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Your track to health!...™Your track to health!...™
A Truly Non-Invasive Glucose Monitor for Self Use
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
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
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
HbA1c as a Function of SMBGSource: The American Journal of Medicine, Vol. 111, July
2001
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American Diabetes Association stated in June 2012:
Reducing HbA1c a Little Less than 1 Point Reduces
Cardiovascular Risk by 45% !
Importance of SMBG Is Recognized!
11International Diabetes Federation, 2009
Why GlucoTrack?
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no incremental costPain: truly non-invasiveCost:
GlucoTrack® Model DF-F
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Main Unit (MU)
Personal Ear Clip (PEC)
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)
“…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
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
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
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
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!
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