NICO /14 Nipro Diagnostics, Inc.

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1 Clinical Performance of the TRUEresult twist Blood Glucose Monitoring System () Using ISO 15197:13 Criteria for Accuracy Utilizing GDH-FAD Enzyme NICO-8 1/1 Nipro Diagnostics, Inc. NICO_8_mmol.indd

2 CLINICAL STUDY SUMMARY EVALUATION OBJECTIVES This clinical evaluation: 1. Evaluates the accuracy of the TRUEresult twist System utilizing international standard ISO 15197:13.. Compares the performance of the TRUEresult twist Blood Glucose Monitoring System utilizing ISO 15197:13 accuracy criteria to the performance of the TRUEresult twist System utilizing the EN ISO 15197:3 international standard. 3. Proves that lay users of the TRUEresult twist Blood Glucose Monitoring System can obtain accurate results consistent with those obtained by trained professionals.. Proves that the TRUEresult twist Blood Glucose Monitoring System is easy to use by first-time users. 5. Proves that the TRUEresult twist Blood Glucose Monitoring System produces precise results when measuring duplicate fingerstick samples. ISO STANDARD 15197:3 1 COMPARED TO ISO 15197:13 An ISO Standard is developed in response to an identified need in the community, and that will eventually be suitable for implementation on as broad a basis as possible. ISO developed the standard for blood glucose monitoring performance based on a consensus of professionals around the world. A clinical accuracy study was conducted according to the methodology requirements of ISO 15197:13. The data were assessed and compared using the accuracy bias limits of both EN ISO 15197:3 and ISO 15197:13. Below is a table outlining the accuracy parameters we evaluate in this study. Accuracy Parameter EN ISO 15197:3 ISO 15197:13 Target blood glucose level from which to base bias or % bias Acceptable bias from reference value for lower target glucose levels Acceptable bias from reference value for higher target glucose levels Acceptable % of all results within bias limits Parkes Error Grid /-.83 +/-.83 +/- % +/- 15% 95% 95% Not required 99% of results within Zones A and B 1 NICO_8_mmol.indd 3

3 CLINICAL STUDY SUMMARY The graph to the right illustrates the comparison of the EN ISO 15197:3 bias limits compared to ISO 15197:13 criteria for accuracy. Bias from YSI () - - Blood Glucose Results ISO 15197:3 ISO 15197:13 SITES AND SUBJECTS YSI Plasma Result () Clinical evaluations of the TRUEresult twist System were conducted at clinical institutions across the U.S. In total, subjects completed the protocol across the evaluation sites. Study demographics shown below. Ethnicity Category White African American Hispanic American Indian Asian Other Not Recorded User Study % 7% % % % % % Accuracy Study 39% 8% % 1% % % % Gender Category Male Female Not Recorded User Study % 53% 1% Accuracy Study 5% 9% 1% Age (Years) Category Average Maximum Minimum User Study Accuracy Study Years of Education Category <1 1 >1 Not Recorded User Study 11% 7% % % Accuracy Study 1% 7% 1% % CLINICAL EVALUATION METHODS Clinical Evaluations performed using the TRUEresult twist Blood Glucose Monitoring System: 1. Accuracy of fingerstick results obtained by patients and healthcare professionals (HCP) compared to the laboratory reference (three test strip lots used).. Accuracy of fingerstick results obtained by healthcare professionals compared to the laboratory reference using Parkes Error Grid analysis (three test strip lots used). 3. User performance evaluation including healthcare professional feedback on first-time user testing technique (one test strip lot used). NICO_8_mmol.indd

4 TRUEresult twist Bias from YSI () TRUEresult twist Clinical Accuracy ISO 15197:13 TOPLINE RESULTS USING ISO CRITERIA - - In this study using fingerstick samples obtained by healthcare professionals, the TRUEresult twist System produced 98.5% of results within the bias limits for EN ISO 15197:3 and 98.8% within the bias limits - for ISO 15197: YSI Plasma () TRUEresult twist Bias from YSI () TRUEresult twist Clinical Accuracy ISO 15197: YSI Plasma () TRUEresult twist Bias from YSI () TRUEresult twist Clinical Accuracy ISO 15197: YSI Plasma () ISO 15197:13 requires 3 lots of test strips to be used in the evaluation TRUEresult twist Clinical Accuracy ISO 15197:3 Summary of TRUEresult twist System accuracy against the YSI reference method using EN ISO 15197:3 and ISO 15197:13. ±.8 EN ISO 15197:3 Samples <. ±.5 ±.83 3/88 7/88 88/88.1% 81.8% 1.% Samples. TRUEresult twist Bias from YSI () - - ±.8 ISO 15197:13 Samples < 5.55 ±.5 ± YSI Plasma () 53/18 1/18 17/18 9.% 7.% 97.8% Samples 5.55 ± 5% ± 1% ± 15% ± % 78/51 8/51 88/51 53/51 5.3% 83.% 95.3% 98.% ± 5% ± 1% ± 15% 55/ 38/ 17/.7% 91.% 99.3% 3 NICO_8_mmol.indd 5

5 TOPLINE RESULTS USING ISO CRITERIA In this study, first-time users of the TRUEresult twist System obtained accurate results compared to the laboratory reference method. TRUEresult twist Bias from YSI () TRUEresult twist User Finger vs. YSI ISO 15197: YSI Plasma () ISO 15197:13 requires 1 data points from user self-testing ±.8 Samples < 5.55 ±.5 ±.83 /3 19/3 3/3.1% 8.% 1.% Samples 5.55 ± 5 % ± 1 % ± 15 % 3/77 9/77 77/77.8% 89.% 1% TRUEresult twist System Accuracy Results for total glucose concentrations. Within +/-.83 and within +/-15% 1/1 (1%) NICO_8_mmol.indd

6 TOPLINE RESULTS USING PARKES ERROR GRID PARKES ERROR GRID 3 Parkes et al. developed an error grid to analyze the clinical significance of the bias between blood glucose system results and lab reference results. For analysis, data points are assigned into one of the five Zones (A-E) on the error grid. Results, or data points, falling into Zones A and B are defined as clinically acceptable, where any observed bias from lab results would not lead to treatment decisions that may put a patient at risk. As the bias, or difference, increases (Zones C, D, and E), there is greater risk of undertreating or overtreating a patient based on the glucose system result. Analysis of data using the Parkes Error Grid is a requirement in ISO 15197:13. The TRUEresult twist System, in the hands of healthcare professionals, is proven to provide accurate fingerstick results that are comparable to the YSI reference method. TRUEresult twist HCP Finger vs. YSI TRUEresult twist HCP Finger Result () E D C B A y = 1.x +.8 R =.99 A B C D ZONE COUNT % Results In Zone Zone # Points % A 1% B % C % D % E % Total 1% YSI Plasma () TRUEresult twist User Finger vs. YSI TRUEresult twist User Finger Result () E D C B y =.99x +.1 R =.98 A 5 A B C D NICO_8_mmol.indd YSI Plasma ()

7 TOPLINE RESULTS USING STANDARD DEVIATION The TRUEresult twist System, in the hands of healthcare professionals, is proven to provide precise results that are comparable to the laboratory reference method. The Standard Deviation for Duplicate Measurements is a statistical calculation that measures how close the individual data points, for each pair of duplicate data points, are to each other. Meter results are more precise with a lower Standard Deviation (S.D.) value. TRUEresult twist S.D. Value.7% S.D. = (Σd /(n)) The Standard Deviation for Duplicate Measurements is calculated by using the above equation where d is the Percent Difference between duplicate data points and n is the number of patient samples. First-time users of the TRUEresult twist System agreed that the system was easy to use and achieved accurate and precise results. Healthcare professionals positively ranked first-time users compliance with the instructions for using the TRUEresult twist System. Was the system easy to use? Was the display easy to read? Were instructions clear on how to read results? Did instructions adequately describe how to apply blood? Were instructions easy to understand? User Evaluation Did patient follow the written instructions? Did patient read result correctly? Did patient apply blood correctly? Did patient insert strip correctly? HCP Evaluation NICO_8_mmol.indd 8

8 CONCLUSION In this study, the TRUEresult twist System demonstrated accurate performance in the hands of both healthcare professionals and first-time users. Clinical data obtained by both first-time users and healthcare professionals exceeded the minimum accuracy criteria for EN ISO 15197:3 and the more rigorous minimum accuracy criteria for ISO 15197:13. First-time users of the TRUEresult twist System agreed that the instructions were easy to understand and the system was easy to use. The TRUEresult twist System produced precise results as evidenced by a Standard Deviation value of.7%. 1. International Organization for Standardization. In vitro diagnostic test systems. Requirements for blood glucose monitoring system for self testing in managing diabetes mellitus. Reference number EN ISO 15197:3 (E). Geneva: International Organization for Standardization; 3.. International Organization for Standardization. In vitro diagnostic test systems. Requirements for blood glucose monitoring system for self testing in managing diabetes mellitus. Reference number ISO 15197:13. Geneva: International Organization for Standardization; Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. ; 3(8): Westgard, James O. Ph.D. Basic Method Validation 3rd Edition. Westgard QC, Inc., 8. FOR ADDITIONAL INFORMATION OR QUESTIONS, ADDRESS WRITTEN REQUESTS TO: FPO Nipro Diagnostics, Inc. NW 55th Ct. Ft. Lauderdale, FL 3339 NICO-8 1/1 Nipro Diagnostics, Inc. NICO_8_mmol.indd 1