| There are 40 million surgical interventions performed annually in the U.S. under general anesthesia. The number of surgical and anesthesia-based interventions both therapeutic and diagnostic is expected to increase as the population ages. There is more than double that number worldwide. EEG processors are poised to be useful in every one of those interventions. Units are positioned to save lives by providing one more way to monitor patient condition. EEG monitoring is of value to the anesthesiologist because it provides direct measurement of brain activity and provides input that cannot be achieved from heart or oxygen saturation level monitoring. A simple automated EEG implemented as a processor monitor permits use and brain wave interpretation in the operating room. Resolution of presentation of information is an essential aspect of systems. Monitoring a patient brain activity during surgery improves patient safety and lowers costs per surgical procedure. Controlling the amount of anesthesia administered during surgeries is a measurable benefit. It reduces the amount of postoperative recovery time required. The electrophysiology of the brain is a center of research. Changes in brain electrophysiologic activity occur during general anesthesia. The EEG seems to provide a direct indication of the patient depth of consciousness as invoked by anesthetic agents. The EEG is the most reliable indicator of excessive administration of anesthesia. The EEG processor medical device industry competition is limited to two major companies. Aspect Medical Systems and Physiometrix are the two companies with working technology for anesthesia. Devices are based on signal processing of the EEG brain waves. Additional competition may come from patient monitoring companies; currently marketing conventional EEG monitors utilizing standard signal-processing techniques such as spectral edge frequency analyses and median frequency analyses. Total worldwide markets for EEG processor and sensors for both surgical and intensive care markets at $51.4 million in 2002 are expected to reach $734.9 by 2008. Table of Contents EEG PROCESSOR MONITOR EXECUTIVE SUMMARY ES-1 Surgical Interventions ES-1 Competitive Factors In The EEG Monitor Market ES-2 EEG Processor Surgery / Anesthesia Market Shares ES-3 EEG Processor Surgical and Intensive Care Market Forecasts ES-5 EEG PROCESSOR MONITOR DYNAMICS AND MARKET DESCRIPTION 1. EEG PROCESSOR MARKET DYNAMICS AND MARKET DESCRIPTION 1-1 1.1 EEG Description 1-1 1.1.1 EEGs As A Broad Based Diagnostic Tool 1-1 1.1.2 Detection Of Abnormalities 1-2 1.2 EEG Procedure 1-2 1.3 Anesthesiologist Objectives 1-5 1.4 Bispectral Index (BIS Index) 1-8 1.5 Administration Of Sedation 1-10 1.6 Surgical Awareness During Monitoring 1-10 1.7 Functional Capacity Evaluations (FCE) 1-10 1.8 Applications For EEG Monitoring In The Operating Theatre 1-11 1.9 Applications For EEG Monitoring In The Intensive Care Unit 1-11 1.10 Brain Responses During Anesthesia 1-12 1.10.1 Monitoring requirements of the American Society of Anesthesiology 1-15 1.10.2 Depth Of Consciousness Monitoring 1-17 1.10.3 Brain 1-19 1.10.4 Processed EEG Monitors 1-19 1.11 Anesthesia Reimbursement 1-21 1.11.1 Third-Party Payors 1-21 EEG PROCESSOR MONITOR MARKET SHARES AND MARKET FORECASTS 2. EEG PROCESSOR MARKET SHARES AND MARKET FORECASTS 2-1 2.1 Surgical and Diagnostic Interventions Performed Under General Anesthesia 2-1 2.1.1 EEG Processor Market Competitive Factors 2-6 2.2 EEG Processor Surgery / Anesthesia Market Shares 2-11 2.2.1 Aspect Medical Systems Group Purchasing Agreements 2-16 2.3 EEG Processor Intensive Care Market Shares 2-18 2.4 EEG Processor Surgery Market Forecasts 2-20 2.4.1 EEG Processor Surgery Market Penetration Forecasts 2-24 2.4.2 EEG Processor Surgery Sensor Market Forecasts 2-25 2.5 EEG Processor Intensive Care Market Forecasts 2-30 2.6 EEG Processor Surgical and Intensive Care Market Forecasts 2-32 2.7 EEG Processor Market Positioning 2-32 2.7.1 Aspect Medical Systems Distribution Agreements 2-33 2.7.2 Aspect Medical Systems Distribution Agreements With Original Equipment Manufacturers 2-33 2.8 EEG Processor International Markets 2-36 2.8.1 Aspect Medical Systems 2-39 2.8.2 Taugagreining / Nervus Monitor 2-40 EEG PROCESSOR MONITOR PRODUCT DESCRIPTIONS 3. EEG PROCESSOR PRODUCT DESCRIPTION 3-1 3.1 EEG Anesthesiology Monitoring Processors 3-1 3.2 Aspect Medical Systems 3-2 3.2.1 Aspect Bi-spectral Index 3-3 3.2.2 A-2000™ BIS Monitor 3-4 3.2.3 A-1050 EEG monitor with Bi-spectral Index Technology 3-4 3.2.4 Aspect Medical Systems BIS XP System 3-7 3.2.5 Aspect Medical Systems A-2000 BIS Monitor 3-7 3.2.6 Aspect Medical Systems BIS Module Kit 3-8 3.2.7 Aspect Medical Systems BIS Module Kit — 4 Channel Support 3-8 3.2.8 Aspect Medical Systems BIS Sensors 3-8 3.2.9 Aspect Medical Systems BIS Pediatric Sensor 3-9 3.2.10 Aspect Medical Systems BIS Quatro Sensor 3-9 3.3 Aspect Medical Systems BIS Sensor Plus 3-10 3.3.1 Aspect Medical Systems BIS Standard Sensor 3-10 3.3.2 Aspect Medical Systems BIS Integrated Systems 3-15 3.3.3 Aspect Medical Systems BIS 3-15 3.4 Physiometrix 3-16 3.4.1 Physiometrix Patient State Analyzer 3-17 3.4.2 Physiometrix PSA 4000 3-17 3.4.3 Physiometrix PSArray2 3-20 3.4.4 Physiometrix Products 3-20 3.4.5 Physiometrix EEG Monitoring Solution 3-22 3.4.6 Physiometrix Proven Electrode Technology 3-25 3.5 ICU Monitoring 3-26 3.5.1 Taugagreining / Nervus Monitor 3-27 3.5.2 Nervus Monitor Unlimited Recording 3-27 3.5.3 Nervus Monitor Brain Hypoxia / Ischemia 3-28 3.5.4 Narcotrend 3-31 EEG PROCESSOR MONITOR TECHNOLOGY 4. EEG PROCESSOR TECHNOLOGY 4-1 4.1 Aspect Medical Systems Technology Positioning 4-1 4.1.1 Aspect Medical Systems BIS Index Technology 4-1 4.2 Clinical Development 4-5 4.2.1 Aspect Medical Systems BIS Index Values During Surgical Procedures 4-8 4.3 Research And Development Efforts Focus 4-9 4.3.1 Aspect Medical Systems Other Product Areas 4-11 4.4 Human Brain 4-15 4.4.1 Aspect Medical Systems Current Initiatives 4-15 4.4.2 Physiometrix Research 4-15 4.4.3 Physiometrix Algorithm Development: 4-16 4.4.4 Physiometrix Algorithm Processing 4-18 4.5 FDA And Foreign Regulatory Approval 4-20 EEG PROCESSOR MONITOR COMPANY PROFILES 5. EEG PROCESSOR COMPANY PROFILES 5-1 5.1 Aspect Medical System 5-1 5.1.1 Aspect Medical System Anesthesia Monitoring System BIS® System 5-1 5.1.2 Aspect Medical System Revenue 5-2 5.1.3 Aspect Medical Systems Revenue 5-4 5.1.4 Aspect Medical Systems Third Quarter Ended September 27, 2003 5-9 5.1.5 Aspect Medical Systems Strategic Alliance with Boston Scientific Corporation 5-11 5.2 Cephalon 5-12 5.3 PhysioMetrics 5-12 5.4 Physiometrix 5-12 5.4.1 Physiometrix Business Strategy 5-13 5.4.2 Physiometrix Strategic Relationship With Baxter 5-14 5.4.3 Physiometrix Outsource Manufacturing 5-14 5.4.4 Physiometrix Revenues 5-14 5.4.5 Physiometrix Positioning 5-16 5.5 Taugagreining / Nervus 5-18 5.5.1 Nervus EEG Continuous Impedance Test 5-19 5.5.2 Nervus EEG Remote Analysis 5-19 5.5.3 Nervus EEG Trends 5-20 5.5.4 Nervus Recorder Key Features 5-21 List of Tables and Figures EEG PROCESSOR MONITOR EXECUTIVE SUMMARY Table ES-1 ES-2 Competitive Factors In The EEG Monitor Market Figure ES-2 ES-4 Worldwide EEG Processor Monitor Anesthesia Market Shares, First Three Quarters, 2003 Table ES-3 ES-6 Worldwide EEG Processor Market Forecasts, Anesthesia and ICU System Shipments, Dollars, 2003-2008 EEG PROCESSOR MONITOR MARKET DYNAMICS AND MARKET DESCRIPTION Table 1-1 1-4 Traditional EEG Procedure Deficiencies Table 1-2 1-5 Traditional EEG Procedure Aspects Table 1-3 1-6 Anesthesiologist Objectives Table 1-4 1-6 Key Elements Of Anesthesia Care Table 1-5 1-7 Anesthesiologist Issues Table 1-6 1-8 Benefits Offered Anesthesiologist By Brain Monitoring Table 1-7 1-13 How EEG Monitoring Works Table 1-8 1-14 EEG monitoring Factors Improving Care And Contributing To Cost Savings In The OR Table 1-9 1-15 Monitoring Requirements Of The American Society of Anesthesiology Table 1-10 1-17 Depth Of Consciousness Monitoring Parameters Table 1-11 1-18 Depth Of Consciousness Monitors EEG PROCESSOR MONITOR MARKET SHARES AND MARKET FORECASTS Figure 2-1 2-2 U.S. Medical Intervention Market Forecasts, Number, 2003-2008 Table 2-2 2-3 U.S. Surgical Procedure Forecasts, Number, 2003-2008 Table 2-3 2-4 U.S. Inpatient Surgery Types And Operations Performed Table 2-4 2-8 Competitive Factors In The EEG Monitor Market Table 2-5 2-9 Aspect Medical Systems Technology Areas Table 2-6 2-10 BIS Monitoring Is Most Widely Used In The OR Figure 2-7 2-11 ERROR MSG Worldwide EEG Processor Monitor Anesthesia Market Shares, First Three Quarters 2003 Table 2-8 2-12 EEG Processor Monitoring For Surgery Market Shares, Worldwide, First Three Quarters 2003 ERROR MSG Table 2-9 2-16 Aspect Medical Systems Group Purchasing Agreements Figure 2-10 2-19 Worldwide EEG Processor Intensive Care Unit Market Shares, Dollars, First Three Quarters, 2003 Table 2-11 2-20 EEG Processor Monitoring For Intensive Care Unit (ICU/NICU) Market Shares, Worldwide, First Three Quarters 2003 Figure 2-12 2-21 Worldwide EEG Processing Monitor Market Forecasts, Dollars, 2003-2008 Table 2-13 2-22 Granada reservacion de hotel Worldwide EEG Processor Monitor Market Forecasts, System Penetration of Surgical Suites and Recovery Rooms, Units, 2003-2008 Figure 2-14 2-23 Worldwide EEG Processing Monitor Market Forecasts, Processors, 2003-2008 Table 2-15 2-24 U.S. EEG Processor Market Forecasts, Systems Penetrations of Surgical Suites and Recovery Rooms, Units, 2003-2008 Figure 2-16 2-25 Worldwide EEG Processor Sensor Market Forecasts, Dollars, 2003-2008 Figure 2-17 2-26 Worldwide EEG Processor Sensor Market Forecasts, Units, 2003-2008 Table 2-18 2-27 luxury hotels in Heraklion U.S. EEG Processor Market Forecasts, Units and Dollars, 2003-2008 Table 2-19 2-28 Worldwide EEG Processor Sensor Anesthesia Market Forecasts, Units and Dollars, 2003-2008 Table 2-20 2-29 U.S. EEG Processor and Sensor Market Forecast Analysis, Units, 2003-2008 Table 2-21 2-31 Worldwide EEG Processor and Sensor Intensive Care Unit (ICU) Market Forecast, Dollars, 2003-2008 Table 2-22 2-32 Worldwide EEG Processor Market Forecasts, Anesthesia and ICU System Shipments, Dollars, 2003-2008 Table 2-23 2-34 Aspect Medical Systems Original Equipment Manufacturer Distribution Agreement Relationships Table 2-24 2-37 Challenges Relating To EEG Processor International Business Activities Table 2-25 2-38 EEG Processor Regional Market Analysis Worldwide, Percent, First Three Quarters 2003 Table 2-26 2-38 Traditional and Packet Based PBX Regional Market Analysis, Worldwide, Dollars, 2002 EEG PROCESSOR MONITOR PRODUCT DESCRIPTIONS Table 3-1 3-2 EEG Monitoring Processor Advantages Table 3-2 3-4 Aspect Medical Systems Principal Product Offerings Table 3-3 3-11 Aspect Medical Systems EEG Advanced Architecture Table 3-4 3-13 Aspect Medical Systems Artifact Conditions Detected Table 3-5 3-14 Aspect Medical Systems EEG Module Licensees Table 3-6 3-19 Physiometrix PSA 4000 Embedded Software Table 3-7 3-20 Physiometrix Product Description Table 3-8 3-23 Physiometrix EEG Monitoring Menu and Dedicated User Controls Table 3-9 3-24 Physiometrix EEG Monitoring Benefits Table 3-10 3-29 Nervus EEG Monitor Uses Table 3-11 3-30 Features of Nervus EEG NICU Monitor EEG PROCESSOR MONITOR TECHNOLOGY Table 4-1 4-3 Aspect Medical Systems BIS System Functions Table 4-2 4-4 Aspect Medical Systems BIS System Features Table 4-3 4-6 Clinical Research And Regulatory Responsibilities Table 4-4 4-7 Measures Of Anesthetic Effect On The Brain Table 4-5 4-10 Aspect Medical Systems Research And Development Areas Of Responsibility Table 4-6 4-12 Aspect Medical Systems Product Areas Table 4-7 4-13 Aspect Medical Systems Technology Areas Table 4-8 4-14 Aspect Medical Systems BIS index correlations Table 4-9 4-19 Set Of Features That Account For Statistical Variance EEG PROCESSOR MONITOR COMPANY PROFILES Table 5-1 5-19 Nervus EEG Remote Analysis Close Window |