Digital Biodetection Market Opportunity Analysis__5-17-2006__Greg Luther

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    1

    BioWarn LLC Market Opportunity AnalysisDeveloped and Presented by Greg Luther, VP

    May 17, 2006

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    About the SmartSense System

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    3

    The SmartSense System

    Product Evolution

    Time

    The SmartSenseSystem

    Very HighThroughput Applications

    Avian FluScreening

    DrugDiscovery

    RemoteSurveillance Applications

    NosocomialInfection Control

    TherapeuticDrug

    Monitoring

    AMP F A/D DSPPC +

    Comms

    SmartSense Processing Suite (SPS)

    Non-Minia tur ized

    SmartSense DetectorLIGAND

    DETECTOR

    Minia tur ized

    AMP F A/D D SPPC +

    Comms

    SmartSense Processing Suite (SPS)

    SmartBoxField Applications

    SmartArray LaboratoryApplications

    SmartSandMiniaturized Applications

    Multiple Applications

    SmartScreen Ha nd-Held Applications

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    The SmartSense System

    Molecules Without MatchingLigands Do Not Bind

    Binding Event Signature Matched

    Against Database of Stored Signatures forPositive Target Identification

    Ligand Chosen to

    Bind with Target

    Detection Target

    SmartSense Detector

    Test Sample

    Computing

    DetectionSignature

    Specific Binding Event

    SmartSense TM Detector Concept

    Binding Event Signal Captured by Detector

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    X

    L a b o n

    a c h i

    p

    H I S S S

    Multiplexed Detection

    No Hands

    Everywhere

    Self-Networking

    Real-Time

    X X X X X X X X Always-On

    S m a r t S e

    n s e T M

    C A N A R

    Y

    E L I S A

    . . .

    N a n o w i

    r e s

    I m m u n

    o a s s

    a y

    X Mins

    X X X X X X X

    X X Laboratory- Based

    X X X X X X X X

    n/a X ? * * X

    Hrs Hrs Hrs- Days

    Hrs Mins

    HH

    ?

    * Depends on how test is deployed, e.g. use of micro-arrays, etc.

    HH HH = Hand-Held

    Hrs- Days

    Makes HIGHTHROUGHPUT

    Possible

    SmartSense Differentiators

    P C R / R T - P C

    R

    H o s p i t a

    l L a b

    M a s s S p e

    c t r o s

    c o p y

    MakesEMBEDDING

    Possible

    Makes HIGHTHROUGHPUT

    Possible

    Makes HIGHTHROUGHPUT

    Possible

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    SmartSense Opens UpNew High-Throughput Detection Possibilities

    SmartSense opens up entirely new possibilities for bio-detection in contexts where throughput is measured in the hundreds of millions which current diagnostic technologies simply cannot address because they are not rapid enough, and they cost too much.

    Avian Flu (H5N1) Screening Users include hospitals, physicians' offices, diagnostic testing

    centers, major air carriers, airport authorities, industrial poultryfarms, and any major enterprise concerned about protecting itspeople from infection.

    High Throughput Screening (HTS) in Drug Discovery Users include major pharmas and research labs

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    SmartSense Opens UpNew Remote Surveillance Possibilities

    SmartSense opens up new possibilities for bio-detection in contexts where detection needs to be embedded , always on ,distributed , and remote which current diagnostic technologies cannot address as well because they require a lab, lab technician time, specialized procedures and equipment.

    Active surveillance of cultures to control nosocomial infectionoutbreaks

    Pharmaceutical clinical trials and post-launch surveillance

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    Potential Markets for the SmartSense System

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    Initial Target Market Potential EstimatesTarget MarketSegments Key Pathogens SmartSand Applications Estimated MarketPotential*

    Healthcare 1. Methicillin-resistantstaphylococcus aureus(MRSA)2. Vancomycin-resistantenterococci (VRE)3. Tularemia

    4. Viral hemorrhagic fevers5. Q fever6. Viral encephalitis7. Avian flu8. Opportunistic respiratoryinfections

    - SmartSand bolt-on units added to HVAC systemsin hospitals, doctor's offices

    - Hand-held SmartSand units for use by nursingstaff, inspectors, infectious disease specialists

    - SmartSand-enabled surgical gloves and surgicaldressings

    - SmartSand-based bedside diagnostic kits

    - SmartSand-enabled dental prosthetics

    $7 Billion

    FoodProcessing &Distribution

    1. Salmonella2. Botulism

    3. E. coli O157:H74. Listeria5. Shigella dysentery6. Typhoid fever7. Vibrio cholerae8. Cryptosporidium parvum

    - SmartSand bolt-on units added to HVAC andeffluent drainage systems in food processing

    plants and distribution centers

    - Hand-held SmartSand units for use by plant staffand inspectors

    - SmartSand-enabled rubber gloves

    $2 Billion

    Bio-Defense 1. Anthrax2. Plague3. Smallpox4. Ricin toxin5. Staphylococcal

    enterotoxin-B6. Avian flu

    - SmartSand bolt-on units added to HVAC systemsin transportation hubs, government and otherpublic or high-profile buildings

    - Hand-held SmartSand units for use by battlefield,first-responder, and haz-mat remediationpersonnel

    - SmartSand-based automated pathogensurveillance systems in shipping containers, ports,trucking hubs, and water supply systems

    $2-3 Billion

    (*Source: International market analysis study funded by Ansell Healthcare Incorporated.)

    SmartSense canalso be used to detectallergens, molds, fungi,and even DNA.

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    How Big Is the Current Biosensors Market?

    $2.5 Billion

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    How Do Market SegmentsCompare by Size and Growth Rate?

    #1 #2#3 #4

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    How Do Market SegmentsCompare by Size and Growth Rate?

    Industrial markets include: food processing, bio-process control, pharmaceutical/medical device development

    and manufacturing, water and waste management

    Excludes the US biochip industry,which was estimated to be $852million in 2003

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    13Confidential and Proprietary 14Confidential and Proprietary 9BioWarn, LLC Board of Managers April 3, 2006

    Additional MarketSegments Not Included in Estimates

    Biodefense Excludes Avian Flu Crisis

    Point-of-Care

    Excludes Commercial Testing Labs ($42 Billion) Quest Diagnostics $5.5 Billion (13% Mkt Share) Lab Corp $3.3 Billion (8% Mkt Share)

    Research Laboratories Excludes the US biochip industry (estimated at $852 million in 2003) Excludes Drug Discovery (> $10 Billion)

    Additional Market Definitions

    Molecular diagnostics ($12 billion by 2010 and $35 billion by 2015) Immunosensors Lab-on-a-Chip (LOC) Electric biochips

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    Opportunity Assessment

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    15Source:Adapted from Pragmatic Marketing, Inc.

    Product Management Framework for Targeting

    Innovation

    Pricing

    Buy, Buildor Partner

    BusinessCase

    ThoughtLeaders

    TechnologyAssessment

    CompetitiveAnalysis

    MarketResearch

    MarketProblems

    DistinctiveCompetence

    ProductContract

    User Personas

    ReleaseMilestones

    SalesProcess

    MarketRequirements

    ProductRoadmap

    Positioning MarketingPlan

    AwarenessPlan

    Customer Acquisition

    Customer Retention

    ChannelTraining

    Competitive

    Write-Up

    EventSupport

    Collateral &Sales Tools

    Presentations& Demos

    WhitePapers

    SpecialCalls

    Answer

    Desk

    LaunchPlan

    MarketMessages

    Lead

    Generation

    Buyer Personas

    Product Marketing Management

    Market Analysis ProductStrategy ProgramStrategyProductPlanningQuantitative Analysis ChannelSupportSalesReadiness S t r a t e

    g i c T

    a

    c t i c al

    Product Strategy Management

    Less Technical

    Technical Product Management

    More Technical

    We AreHere

    Win/LossAnalysis

    OperationalMetrics

    MarketSizing

    ProductPerformance

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    Biosensors were a $7.3 Billion worldwide market in 2003.

    Key Segments: Biodefense Biosensors Market

    Environmental Monitoring Biosensors Market Home Diagnostics Biosensors Market Point-of-Care Biosensors Market Process Industries Biosensors Market Research Laboratories Biosensors Market

    What Are the Market ProblemsThat Present the Best Entrance Opportunities?

    Market Analysis ProductStrategy ProgramStrategyProductPlanningQuantitative Analysis ChannelSupportSalesReadiness S t r a t e

    g i c T

    a

    c t i c al

    TechnologyAssessment

    CompetitiveAnalysis

    MarketResearch

    MarketProblems

    DistinctiveCompetence

    We AreHere

    Independent Tasks Problematic PATHOGENSvary by market segmentand end-user

    Attributes of Successful Products: Highly specific Stable Low cost Small in size Portable Capable of being used by less

    skilled operators Long shelf life Easy to manufacture

    In addition, biosensors mustprovide a response that is:

    Accurate Precise Reproducible

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    What Are the Market Problems? (cont.)

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    Biosensors were a $7.3 Billion worldwide market in 2003.

    Key Segments: Biodefense Biosensors Market

    Environmental Monitoring Biosensors Market Home Diagnostics Biosensors Market Point-of-Care Biosensors Market Process Industries Biosensors Market Research Laboratories Biosensors Market

    Market Analysis ProductStrategy ProgramStrategyProductPlanningQuantitative Analysis ChannelSupportSalesReadiness S t r a t e

    g i c T

    a

    c t i c al

    TechnologyAssessment

    CompetitiveAnalysis

    MarketResearch

    MarketProblems

    DistinctiveCompetence

    We AreHere

    Independent Tasks

    Examples of CompetingPRODUCERS & TECHNOLOGIES:

    Siemens and eBiochip SystemsGmbH - Lab-on-a-Chip (LOC)

    Harvard University - Nanowires

    UC Berkeley and The AcumenFund - Immunosensors

    UC Berkeley- Smart Dust

    DuPont Qualicon - The BAXSystem

    What Is SmartSense Up Against?

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    Biosensors were a $7.3 Billion worldwide market in 2003.

    Key Segments: Biodefense Biosensors Market

    Environmental Monitoring Biosensors Market Home Diagnostics Biosensors Market Point-of-Care Biosensors Market Process Industries Biosensors Market Research Laboratories Biosensors Market

    Market Analysis ProductStrategy ProgramStrategyProductPlanningQuantitative Analysis ChannelSupportSalesReadiness S t r a t e

    g i c T

    a c t i c al

    TechnologyAssessment

    CompetitiveAnalysis

    MarketResearch

    MarketProblems

    DistinctiveCompetence

    We AreHere

    Independent Tasks

    Leading biochip providers(FredoniaGroup):

    Affymetrix, Amersham Biosciences, Applera, Agilent Technologies, PerkinElmer Life and Analytical

    Sciences, Beckman Coulter, Ciphergen Biosystems, and Caliper Life Sciences

    Leading Biosensor MarketParticipants(Frost & Sullivan):

    AZUR Environmental Abbott Laboratories Biosensor BV Bayer Cranefield Biotechnology

    Center Chiron DuPont Biosensor Materials Draeger Safety Ercon, Inc. EG & IC Sensors Johnson & Johnson Integrated Micro Instruments Innovative Biosensors, Inc. LifeScan, Inc. Strategic Diagnostics Sysmex

    Theron, Inc. Molecular Devices Corp. M-Biotech Oxford Biosensors Ltd. QTL Biosensors Roche Diagnostics Radiometer America, Inc.

    Remedios Universal Sensors, Inc. Zellweger

    Who Is BioWarn Sharing the Field With,and Are They Competitors or Partners?

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    20

    X

    L a b o n

    a c h i

    p

    H I S S S

    Multiplexed Detection

    No Hands

    Everywhere

    Self-Networking

    Real-Time

    X X X X X X X X Always-On

    S m a r t S e

    n s e T M

    C A N A R

    Y

    E L I S A

    . . .

    N a n o w

    i r e s

    I m m u n

    o a s s

    a y

    X Mins

    X X X X X X X

    X X Laboratory- Based

    X X X X X X X X

    n/a X ? * * X

    Hrs Hrs Hrs- Days

    Hrs Mins

    HH

    ?

    * Depends on how test is deployed, e.g. use of micro-arrays, etc.

    HH HH = Hand-Held

    Hrs- Days

    Makes HIGHTHROUGHPUT

    Possible

    SmartSense Differentiators

    P C R / R T - P C

    R

    H o s p i t a l L

    a b

    M a s s S

    p e c t r

    o s c o

    p yMakes

    EMBEDDINGPossible

    Makes HIGHTHROUGHPUT

    Possible

    Makes HIGHTHROUGHPUT

    Possible

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    Opportunity Assessment Conclusions

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    Finding: Ease of Market Entry

    Market Segment Degree of

    Competition Price

    Sensitivity Number of

    Competitors

    Research Laboratories 1- Low 1- Low 15

    Biodefense/Public Health 1- Low 1- Low 20

    Environmental Monitoring 1- Low 2- Medium 10

    Process Industries 1- Low 3- High- 25

    Point-of-Care 2- Medium 2- Medium 12

    Home Diagnostics 3- High- 3- High- 10

    (Source: Frost & Sullivan)

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    $1MM$100K$10K$1,000$100$10$1

    Ease of Market Entry (cont.)

    Price perUnit

    Easier Market toEnter

    Harder Market to Enter

    $674

    R e s e a r c

    h L a b

    o r a t o r

    i e s

    $425 E n v i r o n

    m e n t a

    l M o n

    i t o r i n g

    $153 B i o

    d e f e n

    s e / P u

    b l i c H e a

    l t h

    $1,011

    P o i n t -

    o f - C a r e

    $486

    P r o c

    e s s I n

    d u s t r

    i e s

    $1,628

    H o m e

    D i a g n o s

    t i c s

    FDA Approvals

    Higher Market

    Concentration

    BiggerCompetitors

    Non-Healthcare

    Market MoreFragmented,

    Niche-Oriented

    Emphasis onCustomized

    SolutionsNatural Market

    Entry Point

    Natural MarketEntry Point

    Tougher Marketsto Penetrate

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    $1MM$100K$10K$1,000$100$10$1

    Avian flu HIV BSE Anthrax MRSA,

    VRE, E.coli., etc.

    Analysis: Detection Targets vs. Markets

    Price perUnit

    Easier Market toEnter

    Harder Market to Enter

    $674

    R e s e a r c

    h L a b

    o r a t o r

    i e s

    $425 E n v i r o

    n m e n

    t a l M o

    n i t o r i n

    g $153

    B i o d e

    f e n s e /

    P u b l i c

    H e a l t h

    $1,011

    P o i n t -

    o f - C a r e

    $486

    P r o c

    e s s I n

    d u s t r

    i e s

    $1,628

    H o m e

    D i a g n o s

    t i c s

    FDA Approvals

    Higher Market

    Concentration

    BiggerCompetitors

    Non-Healthcare

    Market MoreFragmented,

    Niche-Oriented

    Emphasis onCustomized

    Solutions

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    $1MM$100K$10K$1,000$100$10$1

    Avian flu HIV BSE Anthrax MRSA,

    VRE, E.coli., etc.

    Detection Targets vs. Markets

    Price perUnit

    Easier Market toEnter

    Harder Market to Enter

    $674

    R e s e a r c

    h L a b

    o r a t o r

    i e s

    $425 E n v i r o

    n m e n

    t a l M o

    n i t o r i n

    g $153

    B i o d e

    f e n s e /

    P u b l i c

    H e a l t h

    $1,011

    P o i n t -

    o f - C a r e

    $486

    P r o c

    e s s I n

    d u s t r

    i e s

    $1,628

    H o m e

    D i a g n o s

    t i c s

    FDA Approvals

    Higher Market

    Concentration

    BiggerCompetitors

    Non-Healthcare

    Market MoreFragmented,

    Niche-Oriented

    Emphasis onCustomized

    Solutions

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    $1MM$100K$10K$1,000$100$10$1

    Avian flu HIV BSE Anthrax MRSA,

    VRE, E.coli., etc.

    Detection Targets vs. Markets

    Price perUnit

    Easier Market toEnter

    Harder Market to Enter

    $674

    R e s e a r c

    h L a b

    o r a t o r

    i e s

    $425 E n v i r o

    n m e n

    t a l M o

    n i t o r i n

    g $153

    B i o d e

    f e n s e /

    P u b l i c

    H e a l t h

    $1,011

    P o i n t -

    o f - C a r e

    $486

    P r o c

    e s s I n

    d u s t r

    i e s

    $1,628

    H o m e

    D i a g n o s

    t i c s

    FDA Approvals

    Higher Market

    Concentration

    BiggerCompetitors

    Non-Healthcare

    Market MoreFragmented,

    Niche-Oriented

    Emphasis onCustomized

    Solutions

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    $1MM$100K$10K$1,000$100$10$1

    Avian flu HIV BSE Anthrax MRSA,

    VRE, E.coli., etc.

    Detection Targets vs. Markets

    Price perUnit

    Easier Market toEnter

    Harder Market to Enter

    $674

    R e s e a r c

    h L a b

    o r a t o r

    i e s

    $425 E n v i r o

    n m e n

    t a l M o

    n i t o r i n

    g $153

    B i o d e

    f e n s e /

    P u b l i c

    H e a l t h

    $1,011

    P o i n t -

    o f - C a r e

    $486

    P r o c

    e s s I n

    d u s t r

    i e s

    $1,628

    H o m e

    D i a g n o s

    t i c s

    FDA Approvals

    Higher Market

    Concentration

    BiggerCompetitors

    Non-Healthcare

    Market MoreFragmented,

    Niche-Oriented

    Emphasis onCustomized

    Solutions

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    $1MM$100K$10K$1,000$100$10$1

    Avian flu HIV BSE Anthrax MRSA,

    VRE, E.coli., etc.

    Detection Targets vs. Markets

    Price perUnit

    Easier Market toEnter

    Harder Market to Enter

    $674

    R e s e a r c

    h L a b

    o r a t o r

    i e s

    $425 E n v i r o

    n m e n

    t a l M o

    n i t o r i n

    g $153

    B i o d e

    f e n s e /

    P u b l i c

    H e a l t h

    $1,011

    P o i n t -

    o f - C a r e

    $486

    P r o c

    e s s I n

    d u s t r

    i e s

    $1,628

    H o m e

    D i a g n o s

    t i c s

    FDA Approvals

    Higher Market

    Concentration

    BiggerCompetitors

    Non-Healthcare

    Market MoreFragmented,

    Niche-Oriented

    Emphasis onCustomized

    Solutions

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    Avian Flu Is #1 Detection Target

    Highest degree of urgency (emergency) Highest potential mortality (20 - 100+ million) Severe economic dislocation

    High degree of public alarm

    Significant market problem:

    Unlike currently available tests, SmartSense is fast enough and no-hands enough to be very effective in high-volume settings whereisolation decisions must be made.

    A SmartSense avian flu detector has applications in 5 out of 6 ofidentified biosensor markets

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    Competitive Opportunity for Avian Flu Detector

    Performance characteristics of available tests for Avian Flu

    BioMerieux NucliSens EasyQ(R) Influenza H5 and N1 -

    "Nucleic acid amplification assay Exclusively for research purposes Takes 90 mins Requires instrument

    CDC "Influenza A/H5 (Asian Lineage) Virus Real-Time Reverse

    Transcription--Polymerase Chain Reaction (RT-PCR) Primer andProbe Set

    FDA approved (in 2 weeks!) Takes 4 hours Requires instrument

    MakesProcess-

    EMBEDDINGImpossible

    Makes HIGHTHROUGHPUT

    ScreeningImpractical

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    Competitive Opportunity for Avian Flu Detector (cont.)

    Performance characteristics of available tests for Avian Flu QIAGEN

    "artus Influenza/H5 kit Combines a broad screening test, with a highly specific assay for

    the detection of characteristic nucleic acids (RNA) of avian flu(H5N1) virus strains.

    Takes under 75 minutes Requires LightCycler instrument

    Second Qiagen kit is a specific avian flu (H5N1) molecular detection kit

    launched in 2004 in China by PG Biotech, a company acquired byQiagen

    STMicroelectronics and Veredus Laboratories Rapid-Detection Point-of-Need, Disposable Lab-on-Chip

    RT-PCR on a chip Takes 1 hour Requires instrument and laptop PC

    Avian Flu Detector Can Address

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    Avian Flu Detector Can AddressMultiple Customers and Markets

    Price perUnit

    Easier Market toEnter

    Harder Market toEnter

    $1MM$100K$10K$1,000$100$10$1

    $1,628

    H o m e

    D i a g

    n o s t i c s

    $1,011

    P o i n t -

    o f - C a

    r e

    $674

    R e s e a r c h

    L a b o

    r a t o r i

    e s

    $486

    P r o c e s

    s I n d u

    s t r i e s

    $425 E n v i r o n

    m e n t a

    l M o n i t o r

    i n g $153

    B i o d e

    f e n s e

    / P u b l i c

    H e a l t h

    FDA Approvals

    Higher MarketConcentration

    BiggerCompetitors

    Non-Healthcare(No FDA)

    Market MoreFragmented,

    Niche-Oriented

    Emphasis onCustomized

    Solutions

    Avian Flu Detectors forCDC, WHO andProject BioShield

    Avian Flu Detectors forPoultry Producers and

    Restaurant Chains

    Avian Flu Detectors forUniversity & Other ResearchLabs (vaccine development)

    Avian Flu Detector Can Address

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    Avian Flu Detector Can AddressMultiple Customers and Markets

    Price perUnit

    Easier Market toEnter

    Harder Market toEnter

    $1MM$100K$10K$1,000$100$10$1

    $1,628

    H o m e

    D i a g

    n o s t i c s

    $1,011

    P o i n t -

    o f - C a

    r e

    $674

    R e s e a r c

    h L a b

    o r a t o r

    i e s

    $486

    P r o c e s

    s I n d u

    s t r i e s

    $425 E n v i r o n

    m e n t a

    l M o n i t o r

    i n g $153

    B i o d e

    f e n s e

    / P u b l i c

    H e a l t h

    FDA Approvals

    Higher MarketConcentration

    BiggerCompetitors

    Non-Healthcare(No FDA)

    Market MoreFragmented,

    Niche-Oriented

    Emphasis onCustomized

    Solutions

    Avian Flu Detectors forFirst-Responders

    Avian Flu Detectors forHospitals and Clinics

    Avian Flu Detectors forDoctors Offices

    Avian Flu Detectors forHomes and Businesses

    Avian Flu Detectors forCommercial Labs and Their

    Test Center Networks

    Avian Flu Detector Can Address

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    Avian Flu Detector Can AddressMultiple Customers and Markets

    Price perUnit

    Easier Market toEnter

    Harder Market toEnter

    $1MM$100K$10K$1,000$100$10$1

    $1,628

    H o m e

    D i a g

    n o s t i c s

    $1,011

    P o i n t -

    o f - C a

    r e

    $674

    R e s e a r c

    h L a b

    o r a t o r

    i e s

    $486

    P r o c e s

    s I n d u

    s t r i e s

    $425 E n v i r o n

    m e n t a

    l M o n i t o r

    i n g $153

    B i o d e

    f e n s e

    / P u b l i c

    H e a l t h

    FDA Approvals

    Higher MarketConcentration

    BiggerCompetitors

    Non-Healthcare(No FDA)

    Market MoreFragmented,

    Niche-Oriented

    Emphasis onCustomized

    Solutions

    Ideally:Design a

    device that

    can workin all ormost

    marketsegments

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    Nosocomial Infectious Agents Are Target #2

    High degree of urgency Should be #6 in CDC list of Top 10 Killers

    100,000+ deaths per year in U.S.

    May be 1-2 million worldwide Costs hospitals $5 billion per year (ex-lawsuits) Patient Safety is a critical issue in hospitals across the U.S.

    Significant market problem to solve: Unlike currently available tests, SmartSense is fast enough and

    hands-free enough to be very effective in high-volume settingswhere isolation decisions must be made.

    A SmartSense MRSA+ detector has applications in the two largestbiosensor markets: Point-of-Care and Home(Self)-Diagnostics

    Nosocomial Infection Detector

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    Can Address the Three Largest Markets

    Price perUnit

    Easier Market toEnter

    Harder Market to Enter

    $1MM$100K$10K$1,000$100$10$1

    $674

    R e s e a r c

    h L a b

    o r a t o r

    i e s

    $425 E n v i r o n

    m e n t a

    l M o n i t o r

    i n g $153

    B i o d e

    f e n s e

    / P u b l i c

    H e a l t h

    $1,011

    P o i n t -

    o f - C a

    r e

    $486

    P r o c e s

    s I n d u

    s t r i e s

    $1,628

    H o m e

    D i a g

    n o s t i c s

    FDA Approvals

    Higher MarketConcentration

    BiggerCompetitors

    Non-Healthcare

    Market MoreFragmented,

    Niche-Oriented

    Emphasis onCustomized

    Solutions

    Avian flu HIV BSE Anthrax MRSA,

    VRE, E.coli., etc.

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    #3 - The Drug Discovery Opportunity

    Problem: The flood of data created by the genomics revolution is driving laboratory automation and creating bottlenecks.

    As a result, High Throughput Screening (HTS), has become a keyelement in modern drug discovery.

    Large pharmas are currently generating 20 terabytes of data daily .May go up to 100 terabytes per day in the next year.

    The workhorses of proteomics are mass spectrometry and 2-D gel

    electrophoresis. BUT long detection time is the critical bottleneck in the HTS

    process.

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    Potential HTS Solution: Insert SmartSense TM To Eliminate Key Process Bottleneck

    Genome

    Proteome

    Candidate Epitopes

    Receptors Such AsKnown Major

    HistocompatabilityComplexes (MHCs)

    1) Sample Handling

    2) Plate Loading3) Assay Procedure4) Reading/Detecting5) Capture into Informatics

    Vaccines and Drugs

    Immunity

    The ValidationBottleneck

    Drug Discovery Opportunity

    1) Sample Handling

    2) SmartSense BindingDetection in Micro-Assay Plates

    SmartSenseAlternative

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    Potential HTS Solution: Insert SmartSense TM To Eliminate Key Process Bottleneck

    Genome

    Proteome

    Candidate Epitopes

    Receptors Such AsKnown Major

    HistocompatabilityComplexes (MHCs)

    1) Sample Handling

    2) Plate Loading3) Assay Procedure4) Reading/Detecting5) Capture into Informatics

    Vaccines and Drugs

    Immunity

    The Validation

    Bottleneck

    Drug Discovery Opportunity

    1) Sample Handling2) SmartSense BindingDetection in Micro-Assay Plates

    SmartSenseAlternative

    High ThroughputScreening Opportunity:

    Reduce 5 steps to 2

    High ThroughputScreening Opportunity:

    Reduce 5 steps to 2

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    Drug Discovery Opportunity

    Opportunity: Integrate SmartSense with high-density assay plates used in High Throughput Screening (HTS) to eliminate the detection bottleneck in the drug discovery process.

    Sales for the worldwide DNA sequencing and proteomicsmarkets are projected to rise from $7.8 billion in 2004 to $17.5billion in 2009 .

    Provides BioWarn with entry into the $852 million US biochipsegment of that market.

    Proteomics and biochips are key growth enablers driving thevaccines marketwhich is expected to grow from $5 to $10

    billion over the next 10 years .

    E d f Slid

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    End of Slides

    End of Slides

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    ADDITIONAL MATERIAL

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    The BioWarn Business Model

    Emerging B siness Model

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    The Company

    Proof-of-Concept

    ProductPrototype 1

    ProductPrototype 2

    ProductPrototype N

    ProductPrototype 3

    End-User ProductPrototyping Projects

    IC Manufacturer (e.g. Intel, IBM,Samsung, TI)

    Prototyping Customer

    Third-PartyProduction

    Foundry ProducesICs without Ligands

    Chips Are Injected withLigands and Gelsas per Customer

    Requirements

    Commercial Production

    Smart SenseTM Units Are Embedded in Products

    and Sold to End-Users

    Large

    Quantities

    BioWarn ProducesSmall Batches

    S m a l l

    Q u a n t i t i

    e s

    Emerging Business Model

    The BioWarn Business Model Simplified

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    The BioWarn Business Model Simplified

    Unmet Needs andRequirements

    Prototyping Projects + Limited Production

    Products and Benefits

    Customer

    BioWarn Partner

    Engineering Services Fees / Prepaid Royalties

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    Biodefense Markets for the SmartSense System

    The Biodefense Market for SmartSense

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    The Biodefense Market for SmartSense

    High impact areas for pathogen detection are placeswhere large numbers of people congregate or pass intransitand places that bio-terrorists would consider desirable targets.

    High Population Concentration Areas: The 5 Largest U.S. Cities: New York, N.Y. pop: 8.1 million Los Angeles, Calif. pop: 3.8 million Chicago, Ill. pop: 2.9 million Houston, Tex. pop: 2.0 million

    Philadelphia, Pa. pop: 1.4 million(Bureau of Census estimated 2003 figures)

    City centers Very large or prominent office buildings Concentrated financial or mercantile districts

    Schools Public school districts University systems

    Transportation systems Airports Sea ports Trains and train stations

    Subway trains and stations Bus stations Highway interchanges

    HospitalsGovernment buildingsSports arenas/stadiums

    Places of WorshipMonuments and museums

    High Economic / Disruption Value Targets:

    - Water distribution and supply systems/ companies

    - Food distribution and supply systems/companies

    - Package delivery systems/companies

    - Cargo shipping systems/companies

    - Financial and payments systems/companies Major banks The Federal Reserve System

    - Stock, options and futures exchanges

    - Power (grid) systems/companies

    - Communications systems/companies

    The SmartSense Opportunity Space Is Vast

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    The SmartSense Opportunity Space Is Vast

    NationalAuthorities

    Local Authorities

    The market opportunity for SmartSenseis very large because it benefits any enterprisethat is interested in protecting thehealth and quality of the air , food, and water enteringor entering withthe spaces,transports, packages, and

    outside peoplewhocome into contactwith its community.

    Public orPrivate

    Enterprise

    Supply Chain

    Supply Chain

    Process Chain

    Process Chain

    Watershed

    Farm

    The World

    The World

    Water

    Food

    Goods/Packages

    People

    Potential Buyers:

    Dept of Homeland Security,Center for Disease Control, Deptof Agriculture, FBI, U.S. Customs,

    INS, etc. Local & State Police, Port

    Authorities, Mass TransitAuthorities, etc.

    Corporate or Other InternalProtection Departments and theirSecurity Consultants and

    Contractors Water Utilities/ Companies,

    Bottlersand their SUPPLYCHAINS

    Food Service, Supply,Distribution, and RetailCompanies and their SUPPLYCHAINS

    USPS and delivery companieslike FedExand their PROCESSCHAINS

    Airlines, Cruise Lines, Rail Lines,Transit Stations and Portsand

    their PROCESS CHAINS

    Potential Buyers:

    Dept of Homeland Security,Center for Disease Control, Deptof Agriculture, FBI, U.S. Customs,INS, etc.

    Local & State Police, PortAuthorities, Mass TransitAuthorities, etc.

    Corporate or Other InternalProtection Departments and theirSecurity Consultants and

    Contractors Water Utilities/ Companies,

    Bottlersand their SUPPLYCHAINS

    Food Service, Supply,Distribution, and RetailCompanies and their SUPPLYCHAINS

    USPS and delivery companieslike FedExand their PROCESSCHAINS

    Airlines, Cruise Lines, Rail Lines,Transit Stations and Portsandtheir PROCESS CHAINS

    7

    1

    2

    34

    5

    6

    7

    6

    5

    4

    3

    2

    1

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    Potential Detection Targets

    Pathogen DetectionTargets Differ by Market Segment

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    Targets Differ by Market Segment

    Pathogen DetectionTargets Differ by Market Segment (cont.)

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    Targets Differ by Market Segment (cont.)

    Assess Urgency of Potential Detection Targets

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    g y g

    Assess Urgency of Potential Detection Targets

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    g y g

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    Initial Customer and Product Targets

    Targeted Prospectsand SmartSense Opportunities

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    pp

    Targeted Prospectsand SmartSense Opportunities

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    Approach to the SmartSense Product Question

    The SmartSense Product Question

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    What Type of Device/ Productto Build for ?

    EpidemiologicallySignificant

    EpidemiologicallySignificant

    CorporatePartners

    Objectives

    CorporatePartners

    Objectives

    Patients +Customers +

    Publics Critical

    Unmet Needs

    Patients +Customers +

    Publics Critical

    Unmet Needs

    Product DevelopmentProduct Development

    Legal / RegulatoryLegal / Regulatory

    ManufacturingManufacturing

    MarketingMarketing

    Distribution, Service & SupportDistribution, Service & Support

    Product Revisions /Upgrades

    Product Revisions /Upgrades

    Reach cashflowbreak-even quickly

    Reach cashflowbreak-even quickly

    Speed-to-marketSpeed-to-market

    Demonstrate the Value of

    SmartSense

    Demonstrate the Value of

    SmartSense

    BioWarnsNeeds andObjectives

    BioWarnsNeeds andObjectives

    The Key QuestionsWhich Pathogens?

    XWhich Vectors?

    XWhere in the Infection Chain?

    XFor Which Customers?

    The SmartSense Product Question

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    What Type of Device/ Productto Build for ?

    EpidemiologicallySignificant

    EpidemiologicallySignificant

    CorporatePartners

    Objectives

    CorporatePartners

    Objectives

    Patients +Customers +

    Publics Critical

    Unmet Needs

    Patients +Customers +

    Publics Critical

    Unmet Needs

    Product DevelopmentProduct Development

    Legal / RegulatoryLegal / Regulatory

    ManufacturingManufacturing

    MarketingMarketing

    Distribution, Service & SupportDistribution, Service & Support

    Product Revisions /Upgrades

    Product Revisions /Upgrades

    Reach cashflowbreak-even quickly

    Reach cashflowbreak-even quickly

    Speed-to-marketSpeed-to-market

    Demonstrate the Value of

    SmartSense

    Demonstrate the Value of

    SmartSense

    BioWarnsNeeds andObjectives

    BioWarnsNeeds andObjectives

    The Key QuestionsWhich Pathogens?

    XWhich Vectors?

    XWhere in the Infection Chain?

    XFor Which Customers?

    Strategic Planning Order of Operations:

    1) Target Which Customer-Markets?

    X

    2) For Which Market Problems?- Which Pathogens+Vectors?- With What Performance Characteristics?

    X

    3) With What Product?

    - Targeting Which End-Users?- Providing Which Benefits?- At What Price?

    EXAMPLE: Nosocomial InfectionIs the #6 Cause of Death in the U.S.

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    HospitalCounter-measures

    PatientIsolation

    PersonalProtectiveEquipment

    HandHygiene

    Sanitation/ Sterilization

    ActiveSurveillanceof Cultures

    GlovesMask

    Gown

    Points ofFailure

    Usually only appliedto infected patients,

    not colonized patients

    Inconvenient for staffand no ready way to

    verify efficacy

    Staff falls back to oldhabits and no readyway to verify efficacy

    No ready way toverify surfaces are

    clean

    Other measuresineffective without

    this, but generally notused due to expense.

    The InfectionReservoir

    Infected Individuals

    Colonized Individuals

    The Infection Reservoir

    Infected Individuals

    Colonized Individuals

    Community

    The 10 Leading Causes of Death in the U.S.

    1. Heart disease: 696,9472. Cancer: 557,2713. Stroke: 162,6724. Chronic lower respiratorydiseases: 124,8165. Accidents (unintentionalinjuries): 106,7426. Diabetes: 73,2497. Influenza/Pneumonia: 65,6818. Alzheimer's disease: 58,8669. Nephritis, nephrotic syndrome,and nephrosis: 40,97410. Septicemia: 33,865(Source: N C H S - FASTATS )

    InfectionVectors

    Patients

    Visitors

    Health-care

    Workers

    Environ-mental

    Surfaces

    Equipment& Devices

    Air / Droplets

    BioWarnOpportunities

    Use SmartSensedevices to identifycolonized patients

    Use SmartSensedevices to flag PPEfailures

    Use SmartSensedevices to verify

    compliance

    Use SmartSensedevices to flag

    surfacecontamination

    Use SmartSensedevices to reducecost and increase

    usage of activesurveillance

    Use SmartSensedevices in HVAC

    systems

    So Whats the Right FIRSTProduct to Launch Through a Partner?

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    Reach cashflowbreak-even

    quickly

    Reach cashflowbreak-even

    quicklyMaximize

    speed-to-marketMaximize

    speed-to-market

    Demonstrate thevalue of

    SmartSense

    Demonstrate thevalue of

    SmartSense

    BioWarn Objectives

    the quickest-to-deliver devicefor the technically easier detection of

    an epidemiologically significant pathogen

    that does not require FDA approval

    that a corporate partner can readily manufacture

    that leverages a corporate partners product linesthat leverages a corporate partners existing brand

    and achieves high volumes/low unit costs quickly

    that leverages a corporate partners establishedcustomer base, distribution channels, storage andtransportation, quality standards, warranty, service,and customer support procedures

    The Key Questions

    Which Pathogens?X

    Which Vectors?X

    Where in the Infection Chain?X

    For Which Customers?

    Product DevelopmentProduct Development

    Legal / RegulatoryLegal / Regulatory

    ManufacturingManufacturing

    MarketingMarketing

    Distribution, Service& Support

    Distribution, Service& Support

    Need Areas

    CONFIDENTIAL AND PROPRIETARY 31

    The SmartSand Product Question

    What Type of Device/Product to

    Build for ?

    EpidemiologicallySignificant

    EpidemiologicallySignificant

    CorporatePartners Objectives

    CorporatePartners Objectives

    Patients +Customers +

    PublicsCritical

    Unmet Needs

    Patients +Customers +

    PublicsCritical

    Unmet Needs

    ProductDevelopment

    ProductDevelopment

    Legal /Regulatory

    Legal /Regulatory

    ManufacturingManufacturing

    MarketingMarketingDistribution,

    Service & Support

    Distribution,Service & Support

    Product Revisions / Upgrades

    Product Revisions / Upgrades

    Reach cashflowbreak-even

    quickly

    Reach cashflowbreak-even

    quicklySpeed-to-

    marketSpeed-to-

    marketDemonstratethe Value of SmartSand

    Demonstrate

    the Value of SmartSand

    BioWarnsNeeds andObjectives

    BioWarnsNeeds andObjectives

    The Key Questions

    Which Pathogens?X

    Which Vectors?XWhere in the Infection Chain?

    XFor Which Customers?

    The SmartSense Product Question:FDA Approvals and Speed-to-Market

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    What Type of Device/ Productto Build for ?

    EpidemiologicallySignificant

    EpidemiologicallySignificant

    CorporatePartners

    Objectives

    CorporatePartners

    Objectives

    Patients +Customers +

    Publics Critical

    Unmet Needs

    Patients +Customers +

    Publics Critical

    Unmet Needs

    Product DevelopmentProduct Development

    Legal / RegulatoryLegal / Regulatory

    ManufacturingManufacturing

    MarketingMarketing

    Distribution, Service & SupportDistribution, Service &

    Support

    Product Revisions /Upgrades

    Product Revisions /Upgrades

    Reach cashflowbreak-even quickly

    Reach cashflowbreak-even quickly

    Speed-to-marketSpeed-to-market

    Demonstrate Value of SmartSense

    Demonstrate Value of SmartSense

    BioWarnsNeeds andObjectives

    BioWarnsNeeds andObjectives

    The Key QuestionsWhich Pathogens?

    XWhich Vectors?

    XWhere in the Infection Chain?

    XFor Which Customers?

    FDA approvals for SmartSenseproducts can be a major speed

    bump. They are necessary in some markets

    but not others.

    Product Management Framework

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    Innovation

    Pricing

    Buy, Buildor Partner

    BusinessCase

    ThoughtLeaders

    TechnologyAssessment

    Competitive

    Analysis

    MarketResearch

    MarketProblems

    DistinctiveCompetence

    Product

    Contract

    User Personas

    ReleaseMilestones

    SalesProcess

    MarketRequirements

    ProductRoadmap

    Positioning MarketingPlan

    AwarenessPlan

    Customer Acquisition

    Customer Retention

    ChannelTraining

    CompetitiveWrite-Up

    EventSupport

    Collateral &Sales Tools

    Presentations

    & DemosWhite

    Papers

    Special

    Calls

    Answer Desk

    LaunchPlan

    Market

    Messages

    LeadGeneration

    Buyer Personas

    Product Marketing Management

    Market

    Analysis

    Product

    Strategy

    Program

    Strategy

    Product

    Planning

    Quantitative

    Analysis

    Channel

    Support

    Sales

    Readiness S t r a

    t e g

    i c T a c t i c al

    Product Strategy Management

    Less Technical

    Technical Product Management

    More Technical

    We AreHere

    Win/LossAnalysis

    OperationalMetrics

    MarketSizing

    ProductPerformance

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    END OF ADDITIONAL MATERIAL