Transcript Company profile, July 2010

Your track to health!...™
A Truly Non-Invasive Glucose Monitor for Self Use
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Disclaimer
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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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 US
Engaged 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
increases
382 million people have diabetes
316 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
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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HbA1c as a Function of SMBG
Source: The American Journal of Medicine, Vol. 111, July 2001
American Diabetes
Association stated in
June 2012:
Reducing HbA1c a
Little Less than 1
Point Reduces
Cardiovascular
Risk by 45% !
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Importance of SMBG Is Recognized!
International Diabetes Federation, 2009
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Why GlucoTrack?
Pain: truly non-invasive
Cost: no incremental cost
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GlucoTrack® Model DF-F
Main Unit (MU)
Personal Ear Clip
(PEC)
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GlucoTrack Unique Approach
Three independent (non-optical) technologies
Attempts (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)
 Unique algorithms
Multi sensor
Calibration is only required every 6 months
Calibration is conducted by a simple process
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Users Acceptance Feedback
(from clinical trials participants)
The device is
easy to use
When available to the
market, I will use the
device consistently
7%
7%
10%
6%
43%
12%
4%
48%
35%
28%
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“…Like an iPod!”
(Prof. Steven Edelman)
Just Clip it! ™
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Compelling Economics
Direct Cost Comparison per User: GlucoTrack Versus Invasive Device
$10,000
$9,000
$8,000
5 invasive measurements daily
Virtually unlimited non-invasive measurements
($1,000)
1
2
Invasive
3
Years
GlucoTrack
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$2,900
$2,700
$2,975
$1,350
$0
($275)
$1,000
$2,100
$2,000
$2,300
$3,650
$3,000
$2,500
$5,475
$4,000
$4,600
$7,300
$5,000
$6,225
$9,125
$6,000
$1,825
Cost / Saving
$7,000
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Saving
Assumptions:
Invasive measurement costs $1.00 each
Retail price for GlucoTrack DF-F: $2,000 (including one PEC)
PEC costs $100; replaced every 6 months
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Clinical Trials and Data
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
Demography:
276 subjects
148M; 128F
36 T1DM; 240 T2DM
Body Mass Index (BMI):
18.9 – 47.3 Kg/m²
Clinical trials, conducted by
third party, covered virtually
the entire demography,
including race and levels of
education
Age: 18 - 81 years
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%
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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Non-Invasive Measurement Advantages
Invasive
Non-Invasive
Under-utilized
Frequently utilized
Complex
Extremely simple use
High cost
Cost-effective
Preparation required
(washing hands, etc.)
Just clip it!™
“Stays in the garage”
(not being used)
“Hits the road”
(frequently used)
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Marketing and Sales
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
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 Australia
o Italy
o Belarus
We intend to add distributors for additional
countries during the balance of 2015
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Marketing and Sales
We are increasing our sales, support and field
engineering teams to assist our distributors in
making sales
We are seeking to hire business development
managers to serve as local liaisons to and manage
relationships with our distributors
We 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
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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 Map
DF-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
1
Echo Therapeutics
(MA, USA)
Ultra Sound
Symphony
(ISF)
2
Grove Instruments
(MA, USA)
Gi-200
3
Cnoga Medical
(Israel)
TensorTip Optical; BioCGM –
parameters;
Combo
Look-up table
4
Freedom Meditech
(CA, USA)
Auto
I Sugar X Fluorescence (in No data
front of the eye)
5
AiMedics
(Australia)
Skin
HypoMon
Bio-sensors
6
Cybiocare Optical
(Quebec, Canada)
OHD
Optical Bridge
Optical
Calibration
Measurement Picture
Comments
12 hours
between
calibrations
Continuous
For ICU;
In clinical
trials
No data
Spot
In clinical
trials
Long process
Many (>200) Spot
points
CE Mark
Approved;
“Selling”
Spot
In R&D
stage
No data
Continuous
Received
CE-Mark;
Like DF-N
No data
Continuous
Like DF-N
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Scientific Advisory Board
Prof. Lutz Heineman (Chairman): Business Development of
Profile Institute for Metabolic Research Ltd., Neuss, Germany
Prof. Michael Heise: University of Applied Science of SouthWestphalia, 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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Management
Avner Gal: President & CEO, Chairman (Co-Founder)
o Has held multiple senior management positions in the fields of engineering, technology, and
intelligence systems
o 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
companies
o Substantial background introducing products to market
Ron Roobroeck: Director of Int’l Marketing & Sales
o
o
o
Over 20 years of international experience of marketing, sales and business development
Background in pharmaceutical, medical devices, biotech and diagnostic field
Experience gained from Novartis, Roche, Medtronic, Cyberonics and Terumo
Eran Hertz: CFO
o Over 15 years of finance experience in global publicly traded companies
o Extensive experience in the areas of finance, compliance and financial reporting
o Certified Public Accountant in Israel and in the USA
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Conclusions
The 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
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 options
Approximately 5.35 million shares of common stock
are issuable upon exercise of outstanding warrants
Approximately 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!...™
www.integrity-app.com
Thank You!
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