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

HansBiomed USA, Inc.HansBiomed USA, Inc.

IntroductionIntroductionIntroductionIntroduction

Chief Executive Officer: Mr. Hwang

Establishment: 1993

Location:

- Headquarter: Seoul

- R&D / Production: Techno Valley, Daejeon

Hans Biomed Corp.

1. Company Introduction

HansBiomed USA, Inc.HansBiomed USA, Inc.

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

1. Company Introduction

HansBiomed USA, Inc.HansBiomed USA, Inc.

▶ 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

1. Company Introduction

HansBiomed USA, Inc.HansBiomed USA, Inc.

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

1. Company Introduction

HansBiomed USA, Inc.HansBiomed USA, Inc.

-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

1. Company Introduction

FDA Registration

1. Tissue Establishment Registration

2. Product Listing in FDA

HansBiomed USA, Inc.HansBiomed USA, Inc.

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

Certification - 2

1. Company Introduction

FL Tissue Bank License

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

2. Under review NY, CA and MD

HansBiomed USA, Inc.HansBiomed USA, Inc.

ISO13485 GMP Certificate

Certification - 3

1. Company Introduction

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

1. Company Introduction

HansBiomed USA, Inc.HansBiomed USA, Inc.

establishment approval (no.1)

Patent

1. Company Introduction

HansBiomed USA, Inc.HansBiomed USA, Inc.

Hans Biomed Daeduk Institute

Hans Biomed Daeduk Institute

1. Company Introduction

HansBiomed USA, Inc.HansBiomed USA, Inc.

1. Company Introduction

• 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

HansBiomed USA, Inc.HansBiomed USA, Inc.

• 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

1. Company Introduction

HansBiomed USA, Inc.HansBiomed USA, Inc.

2nd Floor: Skin Graft Product

1. Company Introduction

HansBiomed USA, Inc.HansBiomed USA, Inc.

Main Facility - 1

1. Company Introduction

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

1. Company Introduction

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

1. Company Introduction

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

HansBiomed USA, Inc.HansBiomed USA, Inc.

ProductsProductsProductsProductsProductsProductsProductsProducts

510K 510K 510K 510K HCTPHCTPHCTPHCTP

FDBA - -

DFDBA - Pedi-Stick, OsteoGrow

FDBA+DFDBA - -

DBM SureFuse -

Product list & FDA Status

2. Spine & Ortho Products

HansBiomed USA, Inc.HansBiomed USA, Inc.

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

2. Spine & Ortho Products

HansBiomed USA, Inc.HansBiomed USA, Inc.

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

2. Spine & Ortho Products

HansBiomed USA, Inc.HansBiomed USA, Inc.

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

HansBiomed USA, Inc.HansBiomed USA, Inc.

Specification

Genesis Sponge

- Spinal fusion and general

orthopedic surgeries

- Any bone defect area where the

malleable bone void filler needed

- Dental reconstruction

Indication

HansBiomed USA, Inc.HansBiomed USA, Inc.

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

HansBiomed USA, Inc.HansBiomed USA, Inc.

Specification

Instruction for Use

Pedi-Stick

Surgical Case

HansBiomed USA, Inc.HansBiomed USA, Inc.

OsteoGrow

1) 100% Demineralized Cortical Bone Chip

2) Osteoinduction

3) Osteoconduction

4) High Biocompatibility

HansBiomed USA, Inc.HansBiomed USA, Inc.

Specification

100% Allograft Skin Products(FDA Approved)

HansBiomed USA, Inc.HansBiomed USA, Inc.

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

HansBiomed USA, Inc.HansBiomed USA, Inc.

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

HansBiomed USA, Inc.HansBiomed USA, Inc.

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)

HansBiomed USA, Inc.HansBiomed USA, Inc.

(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

HansBiomed USA, Inc.HansBiomed USA, Inc.

ExFuse

1) Demineralized Bone Matrix with Cancellous

2) Characteristic:

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

HansBiomed USA, Inc.HansBiomed USA, Inc.

- 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

HansBiomed USA, Inc.HansBiomed USA, Inc.

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

HansBiomed USA, Inc.HansBiomed USA, Inc.

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

HansBiomed USA, Inc.HansBiomed USA, Inc.

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

HansBiomed USA, Inc.HansBiomed USA, Inc.

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

HansBiomed USA, Inc.HansBiomed USA, Inc.

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.

HansBiomed USA, Inc.HansBiomed USA, Inc.