sensivida medical technologies, inc. (svmt) investor presentation july 2010

8/9/2019 SensiVida Medical Technologies, Inc. (SVMT) Investor Presentation July 2010

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Jose Mir

President, CTO


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Safe HarborStatement 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. Allstatements other than statements of historical facts contained in this presentation,

including statements regarding SensiVidas future results of operations and

financial position, business strategy and plans and SensiVidas 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-lookingstatements are based largely on SensiVidas 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 theforward-looking statements.


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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

Optical microneedles

Penetrate skin painlesslyCoated with FDA approved chemistryProvide window to the physiology

Multispectral image processi

Sees what the eye cannot seeExtracts digital image data

Input to electronic medical records


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e.g. chemical sampling

PREINSERTION

POSTINSERTION

coated needle

1 mm

images/video


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Digital image processing

% D is tr ib u tio n10% 5

% D is tr ib u tio n1

% D is tr i

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

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

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

*


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Market Applications

COAGULATION

SEX HORMONES

GLUCOSE

TB TESTING CHOLESTEROL

DRUG TESTING

ALLERGY TESTING

ber of $B diagnostic markets are addressable with same technroduct targets $1.2B US allergy test market- product launch 1


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Start with low hangingfruitGrow technology base& value

Sell high marginconsumablesGive away hardwareStrategic partnerships

Channel accessFuture M&A

Business Strategy


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Allergy Testing

Allergy Testing Today

54.3% of the US population suffers from allergiesUS market for allergy testing is $1.2B, growing at 7%

Growing shortage of allergists will not meet future demandTodays test is archaic, painful, inaccurate, and inefficient


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SensiVida Allergy Test

Features

Uses FDA-approved allergens

Allergens applied in a controlled automatedmanner

Optical device analyzes reactions toallergens

Low cost, disposable allergen cartridges,free tester

Real-time results and immediate electronicrecords

Advantages

Microneedles eliminate pain- allergen dosage is reduced by 30x

Quantitative analysis versus subjective diagnosis Greater accuracy and reproducibility than todays test

Takes 10 minutes compared to todays 35 minutes

SensiVida test improves Allergist profitability by 25%

Automatically creates digital electronic records

Allergy TestDevice

Patient viewingSensiVida test results

with physician


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U.S. Allergy Market

54% of U.S. suffer from allergy

PCP sees on average 1 patient a day

with allergy symptoms6M 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

3800 U.S. Allergists

54% growing practices

=> SensiVidas primary target

30% stable practices

=> SensiVidas 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

MARKET TARGET SEGMENT


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Reduced allergy testresponse


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Side-by-side comparison

* SENSIVIDA TEST CONSISTENTLY REDUCES REACTION EXTENT *


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Test accuracy

3m

m

Todays test => highvariability

20-50% variability common

Reaction depends on body

location

Pressure changes allergen-allergen

Reaction measured with rulers

SensiVida test => lowvariability


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Reaction Digital ImageProcessing

ANALYSIS

2.72 mm

WHEAL


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Flare Area Analysis

640 x 480 pixels = 307,200 pixelsEach pixel area = (.05625 mm)2 = .003164 mm2

Flare area = .003164 mm2 x 307,200 x .56 = 544 mm2

Raw imageSaturationEnhanced

Binary Mapped,Histogram Analyzed

WHEALFLARE


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Automated DigitalRecords


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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, inaccurateYoon, Martin and Carr, with the AAAAI Immunotherapy Committeefound that single-headed devices were less painful, likely moresensitive and provided more consistent results than multi-headeddevices. The corner units of multi-headed devices seemed to be moresensitive 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)

Typically used on infants, patients with dermatitis+ Quantitative- Results not immediate, costs are 3X higher, not

Competitive Assessment

SensiVidas test overcomesshortcomings of skin tests while

providing objectivity of in vitrotests at a lower cost and with


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Development Status

Four patents pending covering allergy testing, two in preparation

Working system prototype

Proof-of-principle clinicals on human subjects with quantitative data (140tests)

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

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

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 system prototype (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

2010 2011

Pre-clinical PrototypeFDA Clinicals 510K

Clin. Dosing

Produc

Launch

Commercialization-Launch


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Other Market Applications

iVidas technology addresses needs in other $B diagnostic marOf these, glucose monitoring is by far the largest

COAGULATION

SEX HORMONES

GLUCOSE

TB TESTING CHOLESTEROL

DRUG TESTING

ALLERGY TESTING

Gl M i i


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18M diabetics in US, 144M WW7% growth rate

US cost of diabetes estimated@ $132B

obesity, heart, kidney disease,blindness, atherosclerosis,amputation

Obesity is closely linked toType 2 diabetes

~25% of US population consideredobese

Large $8B market for hospital,home

But a painless, convenient solution

is lacking

Need: automated, less painful test with digital output

Glucose MonitoringNeeds


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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 inf rared by implanted sensor

NIR ex vivo: spectral analysis of near infrared scattered from skin

Ophthalmic: Spectral/fluorescence by retina or aqueous h umor

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 bl ood/interstitial fluid drawn for analysis

Today, only continuous glucose monitors (CGMs) marketed by Dexcom, Medtronics, Abbot have made it into the marketplace

Unfortunately, CGMs and fingerstick tests still have major deficiencies


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Todays glucose monitors

Insertion needle

finge

rstick

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 selfadministered, progress in reducing blood volumesDisadvantages: Low patient compliance/inconvenient, invasive, long term usebad on fingers, not continuous, fails to alert during nighttime, poor for Type IIs


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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

Advantages: Continuous measurements, alarm for low/high levels useful for kids and atnighttime, good for rapid cycling Type I diabeticsDisadvantages: 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)

Insertion needle


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What Is Needed

A continuous/automated glucose monitor that:Is accurate, not adjunct (e.g. >95% of samples in Zone A of Clarkeplot)

Requires minimal calibration

Is not invasive

Does not clog or is susceptible to biofouling

Detects and compensates for complex in vivo environmentDirectly 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/automatedWearable 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

S iVid Gl


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SensiVida GlucoseMonitor

Features Painlessly measures blood glucoselevels

Automatic readings taken at setintervals

Device can be worn

Automatic data recording andmanagementAdvantages

Monitor automation eliminates burden of manual finger prick tests

Customized to patients 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


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Glucose Monitor Landscape

METHOD STRENGTHS WEAKNESSES PATENTS COMPANIES

Fingerstick

Test

Accurate- gold standard

Direct blood measurement

Quick results

Reimbursed, low cost

Painful, tough on the fingers

Poor compliance

User carries several components

Inconvenient

~ 500 Roche

J&J

Abbot

Bayer

Implantable

in vivo(CGM)

Automated

Continuous for 3-7 days

Nighttime alerts

Automatic digital records

Limited life- must be replaced,costly

Invasive insertion in body, risks

Long start-up >2 calibrations/day

Poor Value Proposition for Type 2s

~ 300 Medtronics

Dexcom

Abbott

Optical and

Non Invasive

If feasible, best solution

Continuous

Most convenient to patientPotential low cost/per test

Over 20 years of R&D- still noproduct

Very poor accuracy/reliabilityHas received much investment

Serious scientific/technical issuesremain

~ 200 Large number,many no longer

active

Minimally

Invasive exvivo

Essentially painless

Some automated, semi-continuous

Compact, integrated

functionalityType 1 and Type 2 diabetic use

Cannulas/capillary paths can clog

Fluid extracted from body addscomplexity

Fluid handling affects measurement

~ 100 Integ/J&J

Rosedale/Intuity

Pelikan

Kumetrics


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Glucose Sensors Status

Four pending patents

Microneedle prototypes with actuators have beenfabricated

Non toxic glucose sensing layer demonstrated

Chemistry detects glucose at concentrations of 20mg/dL to >400 mg/dL (exceeds useful range)

Microneedle sensors demonstrated using phantommodels

Proof of principle with human subject

Key


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KeyPeople Jose Mir, President &CTO

Over 30 years experience managing innovation and New Business Development. Co-founder of Eastman Kodaks 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 Lombs $520Msurgical business. Original 10 person start-up team of B&Ls soft contact lens and

solutions products. Co-founder of Kodaks consumer battery business and PictureMaker 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 approvalprocess, reimbursement issues, and CPT Codes.

John Condemi, M.D., Medical Advisor (Independent)

President of the Allergy Asthma Immunology of Rochester (AAIR) and Director of theClinical Research Department and Infusion Center. Fellow of all majorallergy/immunology societies. Over 90 technical papers, 23 chapters, 250 clinicalstudies.

David R. Smith, Chairman of the BoardFormer 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 OptoelectronicIndustry Development Association


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Key People- continued

John Agostinelli

Ph.D (Univ. of Rochester) in Optics. 30 years as a Research Fellow at Kodak and ChiefTechnologist at Kodaks Systems Center. Kodaks Elite Inventor. Over 70 patents issued and severalpending.

Larry DeMejoPhD. (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 Kodaksink jet media technology and novel protective overcoats. Over 80 patents and publications.

Margy LydonSenior level manager with over 20 years experience in operations management, product developmentin the medical device field. Former GM of Angiotech BioCoatings, VP of Operations and ProductDevelopment STS Biopolymers.

Scott RosebroughPhD. (Univ. of Rochester) in Pharmacology. Product development experience in Medical Devices

including Director of drug delivery coatings at Angiotech. Medical Device start ups, including QualityAssurance and Regulatory Affairs.

John SpoonhowerPhD. (Cornell) in Applied and Engineering Physics. Creator of several multi-hundred million dollar

business enterprises at Kodak. Currently serves as Managing Director of Kauffman FoundationInnovation interface at Cornell a multi university project to investigate new businesses at Cornell andMIT. 56 patents and several pending


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Summary

Revolutionary diagnostics technologyplatform

Focused on large medical markets havingunmet needs

Technology is extendable to multiple $Bapplications

Strong team having business, R&D, productd l t b k d ( 240 t t

sensivida medical technologies, inc. (svmt) investor presentation july 2010

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