11 Your track to health!... ™ A Truly Non-Invasive Glucose Monitor for Self Use.

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1 Your track to health!... A Truly Non-Invasive Glucose Monitor for Self Use

Transcript of 11 Your track to health!... ™ A Truly Non-Invasive Glucose Monitor for Self Use.

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Your track to health!...™Your track to health!...™

A Truly Non-Invasive Glucose Monitor for Self Use

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This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and various provisions of the U.S. Securities Act of 1933, as amended, and the U.S. Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, included in this presentation are forward-looking statements. Forward-looking statements included in this presentation address, among other things, our future product development activities, strategies and timing of seeking regulatory approval to market our current product candidate. These statements are based on certain historical trends, current conditions and expected future developments as well as other factors the Company believes are appropriate in the circumstances. In addition to statements which explicitly describe these risks and uncertainties, readers are urged to consider statements labeled with the terms “expects”, “anticipates” and other similar words and phrases to be uncertain and forward-looking. All of the forward-looking statements made in this presentation are qualified by these cautionary statements and there can be no assurance that the actual results anticipated by the Company will be realized or, even if substantially realized, that they will have the expected consequences to or effects on the Company or its business or operations. Whether actual results will conform to the Company’s expectations and predictions is subject to a number of risks and uncertainties that may cause actual results to differ materially. See  the risks described in our reports filed with the Securities and Exchange Commission, including under the heading "Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2014.

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Disclaimer

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About Integrity Applications (OTCQB: IGAP)

CE Mark approval for a 6 month calibration of GlucoTrack® Model DF-F (March 2014)13 distribution agreements with minimum sales quota of $28M (in order to maintain exclusivity; subject to local registration)Recruited a Director of International Marketing and Sales with proven history of launching new pharmaceutical and medical device products (July 2014)Engaged Wistron (Taiwan), a Tier 1 contract manufacturer (July 2014)

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About Integrity Applications (OTCQB: IGAP)

Completed an $8.5M Series B offering (December 2014)Formed a Scientific Advisory Board with Members that are recognized as Key Opinion Leaders and Top Tier scientists (February 2015)Expected submission of pre-submission documents to the US FDA for clinical trials in the USEngaged Ogilvy CommonHealth (Paris) to create a marketing and communication campaign, designed to increase awareness of the GlucoTrack

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Prevalence of Diabetes: 20-79 Years Old

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Prevalence of Diabetes: 20-79 Years Old

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Challenges with Self Monitoring of Blood Glucose

Vast majority of Diabetics do not follow the IDF guideline on the daily number of spot measurements of blood glucose

Conventional (invasive) devices for spot measurement of blood glucose are painful

Conventional (invasive) devices for spot measurement of blood glucose are expensive

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Worldwide Statistics

The number of Type 2 diabetics constantly increases382 million people have diabetes316 million people have Impaired Glucose Tolerance (IGT)175 million people are undiagnosed as diabetics�Diabetes caused 5.1 million deaths in 2013�Every 7 seconds a person dies from Diabetes�11% of worldwide healthcare expenditures were spent on diabetes care

Source: Diabetes Atlas, 6th Edition, Rev. 2014

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Benefits of Frequent Glucose Monitoring

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Frequent glucose monitoring is an essential

component to effective diabetes management

The Diabetes Control and Complications Trial

(DCCT) demonstrated that intensive management

reduced the risk of complications by: 76% for eye disease 60% for nerve disease 50% for kidney disease

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Importance of SMBG Is Recognized!

11International Diabetes Federation, 2009

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Why GlucoTrack?

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no incremental costPain: truly non-invasiveCost:

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GlucoTrack® Model DF-F

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Main Unit (MU)

Personal Ear Clip (PEC)

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Three independent (non-optical) technologiesAttempts (by others) to develop non-invasive glucose monitors have mostly been based upon optical technologies, and have not been successful

Patented combination of technologies (simultaneously): Ultrasound Electromagnetic (Conductivity)

Thermal (Heat Capacity)

Multi sensor

Calibration is only required every 6 months

Calibration is conducted by a simple process14

GlucoTrack Unique Approach

Unique algorithms

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Users Acceptance Feedback

The device is easy to use

When available to the market, I will use thedevice consistently

48%

35%

6%

7%4%

43%

28%

12%

10%

7%

(from clinical trials participants)

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“…Like an iPod!” (Prof. Steven Edelman)

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Just Clip it! ™

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Compelling Economics

1 2 3 4 5($1,000)

$0

$1,000

$2,000

$3,000

$4,000

$5,000

$6,000

$7,000

$8,000

$9,000

$10,000 $1

,825

$3,6

50

$5,4

75

$7,3

00

$9,1

25

$2,1

00

$2,3

00

$2,5

00

$2,7

00

$2,9

00

($27

5) $1,3

50

$2,9

75

$4,6

00

$6,2

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Invasive GlucoTrack SavingYears

Cos

t / S

avin

g

5 invasive measurements dailyVirtually unlimited non-invasive measurements

Assumptions: Invasive measurement costs $1.00 eachRetail price for GlucoTrack DF-F: $2,000 (including one PEC)PEC costs $100; replaced every 6 months

Direct Cost Comparison per User: GlucoTrack Versus Invasive Device

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Clinical Trials and Data

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Initial trials involving more than 25,000 readings from over 450 patients during the past 8 years

Clinical data collected since 2009 indicate positive correlation between GlucoTrack model DF-F readings and those obtained from conventional invasive devices

Safety and performance clinical trial conducted on 135 subjects, yielded 6,275 measurements, of which 96.5% were within clinically acceptable (A & B) zones of the Clarke Error Grid

Expected to begin clinical trials in United States in 2015, pending U.S. FDA protocol approval

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GlucoTrack Results

CEG Zone

Data Points Percent A+B

Zones

A 4,309 46% 97%

B 4,730 51%

C 180 2%

D 135 1%

E 5 0%

Total 9,359 100%

Demography:

276 subjects

148M; 128F

36 T1DM; 240 T2DM

Body Mass Index (BMI):

18.9 – 47.3 Kg/m²

Age: 18 - 81 years

Clinical trials, conducted by third party, covered virtually

the entire demography, including race and levels of

education

97% of the results fall into the clinically acceptable A&B zones of the Clarke Error

Grid (CEG)

GlucoTrack model DF-F has CE Mark approval

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Frequently utilized

Extremely simple use

Cost-effective

Just clip it!™

“Hits the road”(frequently used)

Under-utilized

Complex

High cost

Preparation required (washing hands, etc.)

“Stays in the garage”(not being used)

Non-Invasive Measurement Advantages

Invasive Non-Invasive

InvasiveNon-Invasive

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Marketing and Sales

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Sales are conducted through distributors

Distributors are cleared to sell in:

Turkey Philippines

Thailand Spain

Hong-Kong Lithuania

Uruguay Latvia

Estonia

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Marketing and Sales

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GlucoTrack is pending approval for sale in the following countries:o China (expected in 12 months) o Japan (expected in 18 months)o South Korea (expected in 6 months)o Australiao Italyo Belarus

 

We intend to add distributors for additional countries during the balance of 2015

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We are increasing our sales, support and field engineering teams to assist our distributors in making salesWe are seeking to hire business development managers to serve as local liaisons to and manage relationships with our distributorsWe have hired a Coordinator of Social Media to both monitor social network activity with respect to diabetics and blood glucose measurement devices, and to assist in publicizing GlucoTrack through social networking activity

Marketing and Sales

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Road Map for Current Year

Shortening & simplifying the calibration process

Improvements of the device (Model DF-F)

Expect to ramp commercial sales of GlucoTrack

Preparation for FDA clinical pathway

Development of PEC with smaller sensors

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Contract Manufacturers

Provide full turn-key manufacturing services

o AY Electronics (Israel)

o Wistron Corporation (Taiwan,

manufacturing arm of Acer Computers) 

Wistron expects its production line to be operational in the 3rd quarter of 2015

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Long Term Products Road MapDF-B: Basic model for use in developing countries

DF-C: Continuous monitoring of glucose level

DF-N: Provides Night time advanced warning of hypoglycemic episodes

DF-D: Warn Drivers of low glucose level

DF-I: System for pediatric Incubators

DF-P: Device for (IGT) Pre-diabetic patients

The Company doesn’t guarantee that it eventually will develop all or part of these models.

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Competitive Landscape# Company Product Technology Calibration Measurement Picture Comments

1 Echo Therapeutics (MA, USA) Symphony

Ultra Sound(ISF)

12 hours between calibrations

ContinuousFor ICU;In clinical trials

2Grove Instruments(MA, USA)

Gi-200 Optical Bridge No data Spot In clinical trials

3Cnoga Medical(Israel)

TensorTip CGM – Combo

Optical; Bio-parameters; Look-up table

Long process Many (>200) points

SpotCE Mark Approved;“Selling”

4 Freedom Meditech (CA, USA) I Sugar X

Auto Fluorescence (in front of the eye)

No data Spot In R&D stage

5AiMedics (Australia)

HypoMonSkin Bio-sensors

No data ContinuousReceived CE-Mark;Like DF-N

6 Cybiocare Optical (Quebec, Canada) OHD Optical No data Continuous Like DF-N

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Scientific Advisory BoardProf. Lutz Heineman (Chairman): Business Development of Profile Institute for Metabolic Research Ltd., Neuss, Germany

Prof. Michael Heise: University of Applied Science of South-Westphalia, Iserlohn, Germany

Prof. Mark A. Arnold: Professor of Laser Chemistry at the University of Iowa

Prof. Jens Sandahl Christiansen: Clinical professor at the Department of Endocrinology and Diabetes of Aarhus University Hospital, Denmark

Prof. Jan Bolinder: Professor of Clinical Diabetes Research at the Department of Medicine, Huddinge, Sweden

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ManagementAvner Gal: President & CEO, Chairman (Co-Founder)o Has held multiple senior management positions in the fields

of engineering, technology, and intelligence systemso Served as development engineer and help initialize and bring to life Electronic Warfare

combat suite on board the fleet of the Israeli Navy ships

David Malka: Executive VP & COO (Co-Founder)o Multiple years of experience building and heading

operations departments in a variety of companieso Substantial background introducing products to market

Ron Roobroeck: Director of Int’l Marketing & Saleso Over 20 years of international experience of marketing, sales and business developmento Background in pharmaceutical, medical devices, biotech and diagnostic fieldo Experience gained from Novartis, Roche, Medtronic, Cyberonics and Terumo

Eran Hertz: CFOo Over 15 years of finance experience in global publicly traded companieso Extensive experience in the areas of finance, compliance and financial reportingo Certified Public Accountant in Israel and in the USA

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ConclusionsThe benefits of GlucoTrack will encourage people with diabetes to use it more frequently and regularly

Non-Invasive glucose monitoring

for home use was a dream.

Now it’s reality!

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Capitalization

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Approximately 5.32 million shares of common stock outstanding (December 31, 2014)Approximately 503,989 shares of the Company’s common stock are issuable upon exercise of outstanding stock optionsApproximately 5.35 million shares of common stock are issuable upon exercise of outstanding warrantsApproximately 2.74 million shares of common stock are issuable upon conversion of outstanding shares of convertible preferred stock

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Your track to health!...™Your track to health!...™

Thank You!

www.integrity-app.com