Presentation on theme: "1 Your track to health!... ™ December 2013 (OTCQB: IGAP)"— Presentation transcript:
1 Your track to health!... ™ December 2013 (OTCQB: IGAP)
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, 2012. 2 Disclaimer
Integrity Applications 3 Company Overview; Glucose Monitoring; GlucoTrack®; Market Opportunities; Financial Highlights; Future Achievements and Milestones.
4 About Integrity Applications (OTCQB: IGAP) We are a medical device company focused on the design, development and commercialization of non- invasive 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.
Advances in Blood Glucose Monitoring 5 1965197119811986 19871993 2002 2006 A strip of paper changes its color according to the patient’s glucose level Meter interprets more accurately the light reflected by a color on the meter into a readable number Glucometer (Bayer) becomes the first home glucose monitoring device FDA, CDC and ADA discuss SMBG: key tool in diabetes treatment Industry begins to produce lower-cost home glucose meters, allowing better access to more patients Study shows that patients who conduct SMBG reduce chances for complications (76% for eye disease, 50% for kidney disease and 60% for nerve disease) First continuous glucose monitoring via a device implanted under the skin is released Cygnus introduces GlucoWatch. Causes skin irritation, thus cannot be called “non- invasive”
Benefits of Frequent Glucose Monitoring 6 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.
HbA1c as a Function of SMBG HbA1c as a function of SMBG measurements per day (Source: Diabetes Atlas, 2 nd edition, 2003) 7 ADA (June 2012): Reducing HbA1c a Little Less than 1 Point Reduces CV Risk by 45%
Yet Significant Barriers Exist Prick the fingertip (ouch…) Draw blood, infuse drop onto a test strip Painful; Expensive 9
Why GlucoTrack? 10 Removes or diminishes the two most significant barriers in glucose monitoring: Pain (truly non-invasive); Cost (no disposables). The only device uses three independent technologies; Patented proprietary algorithm.
GlucoTrack ® Model DF-F 12 Main Unit (MU) Personal Ear Clip (PEC)
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) Infrequent re-calibrations (*), by simple process Current model, DF-F: Spot measurement device 13 GlucoTrack Unique Approach Unique algorithms
GlucoTrack Features & Benefits 14 Easy to operate; User friendly (Just clip it! ™ ) Clear and simple instructions Color touch screen Large digits and Audible result within a minute History graph and list of past 1000 readings Average glucose level calculated displayed Glucose average within desired points of time Calculated HbA1c level (estimated) Easy to download data to external storage device Main Unit supports up to 3 users (individually calibrated) Measurement alerts (pre-set by users)
“…Like an iPod!” (Prof. Steven Edelman) Just Clip it! ™ 15
Clinical and Development Milestones 16 Preclinical trials involving 7,000+ readings from 450+ patients over the last 7 years; Clinical data collected since 2009 indicate positive correlation between GlucoTrack 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 zones of the Clarke Error Grid; Expected to begin clinical trials in United States in 2014, pending U.S. FDA protocol approval.
Advances in Blood Glucose Monitoring 17 GlucoTrack model DF-F, A truly non-invasive glucose monitor has gained CE Mark approval June 2013 June 2013: Received CE Mark approval for GlucoTrack in Europe
18 GlucoTrack Results CEG Zone Data Points Percent A+B Zones A4,30946%97% B4,73051% C1802% D1351% E50% Total9,359100% Demography: 276 subjects 148M; 128F 36 T1DM; 240 T2DM Body Mass Index (BMI): 33.1+/- 14.2 Kg/m2 Age: 49.5 +/- 31.5 years Clinical trials, conducted by third party, covered virtually the entire demography, including skin colors 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
Marketing and Sales 19 Total cost of the device (including ear clips) over the useful life anticipated to be substantially lower than the cost of conventional glucose meters and testing strips (see figure on next slide); Lower initial financial burden of purchasing GlucoTrack by: Leasing the device to users; Obtaining coding and reimbursement approval for GlucoTrack from third party vendors (including government and other third party vendors); Worldwide sales through distributors.
20 Compelling Economics 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; Excludes re-calibration costs, which are expected to be approximately $70, in total, over a five year period.
21 Prevalence of Diabetes: 20-79 Years Old Source: IDF Diabetes Atlas, 5 th Edition, 2011
Market volume 23 18,284 18,830 19,407 20,012 20,651 21,324 22,033 22,780 23,567 24,529 25,541 0 5,000 10,000 15,000 20,000 25,000 30,000 20062007200820092010201120122013201420152016 Total Estimated Market Size for Blood Glucose Monitoring Equipment and Supplies in Seven Major World Healthcare Markets 2006-2016 ($Millions) 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
Medical Costs & Expected Growth 24 The U.S. Center for Disease Control and Prevention estimated that the direct medical costs and indirect expenditures attributable to diabetes in the U.S. were $174 billion in 2007; The International Diabetes Federation estimated that worldwide healthcare expenditures to treat diabetes and prevent its complications would totally cost at least $465 billion in 2011, and $595 billion in 2030.
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! 25
Competitive Landscape #CompanyProductTechnologyCalibrationMeasurementPictureComments 1 Echo Therapeutics (MA, USA) Symphony Ultra Sound (ISF) 12 hours between calibrations Continuous For ICU; In clinical trials 2 Grove Instruments (MA, USA) Gi-200Optical BridgeNo dataSpot In clinical trials 3 Cnoga Medical (Israel) TensorTip CGM – Combo Optical; Bio- parameters; Look-up table Long process Many (>200) points Spot CE Mark Approved; “Selling” 4 Freedom Meditech (CA, USA) I Sugar X Auto Fluorescence (in front of the eye) No dataSpot In R&D stage 5 AiMedics (Australia) HypoMon Skin Bio-sensors No dataContinuous Received CE-Mark; Like DF-N 6 Cybiocare Optical (Quebec, Canada) OHDOpticalNo dataContinuous Like DF-N 26
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 initialized and bring to life Electronic Warfare combat suite for the Israeli Navy Missile Patrol Boats and Submarines; Retired Commander from the Israeli Navy. David Malka: Executive VP & COO (Co-Founder) Multiple years of experience building and heading operations departments in a variety of companies; Substantial background in introducing products to market. Eran Hertz: CFO 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. 27
Medical Advisory Board 28 Dr. Ilana Harman-Bohem, MD Manager of Diabetic department at Soroka University Medical Center Prof. Yariv Malimovka, MD Senior consultant to Spanish medical centers in blood vessels & surgery Adi Ickowicz / MedicSense (Regulatory affairs) Rich experience in medical devices arena (FDA & CE Mark) Adi Gluzberg / MedicSense (Regulatory affairs) Rich experience in medical devices arena (FDA & CE Mark)
Recent Achievements; Anticipated Actions Improving the device Smaller version of PEC – expansion of market size (in trials); PMCF: collecting data to enable potential algorithms’ improvement; Embedding state of the art Anti-cloning & Encryption (H/W& S/W) (implementation); Multi-lingual device (Hebrew; English; Russian; Arabic; French). 29
Recent Achievements; Anticipated Actions Preparation to mass production manufacturing Audited potential manufacturers (China; Taiwan; Philippines); Finalization of Main Unit (MU) mold; Design & build tools & testers for MU; Finalization of Personal Ear Clip (PEC) mold; New connector to increase reliability of PEC (Done); Improving assembling process of PEC sensors; Development of Self Test Aid (STA); Functional testers & tools for PEC electrical & mechanical parts. 30
Recent Achievements; Anticipated Actions Marketing & Sales Activities Booth in EASD Conference (September 2013); Table in Medica, Dusseldorf, Germany (November 2013); Launching of an upgraded website (October 2013); Active participation in conferences (posters; presentations); Meetings with Key Opinion Leaders (KOL) in selected markets; Discussions re: Distribution agreements (Europe; Asia; South East Asia; South America); Training Field Engineers. 31
Recent Achievements; Anticipated Actions Regulatory & Other Activities Clinical trials for minors, 6-18 years old; Submission of 6 months trial’s results (Approval expected E/O Q1/14); Preparation for FDA clinical pathway; Development of DF-B Model (for developing countries); Development of Web application (uploading data; analysis; links to distributors websites; sales capabilities); IP enhancing (patents applications); Study regulatory pathways and requirements: China CFDA; Taiwan TFDA; other countries; Discussions; Workshops. 32
Capitalization 33 Approximately 5.14 million shares of common stock outstanding (October 7, 2013); Approximately 472,000 shares of the Company’s common stock are issuable upon exercise of outstanding stock options; Approximately 1.57 million shares of common stock are issuable upon exercise of outstanding warrants; Approximately 1.48 million shares of common stock are issuable upon conversion of outstanding shares of convertible preferred stock.
34 Your track to health!... ™ Thank You! www.integrity-app.com