Hans Biomed Spine & Orthopedic

P / O / W / E / R / P / O / I / N / THans Biomed Corp.Hans Biomed Corp.Hans Biomed Corp.Hans Biomed Corp.

HansBiomed USA, Inc.HansBiomed USA, Inc.Jamie ParkJamie ParkJamie ParkJamie ParkJamie ParkJamie ParkJamie ParkJamie Park

Hans Biomed USA, Inc.Hans Biomed USA, Inc.

01010101 Company IntroductionCompany IntroductionCompany IntroductionCompany Introduction

02020202 Spine & Ortho ProductsSpine & Ortho ProductsSpine & Ortho ProductsSpine & Ortho Products

HansBiomed USA, Inc.HansBiomed USA, Inc.

02020202 Spine & Ortho ProductsSpine & Ortho ProductsSpine & Ortho ProductsSpine & Ortho Products

03030303 Why? Hans Biomed !!!Why? Hans Biomed !!!Why? Hans Biomed !!!Why? Hans Biomed !!!

Company Company Company Company IntroductionIntroductionIntroductionIntroduction


IntroductionIntroductionIntroductionIntroduction

Chief Executive Officer: Mr. Hwang

Establishment: 1993

Location:

- Headquarter: Seoul

- R&D / Production: Techno Valley, Daejeon

Hans Biomed Corp.

1. Company Introduction


Employees: Around 80 as of 2011

(2007~ )

(2001~2006)

(1999~2000)

▶ Establishment DaedukTechnology Institute and registered FDA

▶ First approved Tissue Bank in

▶ Production of Silicone Products and Bone Graft Products.

▶ Bone graft DBM Products (SureFuse, ExFuse) Development and Production Scar

▶ Management Products

History



▶ Sales medical device for preventing scar and treatment

▶ Development of Core technology & Production technology

▶ Production Success of Human skin SureDerm

▶ First approved Tissue Bank in Korea

▶ USA FDA on-site inspection & registration

▶ Starting to export SureDerm

(Scarclinic) Development and Production as first manufacturer in Korea.

▶ Cohesive Gel Breast Implant (BellaGel) Development and Production. CE certificate acquisition as a first in Asia

▶ List in Korean Stock Market

▶ Open US Office in JU

9th Oct 2009Listed in KOSDAQ



KOSDAQ

[ CEO of Hans Biomed]

▶ AATB- AlloSource, CTS etc

▶ EATB- Euro Skin Bank (Holland)

▶ AATB- AlloSource, CTS etc

▶ EATB- Euro Skin Bank (Holland)

Tissue Bank

Cooperation Partner



-Korea Research Institute of Chemical Technology-KAIST-Korea Atomic Energy Research Institute - Korea Institute of Ceramic Engineering and Technology -Korea Research Institute of Chemical Technology-KAIST-Korea Atomic Energy Research Institute - Korea Institute of Ceramic Engineering and Technology

Union / Cooperation research -Hangang Sung Sim Hospital burn center-Bestian Burn center-Ulji Uni Hospital Orthopedics-Seoul National Univ. hospital plastic surgery- Wooridul hospital failed back surgery

-Hangang Sung Sim Hospital burn center-Bestian Burn center-Ulji Uni Hospital Orthopedics-Seoul National Univ. hospital plastic surgery- Wooridul hospital failed back surgeryClinical cooperation / Medical consultant

Certification - 1


FDA Registration

1. Tissue Establishment Registration

2. Product Listing in FDA


OnOnOnOnOnOnOnOn--------site site site site site site site site InspectionInspectionInspectionInspectionInspectionInspectionInspectionInspection- 2003. 9 - 2008. 8

Certification - 2


FL Tissue Bank License

1. Got the FL TB License on 18th Nov 2011

2. Under review NY, CA and MD


ISO13485 GMP Certificate

Certification - 3


HansBiomed USA, Inc.HansBiomed USA, Inc.ISO13485:2003 Certificate

acquisition(Quality management system

certificate)

Compliance with Medical device quality management

standard

KFDA Tissue Bank Approval

Korea first tissue bank, Tissue bank

Certification - 4



establishment approval (no.1)

Patent



Hans Biomed Daeduk Institute

Hans Biomed Daeduk Institute




• 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

• 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 FacilitiesMain FacilitiesMain FacilitiesMain Facilities

Hans Hans Hans Hans DaedukDaedukDaedukDaeduk InstitutesInstitutesInstitutesInstitutes


• 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

• 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

Main FacilitiesMain FacilitiesMain FacilitiesMain Facilities

3rd Floor: Bone Graft Product



2nd Floor: Skin Graft Product



Main Facility - 1


HansBiomed USA, Inc.HansBiomed USA, Inc.Freeze Dryer Freeze Dryer D.I. water

manufacturing system

D.I. water manufacturing

system

Bone GrinderBone Grinder

Main Facility - 1


HansBiomed USA, Inc.HansBiomed USA, Inc.Clean BenchClean BenchDeep FreezerDeep Freezer Auto ClaveAuto Clave


HansBiomed USA, Inc.HansBiomed USA, Inc.USA Branch: HansBiomed USA, Inc.

Address : 140 Sylvan Ave, Englewood Cliffs, NJ 07632

TEL: (201) 224 2333

Spine & Ortho Spine & Ortho Spine & Ortho Spine & Ortho Spine & Ortho Spine & Ortho Spine & Ortho Spine & Ortho ProductsProductsProductsProductsProductsProductsProductsProducts


ProductsProductsProductsProductsProductsProductsProductsProducts

510K 510K 510K 510K HCTPHCTPHCTPHCTP

FDBA - -

DFDBA - Pedi-Stick, OsteoGrow

FDBA+DFDBA - -

DBM SureFuse -

Product list & FDA Status

2. Spine & Ortho Products


DBM W/C ExFuse -

Flex BellaFuse, BellaFuse Inserter -

Cancellous Bone

(FDBA)- SureChip, Block,

Block Bone Sponge - Genesis Sponge

Machined Bone Graft - SureCerv, SureLumb

ADM - AlloCover

100% Allograft Bone Products(FDA Approved)

100% Allograft Skin ProductsClassified Classified



100% Allograft Skin Products(FDA Approved)

Medical Device(Under 510k Review)

Classified Allograft Products

Classified Allograft Products

100% Allograft Bone Products(FDA Approved)

Part Ⅰ. Part Ⅰ. Part Ⅰ. Part Ⅰ. Genesis spongespongespongesponge



Part Ⅱ. Part Ⅱ. Part Ⅱ. Part Ⅱ. Pedi-Stick(DBM Stick)

Part Ⅰ. Part Ⅰ. Part Ⅰ. Part Ⅰ. Genesis spongespongespongesponge

(Demineralized Cancellous Block)

Part Part Part Part Ⅲ. . . . OsteoGrowOsteoGrowOsteoGrowOsteoGrow(Demineralized cortical bone Filler)

1) Cancellous Bone

2) Product: Genesis Sponge Block & Filler

3) Form: Block / Chip

4) Characteristic: Sponge like properties

Genesis Sponge


Specification

Genesis Sponge

- Spinal fusion and general

orthopedic surgeries

- Any bone defect area where the

malleable bone void filler needed

- Dental reconstruction

Indication


Instruction for Use

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

Instruction for Use

Pedi-Stick

Surgical Case


OsteoGrow

1) 100% Demineralized Cortical Bone Chip

2) Osteoinduction

3) Osteoconduction

4) High Biocompatibility


Specification

100% Allograft Skin Products(FDA Approved)


1. Becomes patients own tissue

2. No Immune response

3. Biocompatible and Elastic

4. Recommend to store in refrigerator

Characteristic

1. Small Ligament reinforcement of

the hand and foot

2. Tendon and Rotator Cuff

Augmentation

Application

SureDerm


5. 2 years shelf life 3. Chronic and Acute Defect Wound

Usage

1. Rehydration: Put SureDerm in the normal saline for

10 minutes

2. Put SureDerm’s dermal side to the defected part

SureDerm


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.

Medical Device

(Under 510k Review)


(Under 510k Review)

SureFuse

1) Demineralized Bone Matrix

2) Product: SureFuse II

3) Type: Gel, Putty

4) Characteristic:

- High Osteoinductive Ability

- High Viscosity

- Easy to Handle


ExFuse

1) Demineralized Bone Matrix with Cancellous

2) Characteristic:

- Containing Cancellous Bone, High Osteoconductive Ability and Easy to Handle etc


- Containing Cancellous Bone, High Osteoconductive Ability and Easy to Handle etc

BellaFuse

1) Demineralized Bone Matrix Flex

2) Product: BellaFuse

3) Type: Flex

4) Characteristic: Enhanced Usability


Why?Why?Why?Why?Why?Why?Why?Why?


Why?Why?Why?Why?Why?Why?Why?Why?Hans Biomed !!!Hans Biomed !!!Hans Biomed !!!Hans Biomed !!!Hans Biomed !!!Hans Biomed !!!Hans Biomed !!!Hans Biomed !!!

1. High1. High1. High1. High Quality and SafeQuality and SafeQuality and SafeQuality and Safe

1. Tissue Donors from AlloSource & CTS

2. All products are approved in Korean FDA

3. Passed FDA on-site inspection twice


3. Passed FDA on-site inspection twice

4. Registered Product in FDA as HCT/P

5. Under process 510k- SureFuse, ExFuse and BellaFuse Flex

Hans

Biomed

Hans

Biomed

- OS/NS Products- Revenue: $600 M- OS/NS Products- Revenue: $600 M

- Dental Product - Revenue: $100 M- Dental Product - Revenue: $100 M

2. Market Leader in Korea2. Market Leader in Korea2. Market Leader in Korea2. Market Leader in Korea

1. First Commercial & Leading Tissue Bank

2. Many Experience of OEM supply with Big companies


BiomedBiomed

- Silicone Products- Revenue: $ 300 M- Silicone Products- Revenue: $ 300 M

- NS Products- Revenue: $50 M- NS Products- Revenue: $50 M

3. Reasonableness3. Reasonableness3. Reasonableness3. Reasonableness1. Diverse Products Line

2. Better Price than Competitors

3. Quick reaction and meet Customer Needs

SWOT of Hans

STRENGTH WEAKNESS• Low awareness in the U.S market• Low relationship with regionaldirectors and universities• Lack of Clinical Trials and paperscompare to major competitors• Various Product Line-up• Price competitiveness• Proven Product(Ranked No.1 in domestic Allograft M/S)• FDA Certification• Papers and Clinical Trials • World-class manufacturing Facility• Constantly developing new Products

SWOT Analysis


BIomed

OPPORTUNITY THREAT• High entry barrier due to existingcompetition• New product introductions(Growth factors) by competitors• End-user reluctant to switch newproducts• Reduced implant surgery due torecession• Increased demand in Allograft• Requiring lower payment bypatients due to depression.• Increased GBR case due topopulation aging.• Faster growth in the Bone GraftSubstitute market• Decreased use of autobone.


Documents

Hans Biomed Spine & Orthopedic