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Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012.

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Presentation on theme: "Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012."— Presentation transcript:

1 Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

2 Confidential 1978 First biosensor for Ionized Calcium 1980 First biosensor to measure Chloride in blood 1984 First biosensor to measure Total Calcium 1985 First biosensor to measure Hematocrit by ISE/Conductivity 1987 First biosensor to directly measure whole blood Glucose 1988 First biosensor to measure Lithium 1990 First biosensor to measure BUN (urea) 1992 First biosensor to directly measure whole blood Lactate 1994 First biosensor to measure Ionized Magnesium 1996 First biosensor to measure Creatinine 1996 First biosensor to measure Total CO 2 in whole blood 1997 First multi-wavelength fiber optic SO 2 % assay 1998 First fiber optic Hemoglobin assay 1998 First Ammonium biosensor 1999 First non-diluting direct Glutamine biosensor 1999 First non-diluting direct Glutamate biosensor 2001 First Acetate biosensor 2005 First Hematocrit corrected Glucose strip 2007 First calibration free Glucose strip 2007 First Creatinine strip and meter 2009 First calibration free Ketone strip 2009 First IgG assay on a biotechnology analyzer 2011 First Hematocrit corrected hospital Lactate meter and strip Nova BioSensor Firsts Nova is the World Leader in Whole Blood Biosensors

3 Confidential Nova Brand Products Stat Profile ® pHOx Test Menu: pH, PCO 2, PO 2, SO 2 %, Hct, Hb, Na +, K +, Cl -, Ca ++, Glu, Lac Samples: Whole blood, Serum, Plasma Nova Chemistry Analyzers Test Menu: Na +, K +, Cl -, TCO 2, Ca ++, Mg ++, Li +, TCa, Glu, BUN, Crea, Hct, pH Samples: Whole blood, Serum, Plasma Nova BioProfile FLEX ™ Test Menu: Gluc, Lac, Gln, Glu, NH4+, pH, PO 2, PCO 2, Na +, K +, Ca ++, CD, CV, Osm, IgG, PO 4 Samples: Cell Culture Media Nova MAX ® Link ® Test Menu: Glucose Samples: Whole blood Nova StatStrip ® Test Menu: Lactate Samples: Whole blood * Currently Available outside the U.S. Nova Lactate Plus ® Test Menu: Lactate Samples: Whole blood Nova StatStrip ® Test Menu: Glucose Samples: Whole blood Nova MAX ® Plus Test Menu: Glucose/Ketone Samples: Whole blood Nova StatStrip ® Test Menu: Glucose/Ketone Samples: Whole blood Nova StatSensor ® Test Menu: Creatinine Samples: Whole blood * Stat Profile ® pHOx Ultra Test Menu: pH, PCO 2, PO 2, SO 2 %, Hct, Hb, Na +, K +, Cl -, Ca ++, Mg ++, TCO 2, Glu, BUN, Creat, Lac, HHb, O 2 Hb, Methb, COHb, O 2 Ct, O 2 Cap, tBil Samples: Whole blood, Serum, Plasma

4 Confidential Hospital Laboratory Instrument Platform

5 Confidential Hospital Laboratory Instrument Platform

6 Confidential Hospital Laboratory Platform

7 Confidential Hospital Point-of-Care Glucose Meter

8 Confidential Hospital Point-of-Care Lactate Meter

9 Confidential Hospital Point-of-Care Creatinine Meter

10 Confidential Nova Max ® Plus Home Glucose Monitor Nova Max Link ® Home Glucose Wireless Monitor ®

11 Confidential Professional Lactate Meter

12 Confidential Nova Handheld Point-of-Care Hospital Analyzers *

13 Confidential Nova Multi-Well Technology Creates A New Level of Analytical Performance Hospital Glucose Meter TM

14 Confidential Laboratory quality accuracy and precision from 10 to 600 mg/dL Measures and corrects interferences from: - Hematocrit - Electrochemical interferences including acetaminophen, ascorbic acid, and uric acid No maltose, galactose, xylose or oxygen interference Eliminates calibration codes Fastest results, 6 seconds Small sample, 1.2 µL whole blood Nova Connects ™, Total POC Connectivity Solution StatStrip ® Hospital Connectivity Meter Hospital Glucose Meter The World’s Most Accurate Hospital Glucose Meter Proven in Over 60 Published Hospital Evaluations Worldwide

15 Confidential StatStrip ® Has Earned Worldwide Scientific Acclaim

16 Confidential Plasma Glucose Reference Method Nova StatStrip Whole Blood Glucose Kost, G. et al AACC, July 07; Diabetes Technology, Oct 07 StatStrip ® Multi-Well Technology Correlation Study R 2 : 0.9950SLOPE: 1.018 INTERCEPT: -0.04 mmol/L INTERCEPT: -0.716 mg/dL N=1703 Sy*x = 0.54 mmol/L Sy*x = 9.795 mg/dL TM (mmol/L) (mg/dL) 700 600 400 300 200 100 0 0 200 300 400 500 33.3 5.6 11.1 16.7 22.2 27.8 38.9 33.3 22.2 16.7 11.1 5.6 27.8 38.9 (mmol/L)

17 Confidential Abbott PCx Correlation Study R 2 : 0.9499SLOPE: 0.89 INTERCEPT: 0.00 mmol/L INTERCEPT: 0.084 mg/dL N=559 Sy*x = 1.84 mmol/L Sy*x = 33.194 mg/dL 700 600 400 300 200 100 500 0 600 0 100 200 300 400 500 Plasma Glucose Reference Method Abbott PCx Whole Blood Glucose Kost, G. et al AACC, July 07; Diabetes Technology, Oct 07 38.9 33.3 22.2 16.7 11.1 5.6 27.8 (mg/dL) (mmol/L) 33.3 5.6 11.1 16.7 22.2 27.8

18 Confidential Abbott PXP Correlation Study Sy*x = 1.8 mmol/L Sy*x = 33.15 mg/dL Plasma Glucose Reference Method Abbott PXP Whole Blood Glucose R 2 : 0.97259SLOPE: 0.820 INTERCEPT: 1.05 mmol/L INTERCEPT: 18.886 mg/dL N=225 0 100 200 300 400 500 600 0100200300400500600 (mg/dL) (mmol/L) 5.611.116.722.227.833.3 5.6 11.1 16.7 22.2 27.8 33.3 Kost, G. et al AACC, July 07; Diabetes Technology, Oct 07

19 Confidential Kost, G. et al AACC, July 07; Diabetes Technology, Oct 07 LifeScan SureStep Correlation Study R 2 : 0.9869SLOPE: 1.029 INTERCEPT: - 0.08 mmol/L INTERCEPT: - 1.505 mg/dL N=628 Sy*x = 0.86 mmol/L Sy*x = 15.532 mg/dL Plasma Glucose Reference Method 700 600 400 300 200 100 0 500 600 0 100 200 300 400 500 LifeScan Whole Blood Glucose 38.9 (mmol/L) 33.3 5.6 11.1 16.7 22.2 27.8 33.3 22.2 16.7 11.1 5.6 27.8 (mmol/L) (mg/dL)

20 Confidential Plasma Glucose Reference Method Roche Whole Blood Glucose Kost, G. et al AACC, July 07; Diabetes Technology, Oct 07 Roche Accu-Chek Correlation Study R 2 : 0.9795SLOPE: 1.036 INTERCEPT: 0.28 mmol/L INTERCEPT: 5.002 mg/dL N=273 Sy*x = 1.18 mmol/L Sy*x = 21.197 mg/dL 700 600 400 300 200 100 0 500 600 0 100 200 300 400 500 38.9 (mmol/L) 33.3 5.6 11.1 16.7 22.2 27.8 33.3 22.2 16.7 11.1 5.6 27.8 (mmol/L) (mg/dL)

21 Confidential NSlope Intercept (mg/dL) R2R2 Sy*x (mg/dL) Nova17031.018-0.7160.9959.795 Abbott PCx5590.890.0840.949933.194 Abbott PX I P2250.8218.8860.9725933.15 Roche2731.0365.0020.979521.197 LifeScan6281.029-1.5050.986915.532 Summary StatStrip ® Correlation Study Comparison Kost, G. et al AACC, July 07; Diabetes Technology, Oct 07* * Summary table did not appear in publication

22 Confidential Hematocrit Interference Effect % Hct 45 Glucose Results Normal (Calibration Point) % Hct 25 Glucose Results Artificially High Up to 25% % Hct 65 Glucose Results Artificially Low Up to 30% Hematocrit Interference Effect StatStrip ® Multi-Well TM Technology Measures and Corrects Hematocrit Interference

23 Confidential StatStrip ® Multi-Well TM Technology Measures and Corrects Hematocrit Interference 25%60%45% Error % Due to Uncorrected Hematocrit Glucose result uncorrected for Hct. Glucose result. Hct measured and corrected. Hematocrit Error from Hct Low hematocrit causes erroneously high glucose results High hematocrit causes erroneously low glucose results

24 Confidential StatStrip ® Multi-Well TM Technology Measures and Corrects Hematocrit Interference Karon, B. et al, Diabetes Technology and Therapeutics, Apr 2008 Hematocrit Interference Study Nova StatStrip ® vs. Current Technology Test Strips StatStripAbbott Precision Lifescan SureStepRoche Inform True value

25 Confidential StatStripGD Electrochemical GO PhotometricGD Electrochemical StatStripAbbott Precision Lifescan SureStepRoche Inform Karon, B. et al, Diabetes Technology and Therapeutics, Apr 2008; Hematocrit Interference Study Nova StatStrip ® vs. Current Technology Test Strips StatStrip ® Multi-Well TM Technology Measures and Corrects Hematocrit Interference

26 Confidential StatStrip ® Multi-Well TM Technology Measures and Corrects Hematocrit Interference - 50 -40 -30 -20 -10 10 203040506070 Hematocrit(%) Mean glucose difference (%) Glucose = 486 mg/dL Karon, B. et al, Diabetes Technology and Therapeutics, Apr 2008 Hematocrit Interference Study Nova StatStrip ® vs. Current Technology Test Strips StatStripAbbott Precision Lifescan SureStepRoche Inform 0 True value

27 Confidential Severe hematocrit abnormalities are extremely common in hospitalized patients  Up to 77% of ICU patients an have abnormally low hematocrit (<36%) during their ICU stay 1,2  Average HCT at ICU admission:  33-34% 2,3  29% have HCT<30% 4  HCT declines by an average of 1.5 - 2.0% HCT per ICU day 1 1. Von Ahsen N et. al., Important role of non-diagnostic blood loss and blunted erythropoietic response in the anemia of medical intensive care patients; Critical Care Medicine: 1999; 27(12); 2630-2639 2.Corwin HL et. al., The Crit Study: Anemia and blood transfusion in the critically ill; current practice in the United States;, Crit Care Med. 2004 Jan;32(1):30-52 3. T.S. Walsh et. al., Anemia during critical illness;, et. al., British Journal of Anaesthesia 2006, 97(3):278-291 4. Vincent JL, et al. Anemia and blood transfusion in critically ill patients. JAMA 2002 Sep 25; 288(12):1499-1507

28 Confidential Maltose Interference with Glucose Dehydrogenase (PQQ Mediator) Enzymes FDA issued two “Public Health Notices” regarding the dangers of GDH-PQQ glucose test strips. Between 2004 and 2009,thirteen deaths have been reported directly related to the use of GDH- PQQ glucose strips. On August 13, 2009, the FDA clearly stated “Avoid using GDH-PQQ glucose test strips in healthcare facilities” http://www.fda.gov/MedicalDevices/Safety/Alert sandNotices/PublicHealthNotifications/ucm17699 2.htm

29 Confidential 290 Bed MA Hospital Maltose Interference Studies Nova StatStrip ® vs Roche GDH-PQQ Method

30 Confidential StatStrip lots are interchangeable Eliminates need for lot change over studies Reduces operator steps Eliminates glucose errors due to miscoding Glucose errors as large as 43% can be caused by an incorrect cal code Baum JM et al. Diabet Technol & Ther 2006 Nova StatStrip ® Multi-Well Technology Eliminates Calibration Codes TM

31 Confidential 24 month shelf-life from manufacturer 180 day open vial stability Manufacturing lot size up to 8 million strips Nova StatStrip ® Multi-Well Technology Offers Other Operational Advantages TM

32 Confidential Nova StatStrip ® Multi-Well Technology Creates Significant Performance Improvements Top Layer – Prevents biohazard exposure – Vent hole creates fast sample draw Capillary Layer – 1.2 µL sample fill – Design eliminates overfill errors Measurement Wells Layer Well 1: Interferences and glucose Well 2: Interferences Well 3: Hematocrit Well 4: Reference (and initiates analysis to eliminate short sampling errors) Gold Layer – Noble metal; superb electrochemical stability in all conditions – Classic electrochemical measuring surface – Excellent electrical properties Patent: US#6,287,451;6,837,976;EP#1 212 609;CA 2,375,092 TM

33 Confidential “POCT glucose meters have now been employed for making therapeutically important insulin dosing decisions. It is essential that the accuracy of these measurements be comparable to those of laboratory analyzers..” Khan A.I. 2006 “Careful assessment of glucose measurement and how it may impact the targets selected in the hospital are critical safety issues in intensive management of hyperglycemia.” Dungan K. 2007 Khan AI et al. The Variability of Results Between Point-of-Care Testing Glucose Meters and the Central Laboratory Analyzer. Arch Pathol Lab Med, Vol 130, Oct 2006 Dungan K et al. Glucose Measurement: Confounding Issues in Setting Targets for Inpatient Management. Diabetes Care, Vol 30, Number 2, Februaly 2007 Glucose Management of Hospitalized Patients Demands Improved Glucose Strip Performance JCAHO considers insulin to be one of the highest risk medicines in the inpatient setting

34 Confidential “The inaccuracies of glucose meters occur at the extremes of glucose reportable range (critical values), but in this region the most important and potentially life-threatening decisions concerning therapy must be made.” Vasquez, J. 2005 “Published reports and clinical experience suggest that glucose meters may not be the most accurate and could possibly result in inappropriate insulin dose titration and avoidable adverse events related to glycemic control.” Kanji, S. 2005 “The magnitude of the differences in the glucose values offered by the four different methods of glucose measurement led to frequent clinical disagreements regarding insulin dose titration in the context of an insulin infusion protocol for aggressive glucose control.” Kanji, S. 2005 Kanji S et al. Reliability of point-of-care testing for glucose measurement in critically ill adults. Crit Care Med, Vol.33, No 12, 2005 Vasquez, J et al. Investigating the reliability of POCT glucose meters, Clinical Chemistry, Vol. 51, No. 6, Supplement, 2005 Glucose Management of Hospitalized Patients Demands Improved Glucose Strip Performance

35 Confidential 1. Boyd, JD and Bruns, DE. Quality Specifications for Glucose Meters: Assessment by Simulation Modeling of Errors in Insulin Dose. Clinical Chemistry, 47:2,209-214, 2001 Glucose Management of Hospitalized Patients Demands Improved Glucose Strip Performance Glucose Error Leads To Insulin Dosing Error 1 Total Analytical Error Insulin Dosage Error Rate 5%8-23% 10%16-45% 15%>5% 2-Step Dosing Error

36 Confidential 35 94 LifeScan Cumulative 35 80 98 100 Roche Cumulative 98% of Nova Results Satisfy a 10% Total Error Limit N=133 patient study at Mayo Clinic Nova StatStrip, Lifescan SureStep, Abbott Precision, Roche Inform Versus Reference Method Data analysis from Karon, B. et al, Diabetes Technology and Therapeutics, April 2008; not addressed in publication ADA Specification ISO 15197 Requirement % Bias (Error) Cumulative Abbott ≤5%≤5% 7526 ≤ 15% 100 76 ≤ 25% 100 ≤ 30 % StatStrip Cumulative 71 67 ≤ 10 % 98 56 100 96 ≤ 20% 93 ADA ISO 15197 % of patients

37 Confidential Fast and Easy Glucose Testing at the Bedside

38 Confidential On/Off Button Function Keys Bar Code Scanner Bright, Easy-to-Read Color Touchscreen. Large Easy-to-Use Touchpad. Strip Port

39 Confidential Fastest Results, 6 seconds Sample Volume, 1.2 µL – Easier sample acquisition – Enables use of less painful lancets Fewest Operator Steps – No calibration codes or calibration chips – Strip lot entered automatically by default setting – Built-in 1D or 2D barcode scanner StatStrip ® Connectivity Meter

40 Confidential Color Touch Screen Prompts Operator Through Steps MED4

41 Confidential Operator ID Entered by Scan or Touch Screen MED4

42 Confidential Meter Then Goes Directly to Patient Test Screen MED4

43 Confidential Strip Lot Scanned or Entered Automatically By Default Setting 35475932 MED4

44 Confidential Patient ID (or MRN) Entered by Scan or Touch Screen 194546646 MED4

45 Confidential StatStrip ® Confirms Valid Patient ID 194546646 MED4

46 Confidential Operator Prompted To Final Step MED4

47 Confidential Results In Only 6 Seconds MED4

48 Confidential Results screen displays all information – Patient ID – Strip Lot – Time – Operator ID Color, symbols and text allow easy recognition of normal, abnormal and critical ranges Operator can reject results at the meter – Repeat testing – Optional set-up MED4

49 Confidential Operator selects comments from a pull-down list or enters via free text Comments pull-down list customized by: –Meter location –QC, test or sample type Meters can be configured for mandatory comments Multiple comments can be entered for each result Comments can be designated as chartable or non-chartable MED4

50 Confidential Manual Test Entry Enables electronic capture of non-connected POC tests using StatStrip infrastructure (ie urinalysis, pregnancy…) Undefined number of manual tests configurable Manual tests are configurable by hospital – pre-configured list for results – Numeric, – +/- Captures QC for manual tests Validate lot numbers

51 Confidential Provides network connection for data downloading and meter configuration Charges batteries StatStrip ® Docking Station

52 Confidential Comprehensive features for infection control  StatStrip’s durable case has passed the FDA’s rigorous disinfection testing protocol validate with 10,950 cleaning cycles using commercially available cleaning materials including bleach.  StatStrip’s disposable, protective bags are available for infection control. Patient barcode scanning and meter operation can be performed with the meter inside the protective bag.  Software workflow and operating steps are optimized for infection control:  Operator ID and strip lot number are scanned and test strips pre-loaded into the meter outside the patient room  The carrying case and extra testing supplies remain outside the patient room per CMS recommendation.

53 Confidential StatStrip ® Installation Examples Nova StatStrip ® Healthcare Systems Include: Intermountain Health Care System, UT (900+ meters) Manitoba Regional Healthcare, CN (855 meters) William Beaumont Medical Center, MI (379 meters) Johns Hopkins, MD (310 meters) Baptist Health South Florida, FL (250 meters) Northshore University Health System, IL (250 meters) Scripps Health, CA (400 meters) ROi, MO (1000 meters) Yale New Haven Health System, CT (500 meters) Duke University Health System, NC (400 meters) Kaiser Health, USA (2500 meters)

54 Confidential Largest Healthcare System Implementation Intermountain Healthcare System, UT - 21 Hospitals - 60+ clinics - 900+ meters - 8,000+ operators trained StatStrip ® Installation Examples

55 Confidential Reimbursement

56 Confidential StatStrip ® CPT Code

57 Confidential StatStrip is the only glucose test strip developed specifically for professional use in the hospital, and cleared by the FDA for that intended use. The reimbursement code for StatStrip ® is 82947. Two CPT codes for glucose: 82947 – Quantitative; glucose, blood $5.62 (StatStrip ® ) 82962 – Glucose; blood by monitoring device -$3.27 (FDA cleared specifically for home use) Additional reimbursement for CPT Code #82947 $2.35 At an outpatient usage of 5%, hospital revenues would increase by the following amounts over a 5 year contract Five YearApproximate Increased Total Strip UsageMeters in Use Hospital Revenue 2 million 80 $235,000 4 million 160 $470,000 6 million 240 $705,000 8 million 320 $940,000 StatStrip ® Reimbursement (All other glucose strips)

58 Confidential Connectivity Overview

59 Confidential Scalable connectivity from single hospital to multi-hospital systems Provides a single connectivity solution for all POC device types - Both wired and wireless connections - Manual test entry of off line tests Comprehensive data management and reporting tools Single device-type fee for StatStrip and StatSensor meters StatStrip and StatSensor meters eliminate the need for costly terminal server devices (Lantronix, Dawning). Comprehensive, Cost Effective POC Connectivity

60 Confidential MetersMeter Configuration Lab/Hospital Information Systems Data Management Nova Connects

61 Confidential  Control of point-of-care devices, operators and usage for compliance with point-of-care program requirements  Capture of point-of-care data for analyzing, reporting and sharing  Connect point-of-care testing to multiple data receivers including LIS, HIS and EMR  Compatible with all “Open Connectivity” to all middleware providers

62 Confidential StatStrip ® meters can be customized by location – Assign operators and privileges – Assign normal, abnormal and critical ranges – Assign mandatory fields – Establish download/docking requirements – Establish QC requirements Pass/fail or numeric option, QC frequency, lockout or prompting – Flag results for Tight Glycemic Control – Reject results for repeat testing – Structure patient ID or MRN NovaNet Instrument Manager Management and Control of Bedside Glucose Testing

63 Confidential Program coordinator can send a text message to specific operator or group of operators with an optional “I read this message” acknowledgment Multiple options for appending comments to patient or QC results – By meter location – By QC or test type – Preset or free text – Chartable or non-chartable NovaNet Instrument Manager Management and Control of Bedside Glucose Testing

64 Confidential NovaConnects: Manual Test Entry Manual test results can be entered through the StatStrip touch screen interface. Data is captured through NovaConnects infrastructure Manual tests are configurable by the hospital - Manual tests can be quantitative or qualitative - QC is also captured An unlimited number of manual tests can be configured

65 Confidential Integrated Management and Control of Bedside Testing Nova has worked with virtually all LIS and HIS vendors to provide fully integrated connectivity solutions that include: Complete data management and reporting Operator certification management Electronic (EDI) or scripted interfacing Full support for unsolicited result reporting to the LIS Hospital defined rules for result exception management Consolidated interface for all connected POC device types

66 Confidential Capture all data for patient, device, operator and regulatory records Create standard or customized reports from a large report library Results exceptions Interface exceptions Results repository QA statistics Levy-Jennings Program utilization Operator Certifications Turnaround Time Results Reports Protocol Reports Program Summary Device Summary: Active devices, device location assignment, last upload Operations reports including;  Operator recertification due,  Daily workload,  Device error events,  Overdue device docking,  Reporting exceptions.

67 Confidential Flexible network connections meet variable needs throughout hospital

68 Confidential Nova Wireless Connectivity Options Wireless Bridge - Wireless connection from docking station provides access to Wifi network. - Cost effective vs. installing new network drops - Uses Cisco Linksys WET-200, or other off-the-shelf components - Not Portable Nova Wireless Tote - Integrated docking station and transmitter in tote - “Always On” connection - Portable - No meter connectivity reconfiguration - Rechargeable battery

69 Confidential Enables connections to all POC devices, regardless of manufacture Eliminates connectivity lock-out which limits POC device choice. Allows hospitals to make POC device decisions based on device needs and benefits Removes cost of middleware conversion as a barrier to acquiring new POC devices Non-proprietary, Open Connectivity

70 Confidential Proven success with virtually every LIS and HIS vendor Electronic Data Interface (EDI) or Script-in enables unsolicited results reporting into LIS or HIS Provides a single interface for virtually all POC devices from all vendors Manages data flow by hospital-specific exceptions rules Nova Connects TM and Telcor, Inc. or Alere Informatics

71 Confidential Telcor QML QML provides - Complete data management - ADT data messaging to NovaNet for positive patient ID at the meter - Hospital defined rules for result exception management - Consolidated interface for all connected POC device types

72 Confidential Alere Informatics-RALS RALS provides - Complete data management - ADT data messaging for positive patient ID at the meter - Hospital defined rules for results exception management - Consolidated interface for all connected POC device types

73 Confidential “The StatStrip glucose meter correlated best with a plasma hexokinase reference method over a wide range of glucose concentrations and was least significantly impacted by sample hematocrit and other interfering substances. This should allow for better management of critically ill patients on intensive insulin therapy resulting in better glycemic control with improved outcomes and patient safety..” StatStrip ® Multi-Well Technology Creates A New Level of Analytical Performance Karon, B. et al, Diabetes Technology and Therapeutics, Apr 2008; TM

74 Confidential Thank You Hospital Glucose Monitoring System Hospital Glucose Meter


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