Jose Mir

President, CTO
 Safe Harbor
Statement
This presentation includes forward-looking statements. The protection of the safe
harbor for forward-looking statements as contained in the Private Securities
Litigation Reform Act of 1995 is claimed for all forward-looking statements. All
statements other than statements of historical facts contained in this presentation,
including statements regarding SensiVida’s future results of operations and
financial position, business strategy and plans and SensiVida’s objectives for future
operations, are forward-looking statements. The words “believe,” “may,” “will,”
“estimate,” “continue,” “anticipate,” “intend,” “expect” and similar expressions
are intended to identify forward-looking statements. The forward-looking
statements are based largely on SensiVida’s current expectations and projections
about future events and financial trends that may affect its financial condition,
results of operations, business strategy, short term and long term business
operations and objectives, and financial needs. These forward-looking statements
are subject to a number of risks, uncertainties and assumptions. Factors that might
cause actual results to differ materially from those contemplated by the forward-
looking statements include risks associated with development activities,
competitive pressures, general economic conditions, availability of capital,
regulatory requirements and our effectiveness in achieving our stated goals. In
light of these risks, uncertainties and assumptions, the forward-looking events and
circumstances discussed in this presentation may not occur and actual results
could differ materially and adversely from those anticipated or implied in the
forward-looking statements. 2
 SensiVida Business Summary

• Minimally-invasive, automated, digital clinical diagnostics products

→ pain-free/no blood → improved accuracy → rapid test times → cost-effective → EMR

“Painless, efficient clinical

diagnostics”

ALLERGY, GLUCOSE, BLOOD TESTING TODAY

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 Our Technology

Multispectral image processin

Optical microneedles
Penetrate skin painlessly Sees what the eye cannot see
Coated with FDA approved chemistry Extracts digital image data
Input to electronic medical records
Provide “window to the physiology”

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e.g. chemical sampling
images/video
PREINSERTION

coated μneedle

POSTINSERTION

1 mm

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 Digital image processing

Pre-insertion baseline Post-insertion Difference image Extract color change Extract edge

Total area = (.4)(.5) mm2

Actual area measured:
(.63)(.2 mm2) =.126 mm2
*

% D is trib
% uDtio
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trib
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50 6
 Market Applications
mber of $B diagnostic markets are addressable with same techno
product targets $1.2B US allergy test market- product launch 1.

ALLERGY TESTING

GLUCOSE COAGULATION

DRUG TESTING SEX HORMONES

TB TESTING CHOLESTEROL

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 Business Strategy

Start with “low hanging

fruit”
Grow technology base
& value
Sell high margin
consumables
Give away hardware
Strategic partnerships
Channel access
Future M&A

8
Allergy Testing
Allergy Testing Today
54.3% of the US population suffers from allergies
US market for allergy testing is $1.2B, growing at 7%
Growing shortage of allergists will not meet future demand
Today’s test is archaic, painful, inaccurate, and inefficient

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 SensiVida Allergy Test
 Features
• Uses FDA-approved allergens
• Allergens applied in a controlled automated
manner
• Optical device analyzes reactions to
allergens
• Low cost, disposable allergen cartridges, Allergy Test
free tester Device
 Advantages
• Real-time results and immediate electronic
records
• Microneedles eliminate pain- allergen dosage is reduced by 30x
• Quantitative analysis versus subjective diagnosis
• Greater accuracy and reproducibility than today’s test
• Takes 10 minutes compared to today’s 35 minutes
• SensiVida test improves Allergist profitability by 25%
• Automatically creates digital electronic records Patient viewing
SensiVida test results
with physician 10
U.S. Allergy Market
MARKET
• 54% of U.S. suffer from allergy
• PCP sees on average 1 patient a day
with allergy symptoms
6M have Skin Prick Tests
32M go untested
• US market = $1.2B, 7% CAGR
• 40 allergens tested- typical
• Skin Prick Test reimbursed $4-$8
per allergen- $5 average
TARGET SEGMENT
• 3800 U.S. Allergists
54% growing practices
=> SensiVida’s primary target
30% stable practices
=> SensiVida’s secondary target
• Growing shortage of Allergists
100 additional grads needed/yr
But, there is attrition of 20/yr
• Long waits to appointments
• Allergists test ~ 4-8 patients/day
Allergy tests are their primary income
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11
 Reduced allergy test
response

12
12
Side-by-side comparison

* SENSIVIDA TEST CONSISTENTLY REDUCES REACTION EXTENT *

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Test accuracy

Today’s test => high

variability
• 20-50% variability common
• Reaction depends on body
location
• Pressure changes allergen-
allergen
• Reaction measured with rulers
3 mm

SensiVida test => low

variability
• <<10% variability common
• Uses same body location
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Reaction Digital Image
Processing
WHEAL

2.72 mm

ANALYSIS

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Flare Area Analysis

FLARE WHEAL

Saturation Binary Mapped,

Raw image
Enhanced Histogram Analyzed

640 x 480 pixels = 307,200 pixels

Each pixel area = (.05625 mm)2 = .003164 mm2
Flare area = .003164 mm2 x 307,200 x .56 = 544 mm2

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Automated Digital
Records

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 Competitive Assessment

In vivo (Skin Tests)

85% of US tests- gold standard
+ High sensitivity, immediate results, low cost
- Test is laborious, subjective, can be stressful to
patient
- Multi-headed tests are faster but still painful, not
digital, inaccurate
“…Yoon, Martin and Carr, with the AAAAI Immunotherapy Committee…
found that single-headed devices were less painful, likely more
sensitive and provided more consistent results than multi-headed
devices. The corner units of multi-headed devices seemed to be more
sensitive than adjacent interior heads.”- AAAAI article, J. Arnold)
Market participants:
Alk Abello, Greer, Hollister-Stier, Allergy Labs of Ohio,
Lincoln Diagnostics

In vitro (Blood Tests)

SensiVida’s
Typically used on infants, patients with test overcomes
dermatitis
+ Quantitative shortcomings of skin tests while
- providing
Results not immediate, costs are 3X higher, notobjectivity of in vitro
tests at a lower cost and with 18
 Development Status
Four patents pending covering allergy testing, two in preparation
Working system prototype
Proof-of-principle clinicals on human subjects with quantitative data (140
tests)
Image science algorithm measures reactions less than 1 mm measured
(± .1 mm)
Reduced reaction extent vs. Skin Prick Test (9x)
Improved coefficient of variation vs. Skin Prick Test (better than 5x)
Manufacturing capabilities through partnerships in place
IRB approval received for clinical testing, KOL in place

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Product Timeline Estimates

Launch
Product
2010 2011
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
FDA Clinicals 510K
Pre-clinical Prototype
Clin. Dosing Commercialization-Launch

In vivo subsystem Integrated Dosing Clinical FDA

efficacy prototypes prototypes study Trial Clearance

Pre-clinical IRB approval, clinical feasibility and end user feed back, clinical plan
Prototype Integrated systemprototype (optics and cartridge)
Clinical dosing Dosing-response clinical study
FDA Clinical Formal clinical trial
510(k) 510(k) submission/clearance
Commercialization-Launch Commercialization readiness- manufacturing/inventory

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Financial Projections

(Allergy Test only)

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 Other Market Applications
siVida’s technology addresses needs in other $B diagnostic mark
Of these, glucose monitoring is by far the largest

ALLERGY TESTING

GLUCOSE COAGULATION

DRUG TESTING SEX HORMONES

TB TESTING CHOLESTEROL

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Glucose Monitoring
Needs

18M diabetics in US, 144M WW

7% growth rate
US cost of diabetes estimated
@ $132B
obesity, heart, kidney disease,
blindness, atherosclerosis,
amputation
Obesity is closely linked to
Type 2 diabetes
~25% of US population considered
obese
Large $8B market for hospital,
Need: automated, less painful
home
test with digital output
But a painless, convenient solution
is lacking 23
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Glucose monitors

Many approaches to replace the fingerstick test have been explored over the last 20 years, for example:
• Subcutaneous “CGM”: sensor inserted into abdomen like infusion set
NIR in vivo: spectral analysis of near infrared by implanted sensor
NIR ex vivo: spectral analysis of near infrared scattered from skin
Ophthalmic: Spectral/fluorescence by retina or aqueous humor
Impedance analysis: glucose migrates to skin- impedance analysis
Ultrasonic: glucose diffusion through skin produced by ultrasound
Photoacoustic: IR light pulse into skin produces acoustic signal
Sampling: Small amount of blood/interstitial fluid drawn for analysis
Today, only continuous glucose monitors (CGM’s) marketed by Dexcom, Medtronics, Abbot have made it into the marketplace
• Unfortunately, CGM’s and fingerstick tests still have major deficiencies
•

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 Today’s glucose monitors
fingerstick

Insertion needle
CGM

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Fingerstick Test
• Most widely used test. However, its deficiencies are driving tech race
• Tester is low cost- profit is in consumable
• 18M US diabetics, 2X tests per day @ $1/test ~ $13B
• Crowded field- push towards reducing blood volume and pain
Bayer, Lifescan, Roche, Therasense...(>20 glucose meters)

Advantages: Reliable gold standard, most accurate method, clinically or self

administered, progress in reducing blood volumes
Disadvantages: Low patient compliance/inconvenient, invasive, long term use
bad on fingers, not continuous, fails to alert during nighttime, poor for Type II’s
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Continuous Glucose Monitors
• Probe is inserted by patient .5” below skin using a 26 gauge needle (below)
• Sensor probe remains in body for 3-7 days after needle is removed
• Readings are taken continuously- patient is informed by alarm if levels are off
• Market participants: Dexcom, Medtronics, Abbott

Insertion needle

Advantages: Continuous measurements, alarm for low/high levels useful for kids and at
nighttime, good for rapid cycling Type I diabetics
Disadvantages: Biofouling/position changes requires 2 calibrations/day min (fingerstick),
2-7 hour “start-up” time, inaccurate “adjunct”, sensor “blind” to its complex
environment- takes average readings, insertion of long needle into abdomen unpleasant,
very poor Value Proposition for Type II diabetics (the vast majority) 27
What Is Needed…
• A continuous/automated glucose monitor that:
Is accurate, not adjunct (e.g. >95% of samples in Zone A of Clarke
plot)
Requires minimal calibration
Is not invasive
Does not clog or is susceptible to “biofouling”
Detects and compensates for complex in vivo environment
Directly samples body fluid (vs. failed “non-invasive” approaches)
Is cost effective
Is a good Value Proposition for Type I and II diabetics
• A system as accurate as the fingerstick test (not adjunct) that is:
Totally painless
Continuous/automated
Wearable and easily transportable
Is a good Value Proposition for Type I and II diabetics

There is no system in the technical/patent literature or in the marketplace

that is able to meet all these requirements
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SensiVida Glucose
Monitor
Features
• Painlessly measures blood glucose
levels
• Automatic readings taken at set
intervals
• Device can be worn
• Automatic data recording and
Advantages
management
• Monitor automation eliminates burden of manual finger prick tests
• Customized to patient’s needs- improves compliance and glucose
management
• Micro lancet array technology eliminates “start-up time”
• Reduces need for calibration compared to other in vivo approaches
• No biofouling or clogging
• No implant necessary- lowers risk of tissue damage and infection
• Good Value Proposition to both Type 1 and Type 2 diabetics 29
 Glucose Monitor Landscape
METHOD STRENGTHS WEAKNESSES PATENTS COMPANIES

Fingerstick Accurate- gold standard Painful, tough on the fingers ~ 500 Roche
Direct blood measurement Poor compliance J&J
Test Quick results User carries several components Abbot
Reimbursed, low cost Inconvenient Bayer

Implantable Automated Limited life- must be replaced, ~ 300 Medtronics

Continuous for 3-7 days costly Dexcom
in vivo Invasive insertion in body, risks
Nighttime alerts Abbott
(CGM) Automatic digital records Long “start-up” >2 calibrations/day
Poor Value Proposition for Type 2’s

Optical and If feasible, best solution Over 20 years of R&D- still no ~ 200 Large number,
Continuous product many no longer
Non Invasive Most convenient to patient Very poor accuracy/reliability active
Potential low cost/per test Has received much investment
Serious scientific/technical issues
remain

Minimally Essentially painless Cannulas/capillary paths can clog ~ 100 Integ/J&J

Some automated, “semi- Fluid extracted from body adds Rosedale/Intuity
Invasive ex continuous” complexity Pelikan
vivo Compact, integrated Fluid handling affects measurement Kumetrics
functionality
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Type 1 and Type 2 diabetic use 31
Glucose Sensors Status

• Four pending patents

• Microneedle prototypes with actuators have been
fabricated
• Non toxic glucose sensing layer demonstrated
• Chemistry detects glucose at concentrations of 20
mg/dL to >400 mg/dL (exceeds useful range)
• Microneedle sensors demonstrated using phantom
models
• Proof of principle with human subject

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Key
People 
• Jose Mir, President & CTO
Over 30 years experience managing innovation and New Business Development. Co-
founder of Eastman Kodak’s incubator. GM of $15M digital motion picture business.
Director of Infotonics Biomedical Initiatives. Founder of SensiVida Medical Systems.
70+ patents and publications.
• Kamal Sarbadhikari, Advisor, former CEO
Over 40 years of start-up/turnaround experience. GM of Bausch and Lomb’s $520M
surgical business. Original 10 person start-up team of B&L’s soft contact lens and
solutions products. Co-founder of Kodak’s consumer battery business and “Picture
Maker” kiosk business.
• Scott Taylor, FDA Advisor (Independent)
Has more than 15 years consulting experience with Diagnostics, Medical Device,
Point-of-Care Testing (POCT), and Pharmaceutical companies facilitating FDA approval
process, reimbursement issues, and CPT Codes.
• John Condemi, M.D., Medical Advisor (Independent)
President of the Allergy Asthma Immunology of Rochester (AAIR) and Director of the
Clinical Research Department and Infusion Center. Fellow of all major
allergy/immunology societies. Over 90 technical papers, 23 chapters, 250 clinical
studies.
• David R. Smith, Chairman of the Board
Former CEO, Chairman and Founding Member of Infotonics Technology Center, Inc.
from 2002 to 2008. Director of Engineering and Technology at Eastman Kodak. 35
years of diverse technology development experience. Board Chair of Optoelectronic
Industry Development Association 33
Key People- continued
•John Agostinelli
Ph.D (Univ. of Rochester) in Optics. 30 years as a Research Fellow at Kodak and Chief
Technologist at Kodak’s Systems Center. Kodak’s “Elite Inventor”. Over 70 patents issued and several
pending.

•Larry DeMejo
PhD. (U. Mass.) in Polymer Science and Engineering. Developed and scaled up impact resistant
composites at General Electric. Expertise in adhesion of small particles on surfaces. Developed Kodak’s
ink jet media technology and novel protective overcoats. Over 80 patents and publications.

•Margy Lydon
Senior level manager with over 20 years experience in operations management, product development
in the medical device field. Former GM of Angiotech BioCoatings, VP of Operations and Product
Development STS Biopolymers.

•Scott Rosebrough
PhD. (Univ. of Rochester) in Pharmacology. Product development experience in Medical Devices
including Director of drug delivery coatings at Angiotech. Medical Device start ups, including Quality
Assurance and Regulatory Affairs.

•John Spoonhower
PhD. (Cornell) in Applied and Engineering Physics. Creator of several multi-hundred million dollar
business enterprises at Kodak. Currently serves as Managing Director of Kauffman Foundation
Innovation interface at Cornell – a multi university project to investigate new businesses at Cornell and
MIT. 56 patents and several pending

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Summary

Revolutionary diagnostics technology

platform

Focused on large medical markets having

unmet needs

Technology is extendable to multiple $B

applications

Strong team having business, R&D, product

development, backgrounds (over 240 patents 35