A Truly Non-Invasive Glucose Monitor for Self Use · 2016-04-22 · DF-C: Continuous monitoring of...
Transcript of A Truly Non-Invasive Glucose Monitor for Self Use · 2016-04-22 · DF-C: Continuous monitoring of...
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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)
Regulatory Progress
CE Mark approval for a 6 month calibration of
GlucoTrack® Model DF-F (March 2014)
CE Mark approval for improved device (short
calibration (<30 min.) and intended to use also by
pre-diabetics) of GlucoTrack® Model DF-F
(August 2015)
CE Mark approval for improved device (better
accuracy and glucose tracking) of GlucoTrack®
Model DF-F (December 2015)
Annex II certification from the European Union
(EU) (February 2016)
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About Integrity Applications (OTCQB: IGAP)
Regulatory Progress
Submitted pre-submission documents to the US FDA
for clinical trials in the US (August 2015)
Met with the US FDA for initiating the regulatory
process in the US (October 2015). Expected to begin
trials in US 1H/16, pending FDA approvalProgressing with CFDA for Chinese regulatory
approval (on going)
Progressing with KFDA for South Korea regulatory
approval (on going)
Progressing with PMDA for Japanese regulatory
approval (on going)
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About Integrity Applications (OTCQB: IGAP)
General Progress
15 distribution agreements with minimum sales
quota of $28M (in order to maintain exclusivity) -
subject to local registration
Engaged Wistron (Taiwan), a Tier 1 contract
manufacturer (July 2014)
Recruited Director of International Marketing and
Sales with proven history of launching new
pharmaceutical and medical device products (July
2014)
Recruited International Sales Manager to enhance
commercialization (January 2016)
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About Integrity Applications (OTCQB: IGAP)
General Progress
Recruited Chief Operating Officer (COO) to
enhance commercialization (January 2016)
Recruited (and keep recruiting) regional Business
Development Managers with proven sales
experience in the Diabetes field (on going)
Formed a Scientific Advisory Board with
Members that are recognized as Key Opinion
Leaders and Top Tier scientists (February 2015)
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 in Self Monitoring of Blood
Glucose (SMBG)
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
Conventional (invasive) devices are subject to
human factors which (meaningfully) decrease the
accuracy of the measurement
(IDF: International Diabetes Federation)
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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
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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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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% !
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Why GlucoTrack?
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no incremental cost
Pain: truly non-invasive
Cost:
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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 sensors
Calibration is only required every 6 months
Calibration is conducted by a simple (short) process
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GlucoTrack Unique Approach
Unique algorithms
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Calibration Process
Short (less than half an hour);
Simple (3 data pairs) process;
Required only when replacing PEC (every 6 months)
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“…Like an iPod!” (Prof. Steven Edelman)
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Just Clip it! ™
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Compelling Economics
$1
,82
5
$3
,65
0
$5
,47
5
$7
,30
0
$9
,12
5
$2
,10
0
$2
,30
0
$2
,50
0
$2
,70
0
$2
,90
0
($2
75
)
$1
,35
0
$2
,97
5
$4
,60
0
$6
,22
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 2 3 4 5
Co
st /
Sa
vin
g
Years
Invasive GlucoTrack Saving
5 invasive measurements daily
Virtually unlimited non-invasive measurements
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
Direct Cost Comparison per User: GlucoTrack Versus Invasive Device
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Clinical Trials and Data
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Accumulated clinical trials involving more than25,000 readings from over 750 subjects duringthe past 10 years
Safety and performance clinical trial conductedon 135 subjects, yielded 6,275 measurements, ofwhich 96.5% were within clinically acceptable (A& B) zones of the Clarke Error Grid
Latest software version data (14,656 data points,collected from 187 Type 2 subjects) demonstrateimproved correlation between GlucoTrack modelDF-F readings and those obtained fromconventional invasive devices
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GlucoTrack Latest Version Accuracy
CEG Zone Mean
ARD [%]
Median
ARD [%]
MAD
[mg/dL]A+B A B C D E Total
% 97.3 52.9 44.5 0.4 2.3 0.0 100.0
23.4 18.7 33.6# 14,264 7,748 6,516 58 333 1 14,656
187 participants with T2DM
Category Group # of subjects
Gender
Male 97
Female 90
Age
18-60 years 88
60+ years 99
BMI
15-25 kg/m2 24
25-30 kg/m2 80
30+ kg/m2 83
97.3% in the
clinically
acceptable A+B
zones
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GlucoTrack Versions Improvement
96.0% 96.0%
97.3%
ver. A* ver. B ver. C
Clarke Error Grid (CEG) Zones A+B
42.7%
47.2%
52.9%
ver. A* ver. B ver. C
CEG Zone A
* Version A was tested on 172 subjects
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GlucoTrack Versions Improvement
* Version A was tested on 172 subjects
29.8%
24.5%23.4%
ver. A* ver. B ver. C
Mean Absolute Relative Difference (ARD)
23.8%
21.2%
18.7%
ver. A* ver. B ver. C
Median ARD
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Glucose Trends Examples
Meal
Subject #2
Post-prandial
Time after meal (hours)
Glu
co
se (
mg
\dL
)
-1 -0.5 0 0.5 1 1.5 2
Subject #4
Pre-prandial
Meal
Post-prandial
Time after meal (hours)
Glu
co
se (
mg
\dL
)
-1 -0.5 0 0.5 1 1.5 2
Subject #1
Mea
l
Pre-prandial Post-prandial
Time after meal (hours)
Glu
co
se (
mg
\dL
)
-1 -0.5 0 0.5 1 1.5 2
Pre-prandial
Subject #3
Meal
Post-prandial
Glu
co
se (
mg
\dL
)
-1 -0.5 0 0.5 1 1.5 2
Time after meal (hours)M
ea
l
Post-prandial
Meal
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Glucose Trends Examples
Meal
Pre-prandial Post-prandialGlu
co
se (
mg
\dL
)
Time after meal (hours)
Subject #6Subject #5
Meal
Pre-prandial Post-prandial
-1 -0.5 0 0.5 1 1.5 2
Time after meal (hours)
Glu
co
se (
mg
\dL
)
Subject #8
Meal
Pre-prandial Post-prandial
Glu
co
se (
mg
\dL
)
-1 -0.5 0 0.5 1 1.5 2
Time after meal (hours)
Subject #7
Meal
Pre-prandial Post-prandialGlu
co
se (
mg
\dL
)
Time after meal (hours)
-1 -0.5 0 0.5 1 1.5 2
-1 -0.5 0 0.5 1 1.5 2
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Marketing and Sales
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Sales are conducted through distributors
Distributors are cleared to sell in:
Israel Turkey
Thailand Spain
Hong-Kong Lithuania
Uruguay Latvia
Estonia Italy
Philippines Switzerland
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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 7-10 months)
o Japan (expected in 12-18 months)
o South Korea (expected in 1-2 months)
o Australia
o Belarus
We intend to add distributors for additional
countries throughout the year
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We are increasing our sales, support and field
engineering teams to assist our distributors in
making sales
We hired and keep seeking to hire more business
development managers to serve as local liaisons
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
Marketing and Sales
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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
Approved by 2Q/16 (currently in pilot
production)
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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 cannot provide any assurance that it will develop all or any of these models
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Competitive Landscape
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Company Product Technology Measurement Picture
Cnoga Medical
(Israel)
TensorTip
CGM – Combo
Optical; Bio-
parameters;
Look-up table
Spot
GlucoWise
(UK)
GlucoWise Radio Waves Spot/claim
continuous
Echo
Therapeutics
(MA, USA)
Symphony Ultra Sound
(ISF)
Continuous, for
ICU
(USA)
Google Lens Tear Drops Continuous
Novio Sense
(Germany)
NovioSense Enzymatic
Detection
Continuous
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Scientific Advisory Board
Prof. Lutz Heinemann (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. Jan Bolinder: Professor of Clinical Diabetes Research at
the Department of Medicine, Huddinge, Sweden
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Management
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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
Eran Cohen: COOo Over 17 years of extensive and diversified experience in global executive roles in variety of
high-tech and bio-med companies
o Domestic and overseas experience in the areas of operations
David Malka: Executive VP Operations (Co-Founder)
o Multiple years of experience building and heading operations departments in a variety of
companies
o Substantial background introducing products to market
Eran Hertz: CFOo 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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Management
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Eugene Naidis: Project Managero Extensive experience in software development and management of R&D projects
o lead complex projects in the field of industrial and medical measurement applications
o Invention of a symbiotic and revolutionary approach of a measurement technology
Ron Roobroeck: Director of Int’l Marketing & Saleso Over 20 years of international experience of marketing, sales and business development
o Background in pharmaceutical, medical devices, biotech and diagnostic field
o Experience gained from Novartis, Roche, Medtronic, Cyberonics and Terumo
Erin Berry: Marketing Manager & Executive Assistanto Large experience in mass media and international trading in the global marketplace
o Background and experience in brand marketing of a number of retail products
Yulia Mayzel: Executive Research Engineero Over 10 years experience of working in clinical and scientific research, including data
analysis and algorithm development
o Extensive knowledge in pharmaceutical, medical devices, biotech and diagnostic field
• Eran
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Capitalization (as of December 31, 2014)
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Approximately 5.32 million shares of common stock
outstanding
Approximately 2.74 million shares of common stock
are issuable upon conversion of outstanding shares
of convertible preferred stock
Approximately 5.35 million shares of common stock
are issuable upon exercise of outstanding warrants
Approximately 0.50 million shares of the Company’s
common stock are issuable upon exercise of
outstanding stock options
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Your track to health!...™
Thank You!
www.integrity-app.com