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  • Presentation to Vodafone KK October 29, 2012 In commercial confidence
  • Presentation to Vodafone KK October 29, 2012 In commercial confidence

EZscan Malaysia EZscan Malaysia Presentation Transcript

  • EZSCAN Presentation toMINISTRY OF HEALTH MALAYSIA 23th October 2012
  • IMPETO MEDICALCOMPANY PRESENTATION 2
  • IMPETO MEDICAL HISTORY IN BRIEF HEADQUARTERS ARE BASED IN PARIS, FRANCE 2010 US FDA approved 2008 10 publications SFDA approved2006 Large studies launchedCE markedIn vitro studies 2012 15 patents Chinese Guidelines 2011 Clinical use proven US Subsidiary 700+ installations 2009 all over the world 2007 3 patents China Subsidiary2005 Validation First Ezscan sales 19 publicationsIncorporation Clinical + 6 ongoingFirst patent studiesPrototypes 3
  • QUALITY MANUFACTURING IN FRANCE ISO 13485 CERTIFIED FACTORY 4
  • MEDICAL DEVICES ALREADY APPROVED FOR SALES Europe China Thailand Indonesia USA Canada Mexico Australia 5
  • • TECHNOLOGY PROVEN BY CLINICAL STUDIES A STRONG INVOLVEMENT BY KEY OPINION LEADERS PARTICIPANTS ADA 2012 Investigator meeting M.A. Abdul-Ghani, J. Chan, B. Freedman, R. Pop-Busui, P. Schwarz, S. Tesfaye, A Vinik 6
  • WORLD WIDE CLINICAL STUDIES PROGRAM GERMANY - Dresden: PI: Pr. Schwarz* -Dresden: PI: Dr. Viniecki -Dresden: PI: Pr. Ziemssen -Dresden: PI: Pr. Schwarz -Berlin: PI: Pr. Pfeiffer SWEDEN Completed - Stockholm: PI: Pr. Rydén NETHERLANDS - Amsterdam: PI: Pr. Dekker FINLANDE - Tornio: Aino Activ * Published UNITED KINGDOM ePredice - Sheffield : PI: Pr. Tesfaye -Ipswich : PI: Pr. Rayman -Leicester: PI:Pr. Davies CHINA -Shanghai: PI Pr. Wang* FRANCE - Beijing: Pr. Hu (ACE) - Begin: PI: Pr. Bauduceau* - Cochin: PI: Pr. Fajac* - Haut-Lévêque: PI: Pr Gin* -Val de Grâce: PI: Pr. Ricard -Toulouse: PI: Dr. Le Traon HONG KONG USA - Hong Kong: PI: Pr. Chan* - Norfolk: PI: Pr. Vinick-Winston Salem: PI: Pr. Freedman -Ann Arbor: PI: Pop-Busui - Hong-Kong: PI: Pr. Chan -Salt Lake city: PI: Smith -Baltimore: PI: Russell -San Diego: PI: Schean COLOMBIA- Barranquilla: PI: Pr. Tuomilehto INDIA - Chennai 1: PI: Pr. Ramachandran* -Chennai 2: PI: Pr. Ramachandran* -Pune: PI: Pr. Yajnik -New Dehli: PI:Anoop Mihra AUSTRALIA -Hyderabad: PI: Pr. Ramakrishna -Perth: PI: Pr. Davis(Fremantle) -Melbourne: PI: Pr. Shaw (Ausdiab) 7
  • USA CLINICAL STUDIES PROGRAM 8
  • DIABETES PROBLEM STATEMENT 9
  • DIABETES: A SILENT PANDEMIC In 2003: 194 million DM! In 2003: 194 million DM! In 2025: 333 million DM! In 2025: 333 million DM! + 50 % of DM are not aware of it 10% of DM = 50% of the costs ! 10
  • MALAYSIA’S GROWING CONCERN 11
  • MALAYSIA’S GROWING CONCERN 12
  • Diabetes is associated with serious complications Stroke Complications Affecting Cardiovascular Complications Affecting Cardiovascular 2- to 4-fold increase in System, Vision, and Kidney Function System, Vision, and Kidney Function cardiovascular mortality and stroke5 A. Coronary Artery Disease A. Coronary Artery Disease 1.1. Major risk of myocardial infarction Major risk of myocardial infarction inin Type 2 diabetics Type 2 diabeticsDiabetic 2.2. Most common cause of death for Most common cause of death forRetinopathy diabetics (40 – – 60%) diabetics (40 60%)Leading cause 3.3. Diabetics more likely to develop Diabetics more likely to developof blindness Congestive Heart Failure Congestive Heart Failure A. Hypertension A. Hypertensionin adults1,2 1.1. Affects 20 – 60 % of all diabetics Affects 20 – 60 % of all diabetics 8/10 individuals with 2.2. Increases risk for retinopathy, Increases risk for retinopathy, diabetes die from CV nephropathy nephropathy events6 3.3. Stroke: Type 2 diabetics are 2 – 6 Stroke: Type 2 diabetics are 2 – 6 times more likely toto have stroke times more likely have stroke A. Peripheral Vascular Disease A. Peripheral Vascular Disease 1.1. Increased risk for Types 1 and 2 Increased risk for Types 1 and 2 diabetics diabetics 2.2. Development of arterial occlusion Development of arterial occlusion Diabetic and thrombosis resulting inin gangrene and thrombosis resulting gangrene 3.3. Gangrene from diabetes most Gangrene from diabetes most Neuropathy common cause of non-traumatic common cause of non-traumaticDiabetic lower limb amputation lower limb amputationNephropathy A. Diabetic Neuropathy A. Diabetic NeuropathyLeading cause ofend-stage renal disease3,4 13
  • GUILTY EVOLUTION ?Homo Australopithecus H. erectus H. sapiens H. McDonald’s Million years 50 years 14
  • SCIENTIFIC BACKGROUND 15
  • PERIPHERAL NERVOUS SYSTEM 16
  • LONG SUDOMOTOR NERVES ARE VERY SENSITIVE 17
  • SMALL NERVES ARE DAMAGED IN DIABETES Control Diabetes Metabolic Syndrome or prediabetesPittenger, Burcus, McNulty, Basta, Vinikl. Diabetes Care 27:1974-79, 2004;Pittenger,Mehrabyan, Simmons, Rice, Dublin, Barlow,Vinik,Metab. Syndrome 3:113-121, 2005 18
  • Prevalence of retinopathy vs FPG and 2hPG levelsDiabetes Care 2009 19
  • DIAGNOSE TYPE 2 DIABETES EARLY COMPLICATIONSThreshold of diabetes diagnosis (glucose, 2hPG,HbA1C) has been defined by a significant increase of prevalence of retinopathy. But retinopathy is irreversible! Small fiber neuropathy is more sensitive and reversible, even more when detected early 20
  • SMALL FIBER NEUROPATHY (SFN)• DETECTION RECOMMENDED BY NEW ADA/EASD GUIDELINES (exercise, personalized treatments)• SUDOMOTOR TESTS RECOGNISED AND REIMBURSED (USA)• INSULIN BENEFIT SHOWED ON SFN IN NORMAL PRACTICE 21
  • EVALUATION OF INSULINO RESISTANCE Type 2 Diabetes Diabetes Diagnosis ? ? ? Insulin resistance Proinsulin secretion Insulin Blood glucose Normal Impaired glucose tolerance IFG glucose tolerance DiabetesModified from: DeFronzo RA et al., Diabetes Care 1998 22
  • WHO IS INSULIN RESISTANT?• 90% of patients with type 2 diabetes• 60% of patients with CVD• 55% of patients with hypertension• 85% of patients with low HDL and high LDL• 30% of the US population between 40–74 years (probably 40% of Aisian population)• 50% of patients with CHD without family history of diabetes 23
  • PREVENTION: The Sooner The Better! Diabete Diagnostic HIGH RISK TO BECOME DIABETIC Glucose Intervention is more efficient and Insulin less costly Intervention Is too lateNormal Impaired glucose Diabetesglucose tolerance tolerance 24
  • CHALLENGE TO PREDICT DIABETES Quality of the test Costs Availability Handling of the people diagnosed with increased diabetes risk 25
  • CURRENT METHODS TO DETECT PREDIABETES• QUESTIONNAIRES: simple, easy to perform, non invasive• URINARY GLUCOSE: simple non invasive, well accepted by the patient• CAPILLARY RANDOM BLOOD GLUCOSE: quick, does not require fasting• FASTING PLASMA GLUCOSE: results easily understandable by the patient• POST PRANDIAL GLUCOSE: does not require fasting• HBA1C: does not require fasting , view of last 3 months• 2H-OGTT: more information on a dynamic process (insulin resistance)• 1H-OGTT: more precise and more informative than 2H- OGTT• A COMBINATION OF ABOVE: increased sensitivity 26
  • EX : From questionnaires…Diabetes risk based on added risk factors BMI ≥ 25 kg/m2 plus at least another risk factor: 0 - Little physical activity 1 - First degree relative to Type2 Diabetes > - Ethnic group at risk K - Hypertension (140 / 90 mmHg or under antihypertensive treatment) IS - HDL Cholesterol 35 mg/dl (0.90 mmol/l) R and / or Triglyceride 250 mg/dl (2.82 mmol/) D - PCOS I N - IGT or IFG Test F - Other symptom related to Insulinresistance (overweight, …) - Cardiovascular event Without any above criteria: older than 45 ADA Standards of Medical Care in Diabetes - 2009. DIABETES CARE, VOLUME 32, SUPPLEMENT 1, JANUARY 2009 27
  • ...to a combination of several blood tests... # of subjects Total # of Odds Ratio (95% Condition developed Risk (%) P subjects diabetes CI) HbA1c<5.65%, 224 0 0% 1 1h PG< 155 mg/dl HbA1c<5.65% 181 7 3.87% 8.92 (1.09-73.18) 0.025 1h PG>155 mg/dl HbA1c>5.65% 86 3 3.49% 7.78 (0.99-75.8) 0.07 1h PG < 155 mg/dl HbA1c >5.65% 133 24 18.1% 40.24 (5.38-300.9) <0.0001 1h PG> 155 mg/dlSchwarz et al, J Clin Endocrinol Metab. 2011 Aug;96(8):2596-600. Epub 2011 Jun 6. HbA1c + 1hPG for predicting Diabetes 28
  • THEY ARE ALL DIFFICULT TO APPLY IN LARGE SCREENING• QUESTIONNAIRES: to be adapted, non objectives, low change with lifestyle improvement• URINARY GLUCOSE: low sensitivity, not quantitative• CAPILLARY RANDOM BLOOD GLUCOSE: low sensitivity, inaccuracy of the method• FASTING PLASMA GLUCOSE: invasive, fasting required, low sensitivity• POST PRANDIAL GLUCOSE: invasive, long , low sensitivity• HBA1C: low sensitivity for low values, accuracy of the method used• 2H-OGTT: sensitivity improved but long, invasive, fasting required• 1H-OGTT: best sensitivity, Fasting required, long• A COMBINATION OF ABOVE: to improve sensitivity further, but more complex 29
  • WHY NONE IS ABLE TO DECREASE THE PREVALENCE RATE?• QUESTIONNAIRES• URINARY GLUCOSE• CAPILLARY RANDOM BLOOD GLUCOSE• FASTING PLASMA GLUCOSE• POST PRANDIAL GLUCOSE• HBA1C• 2H-OGTT• 1H-OGTT• COMBINATION OF ABOVE 30
  • Low values of HbA1c are not significant… CGM IN A HEALTHY PERSON Female, 26 years old, HbA1c 5.2%, typical snack-eater 5.9 5.4 Slides with permission from Prof. Hanefeld 31
  • …because Postprandial Glucose PEAKS are not seen! Increase in fluctuation leads to increase in oxidative stress 61 years old male patient with IGT, HbA1c 5.0%Diabetes Starts with Postprandial Glucose Peaks!Slides with permission from Prof. Hanefeld 32
  • WHY DIABETES PREVENTION IS NOT WELL DEVELOPEDDiabetes risk is not well screened today Invasive procedures Fasting is required Sensitivity of existing tests are too low Cost of diagnosis is too high because too complex Diagnosis is done too lateExisting tools are too time consuming for Physicians and Patients Most significant blood tests require preparation and are time consuming Blood tests confirmation are often needed due to the lack of robustness of the tests which is even further time consuming. Many patients are not coming back after a first test.AS A RESULT, Diabetes Prevention is not well developed Procedures are known, scientificaly published (Lifestyle)… but not used in daily practice No easy sensitive and robust tests exist to follow up patient progresses  The lack of sensitivity of weight measurement demotivates many people. 33
  • EZSCAN UNIQUE PROPOSITION Non-invasive No risk of blood contamination No patient preparation or fasting requiredMore sensitive than usual screening methods Easy to use - Quick and safe procedure Low operating costs Immediate objective & quantitative results Results easily understandable =>Better motivation of the patient =>Higher efficacy of prevention 34
  • EZSCAN COMPETITIVE LANDSCAPE How is eZscan better than • FPG: very low alternatives? sensitivity, blood draw, fasting FSOGTT • OGTT (WHO goldEfficacy (Test Performance, Accuracy) OGTT standard): fasting, too EZSCAN long, blood draw HbA1c • HbA1c: too late, +/-20% precision, FPG result of high glucose • Questionnaires / Survey: low sensitivity, depends on lifestyle RBG –Finger prick Questionnaires habits which change quickly and depend on culture Effectiveness (Convenience, Low Cost, Ease of Use) 35
  • HOW TO MEASURE SUDOMOTOR FUNCTION?Classic Sudomotor tests (QSART): developed 20 years ago in the US (Mayo clinic) and reimbursed by Medicare, but long, cumbersome, sensitive to environment, expensive. Modern Sudomotor tests (EZSCAN): a fast, new and more practical way of doing these well known Sudomotor tests. IMPETO MEDICAL DID NOT INVENT A NEW CONCEPT: IMPETO MEDICAL DESIGNED A NEW TECHNOLOGY TO MAKE SUDOMOTOR FUNCTION MEASUREMENT PRACTICAL ! 36
  • EZSCAN TECHNOLOGY 37
  • A simple method to measure sudomotor function Degeneration of small C-fiber innervating sweat glands as observed in diabetes. (reproduced from Lauria et al.) Measurement of Electrochemical Sweat Conductances, directly dependent from the glands capability to transfer chlorides and reflecting small-C fiber status.Application of a low voltage toelectrodes on hands and feet toextract chlorides from the sweat.Electrochemical reaction betweenthe chlorides of the sweat and thestainless-steel electrodes.
  • SIMPLE, QUICK & NON-INVASIVE INVESTIGATION 39
  • EZSCAN, new tool for massive screening campaign 40
  • EZSCAN SCORESResults are easy to explain… and to understand! 41
  • EZSCAN MOTIVATES THE PATIENT BETTER 42
  • EZSCAN can easily estimate insulin dynamic behaviorGLUCOSE & INSULIN PROFILES DURING FSOGTT Glucose Insulin Green=normal; yellow=IR; orange/red=DM 43
  • EZSCAN: ONLY ONE INDICATOR FOR PREVENTION Diabetes Diagnosis EZSCAN EvaluationType 2 Diabetes Risk fasting glucose Insulin resistance HbA1c FFA Insulin 2hr gluc 1hr glucose Blood glucose Risk score use Normal Impaired Glucose tolerance IFG Glucose tolerance Diabetes 44
  • PROVEN TECHNOLOGYPUBLISHED CLINICAL TESTS 45
  • ROBUSTNESS OF THE METHODProven reproducibility, regardless of patient condition(Schwarz et al. British Journal of Diabetes & Vascular diseases. 011;11(4):204-9) – Good reproducibility: 5-10% change between two successive measures – No impact of effort: less than 10% change before and after exercise – No impact of glycemia: less than 10% change between normal and hyperglycemia 3% 46
  • CLINICAL STUDIES – Published Papersgood sensitivity, specificity andreproducibility of EZSCAN forassessing sudomotor dysfunction 47
  • CLINICAL STUDIES – Published Papers EZSCAN: •More sensitive to detect diabetes and prediabetes •Better predictive parameter EZSCAN… a very useful tool in diabetes risk diagnostics 48
  • CLINICAL STUDIES – Published PapersEZSCAN demonstrated good sensitivityto detect IGT and DM Measuring ion fluxes… a powerful method for early detection of IGT and DM 49
  • CHENNAI 1 STUDY : EZSCAN vs FPGA FPG B EZSCAN MS DM n 57 24 FPG>126 mg/dl 1 7 Sensitivity % 2% 29% FPG>110 mg/dl 2 11 Sensitivity % 4% 46% EZSCAN 52 22 Sensitivity % 91% 92% With FPG, we miss 1 DM patient out of 2!FPG ofno value FPG of limited value Ramachandran A et al Diabetes Res Clin Pract 2010 88 302 50
  • CLINICAL STUDIES – Published PapersEZSCAN …very useful to identify subjects at riskfor developing glucose intolerance 51
  • CLINICAL STUDIES – Published Papers EZSCAN might be useful in screening diabetes… 52
  • CLINICAL STUDIES – Published Papers EZSCAN test is a good and simple screening technique for early predicting metabolic syndrome… 53
  • EZSCAN screening for insulin resistance Pr P Schwarz, Dresden, GermanyObjectives To assess the ability of EZSCAN to be used as a screening tool in a German population of subjects at risk of metabolic diseasesMethods • 114 German subjects at risk of prediabetes or diabetes • Oral glucose tolerance test (OGTT) with measurement of glucose, insulin, pro- insulin, C-peptide, free fatty acid • Insulin sensitivity (Minimal model), Insulin resistance with HOMA-IR and Matsuda index. Inflammation markers. • Measurement of electrochemical sweat conductance (ESC) with EZSCAN and classification of subjects in no risk (green), moderate risk (yellow), high risk (red)Main • 29 subjects with Impaired fasting glucose or impaired glucose toleranceresults according to Who classification, 18 moderate risk / 10 high risk according to EZSCAN • 7 subjects with diabetes according to Who classification 2 had moderate risk / 5 had high risk according to EZSCAN • No adverse events reported during and after the study • Results in accordance with a previous study performed in India 54 54
  • EZSCAN is a good prediction for HbA1c progression P Schwarz Dresden University Germany 55 Predictive value of hand and foot ESC for HbA1C 5.7% 16 months in advance vs usual methods 55
  • EZSCAN for early detection of neuropathies in prediabetesObjectives To evaluate the effect of early treatment intervention on occurrence of complications in subjects with hyperglycemiaMethods • 15 European centers for diabetes screening • 3000 subjects with hyperglycemia without clinical evidence of micro or macrovascular complications • 4 groups with lifestyle intervention, Metformin, Vildagliptin or Liraglutide • 36 months follow-up with new occurrence of: • Retinopathy (by fondus of eye) • Impairment of renal function (by creatinin level) • CAN (by EZSCAN) • Autonomic neuropathy (by SUDOSCAN)Pr J Tuomilehto, E-PREDICE, EU commission funded project 56
  • OFFICIAL ENDORSEMENT IN CHINABREAKING NEWS: EZSCAN IN THE NEW ‘2012 MEDICAL CONSENSUS’ GUIDE! 57
  • EZSCAN IN THE PRESS IN CHINA 58
  • QUICK EPIDEMIOLOGICAL DATA COLLECTION (Samples at Medical Congress Events) Male caucasian Diabetes Physicians Mean age Mean age Mean age 46y+/-10 Male/female 45y+/-10 46y+/-10 American/Asian/Female caucasian AfricanDiabetes nurses green yellow orange+red Sum Diabetes FEND 79 14 3 96 Physicians EASD 84 23 16 123 and IDF IDF 87 39 53 179 Sum 254 77 72 403 organizations members 59
  • EZSCAN FOR EASY SCREENING OF LARGE POPULATIONSIn pharmacies (Germany, France, 15,000 patients in the NetherlandsAustralia, Canada, Chile…) Occupational health 60
  • EZSCAN CHOSEN FOR LARGE EPIDEMIOLOGICAL STUDIES The Australian Diabetes, Obesity and Lifestyle (AusDiab) study is the largest Australian longitudinal population based study (11,247 individuals) examining the natural history of diabetes, pre-diabetes, heart disease and kidney disease. Dutch diabetes prevention campaign (15,000+ people screened within less 1 year) 61
  • EZSCAN SELECTED IN EUROPEAN PROGRAM ‘IMAGE’ 62
  • PROGRAM ‘IMAGE’ : HOW TO IDENTIFY PEOPLE AT RISK GE IMAGE ‘TOOLKIT’ 63
  • DEVELOPING A PREVENTION STRATEGY be structured – easy to understand find people where they are – setting approach focus on the individual – empowerment involve regular contact with individuals with prediabetes recruit educated lifestyle managers continuously evaluate the success of prevention strategies use screening tools that are applicable in a population setting include quality management – prevention management 64
  • SUMMARYQUICK ECONOMICAL STUDY 65
  • SUMMARY: WHY EZSCAN?Diabetes risk is not well screened todayExisting tools are too time consuming for Physicians and PatientsAs a result, Diabetes Prevention is not well developedRationale in using eZscan for screening large populations :•Non invasive, no need for fasting and objective eZscan measures actual damages for each individual•More sensitive, convenient and quicker than blood test eZscan allows detecting PREDIABETES on time, when it is reversible, saving future costs•Complementary no-fasting tool to current gold standards without preparation, eZscan can scan much larger (100%?) populations, only applying the burden and costs of standard blood tests among those 10-15 % people detected at high risk 66
  • DIABETES IN MALAYSIATop Ten! Malaysia has one of the highest prevalence in the world! 67
  • Population with diabetes in 2010 and 2030According to the study of IDF Atlas in 2010, there is 1.8 millions of diabetics inMalaysia, with a prevalence of 10.9%.The prevision for 2030 is 3.2 millions of diabetics with a prevalence of 13.4%. 68
  • Evaluation of population to screen• In Malaysia, the population at risks (people over 40) that will have to be screen in priority represents 6 778 537 people. Identified patients will be invited to make an EZSCAN test at the nearest institution equipped with EZSCAN (pharmacy, hospitals, clinics etc.). 69
  • COST OF DIABETES IN MALAYSIA 802 million of USD/year 70
  • Benefit of an EZSCAN campaign in Malysia 71
  • MINISTRY OF HEALTH MALAYSIA Proposed Implementation of EZSCAN & Tanita MC980 in Government Hospitals, Clinics and Klinik 1Malaysia BY LAZCORP HOLDINGS SDN BHD