exhibit 2-33: Selected PSG Suppliers and Systems, 2007

Exhibit 2-34: Selected Non-PSG Home Screening and Diagnostic Products, 2007

Exhibit 2-35: Polysomnograph Systems & Accessories, Market Forecast, 2005-2011

Exhibit 2-36: U.S. Market for Non-PSG Diagnostic Products, 2005-2011

Exhibit 2-37: U.S. Sleep Diagnostics, Supplier Shares, 2006

3.0 Pulmonary Disease Therapies

3.1 Drug Therapy

3.1.1 Bronchodilators

3.1.2 Anti-Inflammatory Agents

3.1.3 Other Medications

3.1.4 Emerging Drugs

3.2 Pulmonary Rehabilitation

3.2.1 Therapeutic Goals

3.2.2 Therapeutic Tools

3.3 Oxygen Therapy

3.3.1 Therapeutic Goals

3.3.2 Delivery Modalities

3.3.2.1 Compressed Oxygen

3.3.2.2 Liquid Oxygen Systems

3.3.2.3 Oxygen Concentrators

3.3.3 Oxygen Conserving Devices

3.3.4 Oxygen Concentrator Market Analysis

3.4 Peak Flow Monitoring

3.4.1 Monitoring Process and Readings

3.4.2 Peak Flow Meters

3.4.2.1 Product Trends

3.4.2.2 Products and Suppliers

3.4.3 Market Analysis

3.5 Noninvasive Ventilation

3.5.1 Devices

3.5.2 Clinical Applications

3.5.3 Advantages and Limitations

3.5.4 Market Analysis

3.6 Emerging Pulmonary Therapies

3.5.1 Artificial Lung and Lung Assist Technologies

3.5.1.1 ALung Technologies

3.5.1.2 Haemair

3.5.1.3 MC3/Novalung

3.5.1.4 NovaLung

3.5.1.5 Market Analysis

3.5.2 Bronchial Thermoplasty (Asthmatx)

3.5.2.1 Procedure

3.5.2.2 Clinical Experience

3.5.2.3 Company History

3.5.2.4 Market Forecast

3.5.3 Chest Compression Systems

3.5.3.1 Dymedso

3.5.3.2 Electromed

3.5.3.3 Hill-Rom

3.5.3.4 RespirTech

3.5.3.5 Market Analysis

3.5.4 Diaphragm Pacing (Synapse Biomedical)

3.5.4.1 NeuRx DPS System

3.5.4.2 Clinical Experience

3.5.4.3 Ventilator-Associated Pneumonia Prophylaxis

3.5.4.4 Product Pricing

3.5.4.5 Company History

3.5.4.6 Market Forecast

3.5.5 Lung Volume Reduction

3.5.5.1 Aeris Therapeutics

3.5.5.2 Emphasys Medical

3.5.5.3 Johnson & Johnson Closure Medical

3.5.5.4 Novatech

3.5.5.5 PneumRx

3.5.5.6 Pulmonx

3.5.5.7 Spiration

3.5.5.7.1 VALR System

3.5.5.7.2 Intra-Bronchial Valve (IBV)

3.5.5.8 Uptake Medical

3.5.5.9 Market Forecast

3.5.6 Airway Bypass

3.5.6.1 Broncus Technologies

3.5.6.2 Market Forecast

3.5.7 Shunt Technologies (Rox Medical)

Exhibit 3-1: Overview of Major Treatment Approaches to Pulmonary Disease

Exhibit 3-2: Drug Therapy For Asthma

Exhibit 3-3: Drug Therapy for COPD

Exhibit 3-4: Home Oxygen Therapy Formats

Exhibit 3-5: Selected Oxygen Concentrators, 2007

Exhibit 3-6: Selected Transfilling Systems, 2007

Exhibit 3-7: Oxygen Conserving Technologies and Approaches

Exhibit 3-8: Oxygen Concentrators, Market Forecast by Type, 2005-2011

Exhibit 3-9: Oxygen Concentrators, Supplier Shares, 2006

Exhibit 3-10: Selected Peak Flow Meters, 2007

Exhibit 3-11: Peak Flow Meters, Market Forecast, 2005-2011

Exhibit 3-12: Peak Flow Meters, Supplier Shares, 2006

Exhibit 3-13: Selected Noninvasive Ventilation Technologies, 2007

Exhibit 3-14: Advantages and Limitations of Noninvasive Ventilation

Exhibit 3-15: Noninvasive Ventilation Technologies, Market Forecast, 2005-2011

Exhibit 3-16: Noninvasive Ventilation Products, Supplier Shares, 2006

Exhibit 3-17: Selected Emerging Approaches to Pulmonary Diseases, 2007

Exhibit 3-18: Selected Artificial Lung and Lung Assist Technologies, 2007

Exhibit 3-19: Hattler Respiratory Assist Catheter and HemoLung Console

Exhibit 3-20: Haemair Respiratory Aid and Prosthetic Lung

Exhibit 3-21: MC3/Novalung Biolung Prosthetic Lung

Exhibit 3-22: Novalung Interventional Lung Assist (iLA) Device

Exhibit 3-23: Artificial Lung/Lung Assist Devices, Market Forecast, 2009-2015

Exhibit 3-24: Asthmatx Alair Bronchial Thermoplasty System

Exhibit 3-25: Bronchial Thermotherapy, Patient & Market Forecast, 2009-2015

Exhibit 3-26: Chest Compression Therapy: Indications and Contraindications

Exhibit 3-27: Selected Chest Compression Systems, 2007

Exhibit 3-28: Chest Compression (HFCWO) Systems, Market Forecast, 2005-2011

Exhibit 3-29: Chest Compression Systems, Supplier Shares, 2006

Exhibit 3-30: Synapse Biomedical NeuRx System

Exhibit 3-31: Advantages of Diaphragm Pacing Stimulation

Exhibit 3-32: Diaphragm Pacing, Market Forecast by Application, 2008-2015

Exhibit 3-33: Minimally Invasive Approaches to Lung Volume Reduction Surgery

Exhibit 3-34: Aeris Therapeutics’ Biological Lung Volume Reduction System

Exhibit 3-35: Emphasys Medical Zephyr Endobronchial Valve

Exhibit 3-36: Spiration VALR Compression-Banding Technology

Exhibit 3-37: Spiration Intra-Bronchial Valve (IBV) Technology

Exhibit 3-38: MI LVR Technologies, Market Forecast, 2008-2015

Exhibit 3-39: Broncus Technologies’ Exhale Stent and Airway Bypass Procedure

Exhibit 3-40: Airway Bypass, Patient and Market Forecast, 2012-2015

4.0 Sleep Apnea Therapy

4.1 Rationale for Treatment

4.2 Behavioral Modification

4.3 Inhaled Carbon Dioxide

4.4 Oxygen Therapy

4.5 Positive Airway Pressure

4.5.1 Continuous Positive Airway Pressure

4.5.2 Bi-Level Positive Airway Pressure Generators

4.5.3 Automatic-Adjustable Positive Airway Pressure Generators

4.5.4 Adaptive Servo-Ventilation

4.5.5 Masks and Interfaces

4.5.6 Humidifiers and Accessories

4.5.7 Reimbursement

4.5.8 Trends in Positive Airway Pressure Therapy

4.5.9 Products and Suppliers

4.5.9.1 Covidien

4.5.9.2 DeVilbiss Healthcare

4.5.9.3 Fisher & Paykel Healthcare

4.5.9.4 Invacare

4.5.9.5 ResMed

4.5.9.6 Respironics

4.5.9.7 Viasys Healthcare

4.5.9.8 Vital Signs

4.5.10 Patient Forecast

4.5.11 Market Analysis

4.5.11.1 Market by Patient Type

4.5.11.2 Market by Technology

4.5.12 Supplier Shares

4.6 Oral Appliances

4.6.1 Mandibular Repositioning Appliances

4.6.2 Tongue Retaining Devices

4.6.3 Clinical Experience

4.6.4 Clinical Trials

4.6.5 Products and Suppliers

4.6.6 Patient Forecast

4.6.7 Market Analysis

4.7 Surgery

4.7.1 Palatal Surgeries

4.7.1.1 Uvulopalatopharyngoplasty

4.7.1.2 Thermal Ablation Palatoplasty

4.7.2 Tongue-Base Surgeries

4.7.2.1 Genioglossus Advancement

4.7.2.2 Hyoid Advancement

4.7.2.3 Maxillomandibular Advancement

4.7.2.4 Maxillomandibular Expansion

4.7.2.5 Radiofrequency Tongue-Base Reductions

4.7.3 Combined Surgical Approaches

4.7.4 Other Surgeries

4.7.4.1 Tracheostomy

4.7.4.2 Bariatric Surgery

4.7.5 Clinical Trials

4.7.6 Products and Suppliers.

4.7.6.1 ArthroCare ENT

4.7.6.2 Gyrus ENT

4.7.7 Surgical Implants

4.7.7.1 Apneon

4.7.7.2 Aspire Medical

4.7.7.3 InfluENT Medical

4.7.7.4 Restore Medical

4.7.8 Market Analysis

Exhibit 4-1: Therapies for Sleep-Related Breathing Disorders

Exhibit 4-2: Types of PAP Generators Used to Treat Sleep Apnea

Exhibit 4-3: Replacement Schedule Allowed by Medicare for Accessories, 2007

Exhibit 4-4: Selected Studies Examining the Effectiveness of PAP Therapy

Exhibit 4-5: Selected Studies of Compliance with PAP Therapy

Exhibit 4-6: Selected Positive Airway Pressure Products and Suppliers, 2007

Exhibit 4-7: Selected Studies of ASV in CSA and CompSA Patients

Exhibit 4-8: Positive Airway Pressure Therapy, Patient Forecast, 2005-2011

Exhibit 4-9: U.S. PAP Therapy Market by Patient Type, 2005-2011

Exhibit 4-10: U.S. Market for PAP Flow Generators by Type, 2005-2011

Exhibit 4-11: U.S. PAP Therapy Market by Technology, 2005-2011

Exhibit 4-12: Positive Airway Pressure Supplier Shares, 2005 and 2006

Exhibit 4-13: Overview of Oral Appliances by Type

Exhibit 4-14: Selected Studies of Oral Appliances in Obstructive Sleep Apnea

Exhibit 4-15: Oral Appliance Products and Suppliers, 2007

Exhibit 4-16: Oral Appliances, U.S. Patient Forecast, 2005-2011

Exhibit 4-17: Oral Appliances for OSA, U.S. Market Forecast, 2005-2011

Exhibit 4-18: Overview of Surgical Approaches to Treat Sleep Apnea

Exhibit 4-19: Selected Studies of Palatal Surgeries for OSA

Exhibit 4-20: Selected Studies of Tongue-Base Surgeries for OSA

Exhibit 4-21: Selected Studies of Combined Surgical Approaches for OSA

Exhibit 4-22: ArthroCare’s Coblation Technology

Exhibit 4-23: Surgical Implants for OSA, Products and Suppliers, 2007

Exhibit 4-24: Apneon Prototyope Magnetic Implant

Exhibit 4-25: Aspire Medical’s Advance System

Exhibit 4-26: Restore Medical’s Pillar System

Exhibit 4-27: Selected Studies of the Pillar System for OSA

Exhibit 4-28: U.S. Market for Surgical Implants to Treat OSA, 2005-2011

Exhibit 4-29: U.S. Surgical Implants for OSA, Supplier Shares, 2006

5.0 Company Profiles

5.1 AirSep Corporation

5.2 Covidien Ltd

5.3 DeVilbiss Healthcare

5.4 Fisher & Paykel Healthcare Corporation Ltd

5.5 Flaga Group hf

5.6 Hill-Rom (Hillenbrand Industries, Inc.)

5.7 Invacare Corporation

5.8 Medical Graphics Corporation/Angeion

5.9 nSpire Health, Inc

5.10 Olympus America, Inc

5.11 ResMed, Inc

5.12 Respironics, Inc

5.13 Viasys Healthcare, Inc