www.i-sens.com

i-SENS (Jiangsu) Co., Ltd. Huatai Road, Gangkou Street Fenghuang Town, Zhangjiagang City, Jiangsu Province, ChinaTel : +86-25-6668-6681

iSENS BIOSENSORS INDIA Pvt.Ltd. Unit No.1116-17, JMD Megapolis, Sohna Road, Gurgaon, Haryana 122001, IndiaTel : +91-0124-651-6606

i-SENS, Inc. Germany Ludwig-Erhard Strasse 30-34, 65760 Eschborn, GermanyTel : +49-6196-9675635

i-SENS CHILE SpA. Manzano 343, Oficina 412. Recoleta. Santiago. ChileTel : +59-228-409-536

i-SENS USA, Inc. 10050 Medlock Bridge Road, Suite 100, Duluth, GA 30097, USATel : +1-678-417-5990

i-SENS, Inc. Headquarters43, Banpo-daero 28-gil, Seocho-gu, Seoul 06646, KoreaTel : +82-2-910-0696 Fax : +82-2-941-0868

PG

A1E9500 R

EV1 2015/09

02 / 03Introduction of i-SEN

S

2000 - 2003 2003 Launched blood glucose monitoring system ‘CareSens ’

2003 Successfully developed ‘CareSens ’ glucose strips

2002 Completion of Seoul factory and R&D center

2000 Founded i-SENS, Inc.

2004 - 2006 2006 Manufactured 1,000,000 glucose strips per day

2005 ODM glucose strips FDA cleared

2004 EM Mark, Europe CE, ISO 13485 certification

2007 - 2008 2008 Established branch office in China

2008 Launched CareSens N

2008 CareSens II, CareSens POP cleared by FDA

2007 ODM glucose monitoring system certified by Japan’s MHLW

2007 Completed Wonju factory

2009 - 2010 2010 Established i-SENS, USA.

2010 CareSens N certified by China CFDA

2009 Frost & Sullivan award for Self-Monitoring Product of the year

2009 Launched electrolyte analyzer ‘i-Smart 30’

2011 - 2012 2012 New Zealand sole suppliership

2012 Launched CareSens N POP, CareSens N Voice

2012 Completed Songdo factory

2011 Established branch office in Europe

2011 Japan OEM launched

2013 - 2014 2014 Established i-SENS(Jiangsu) Co., Ltd.

2014 Launched CareSens N NFC

2014 Launched VetMate

2013 Listed on KOSDAQ

2013 “World Class 300” by The Ministry of Knowledge Economy of Korea

20152015 Launched A1Care & i-Smart 300

2015 Established i-SENS CHILE SpA. & iSENS BIOSENSORS INDIA Pvt.Ltd.

2015 Launched GDH-FAD BGMS

Our vision is to improve health with high quality products

based on cutting edge biosensor technology.

CEO, i-SENS, Inc.

Geun Sig Cha

History of i-SENS

World-class Production Facilities

• Clean area facility • High-tech monitoring & control stations • Electronic visual inspection system

Songdo (IFEZ) Plant

Capacity : 0.8 billion strips

Overseas Branch and Subsidiary Companies

Headquartersi-SENS, Inc. Germany

i-SENS (Jiangsu) Co., Ltd. i-SENS, Inc. Shanghai Daibiaochu

04 / 05Introduction of i-SEN

S

i-SENS USA, Inc.

i-SENS, Inc. Headquarters

iSENS BIOSENSORS INDIA Pvt.Ltd.

i-SENS CHILE SpA.

Wonju Plant

Capacity : 2 billion strips

Simple and Reliable Code Detection System

CodeSens™ is our patented no-coding technology. Superior No Coding Technology. CodeSens™ allows glucose meter to automatically recognize the code number of each glucose strip so that users can get the most reliable and accurate results.

No code chip, code strip, nor barcode reader required. It automatically detects the code number when a glucose test strip is inserted into the meter.

Advanced Electrochemical Signal Processing Technology

• Uses a set of glucose-specific signals extracted from sophisticated signals.

• Provides highly accurate and precise glucose value.

• Provides users with the most accurate results and convenience.

• Eliminates the anxiety of inaccurate results from miscoding.

i-SENS’ CoreSignal™ Technology is an electrochemical signal processing technology developed for very accurate and far more precise monitoring of blood glucose level than the conventional glucose self monitoring products.

Electrochemical signals generated from a tiny glucose strip filled with human blood is not as simple as it may sound; the physical, chemical and biological properties of blood are so diverse from person to person that the signal pattern is complicated.

06 / 07Technology of i-SEN

S

CareSens BGMS with CoreSignal™ Technology and CodeSens™ Technology fulfills not only the accuracy requirements of ISO 15197:2013, but also all other requirements such as the hematocrit bias and interference effects presented in the ISO 15197:2013 guidance.

Figure 1. System Accuracy of CareSens BGMS (2,400 test results).

Car

eSen

s, m

g/dL

CareSens

, mm

ol/L

Reference YSI 2300 STAT PLUS, mg/dL

Figure 2. Hematocrit Dependent Bias of CareSens BGMS.

Hematocrit, %

Mean D

ifference in Bias from

C

ontrol, %(Interval 2, 3)

Mea

n D

iffer

ence

in B

ias

from

C

ontr

ol, m

g/dL

(Inte

rval

1)

Diabetes Management Software

08 / 09

Available Operating Systems Integrated Management System

For Mobile (Android, iOS)

( Push Setting )( Logbook )( Daily Graph )( Statistics )( Summary )

For PC (Windows, MAC, Web)

SmartLog™

SmartLog™’s Extensive Networking SmartLog™ provides mobile healthcare services through 3G, Bluetooth and NFC.

Family Doctor

10 / 11

Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L) • Hematocrit : 15-65 %• 1,000 test result memory• 5-50 °C(41-122 °F)

Features• No coding required• Hypoglycemia indicator• Strip expiration date indicator• Auto back-lighted LCD• 1, 7, 14, 30, 90-day test averages (total, pre-meal and post-meal) • Post-meal flagging• PP2* alarm *2 hours after meal• Data port

Slim & Smart

Talking Function

Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L) • Hematocrit : 15-65 %• 500 test result memory• 5-50 °C(41-122 °F)

Features• No coding required • Talking function • Hypoglycemia indicator • Strip ejection button• 1, 7, 14, 30, 90-day test averages (total, pre-meal and post-meal) • Post-meal flagging• 4 alarms(PP2* and 3-time set alarms) *2 hours after meal• Data port

Millions of Customers' Choice

Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L)• Hematocrit : 15-65 %• 1,000 test result memory • 5-50 °C(41-122 °F)

Features• No coding required• 1, 7, 14, 30, 90-day test averages (total, pre-meal and post-meal) • Post-meal flagging• 4 alarms(PP2* and 3-time set alarms) *2 hours after meal• Data port

Convenient with NFC

Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L) • Hematocrit : 15-65 %• 500 test result memory• 5-50 °C(41-122 °F)

Features• No coding required• Hypoglycemia indicator• Strip expiration date indicator• 1, 7, 14, 30, 90-day test averages (total, pre-meal and post-meal) • Post-meal flagging• 4 alarms(PP2* and 3-time set alarms) *2 hours after meal • NFC(Near Field Communication)• Data port

Blood G

lucose Monitoring System

12 / 13B

lood Glucose M

onitoring System

Specifications• 0.4 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L)• Hematocrit : 15-65%• 5-45 °C(41-113 °F)• Fresh capillary/venous whole blood

Features• Enzyme : GDH-FAD• No coding required• Hypoglycemia indicator• Strip expiration date indicator• Strip ejection button• 1, 7, 14, 30, 90-day test averages• Pre-meal, Post-meal, Fasting and No-mark flagging• 4 alarms(PP2* and 3-time set alarms) *2 hours after meal• Data port

No Oxygen Interference

Convenient with Bluetooth SMART

Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L) • Hematocrit : 15-65 %• 1,000 test result memory• 5-50 °C(41-122 °F)

Features• No coding required• Hypoglycemia indicator• Strip expiration date indicator• Strip ejection button• Auto back-lighted LCD• 1, 7, 14, 30, 90-day test averages • Pre-meal, Post-meal, Fasting and No-mark flagging• 4 alarms(PP2* and 3-time set alarms) *2 hours after meal• Bluetooth SMART• Data port

Specifications• 0.4 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L)• Hematocrit : 15-65 %• 1,000 test result memory• 5-45 °C(41-113 °F)• Fresh capillary/venous whole blood

For blood β-Ketone testing• 0.5 μL / 8 seconds• 0.1-8.0 mmol/L• Hematocrit : 30-60%• 15-30 °C(59-86 °F)

Feature• Enzyme : GDH-FAD• No coding required• Hypoglycemia / Hyperglycemia indicator• Strip expiration date indicator• Strip ejection button• Auto back-lighted LCD• 1, 7, 14, 30, 90-day test averages• Pre-meal, Post-meal, Fasting and No-mark flagging• 4 alarms(PP2* and 3-time set alarms) *2 hours after meal• Ketone test alarm• Bluetooth® SMART• Data port

Blood Glucose and -Ketone Monitoring System

Checks Ketone Too

NEW

NEW

14 / 15B

lood Glucose M

onitoring System

Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L) • Hematocrit : 15-65%• 1,000 test result memory• 5-50 °C(41-122 °F)

Features• Coding required• Hypoglycemia indicator• Strip expiration date indicator• 1, 7, 14, 30, 90-day test averages• Pre-meal, Post-meal, Fasting and No-mark flagging• PP2* alarm *2 hours after meal• Data port

Proven Accuracy

Simple & Easy

Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L) • Hematocrit : 20-60 %• 10 test result memory• 10-40 °C(50-104 °F)

Features• No coding required • Ring for strap

Large Display, Easy to Read

Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L)• Hematocrit : 15-65 %• 1,000 test result memory• 5-50 °C(41-122 °F)

Features• No coding required• Hypoglycemia indicator• Strip expiration date indicator• 1, 7, 14, 30, 90-day test averages• Pre-meal, Post-meal, Fasting and No-mark flagging• 4 alarms(PP2* and 3-time set alarms) *2 hours after meal• Data port

For Your Pet

Specifications• 0.4 μL / 5 seconds• 10-600 mg/dL(0.6-33.3 mmol/L) • Hematocrit : 20-60 % • 500 test result memory• 5-50 °C(41-122 °F)

Features• Enzyme : GDH-FAD • No coding required• Hypoglycemia indicator• Strip ejection button• Auto back-lighted LCD• 14-day test averages(each animal type and ID)• Maximum number of ID entries : 4 dogs & 4 cats• Calibrated for dogs & cats• 5-time set alarms • Compatible with VetLog™ animal diabetes management software• Data port

Hospital Blood Glucose Monitoring System

16 / 17P

OC

T

Compact & Smart, Fits in your hand

Specifications• 0.4 μL / 5 seconds• 10-600 mg/dL(0.6-33.3 mmol/L)• Hematocrit : 15-65%• 1,500 test result memory• Measurement temperature : 5-45 °C(41-113 °F)• 3.7V Li-ion polymer rechargeable battery

Features• Enzyme : GDH-FAD• Strip ejection button• No coding required• 3.5〃color LCD(touch screen)• Barcode scanner(1D or 2D)• Data transfer : WiFi, USB• Standard : POCT1-A, IHE DEC(ASTM&HL7)• Efficient QC management

CareSens Data Manager SolutionConnect easily to your hospital network with our system over WiFi or wired. · Web-based system enables users to access CareSens® Data Manager from any location at any time. · CareSens® EXPERT & CareSens® Data Manager system supports multiple security protocols (POCT1- A and IHE DEC(incl. ASTM&HL7)) to ensure the integrity of patient data.

Performance of CareSens Expert CareSens EXPERT Hospital blood glucose monitoring system fulfills not only the accuracy requirements of ISO 15197:2013, but also all other requirements such as the hematocrit bias and interference effects presented in the ISO 15197:2013 guidance.

Car

eSen

s E

XPER

T, m

g/dL

Reference YSI 2300 STAT PLUS, mg/dL Hematocrit, %

Mean D

ifference in Bias from

Control, %

(Interval 2, 3)Mea

n D

iffer

ence

in B

ias

from

Con

trol

, mg/

dL(In

terv

al 1

)

• System Accuracy Test Results • Hematocrit Effect Test Results

Web-based CareSens Data Manager

Accuracy Criteria

Percent (n/n)within criteria 580/864 (67.1 %) 812/864 (94.0 %) 853/864 (98.7 %)

Within ± 5 mg/dLor ± 5 %

Within ±10 mg/dLor ± 10 %

Within ±15 mg/dLor ± 15 %

Specifications• Cartridge

• Analyzer

Sample & volume Measurement time Accuracy Precision Dimension & weight Operating temperature Humidity DisplayMemoryInterfaceOS

Whole Blood(Venous, Capillary); 2.5 μL4 minutes 20 seconds±6 % of target value(95 % CI)C.V. 3 %290 X 250 X 130mm; 3.8 kg15-32 °C(59-90 °F)10-90 %7〃touch screen, color LCD5,000 Sample dataUSB; Serial(RS232), LAN(R145 Ethernet)Android

18 / 19P

OC

T

STEP-1

HbAo + HbA1c+ Hbx etc.

Glycated peptidesIncluding

Fructosyl-Val-HisHydrogen Peroxide

HbA1cRBC Lysis

Lysingbuffer

Fructosyl-Val-His Hydrogen Peroxide

STEP-2 STEP-3 STEP-4

ProteaseFPOX POD

Color change

Assay Principle

IFCC IssueDeviation

from IFCC target (mmol/mol)

Reproducibility (%)

Excellent 0.0 – 1.9 < 2 > 0.9950

0.8 (at 30)1.2 (at 60)1.6 (at 90)

1.85 0.9987

Good 2.0 - 3.9 2.00 – 3.49 0.9901 – 0.9950

Acceptable 4.0 - 6.9 3.50 – 4.99 0.9851 – 0.9900

Poor 7.0 - 9.9 5.00 – 6.99 0.9801 – 0.9850

Unacceptable > 9.9 > 6.99 < 0.9801

A1CareTM

Linearity

POCT HbA1c Analyzer

» Simple & Easy Preparation» Fast & Reliable Result» High Usability

Advantages of A1CareTM

• Easy & simple installation• All-in-one, self-contained reagent cartridge• Small blood sample size (2.5 μL)• No sample pretreatment and pipetting required

Simple & Easy Preparation• On-screen step-by-step guide• Android OS-Useful and easy to use• Intuitive color touch screen• External barcode scanner for safer and faster patient ID entry• No complicated maintenance required due to all-in-one cartridge

High Usability

• HbA1c test results within 4 minutes 20 seconds • All-in-one cartridge to minimize user error• Internal temperature control system

Fast & Reliable Result

PerformanceA1CareTM has acquired the NGSP and IFCC certifications with its performance beyond the standards required by the National Glycohemoglobin Standardization Program (NGSP) and International Federation of Clinical Chemistry (IFCC).

A1CareTM 40 of 40 results within ± 6%

NGSP Criteria 37 of 40 results within ± 6%