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

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

3

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

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

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% !

Why GlucoTrack?

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no incremental cost

Pain: truly non-invasive

Cost:

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 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)

“…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

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

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

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)

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

Google

(USA)

Google Lens Tear Drops Continuous

Novio Sense

(Germany)

NovioSense Enzymatic

Detection

Continuous

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

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

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

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