CompanyOverview
www.nanoentek.com
www.nanoentek.com
2K12
Copyright @ NanoEnTek Inc. All rights reserved
Inc.
www.nanoentek.com
Copyright @ NanoEnTek Inc. All rights reserved
Introduction of
Name of
Company
President & CEO
Date of
Foundation
Stock market
Main Office
Jun Keun Chang, Ph. D. (Founder)
June 2000
KOSDAQ in Korea (# 039860)
Ace High-end tower 12th floor, 235-2, Kuro3-dong, Kuro-gu, Seoul,
Korea
Production site
Jiwol-ri, Paltan-myun, Hwasung-Si, Kyungki-do, Korea
Main Business
Core Technologies: Lab On-a-Chip Technology
R&D and manufacturing of
Life Science - instruments and disposables
Medical device - instruments and disposables
Affiliated
Companies
www.nanoentek.com
NanoEnTek Inc. http://www.nanoentek.com
Digital Bio Technology co., Ltd.(Korea),
NanoEnTek Inc.(USA)
Copyright @ NanoEnTek Inc. All rights reserved
3
Introduction of CEO
• Ph.D. Seoul National University - Biomedical Engineering, Cellular and Tissue Engineering
Educational
background
• Master of Sc. Seoul National University - Biomedical Engineering, Artificial organs and implantable devices
• B.Sc. Seoul National University - Mechanical Engineering
• BK Professor of Electrical Engineering at Seoul National University(BioMEMS)
Career
Experience
• President & CEO of NanoEnTek (2006-present)
• Founder & CEO of Digital Bio Technology (2000-present)
• BK Professor of Electronic Engineering in Seoul National University(2000-2006)
• Seoul Economic Vision 2020 Member, Department of Economic Policy, Korea(January 2010 to Present)
• Industrial Convergence Committee, The Ministry of Knowledge Economy, Korea(March 2010 to Present)
• Interim Member, Korean R&D Strategic Planning Committee (May 2010 to Present)
Professional
Activities
• Bio-Smartcare Committee, The Korean Academy of Science and Technology (May 2010 to July 2010)
• IP Wisemen Committee for IP-R&D Policy, Korean Intellectual Property Office (March 2010 to March 2011)
• Board member, Korea Venture Business Association(March 2010 to Present)
• KISTI (Korea Institute of Science and Technology Information), Seoul Science and Technology Information
Committee (Sep 2009 to Dec 2010)
• Planning Member, Future Strategy Committee, New Growth Engine Business: Bio/Medicine Part (May 2009)
• Venture Korea, Industrial Prize Winner (2010)
• Trade-day, Ministry of Knowledge Economy Citation Winner (2010)
• Venture Philanthropy Prize: Industrial Winner, Korea Venture Business Association (2010)
• IR52 Jang Young Shil Award (2010)
Jun Keun Chang
Ph D. (Founder)
Award
and
Honors
• Venture Korea, Minister of Knowledge Economy Citation Winner (2009)
• Grand Awards for Excellence in Sustainability Management: Small-Medium Enterprise part, Ministry of
Knowledge
Economy, Grand Prize (2009)
• Grand Awards for Korea Growth Engine Management: Bio, Medicine, Medical Devices, Grand Prize (2009)
• Health Industry Technology (Prime Minister) Award, Grand Prize (2008)
• 38th Korea Micro Industry Technology Award, Small & Medium Business Administration Prize Winner (2008)
www.nanoentek.com
Copyright @ NanoEnTek Inc. All rights reserved
4
Company History
2011
• Strategic Alliance with SK Telecom for Global Healthcare Business
 25 Billion KRW investment to NanoEnTek(CB 14 B KRW, Paid-in Capital increase 1.1 B KRW)
2010
• MOU with Hanmi Medicare for domestic sales of medical products
• MOU with Cha Hospital group for stem cell and U-Healthcare business
• KFDA approval of AFP, CEA diagnostic kits
• CE IVD approval of PSA diagnostic kits
2009
• Manufacture and supply contract with Life Technologies with 4.5M$ of R&D investment
• Patent of gene transfection technologies sales to Life Technologies with 13M$
• KFDA approval of C-Box and PSA diagnostic kit
2008
• Strategic Alliance with Life Technologies to supply Countess by ODM
• KFDA approval of Troponin-I diagnostic kits
2007
• Establish NanoEnTek Inc. (USA; Boston, MA)
• Establish Production factory in Hwasung si, Kyungki do, Korea
2006
• Reverse merging to NanoEnTek, Inc and enlisted on KOSDAQ(Korea Stock Market)
2005
• Complete the development of C-Reader CRP series and start to sale
2004
• Start to mass-produce the C-chip DHC series and the G-slide GSC series
• Mass-produce of the C-Reader CRV, CRM series and sale
2003
• Co-operate with SKC Co., Ltd
2002
• Development of Micro CE (Capillary Electrophoresis) "DBCE“
• Development of Cell Counter-“C-Box”
2001
• 1st Development of disposable plastic microchip for cellular toxicity
2000
• Founding of company research institute as academic venture in Seoul National University
www.nanoentek.com
Copyright @ NanoEnTek Inc. All rights reserved
5
Board of Directors
Name
Position
JK Chang, Ph.D.
President & CEO
JH Park
COO & CFO
AD Choe
President
CI Chung Ph.D.
CTO
HS Jo, Ph.D.
Manufacturing
Director
HD Ahn
Marketing
Director
TB Volker
Senior Vice President
JW Byun, Ph.D.
External Director
Ph.D. of Electronics of Polytechnic university
Chief of SK TIC Convergence Group
TS Yook
External Director
Bachelor Degree of Industrial engineering in Seoul National
University
Chief of IPE Business Division of SK Telecom
SY Bae
Auditor
www.nanoentek.com
Careers
Remarks
President and CEO of
NanoEnTek Inc.
Majority
shareholder
Master of business in Seoul National University
Director of NanoEnTek Inc.
NanoEnTek Inc. (USA)
MBA,
Ph.D. of Medical Engineerin, Seoul National University
Director of NanoEnTek Inc.
Ph.D. of Mechanical engineering, Seoul National University
Director of NanoEnTek Inc.
MBA, University of Akron
Ph. D. Thesis in Biochemistry, Universite de Bordeaux, France
Executive MBA, INSEAD, Fontainebleau & Singapore
President and CEO of WITH audit company
Copyright @ NanoEnTek Inc. All rights reserved
6
Key Technology: Lab-On-a-Chip
Lab-On-a-Chip
Labor-intensive benchtop tasks are reduced in size
and time to completion using microfluidic technologies
and microfabrication techniques
<Image> World wide market size of Lab on a chip & Biochip
* Sourced by BioCHIPS & BioMEMS -Global Markets, Applications & Competitors: 2005-2010, Analysis &
Forecasts, Apr., 2005
[Chip Structure ]
www.nanoentek.com
Large
Compact
Unmovable
Hand-held/Wireless
Mass capacity
Small capacity
High-priced
Reasonable-priced
Public usage
Personalized
Copyright @ NanoEnTek Inc. All rights reserved
7
Key Technology: Lab-On-a-Chip
Disruptive Innovation Using Lab-On-a-Chip Technology
Lab-On-a-Chip
Large / High-priced / Unmovable
Disruptive Innovation
•Downsizing
•Down Prices
•Movable
•Multifunction
Personalized Tool
www.nanoentek.com
Networking Tool
Point-Of-Care
Tool
Copyright @ NanoEnTek Inc. All rights reserved
8
Product Portfolio
Tool & Solution Provider
JuLI
FREND
Countess
Adam
MC
Adam
SCC
Tali
Microporator
Adam
rWBC
C-Chip
www.nanoentek.com
Copyright @ NanoEnTek Inc. All rights reserved
Medical Devices
New solution
for rWBC
counting
Outline
• Intended Use
• Existing solution
• New solution
• Principle of the procedure
• How to use
• Performance Characteristics
• Accuracy and Linearity (ADAM vs Leucocount)
• Compositions/Storage/Calibration
• Appendix. Specifications
www.nanoentek.com
Copyright @ NanoEnTek Inc. All rights reserved
Medical Devices
Intended Use
The ADAM-rWBC system is designed for counting residual white blood cells(rWBCs) in leukoreduced blood products
Existing solution for rWBC counting
Nageotte or flow cytometry are currently used to determine the leukoreduction status of platelet and red cell products
Nageotte
(Manual counting)
• Labor-intensive
• Subjective
Flow cytomery
• Complex
• Expensive
☞ How can we assure that white blood cells had been filtered out properly ?
☞ We need the new solution to replace the existing technology for rWBC counting.
www.nanoentek.com
3
Copyright @ NanoEnTek Inc. All rights reserved
Medical Devices
New solution for rWBC counting
Accurate result
• r2 = 0.989
• Substantially equivalent to flow cytometry
Fast measurement
• 3 minutes after sample loading
• Preparation for next slide during
4 minute settling time
Easy to use
• Simply 3 step for operation
• Anyone can use it
☞ The ADAM-rWBC is an alternative to Nageotte or Flow cytomery.
www.nanoentek.com
4
Copyright @ NanoEnTek Inc. All rights reserved
Medical Devices
Principles of the procedure
Principles of the procedure
The ADAM-rWBC utilizes sensitive fluorescence dye
staining, LED excitation and CCD detection technologies to
make the WBC analysis more accurate and reliable.
The ADAM-rWBC automatically focuses on the slide. The
stained cells are taken and recorded by a sensitive CCD
camera. The ADAM-rWBC analyzes and reports a result in
using integral image analysis software
r-Slide
☞ WBC staining is the equivalent to flow cytometry
www.nanoentek.com
☞ Adam-rWBC counts the cells 203 times and averages out the
counting results to increase the accuracy z
5
Copyright @ NanoEnTek Inc. All rights reserved
Medical Devices
Performance characteristics
How to use
Samples preparation (diluted 1:5 in r-Solution)
Sample loading ( 100 μL) and settling
Sample reading (3 min.)
Result
• Analysis time : 3 min. /test
• Measuring range : 1~100 cells/μL
• Loading sample vol. 100 μL/test
• Measuring vol. 57 μL/test
Accuracy
• The ADAM r-WBC system correlates well with & is
substantially equivalent to Leucocount.
Linearity
• Demonstrated within 1 and 100 WBC/µL.
FDA approval
• FDA approval(510K) cleared
☞ Adam-rWBC Procedure is very simple and easy so that everyone can use it.
www.nanoentek.com
6
Copyright @ NanoEnTek Inc. All rights reserved
Medical Devices
Accuracy (ADAM vs. LeucoCOUNT)
Linearity (ADAM vs. LeucoCOUNT)
Platelet products
RBC products
120
120
100
100
80
80
60
60
40
40
r2 = 0.983
Slope = 1.058
20
0
0
0
50
100
150
Leucocount WBC/µL
www.nanoentek.com
r2 = 0.990
Slope = 1.046
20
0
50
100
150
Leucocount WBC/µL
7
Copyright @ NanoEnTek Inc. All rights reserved
Medical Devices
Composition/Storage/Calibration
Disposables
rWBC Kit (Cat No. AD1K-050)
[ r-Slide, r-Solution and Standard Bead (50 Tests)]
r-Solution
vol. 25 mL
standard bead
vol. 7 mL
r-Slide
(Cat no. RDS-50)
(Cat No. RDR-50) (Cat No. ADST-001)
optional
Storage and Handling
• r-Solution : 2-8°C
• Standard Bead: 2-8°C,
• r-Slides : 20-25°C ( 1 year )
※ Expiration date(r-Solution and standard bead) : 1 year before open, 6 month after open
Calibration
Standard Bead Solution is used
• to provide absolute particle numbers
• to calibrate the Automatic Focus
• to check the position of the slide stage
www.nanoentek.com
8
Copyright @ NanoEnTek Inc. All rights reserved
Medical Devices
Appendix. Specifications
ADAM-rWBC
Voltage: AC100~240 V, 50~60 Hz
Current: max. 1.8 A, max 100 W
Fuse: F3.15AL250V
Objective lens: 4 X
LED: 4W Green LED
CCD camera: B/W CCD
Filter: Excitation filter, Dichroic filter,
Emission filter
Weight: 9 Kg
Size (W×L×H): 220 × 375 × 250 mm
Degree of protection : IPX0
r-Slide
Measuring range: 1 ~ 100 cells /μl
Analysis time: 2.5 ~ 3 min /test
Loading sample vol.: 100 µL /r-Slide
Measuring vol.: 56.73 µL /r-Slide
r-Solution
PI (Propidium Iodide) staining of leucocytes.
External video monitor
(Fuse: 250 VAC, 3 A; F3.15AL250V)
Accessories
Barcode reader : LS2208 (optional)
Color: Twilight black, Cash register white
Corded: Yes
Dimensions: 6 in. H x 2.5 in. W x 3.34 in. D 15.2 cm H x 6.3 cm W x 8.4 cm
Handheld: Yes
Power source: Host power or external power supply; depends on host type
Voltage and current: 5 volts +/- 10% at 130 mA typical, 175 mA max
Weight: 5.15 oz./146 gm
optional
www.nanoentek.com
9
Copyright @ NanoEnTek Inc. All rights reserved
Medical Devices
Instrument Final QC Line
Instrument Production Line
www.nanoentek.com
QC Control (1)
Instrument Durability Test
QC Control (2)
Package Vibration Test
Copyright @ NanoEnTek Inc. All rights reserved
Medical Devices
Certificates
CE: ADAM rWBC Device
Certificate Of GMP
CE: ADAM rWBC Kit
www.nanoentek.com
ISO13485 Certificate
Copyright @ NanoEnTek Inc. All rights reserved
POCT Medical Diagnostic equipment and supplies
FREND
www.nanoentek.com
Copyright @ NanoEnTek Inc. All rights reserved
POCT Medical Diagnostic equipment and supplies
Products of Medical diagnostic kits - Line up Plan
Acute Disease
New Items
•TSH
•Myoglobin
•Tn-I
•CK-MB
•Tn-I
•CRP
•Cardiac Triple
Chronic disease
•AFP
•CEA
•PSA
•AFP
•CEA
•hsCRP
•CRP
•TSH
www.nanoentek.com
•PSA
Copyright @ NanoEnTek Inc. All rights reserved
POCT Medical Diagnostic equipment and supplies
Role and Meaning of the Plant
Distinctive Feature (I)

The nation’s first mass production facility for plastic microchips :
- Maximum 10 million chips / year (disposables for life science products)
- Maximum 8 million kits / year (immunoassay kit for medical diagnostics products)

Clean room facility for biochips isolated from dust and minimized the bio-contamination

Specialized production machines developed internally: guaranteeing production quality and increasing competitive barriers

ISO 13485 (Medical Device) and ISO 9001 (Laboratory Device) Certification: acquired from TUV, Sep. 2007.

GMP (Good Manufacturing Practice) Validation: from KFDA, Jul. 2008

Equipment for MEMS development process (1000 class clean room and 100 class yellow room): Photo lithography, wet etching,
furnace, spin coater, etc .
- Supply precision stamper mold for microchip and immunoassay kits
Distinctive Feature (II)

Located within 1 hour distance from head office (Kuro, Seoul) and near Highway IC for easy delivery

Innovating and improving of production efficiency, reduction of production costs, innovative production technology and rapid
response to customer complaints
Competitiveness of Plant
www.nanoentek.com

Focused toward core production technology and Q/C and Q/A: using many low-cost contracters near Kyunggi-do metropolitan area

Flexible production lines: easily expandable to the various products, due to platform design and production technologies
Copyright @ NanoEnTek Inc. All rights reserved
POCT Medical Diagnostic equipment and supplies
Kit development plan for FREND
Reader/Platform
based
Contents expanding
Personalized Medicine
Companion Diagnosis
New Market expanding
Medical Diagnosis
expanding
Convergence with
ICT technologies
(FMS)
Healthcare DIY
Acute
Personalized Medicine
Medical Diagnosis
FREND Mobile Service
Healthcare DIY
•Tn-I
•Combo
(Tn-I, CK-MB, Myoglobin)
•hsCRP
•HbA1c
•xerophthalmia
•Decayed tooth
Chronic
Companion Diagnosis
•PSA
•AFP
•CEA
•TSH
•D-Dimer
•LP-PLA2
•CA125/HE4
•BNP
•NGAL
•Hormone(TSH)
•Self immune
•Allergy
•Alzheimer
•Rare nutriments
•obesity
•Skin care
•osteoporosis
•HbA1c
Security Networks
Community Building
•U-Health/Home Care
New Market
Chemistry
Lower price platform
•Animal diagnosis
www.nanoentek.com
Copyright @ NanoEnTek Inc. All rights reserved
24
Live cell movie analyzer
Live cell movie analyzer
JuLITM Br, the smart brightfield-cell movie analyzer, has been developed to enable a variety of biological
experiments for live-cell imaging.
Scope unit
Smart live cell viewer
White LED
View and capture the live single image inside your cell-culture incubator.
Neck
Stage
Real time movie recorder
Focus knob
Sequential time-lapse images are stored, and can be converted to movie file automatically.
Intelligent confluence analyzer
Detect cell confluence and make growth curve using image based analysis.
Station unit
LCD touch screen
Real time cell growth curve
Applicable long-term monitoring, Over 72 hours in real time.
It works inside your incubator !
www.nanoentek.com
Copyright @ NanoEnTek Inc. All rights reserved
Live cell movie analyzer
Key features
Time-lapse image capture and movie recording
user were recorded every 10
minutes and analyzed in
monolayer confluence. e.
Automated cell confluence detection
Real-time cell growth curve generation
10.1” color LCD touch screen
Focus adjustment through LCD
quantified cell confluence results with low user variation
user friendly interface
www.nanoentek.com
Copyright @ NanoEnTek Inc. All rights reserved
Live cell movie analyzer
Application
Time-lapse image capture & recording movie
Cell-growth images were captured for 60 hours with 10 minute interval in Hep3B cell line.
Automated quantitative cell confluence analysis
Real-time cell growth curve
NIH-3T3 cells growth were observed 65 hours through JuLI™ Br.
All images were recorded every 10 minute and analyzed monolayer confluence.
www.nanoentek.com
Copyright @ NanoEnTek Inc. All rights reserved
Live cell movie analyzer
Movie
NIH-3T3 cells growth by using JuLI™ Br
NIH-3T3 cells growth observed 64 hours through Live image movie analyzer, JuLI™ Br.
This movie was made by 394 images at 10-minute intervals.
Research lab, NanoEnTek Inc. (Korea)
http://youtu.be/UmFXLjJx_Jc
A549 wound healing assay movie by JuLI™ Br
A549 cells were incubated for 68 hours after scratch.
Live cell movie analyzer, JuLI™ Br calculated the confluence with growth of surface
Unfarmed automatically.
Research lab, NanoEnTek Inc. (Korea)
http://youtu.be/v9xq_GiRXeE
[Control sample]
Fibroblast (FY11) cells growth by using JuLI™ Br
Nanobio research lab, Gachon University (Korea)
http://youtu.be/HN6voPgOWIE
[Experimental sample]
Morphological changes of Fibroblast (FY11) cells
Incubated with Gold nanorods observed
by using Live image movie analyzer, JuLI™ Br
Nanobio research lab, Gachon University (Korea)
http://youtu.be/y1l8GUKYTM0
www.nanoentek.com
Copyright @ NanoEnTek Inc. All rights reserved
Live cell movie analyzer
Specification
Cat no
JULI-BR04 (Full set)
JULI-BRSC (Scope)
Magnification
Objective 4 X and digital zoom (~ 400 X)
Image resolution
2560 X 1920 pixels (5M)
Exported formats
JPEG (image), AVI (movie),
XLS (law data)
Display
10.1’’ LCD touch screen
Light source
White LED
Dimensions & Weight
Scope: 300 x 190 x 188 mm, 4 kg
Station: 282 x 285 x 160 mm, 3.2 kg
Storage
www.nanoentek.com
320 GB Hard drive
Copyright @ NanoEnTek Inc. All rights reserved
Cell Imaging [ JuLI™ ]
• JuLI = Just Look at It !
• Cell Image Viewer
→ Clean bench incubator or from observation and photographing real-time Image Time lapse shot
→ cell culturing process, a video shoot and smart phones Remote control
Competitors AMG (EVOS), ZEISS / LEICA / OLYMPUS / NIKON (Microscope)
Functions of JuLI
Trends of Sales Revenue(KRW)
Microscopy
For
10
Bright &
GFP
JuLI
Live Cell
imaging
8
Counting
6
&
9
4
Analyzing
2
2
0
2007
Cell Image Viewing Market(M$)
7000
6000
5000
4000
3000
2000
1000
0
SPM
Electron
Optical
Confocal 4.3 B$
3.5 B$
2008
2009
2010 2011년
Market Positioning
Accessories
[CCD/ PC/ Board/ Software]
Stand Alone
1896
2007
www.nanoentek.com
6.0 B$
7
2208
2010
2849
2015년
Inside Clean bench
[Available]
CCD/ PC/ Board/ Software
Copyright @ NanoEnTek Inc. All rights reserved
Cell Counting
MC: Mammalian Cell Counter
C-CHIP ™
SCC: Somatic Cell Counter
• High-end personal automated cell counter
• Instruments and disposable chips
• High accuracy in cell imaging counting
Cell Counting Methods
Manual
Automated
C-CHIP
COUNTESS ™
• World 1st portable Somatic cell counter
- Chinese and Mongolian markets for QC for milk
Trends of Sales Revenue(KRW)
90
75
COUNTESS
45
70
ADAM-MC
Staining Method for Cell Counting
0
57
8
30
Viable cell
5
60
Glass type
Hemocytometer
15
ADAM-MC ™
ADAM
6
28
22
2
2
3
2007
2008
6
6
2009
6
2010
C-CHIP
7
2011
Current Competitors in Cell Counters
Add Reagent
Not Stained Nuclei
Countess
[Invitrogen]
Non Viable cell
TC-10
[Bio-Rad]
Cellometer
[Nexcelom]
Add Reagent
Stained Nuclei
ADAM-SCC™
www.nanoentek.com
Nucleocounter
[Chemometec]
Scepter
[Milipore]
Moxi Z
[Orflo]
Copyright @ NanoEnTek Inc. All rights reserved
™
[
Neon
]
Gene Transfection
• Capillary-based electroporator
• Higher gene transfection rate and cell viability - stem cells, human primary cell transfection
• #1 market share domestically and in Japan
• Patents sale to Life Technologies, US (Feb. 2009): $ 13M
Transfection Process
Trends of Sales Revenue(KRW)
High Voltage
siRNA
DNA
40
30
Neon
(Microporator)
40
20
Cell
10
21
22
2007
2008
25
26
2010
2011
0
Mammalian cell line
Primary cell line
Transfection Reagent Market(M$)
2009
Market Share by Customers(M$)
Others, 29,
400
200
170 180 186 204
250
274
300
328
16%
Pharma, 13,
7%
Academic,
126, 68%
0
2008 2009
2010 2011
2012 2013
2014 2015
Source: Frost & Sullivan, genomeweb.com
www.nanoentek.com
Biotech, 17,
9%
Source: Biocompare Market Report, 2009
Copyright @ NanoEnTek Inc. All rights reserved
Cell Analyzing [ TaLI™ ]
• Image-Based Cytometer
•Tali is a Benchtop Cytometer that counts enough cells for statistical significance and is married to specific existing cell assays.
- GFP and RFP Expression analysis for genetic analysis
- Sytox Blue and PI, and Apoptosis Analysis Available
- Excellent fluorescence sensitivity, dynamic range, a wide range of user-centered interface design, etc.
Image Based Analyzer
Agreement with Life Technologies
• December 2009: new product development and
supply agreement
- Research and development expenses 450 million
- Min. Guarantee 1,500 units / 3 years
TaLI
• May 2011 1st release Tali products
Detection of
GFP, RFP Expression
Live, Dead, Apoptotic cells
Image Cytometry Evolution
Market Positioning
Cost
(High)
Countess
-Bright field Analysis
ADAM
-Fluorescence Analysis
Becton Dickenson
FACS Analyzer
Tali
Tali
-Brightfield,
2-Color Fluorescence
Analysis
www.nanoentek.com
Function
Copyright @ NanoEnTek Inc. All rights reserved
Quality Management System Diagram
Quality Management
ISO 9001:2008, ISO 13485:2003, KGMP, QSR(cGMP)
Quality Policy
Product
Design and
development
•
•
Product
Realization Plan
•
•
Design Review
Design History
File(DHF)
- Development
Research
- Product Design
- Prototype
- Product Transfer
QUALITY
MANAGEMENT
SYSTEM
Production
Preparation
•
•
•
•
•
•
Sale Plan
Production Plan
Equipment Plan
Material
Purchase Plan
In-coming
Inspection
Material
Warehousing
“ World Best, World First, Global
Niche POCT Leader“
Quality
Improvement
•
•
•
•
•
•
•
Production
Process Control
Process Inspection
Product Inspection
Finished-Product
Warehousing
Customer
Satisfaction
Preventive &
Quality
Improvement
Sale and
service
provision
Production
www.nanoentek.com
Market Search
Trends Search
•
•
Storage &
Release
•
•
Outgoing Inspection
Storage and Release
Our quality policy is to realize
improvement of highest value
and trust given by customers.
We established quality
management systems based on
ISO 9001, 13485, KGMP and
CFR 820 QSR(cGMP)
Product
Traceability •
Control (DHR) •
Sale
Customer Complaint
Receive
Cause & establish a
countermeasure
Customer Complaint
Clear
Four Level of quality
management system
Level 1
SOP
Quality Management
Manual
Level 2
SOP
Quality Procedure
Level 3
SOP
Quality Instruction
Level 4
SOP
Record
Copyright @ NanoEnTek Inc. All rights reserved
Production Line
kit production Line (Overall)
FREND kit Line
www.nanoentek.com
Kit production Line (Overall)
Kit Q/C Line
kit production Line (Overall)
Dry Incubator Module
Copyright @ NanoEnTek Inc. All rights reserved
Global Partners of NanoEnTek
Expanding Global coalition in Life Science and Healthcare industry
Life Science
Healthcare(POCT)
R&D
NEW
Manufacturing
Life
Technologies
BRAND
Global
marketing
Countess
• R&D and manufacturing
- various compact and
personalized products
with disposables
Neon
Tali
• Countess:
- Global Cell counting
market share 30%
• Neon:
- Patent sale (13M$)
• Tali
- R&D fee 4.5M$
- Launch in May 2011
- Create new market of
Image Cytometry
Marketing
coalition
Global Partners
ICT technology
Co-development
Marketing
coalition
FREND
C-Chip
JuLI
ADAM-SCC
ADAM-MC
MD
• SK Telecom:
- Invest 25 B KRW on Feb
2011(major shareholder)
- focus on China’s
Healthcare market
→ Diagnostic products
for immuno-assay and
Molecular Diagnosis
FREND
MD
• Marketing for EU/USA
• Searching local partners
and setup sales channels
ADAM-rWBC
36
U-Healthcare Biz Model
by NanoEnTek and SK Telecom
POC device
ICT technologies, SI
Home
Chronic disease,
Dementia old person,
Chronic patients
Asylum for the aged
Mobile Health Monitoring
Vital signs measurement
On line
Emergency out
Location tracking
Vital signs measurement
Central hospital
Hospital
Local hospital
(POL)
Local hospital
(Small and Medium)
POC device
Clinical/Fitness
Centers
POC device
iu
Patient
* SK Group: The third Largest Group In Korea
www.nanoentek.com
Copyright @ NanoEnTek Inc. All rights reserved
37
Summary of the Financial Statements
[hundred KRW]
2011 (3rd quarter)
2010
2009
Current Asset*
36,778
17,420
21,001
Noncurrent Asset
17,886
19,176
23,838
54,664
36,596
44,839
4,875
6,349
7,413
13,868
1,356
2,405
18,743
7,705
9,818
9,728
8,825
8,824
22,265
10,416
10,416
Capital Adjustments
2,618
2,618
1,978
Accumulated Other Comprehensive
Income
△956
△732
△475
Earned Surplus
2,266
7,764
14,277
35,921
28,891
35,021
Total Assets
Current Liabilities
Noncurrent Liabilities*
Total Liabilities
Capital Fund
Capital Surplus*
Total Ownership Interest
Sales
8,862
15,096
13,270
Business Profits
△4,139
△1,789
1,782
Net Profit During the Term
△5,154
△6,395
14,277
* The increase in the current assets, noncurrent liabilities, and capital surplus in 2011 is the result of the capital investment from
SK Telecom.
 Increase in noncurrent liabilities: convertible bond 14 billion KRW
 Increase in capital surplus: paid-in capital increase 1.1 billion KRW
* The financial statements for the third-quarter in 2011 and 2010 were created based on IFRS.
www.nanoentek.com
Copyright @ NanoEnTek Inc. All rights reserved
38
Contact us
www.nanoentek.com
12F, Ace High-end Tower, 235-2, Guro-3dong,
Guro-gu, Seoul, 152-740, KOREA
Email: st@digital-bio.com
Tel. +1.617.965.1414 (Boston, USA)
+82.2.6220.7942 (Seoul, Korea)
Copyright @ NanoEnTek Inc. All rights reserved