sensivida medical technologies allergy products presentation

8/9/2019 SensiVida Medical Technologies Allergy Products Presentation

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Jose Mir

President, CTO

[email protected]


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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 painlesslyoupled with FDA approved chemistry

Arrays allow multiple tests in parallel

Multispectral image processi

Sees what the eye cannot seeExtracts digital image data

Input to electronic medical records


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Grow technology base& valueSell high marginconsumables

Give away hardwareStrategic partnerships

Channel accessFuture M&A

Business Strategy


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SensiVida Allergy Skin Test

Summary

IRB approval for clinical testing: non-significant risk

Uses FDA-approved allergens

Allergens applied in a controlled,automated manner

Optical device analyzes reactions toallergens

Low cost, disposable allergen cartridges,free tester

Real-time results, electronic records (EMR)

Advantages

Microlancets eliminate pain, allergen dosage is reduced by 30x

Novel image processing for precise, fine reaction analysis

Quantitative versus todays subjective measurements

Greater accuracy and reproducibility than todays test

Fast patient prep, one step test, faster kinetics, instant EMR

SensiVida test improves Allergist profitability by 25%

Allergy TestDevice

Patient viewing

SensiVida test resultswith nurse


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Micro-lancetArrays

Individually Actuated

Microlancet

Height: 400-700 mmTip diameter: ~ 10 m

SEM of MicrolancetArray

Packaged Cartridge

Batch fabricated using MEMS technoCurrently use transparent quartz

Plastic molded also possible


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SUBJECT

llergy Test: Actuation

ACTUATIONREACTION

IMAGE CAPTURE SYSTEM


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REDUCED REACTION

ose-Response Model


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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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Digital ImageProcessing

Optoelectronics and image processingare competencies in team and region

KodakXeroxITTRochester Photonics Cluster

University of RochesterRochester Institute of Technology

Optoelectronic Module Allergic Wheal/Flare Processing


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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 pixels

Each pixel area = (.05625 mm)2 = .003164 mm2

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

Raw imageSaturation

EnhancedBinary Mapped,

Histogram Analyzed

WHEALFLARE


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Wheal Growth Kinetics

Wheal Size vs. time (8/7/0

0

0.5

1

1.5

2

2.5

3

3.5

0 5 10 15 20

minutes

Dia

meter(mm)

pc 1

pc2

rw1

rw2

rw3


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Test accuracy

3m

m

Todays test => highvariability

20-50% variability common

Reaction depends on body location

Pressure/penetration change

Reaction measured visually withrulers

SensiVida test => lowvariability


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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:

Greer, Alk Abello, Hollister-Stier, Allergy Labs of Ohio,Lincoln Diagnostics

In vitro

Typically used on infants, patients with dermatitis+ Quantitative

- Results not immediate, costs are 3X higher, typ. notreimbursed

Competitive Assessment

SensiVidas test overcomesshortcomings of skin tests while

providing objectivity of in vitrotests at a lower cost and with


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Primary BusinessResearch

Summaries of three separate data gathering activities:1) Telephone and in-person interviews (15 nurses, 2 allergists)

Interest in test objectivity

Digital patient record a plus

Cost must be lower than todays test for adoption

2) Personal meetings and in-depth interviews with 6 allergists(prototype shown)

Provides much needed standardization, objectivity

Opens up skin testing for kids

May be useful for dark-skinned individuals

Test likely to be adopted if it performs as expected

Full combination of features important

Potential labor savings important

3) Telephone interviews with 13 allergists and immunologists Dx standardization has merit

Useful if automation is truly possible Has to be cost effective- would adopt if


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Value Chain: Supplier-Allergist

Skin Prick Test: CPT code 95004, $4 - $8 reimbursed/allergentested

Pre-packaged allergen-lancet cartridge is a value add

Allergist: Increases practice productivity, reduces test time

Supplier: Increases revenue and margin per tested allergen

Example (40 allergen cartridge)

Mfg cost ~ $10 (quartz)

Selling price ~ $40

Revenue/allergen ~ $1, GM ~ 65%

Test reimbursement ~ $200 (assume $5/allergen) Estimated SensiVida test cost to allergist (mtls., labor, overhead)

~ $72

Estimated test cost per allergen to allergist ~ $1.80

anced revenue per test to supplier, reduced test cost to allerg

ll i h


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Allergy Patients- theNumbers

Allergists(US total 3800)

Pharmacy

Do Nothing

PCPs

GPs (73,300)

Internists (85,600)

Pediatricians (43,000)

(1 patient/day/doc)

54.3% of US Population Suffer From Allergies

Referral

Prescription/OTC Rx

invitrotest(lab)

Suffer Symptoms

Blood Work

40Mpatients/yr

with AllergySymptoms

6M have Skin Test

2M have in vitro Test

32M untested

Target: 1/3of untested

Retail clinics

Target: 1/3of untested

Retail clinics

Target: 1/3docsEarly

adopters

Target: 1/3docsEarly

adopters


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Business Strategysell disposables, give away hardware

SECOND PRODUCT: GP OFFICE AND REFERRED

Patients allergy

symptoms

(40M/year)

Clinics

Retail (e.g. CVS)

Health Care Nets

General

Practitioner

CLINIC REFERRAL

SENSIVIDA TEST

15 ALLERGENS

RECORDS MANAGEMENT SERVICES

2011 LAUNCH

WALK-INS

Patients allergy

symptoms

(40M/year)

Clinics

Retail (e.g. CVS)

Health Care Nets

General

Practitioner

CLINIC REFERRAL

SENSIVIDA TEST

15 ALLERGENS


2011 LAUNCH

WALK-INS

Clinics

Retail (e.g. CVS)

Health Care Nets

General

Practitioner

CLINIC REFERRAL

SENSIVIDA TEST

15 ALLERGENS


Targets

$25 cartridge ASP

Targets

$25 cartridge ASP

Targets1/3 untested patients$25 cartridge ASP

Free HardwareSoftware license

2012 LAUNCH

SECOND PRODUCT: SCREEN PANEL

WALK-INS

Patients allergy

symptoms

(40M/year)

General

Practitioner

Allergists

(Early adopters)

40 allergens

REFERRAL

2010 LAUNCH

MARKET ENTRY: EARLY ADOPTER ALLERGISTS

Patients allergy

symptoms

(40M/year)

General

Practitioner

Allergists

(Early adopters)

40 allergens

Targets

$40/cartridge ASPFree H/S

Targets

1/3 total allergists$40/cartridge ASP

Free H/S

REFERRAL

2011 LAUNCH

MARKET ENTRY: EARLY ADOPTER ALLERGISTS


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Financial Projections

(Allergy Test only)


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Development Status

Four patents pending covering allergy testing, two in preparation

Working system prototypes

IRB approval for clinical testing

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

Image science algorithm measures reactions less than 1 mm measure( .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


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K


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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.

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.

Scott Taylor, FDA and Reimbursement 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.

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 Chief Technologist atKodaks Systems Center. Kodaks Elite Inventor. Over 70 patents issued and several pending.

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.

Ram Dhurjaty

Ph.D (Yale) in Biomedical Engineering. President of Dhurjaty Consultants, a company that designs anddevelops bio-medical devices and electro-optical systems. 30 years of creating and managing winningEng. Teams at Bose, Analogic Corp., Beckton Dickinson and Kodak.

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

sensivida medical technologies allergy products presentation

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