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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Content
Company Overview
Treating Diabetes
Reality
Monitoring Alternatives
The GlucoTrack® Solution
Competitors
Future…
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About Integrity Applications (OTCQB: IGAP)
We are a medical device
company focused on the
design, development and
commercialization of noninvasive glucose monitoring
devices for diabetes patients
Developer of non-invasive glucose monitor, GlucoTrack
R&D began in 2001 (Israel)
Initial prototype completed in late 2003
Methodology patent received October 2005
Incorporated in Delaware in 2010
Became an SEC reporting company on November 14, 2011
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Treating Diabetes
Required:
Education
Diet
Activity
Medications
Monitoring
Or higher chances for Complications!
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In Reality
Education: meaningful lack of knowledge!
Diet: good food around…
Activity: who has the time?
Medications:
o Oral agents; Insulin; Insulin Pump
Self Monitoring of Blood Glucose (SMBG):
o By far less than required!
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Self Monitoring of Blood Glucose
Once in a while (occasionally…) – not enough!
When frequently measured – still low frequency
Lack of data records
Possible fake data
Unreadable data for the clinic
Sporadic measurements
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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
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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Yet Significant Barriers Exist
Pricking the fingertip (ouch…)
Draw blood, infuse drop onto a test strip
Painful; Expensive
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Why GlucoTrack?
Pain: truly non-invasive
Cost: no disposables / 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 sensors
Calibration is required only 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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Individually Consideration
Invasive
Non-Invasive
Under-utilized
Frequently utilized
(Theoretically) Accurate
- when used correctly
Less accurate
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
Expanding distributors - in process
Assigned experienced Director for
International Marketing & Sales
Assigning account managers - in process
Active Scientific Advisory Board
Using Ogilvy CommonHealth (Paris) for
marketing consultancy
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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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Market volume
Total Estimated Market Size for Blood Glucose Monitoring Equipment
and Supplies in Seven Major World Healthcare Markets
2006 - 2016
($Millions)
30,000
25,000
20,000
18,284
18,830
2006
2007
19,407
20,012
2008
2009
20,651
21,324
22,033
22,780
23,567
24,529
25,541
15,000
10,000
5,000
0
2010
2011
2012
2013
2014
2015
2016
Source: Kalorama Information Diabetes and Diabetic Complications March 2007
Self Monitoring of Blood Glucose Market is estimated as $8B In 2010
Source: Pharmalive.com, May 2010
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Road Map for Current Year
Clinical trials for minors, 6-18 years old
PEC with smaller sensors (expanding the market)
Preparation for FDA clinical pathway
Improvements of the device (Model DF-F)
Shortening & simplifying the calibration process
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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: Warns 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
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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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Management
Avner Gal: President & CEO, Chairman (Co-Founder)


Has held multiple senior management positions in the fields of engineering, technology, and
intelligence systems
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)
 Multiple years of experience building and heading operations departments in a variety of
companies
 Substantial background introducing products to market
Ron Roobroeck: Director of Int’l Marketing & Sales



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



Over 15 years of finance experience in global publicly traded companies
Extensive experience in the areas of finance, compliance and financial reporting
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
A choice of invasive vs. non-invasive SMBG
should be considered according to individual
needs
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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