1. Hans Biomed Corp.
P/O/W/E/R/P/O/I/N/T
Jamie Park
Hans Biomed USA, Inc.
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2. 01 Company Introduction
02 Spine & Ortho Products
03 Why? Hans Biomed !!!
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Introduction
Company

4. 1. Company Introduction
Hans Biomed Corp.
Chief Executive Officer: Mr. Hwang
Establishment: 1993
Location:
- Headquarter: Seoul
- R&D / Production: Techno Valley, Daejeon
Employees: Around 80 as of 2011
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5. 1. Company Introduction
History
(2007~ )
▶ Production of Silicone
(2001~2006) Products and Bone Graft
Products.
Establishment Daeduk ▶ Bone graft DBM Products
Technology Institute and (SureFuse, ExFuse) Development
registered FDA and Production Scar
(1999~2000)
First approved Tissue Bank in ▶ Management Products
Korea (Scarclinic) Development and
▶ Sales medical device for Production as first
preventing scar and treatment manufacturer in Korea.
USA FDA on-site inspection &
▶ Development of Core registration
▶ Cohesive Gel Breast Implant
technology & Production (BellaGel) Development and
technology Starting to export SureDerm
Production. CE certificate
acquisition as a first in Asia
▶ Production Success of
Human skin SureDerm ▶ List in Korean Stock Market
▶ Open US Office in JU
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6. 1. Company Introduction
9th Oct 2009
Listed in
KOSDAQ
[ CEO of Hans Biomed]
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y g ol o n h c e T d n a
y g ol o n h c e T d n a
y r e g r u s k c a b d eli a f l a ti p s o h l u di r o o W -
g ni r e e ni g n E ci m a r e C f o e t u ti t s nI a e r o K -
g ni r e e ni g n E ci m a r e C f o e t u ti t s nI a e r o K -
yregrus citsalp latipsoh ..vinU lanoitaN luoeS-
y r e g r u s ci t s al p l a ti p s o h vi n U l a n oi t a N l u o e S -
e t u ti t s nI h c r a e s e R y g r e n E ci m o t A a e r o K -
s ci d e p o h t r O l a ti p s o H i n U ijl U -
T SI A K -
T SI A K -
r e t n e c n r u B n ai t s e B -
r e t n e c n r u B n ai t s e B -
y g ol o n h c e T
l a ci m e h C f o e t u ti t s nI h c r a e s e R a e r o K - r e t n e c n r u b l a ti p s o H mi S g n u S g n a g n a H -
Cooperation research Medical consultant
Union / Clinical cooperation /
- Euro Skin Bank (Holland)
EATB
- AlloSource, CTS etc
AATB
Tissue Bank
Cooperation Partner
1. Company Introduction

8. 1. Company Introduction
Certification - 1
FDA Registration
1. Tissue Establishment
Registration
2. Product Listing in FDA
On-
On-site Inspection
- 2003. 9
- 2008. 8
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9. 1. Company Introduction
Certification - 2
FL Tissue Bank License
1. Got the FL TB License on
18th Nov 2011
2. Under review NY, CA and MD
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10. 1. Company Introduction
Certification - 3
ISO13485 GMP Certificate
ISO13485:2003 Certificate Compliance with Medical
acquisition device quality management
(Quality management system standard
certificate)
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11. 1. Company Introduction
Certification - 4
KFDA Tissue
Bank Approval
Korea first tissue bank, Tissue bank
establishment approval (no.1)
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Patent
1. Company Introduction

13. 1. Company Introduction
Hans Biomed
Daeduk Institute
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14. 1. Company Introduction
Hans Daeduk Institutes
• Establishment : June 2002
• Total Area : 11,337 m2
• Total Floor Area: 2,517 m2
- 1st Floor: Silicone Polymer Product
- 2nd Floor: Skin Graft Product
- 3rd Floor: Bone Graft Product
Main Facilities
• D.I. water manufacturing system
• Freeze drier for clean room
• EO gas & Irradiation
• High Pressure Steam
• Ultra lower freezer storage
• Histologic laboratory
• Silicone Injection Molding facility
• Mass Drying facility for the silicone
• Quality management and Inspection facility
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15. 1. Company Introduction
3rd Floor: Bone Graft Product
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16. 1. Company Introduction
2nd Floor: Skin Graft Product
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17. 1. Company Introduction
Main Facility - 1
D.I. water Freeze Dryer Bone Grinder
manufacturing
system
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18. 1. Company Introduction
Main Facility - 1
Deep Freezer Clean Bench Auto Clave
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19. 1. Company Introduction
USA Branch: HansBiomed USA, Inc.
Address : 140 Sylvan Ave, Englewood Cliffs, NJ 07632
TEL: (201) 224 2333
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Products
Spine & Ortho

21. 2. Spine & Ortho Products
Product list & FDA Status
510K HCTP
FDBA - -
DFDBA - Pedi-Stick, OsteoGrow
FDBA+DFDBA - -
DBM SureFuse -
DBM W/C ExFuse -
Flex BellaFuse, BellaFuse Inserter -
Cancellous Bone
- SureChip, Block,
(FDBA)
Block Bone Sponge - Genesis Sponge
Machined Bone Graft - SureCerv, SureLumb
ADM - AlloCover
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22. 2. Spine & Ortho Products
100% Allograft Bone Products
(FDA Approved)
Classified 100% Allograft Skin Products
Allograft (FDA Approved)
Products
Medical Device
(Under 510k Review)
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23. 2. Spine & Ortho Products
100% Allograft Bone Products
(FDA Approved)
Part Ⅰ. Genesis sponge
(Demineralized Cancellous Block)
Part Ⅱ. Pedi-Stick
(DBM Stick)
Part . OsteoGrow
(Demineralized cortical bone Filler)
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24. Genesis Sponge
1) Cancellous Bone
2) Product: Genesis Sponge Block & Filler
3) Form: Block / Chip
4) Characteristic: Sponge like properties
Specification
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25. Genesis Sponge
Indication
- Spinal fusion and general
orthopedic surgeries
- Any bone defect area where the
malleable bone void filler needed
- Dental reconstruction
Instruction for Use
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26. Pedi-Stick
1) Stick Type 100% Demineralized Cortical Bone
2) Right size to the Pedicle Hole
3) Osteoinduction
4) High Biocompatibility
Instruction for Use
Specification
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Surgical Case
Pedi-Stick

28. OsteoGrow
1) 100% Demineralized Cortical Bone Chip
2) Osteoinduction
3) Osteoconduction
4) High Biocompatibility
Specification
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29. 100% Allograft Skin Products
(FDA Approved)
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30. SureDerm
Characteristic Application
1. Becomes patients own tissue 1. Small Ligament reinforcement of
2. No Immune response the hand and foot
3. Biocompatible and Elastic 2. Tendon and Rotator Cuff
4. Recommend to store in refrigerator Augmentation
5. 2 years shelf life 3. Chronic and Acute Defect Wound
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31. SureDerm
Usage
1. Rehydration: Put SureDerm in the normal saline for
10 minutes
2. Put SureDerm’s dermal side to the defected part
Distinguish Dermal Side
How to distinguish Dermal Side
- When you moisten rehydrated SureDerm with
patient’s blood, the dermal side becomes red
clearly.
- Fix the derma side to face patient’s body.
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32. Medical Device
(Under 510k Review)
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33. SureFuse
1) Demineralized Bone Matrix
2) Product: SureFuse II
3) Type: Gel, Putty
4) Characteristic:
- High Osteoinductive Ability
- High Viscosity
- Easy to Handle
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34. ExFuse
1) Demineralized Bone Matrix with Cancellous
2) Characteristic:
- Containing Cancellous Bone, High Osteoconductive Ability and Easy to Handle etc
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35. BellaFuse
1) Demineralized Bone Matrix Flex
2) Product: BellaFuse
3) Type: Flex
4) Characteristic: Enhanced Usability
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36. . c nI , A S U d e m oi B s n a H
Hans Biomed !!!
Why?

37. 1. High Quality and Safe
1. Tissue Donors from AlloSource & CTS
2. All products are approved in Korean FDA
3. Passed FDA on-site inspection twice
4. Registered Product in FDA as HCT/P
5. Under process 510k
- SureFuse, ExFuse and BellaFuse Flex
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38. 2. Market Leader in Korea
1. First Commercial & Leading Tissue Bank
2. Many Experience of OEM supply with Big companies
- OS/NS Products
- Dental Product
- Revenue: $600 M
Hans - Revenue: $100 M
Biomed
- NS Products - Silicone Products
- Revenue: $50 M - Revenue: $ 300 M
3. Reasonableness
1. Diverse Products Line
2. Better Price than Competitors
3. Quick reaction and meet Customer Needs
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noissecer
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THREAT OPPORTUNITY
BIomed
SWOT of Hans
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tekram S.U eht ni ssenerawa woL • ssenevititepmoc ecirP •
pu-eniL tcudorP suoiraV •
WEAKNESS STRENGTH
SWOT Analysis

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