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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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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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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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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