Your track to health!... A Truly Non-Invasive Glucose Monitor for Self Use

Transcription

1 Your track to health!... A Truly Non-Invasive Glucose Monitor for Self Use 1

2 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,

3 Prevalence of Diabetes: Years Old 3

4 Prevalence of Diabetes: Years Old 4

5 Diabetes at a Glance 382 million people are diagnosed with diabetes 316 million people are 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, 6 th Edition, Rev

6 Benefits of Frequent Glucose Monitoring Frequent glucose monitoring is an essential component for effective diabetes management The Diabetes Control and Complications Trial (DCCT) demonstrated that intensive glycemic control in T1DM patients reduced the risk of incidence and progression pf complications by: 76% for eye disease (retinopathy) 60% for nerve disease (neuropathy) 50% for kidney disease (nephropathy) 6

7 Benefits of Frequent Glucose Monitoring The United Kingdom Prospective Diabetes Study (UKPDS) conducted on T2DM showed that any improvement in glycemic control is beneficial (similar to the findings of the DCCT) 7

8 HbA1c as a Function of SMBG More frequent SMBG levels is associated with clinically and statistically better glycemic control, regardless of diabetes type or therapy Source: The American Journal of Medicine, Vol. 111, July

9 Benefits of Frequent Glucose Monitoring American Diabetes Association stated in June 2012: Reducing HbA1c a Little Less than 1 Point Reduces Cardiovascular Risk by 45%! 9

10 Challenges in Self Monitoring of Blood Glucose (SMBG) Vast majority of Diabetics do not follow the recommended number of measurement Conventional (invasive) devices are painful Conventional (invasive) measurements are expensive Conventional (invasive) devices are subject to human factors which (meaningfully) decrease the accuracy of the measurement 10

11 Why GlucoTrack? no incremental cost Pain: truly non-invasive Cost: 11

12 GlucoTrack Model DF-F Main Unit (MU) Personal Ear Clip (PEC) 12

13 Calibration Characteristics How many? How long? How often? 13

14 Calibration Process How many? Simple (3 data pairs) process; How long? Short (less than half an hour); How often? Only when replacing PEC (every 6 months) PEC: Personal Ear Clip 14

15 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 15

16 Recent Company Milestones CE Mark approval for improvements: less than 30 min calibration and expansion of the label for prediabetics (Aug. 2015) CE Mark approval for improvements: improved accuracy and glucose profile (Dec. 2015) Annex II certification from the European Union (Feb. 2016) Supplement Pre-Submission to US FDA (May 2016) Regulatory approval from KFDA (May 2016). Sales pending GMP documentation audit 16

17 Glucose (mg\dl) Meal Glucose (mg\dl) Meal Meal Glucose (mg\dl) Meal Glucose (mg\dl) Meal Meal Glucose Trends Examples Subject #1 Subject #2 Pre-prandial Post-prandial Time after meal (hours) Subject #3 Post-prandial Time after meal (hours) Subject #4 Pre-prandial Post-prandial Time after meal (hours) Post-prandial Pre-prandial Post-prandial Time after meal (hours) 17

18 Glucose (mg\dl) Meal Glucose (mg\dl) Meal Glucose (mg\dl) Meal Glucose (mg\dl) Meal Glucose Trends Examples Subject #5 Subject #6 Pre-prandial Post-prandial Time after meal (hours) Subject #7 Pre-prandial Post-prandial Time after meal (hours) Subject #8 Pre-prandial Post-prandial Time after meal (hours) Pre-prandial Post-prandial Time after meal (hours) 18

19 Manufacturing Full turn-key manufacturing services: o AY Electronics (Israel) o Wistron Corporation (Taiwan, manufacturing arm of Acer Computers) - currently in pilot production; manufacturing readiness expected Q3-Q4/16, subject to completion of TFDA GMP audit 19

20 Marketing & Sales Engagement with Ogilvy CommonHealth (Paris): o Marketing material for professionals and users o Increase market awareness of the GlucoTrack o Social Media ( ) Sales by experienced distributors in the field Business Development Managers per territory Assisting and support distributors activities 20

21 Management Key Roles 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: COO o 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 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 21

22 Sales Key Roles 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 Boudewijn Baks: Int l Sales Manager o Over 25 years of international experience of marketing, sales and management o o Background in pharmaceutical, medical devices, biotech and diabetes fields Experience gained from Merck, Pfizer, Abbott Diabetes Care and other companies 22

23 Scientific Advisory Board Prof. Dr. Lutz Heinemann (Chairman): CEO, Science & Co, Düsseldorf, Germany Prof. Irl B. Hirsch: University of Washington, School of Medicine, WA, USA Prof. Dr. Michael Heise: University of Applied Science of South-Westphalia, Iserlohn, Germany Prof. Jan Bolinder: Professor of Clinical Diabetes Research at the Department of Medicine, Huddinge, Sweden Prof. Katharine Barnard: Health Psychologist, Bournemouth University, Faculty of Health and Social Science, England Dr. Barry H. Ginsberg: Diabetes Consultant, DMTC, NJ, USA 23

24 Long Term Products Road Map Wireless Module (WLM) under development 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 models24

25 Competitive Landscape Company Product Technology Measurement Picture Cnoga Medical (Israel) GlucoWise (UK) Echo Therapeutics (MA, USA) Google (USA) Novio Sense (Germany) TensorTip CGM Combo Optical; Bioparameters; Look-up table Spot GlucoWise Radio Waves Spot/claim continuous Symphony Ultra Sound (ISF) Continuous, for ICU Google Lens Tear Drops Continuous NovioSense Enzymatic Detection Continuous Abbott (USA) Libre Flash (Invasive) (Semi) Continuous 25

26 Initial Sales 1Q/16: Orders totaling approximately $300K 1Q/16: $89K shipped and recognized as revenues 2-3Q/16: Orders totaling approximately $1.45M (subject to receiving local regulatory approval) 26

27 Capitalization (as of April 15, 2016) Approximately 5.69 million shares of common stock outstanding Approximately 3.68 million shares of common stock are issuable upon conversion of outstanding shares of convertible preferred stock Approximately 5.96 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 27

28 Your track to health!