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

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

Confidential

Hospital Glucose Monitoring System

Hospital Glucose Meter

Hospital Glucose Meter

No. 260 StatStrip Glucose Rev 10/04/2012

Page 2: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

Confidential

1978 First biosensor for Ionized Calcium1980 First biosensor to measure Chloride in blood1984 First biosensor to measure Total Calcium1985 First biosensor to measure Hematocrit by ISE/Conductivity1987 First biosensor to directly measure whole blood Glucose1988 First biosensor to measure Lithium1990 First biosensor to measure BUN (urea)1992 First biosensor to directly measure whole blood Lactate1994 First biosensor to measure Ionized Magnesium1996 First biosensor to measure Creatinine1996 First biosensor to measure Total CO2 in whole blood1997 First multi-wavelength fiber optic SO2% assay1998 First fiber optic Hemoglobin assay1998 First Ammonium biosensor1999 First non-diluting direct Glutamine biosensor1999 First non-diluting direct Glutamate biosensor2001 First Acetate biosensor2005 First Hematocrit corrected Glucose strip2007 First calibration free Glucose strip2007 First Creatinine strip and meter2009 First calibration free Ketone strip2009 First IgG assay on a biotechnology analyzer2011 First Hematocrit corrected hospital Lactate meter and strip

Nova BioSensor Firsts

Nova is the World Leader in Whole Blood Biosensors

Page 3: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Nova Brand Products

Stat Profile® pHOxTest Menu: pH, PCO2, PO2, SO2%, Hct,Hb, Na+, K+, Cl-, Ca++, Glu, Lac

Samples: Whole blood, Serum, Plasma

Nova Chemistry AnalyzersTest Menu: Na+, K+, Cl-, TCO2, 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,PO2, PCO2, Na+, K+, Ca++, CD, CV, Osm,IgG, PO4

Samples: Cell Culture Media

Nova MAX® Link ®

Test Menu: GlucoseSamples: Whole blood

Nova StatStrip®

Test Menu: LactateSamples: Whole blood

* Currently Available outside the U.S.

Nova Lactate Plus ®

Test Menu: LactateSamples: Whole blood

Nova StatStrip®

Test Menu: GlucoseSamples: Whole blood

Nova MAX® PlusTest Menu: Glucose/Ketone

Samples: Whole blood

Nova StatStrip®

Test Menu: Glucose/KetoneSamples: Whole blood

Nova StatSensor®

Test Menu: CreatinineSamples: Whole blood

*

Stat Profile® pHOx UltraTest Menu: pH, PCO2, PO2, SO2%, Hct,Hb, Na+, K+, Cl-, Ca++, Mg++, TCO2, Glu,BUN, Creat, Lac, HHb, O2Hb, Methb,COHb, O2Ct, O2Cap, tBilSamples: Whole blood, Serum, Plasma

Page 4: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Hospital Laboratory Instrument Platform

Page 5: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Hospital Laboratory Instrument Platform

Page 6: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Hospital Laboratory Platform

Page 7: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Hospital Point-of-Care Glucose Meter

Page 8: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Hospital Point-of-Care Lactate Meter

Page 9: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Hospital Point-of-Care Creatinine MeterHospital Point-of-Care Creatinine Meter

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

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Nova Max® PlusHome Glucose Monitor

Nova Max Link®

Home Glucose Wireless Monitor

®

Page 11: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Professional Lactate Meter

Page 12: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Nova Handheld Point-of-Care Hospital Analyzers

*

Page 13: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Nova Multi-Well

Technology CreatesA New Level of Analytical Performance

Hospital Glucose Meter

Hospital Glucose Meter

TM

Page 14: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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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 MeterProven in Over 60 Published Hospital Evaluations Worldwide

Page 15: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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StatStrip® Has Earned Worldwide Scientific Acclaim

Page 16: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Plasma Glucose Reference Method

Nov

a St

atS t

rip W

hole

Blo

od G

luco

se

Kost, G. et al AACC, July 07;Diabetes Technology, Oct 07

StatStrip® Multi-Well Technology Correlation Study

R2: 0.9950SLOPE: 1.018 INTERCEPT: -0.04 mmol/LINTERCEPT: -0.716 mg/dLN=1703 Sy*x = 0.54 mmol/L

Sy*x = 9.795 mg/dL

TM

(mm

ol/L

)

(mg/

dL)

(mg/dL)

700

700 600

600

400

300

200

100

0 0 100 200 300 400 500

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)

Page 17: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Abbott PCx Correlation Study

R2: 0.9499SLOPE: 0.89 INTERCEPT: 0.00 mmol/LINTERCEPT: 0.084 mg/dLN=559 Sy*x = 1.84 mmol/L

Sy*x = 33.194 mg/dL

700

600

400

300

200

100

500

0 6000 100 200 300 400 500

Plasma Glucose Reference Method

Abb

ott P

Cx

Who

le B

lood

Glu

cose

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)

(mg/dL)

(mmol/L)

(mm

ol/L

)

33.3 5.6 11.1 16.7 22.2 27.8

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Abbott PXP Correlation Study Sy*x = 1.8 mmol/LSy*x = 33.15 mg/dL

Plasma Glucose Reference Method

Abb

ott P

XP W

hole

Blo

od G

luco

se

R2: 0.97259SLOPE: 0.820 INTERCEPT: 1.05 mmol/L INTERCEPT: 18.886 mg/dL

N=225

0

100

200

300

400

500

600

0 100 200 300 400 500 600

(mg/

dL)

(mg/dL)

(mmol/L)

(mm

ol/L

)

5.6 11.1 16.7 22.2 27.8 33.3

5.6

11.1

16.7

22.2

27.8

33.3

Kost, G. et al AACC, July 07;Diabetes Technology, Oct 07

Page 19: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Kost, G. et al AACC, July 07;Diabetes Technology, Oct 07

LifeScan SureStep Correlation Study

R2: 0.9869SLOPE: 1.029 INTERCEPT: - 0.08 mmol/LINTERCEPT: - 1.505 mg/dLN=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

Life

S ca n

Who

le B

lood

Gl u

cose

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

(mm

ol/L

)

(mg/dL)

(mg/

dL)

Page 20: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Plasma Glucose Reference Method

Roc

he W

h ole

Bl o

od G

luc o

s e

Kost, G. et al AACC, July 07;Diabetes Technology, Oct 07

Roche Accu-Chek Correlation Study R2: 0.9795SLOPE: 1.036 INTERCEPT: 0.28 mmol/L

INTERCEPT: 5.002 mg/dLN=273 Sy*x = 1.18 mmol/LSy*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

(mm

ol/L

)

(mg/dL)

(mg/

dL)

Page 21: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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N Slope Intercept(mg/dL)

R2 Sy*x(mg/dL)

Nova 1703 1.018 -0.716 0.995 9.795

Abbott PCx 559 0.89 0.084 0.9499 33.194

Abbott PXI P 225 0.82 18.886 0.97259 33.15

Roche 273 1.036 5.002 0.9795 21.197

LifeScan 628 1.029 -1.505 0.9869 15.532

Summary

StatStrip® Correlation Study Comparison

Kost, G. et al AACC, July 07;Diabetes Technology, Oct 07*

* Summary table did not appear in publication

Page 22: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Hematocrit Interference Effect

% Hct 45

Glucose ResultsNormal

(Calibration Point)% Hct 25

Glucose ResultsArtificially High

Up to 25%

% Hct 65

Glucose ResultsArtificially Low

Up to 30%

Hematocrit Interference Effect

StatStrip® Multi-WellTM Technology Measures and Corrects Hematocrit Interference

Page 23: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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StatStrip® Multi-WellTM Technology Measures and Corrects Hematocrit Interference

-30%

-20%

-10%

0%

10%

20%

30%

25% 60%45%

Error % Due to Uncorrected Hematocrit

Glucose resultuncorrected for Hct.

Glucose result.Hct measuredand corrected.

Hematocrit

Err

or

fro

m H

ct

Low hematocrit causes erroneously high glucose resultsHigh hematocrit causes erroneously low glucose results

Page 24: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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StatStrip® Multi-WellTM Technology Measures and Corrects Hematocrit Interference

Karon, B. et al, Diabetes Technology and Therapeutics, Apr 2008

Hematocrit Interference StudyNova StatStrip® vs. Current Technology Test Strips

Hematocrit (%)

Mea

n gl

ucos

e di

ffere

nce

(mg/

dL)

-20

-15

-10

-5

0

5

10

15

20 30 40 50 60 70-

-

-

-

Glucose = 54 mg/dL

StatStrip Abbott Precision Lifescan SureStepRoche Inform

True value

Page 25: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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StatStrip GD Electrochemical GO PhotometricGD Electrochemical StatStrip Abbott Precision Lifescan SureStepRoche Inform

Karon, B. et al, Diabetes Technology and Therapeutics, Apr 2008;

Hematocrit Interference StudyNova StatStrip® vs. Current Technology Test Strips

StatStrip® Multi-WellTM Technology Measures and Corrects Hematocrit Interference

-50

-40

-30

-20

-10

10

20 30 40 50 60 70Hematocrit (%)

Mea

n gl

ucos

e di

ffere

nce

(%)

-

-

-

-

-

Glucose = 247 mg/dLTrue value 0

Page 26: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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StatStrip® Multi-WellTM Technology Measures and Corrects Hematocrit Interference

-50

-40

-30

-20

-10

10

20 30 40 50 60 70Hematocrit (%)

Mea

n gl

ucos

e di

ffere

nce

(%)

Glucose = 486 mg/dL

Karon, B. et al, Diabetes Technology and Therapeutics, Apr 2008

Hematocrit Interference StudyNova StatStrip® vs. Current Technology Test Strips

StatStrip Abbott Precision Lifescan SureStepRoche Inform

0 True value

Page 27: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Severe hematocrit abnormalities are extremely common in hospitalized patients

Up to 77% of ICU patients an have abnormally low hematocrit (<36%) during their ICU stay1,2

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 day1

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); 2630-26392.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):278-2914. Vincent JL, et al. Anemia and blood transfusion in critically ill patients. JAMA 2002 Sep 25; 288(12):1499-1507

Page 28: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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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/AlertsandNotices/PublicHealthNotifications/ucm176992.htm

Page 29: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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290 Bed MA Hospital

Maltose Interference StudiesNova StatStrip® vs Roche GDH-PQQ Method

Glu

cose

(mg/

dL)

Glu

cose

(mg/

dL)

Glu

cose

(mg/

dL)

Maltose Interference

54

108

163

0 100 200

Maltose (mg/dL)

Roche

Maltose Interference

217

280

344

Maltose (mg/dL)

Maltose Interference

380

460

540

Maltose (mg/dL)

StatStrip RocheGDH

StatStrip GDH

StatStrip GDH

StatStrip GDH

0 100 200

0 100 200

150 Bed CT Hospital

Glu

cose

(mg/

dL)

Glu

cose

(mg/

dL)

Glu

cose

(mg/

dL)

Maltose Interference

54

120

180

0 100 200

Maltose (mg/dL)

Maltose Interference

199

271

344

0 100 200

Maltose (mg/dL)

380

450

522

0

Maltose (mg/dL)

Maltose Interference

StatStrip GDH

StatStrip GDH

StatStrip GDH

100 200

Page 30: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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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 TechnologyEliminates Calibration Codes

TM

Page 31: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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24 month shelf-life from manufacturer

180 day open vial stability

Manufacturing lot size up to

8 million strips

Nova StatStrip® Multi-Well TechnologyOffers Other Operational Advantages

TM

Page 32: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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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 LayerWell 1: Interferences and

glucoseWell 2: InterferencesWell 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

Page 33: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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“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

Page 34: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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“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

Page 35: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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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 Error1

Total Analytical

Error

InsulinDosage Error

Rate 5% 8-23%

10% 16-45%

15% >5% 2-Step Dosing Error

Page 36: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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35

94

LifeScan

Cumulative

35

80

98100

Roche

Cumulative

98% of Nova Results Satisfy a 10% Total Error Limit

N=133 patient study at Mayo ClinicNova 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 SpecificationISO 15197 Requirement

% Bias(Error)

Cumulative

Abbott

≤5%

75 26

≤15% 100 76

≤25% 100≤30%

StatStrip

Cumulative

71 67≤10%

98 56

100 96≤20% 93

ADA

ISO 15197

% of patients % of patients % of patients % of patients

Page 37: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Fast and Easy Glucose Testing at the Bedside

Page 38: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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On/Off Button

Function Keys

Bar Code Scanner

Bright, Easy-to-ReadColor Touchscreen.

Large Easy-to-UseTouchpad.

Strip Port

Page 39: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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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

Page 40: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Color Touch Screen Prompts Operator Through Steps

MED4

MED4

Page 41: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Operator ID Entered by Scan or Touch Screen

MED4

Page 42: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Meter Then Goes Directly to Patient Test Screen

MED4

Page 43: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Strip Lot Scanned or Entered Automatically By Default Setting

35475932MED4

Page 44: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Patient ID (or MRN) Entered by Scan or Touch Screen

194546646MED4

Page 45: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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StatStrip® Confirms Valid Patient ID

194546646

MED4

Page 46: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Operator Prompted To Final Step

MED4

Page 47: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Results In Only 6 Seconds

MED4

Page 48: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Results screen displays all information–Patient ID–Strip Lot–Time–Operator ID

Color, symbols and text alloweasy recognition of normal,abnormal and critical ranges

Operator can reject results at the meter –Repeat testing–Optional set-up

MED4

Page 49: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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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

MED4

Page 50: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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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

Page 51: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Provides network connection for data downloading and meter configuration

Charges batteries

StatStrip® Docking Station

Page 52: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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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.

Page 53: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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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)

Page 54: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Largest Healthcare System Implementation

Intermountain Healthcare System, UT

- 21 Hospitals

- 60+ clinics

- 900+ meters

- 8,000+ operators trained

StatStrip® Installation Examples

Page 55: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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Reimbursement

Page 56: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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StatStrip® CPT Code

Page 57: Confidential Hospital Glucose Monitoring System Hospital Glucose Meter No. 260 StatStrip Glucose Rev 10/04/2012

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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 Year Approximate Increased TotalStrip Usage Meters in Use Hospital Revenue2 million 80 $235,0004 million 160 $470,0006 million 240 $705,0008 million 320 $940,000

StatStrip® Reimbursement

(All other glucose strips)

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Connectivity Overview

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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

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Op: 8636

13:42Meter Name: NICU-1

OK

Enter Patient ID

_________________________

Clear

1 2 34 5 67 8 9

ABC...0Scan

Accept

194546646

Meters Meter Configuration

Lab/Hospital Information

Systems

Data Management

Nova Connects

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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

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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

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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

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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

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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

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Capture all data for patient, device, operator andregulatory records Create standard or customized reports from a large report libraryResults exceptionsInterface exceptionsResults repository QA statisticsLevy-JenningsProgram utilizationOperator Certifications Turnaround TimeResults ReportsProtocol ReportsProgram Summary

Device Summary: Active devices, device location assignment, last uploadOperations reports including;

Operator recertification due, Daily workload, Device error events,Overdue device docking, Reporting exceptions.

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Flexible network connections meet variable needs throughout hospital

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Nova Wireless Connectivity OptionsWireless 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

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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 deviceneeds and benefits Removes cost of middleware conversion as a barrier to acquiringnew POC devices

Non-proprietary, Open Connectivity

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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 ConnectsTM

and Telcor, Inc. or Alere Informatics

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Telcor QMLQML 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

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Alere Informatics-RALSRALS 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

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“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 CreatesA New Level of Analytical Performance

Karon, B. et al, Diabetes Technology and Therapeutics, Apr 2008;

TM

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Thank You

Hospital Glucose Monitoring System

Hospital Glucose Meter

Hospital Glucose Meter