SensiVida Medical Technologies, Inc. (SVMT) Investor Presentation July 2010
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Transcript of 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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3131
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