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Hydrophilic PU foam BIOPOL GLOBAL CO., LTD. BIOPOL GLOBAL CO., LTD.

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Page 1: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Hydrophilic PU foam

BIOPOL GLOBAL CO., LTD.BIOPOL GLOBAL CO., LTD.

Page 2: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Vision

Ⅰ. Company Overview

We pursue the innovative technology based society for

human.

We pursue the person who develops the innovative

technology.

We are aiming to make commitment to the public

welfare of the human society.

We believe that the technology is a creation and

creation needs to be based upon understanding of the

human being.

Our product stem to the belief that contribution for

human. Therefore, we are proudly produce our product

for better society, better life of human, better health of

human being.

We are focusing on developing revolutionary technology

based product in wound care industry.

We have confidence in ourselves to become a leading

company in global wound care market and It will be

happening in the near future with your close hand.

Here and Now, We create the future !!

BIOPOL GLOBAL CO., LTD.

Page 3: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

History

- Oct. 2002 : Export contracted MEDIFOAM to Singapore, Malaysia and Indonesia (US$ 7.5 Million)

- Sep. 2002 : Prime Minister (Gold) awarding in INO tech-show 2002

(Ministry of Government Administration and Home Affairs)

- Jun. 2002 : Export contracted MEDIFOAM to China (US$ 10,000,000)

- May. 2002 : Established BIOPOL GLOBAL CO., LTD. for the Exclusive Overseas Sales

- Mar. 2002 : Applied for FDA registration

- Mar. 2002 : CE 0120, ISO 9001 and EN 46001 Mark certified

- Nov. 2001 : Certified as INNO-BIZ Company (Small and Medium Business Administration)

- Oct. 2001 : Began to sell Medifoam® series

- Jun. 2001 : Contracted ILDONG Pharmaceutical Co., Ltd. for the Exclusive Domestic Sales

- May. 2001 : Own factory completed and began to produce Medifoam® series

- Nov. 2000 : Venture company certified (Small and Medium Business Administration)

- Sep. 2000 : Completed the development of Medifoam series and began to produce samples

- Aug. 2000 : Established Biopol Co., Ltd.

- Nov. 1996 : Began to develop Medifoam® series

BIOPOL GLOBAL CO., LTD.

Ⅰ. Company Overview

Page 4: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Future Business

PharmacyPharmacy

MedicalMedical

BioEngineering

BioEngineeringPolymerPolymer

SkinSkin

Biocompatible MaterialBiocompatible Material

CulturedSkin

Chitin/ChitosanOcclusive Dressi

ngEtc.

Drug Delivery SystemDrug Delivery System

< First step >

< Second step> < Third step>

MEDIFOAM

MEDIFOAM B

MEDIFOAM 2

MEDIFOAM A

EPICARE ULTRASORB Moist bandage

ApplicableProducts

Occlusive and/or Moist Wound DressingOcclusive and/or Moist Wound Dressing

Ⅰ. Company Overview

BIOPOL GLOBAL CO., LTD.

Page 5: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Ⅱ. Product ComparisonClinical & Economical differences

Low thermal insulation Less absorption capacity of exudates Dry environment cause delayed cure High vulnerability of Infection Adhesive on wound surface High cost of production High price Frequent change of gauze

Other products

High thermal insulation Twice better absorption of body fluid and blood Moisture wound environment Preventing bacteria’s proliferation Protecting from infection Non-adhesive on wound surface Decreasing of scar and no pain Saving cost of production General to open surgical wound Low price

BIOPOL MEDIFOAM

Wound contact layer’s micro pores size is even much smaller than the cell, 20m. It protects epithelial growth into the pore. It is a highly advanced technology that eventually leads patients feel no pain with much much less scar.

Biopsy, toxicity and clinical tests which conducted by “Seoul National University” and other major hospitals testified that the MEDIFOAM has much better quality effects than any other company’s wound care products existing in the world currently

BIOPOL GLOBAL CO., LTD.

Page 6: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Gauze dressing’s main problem

Ⅱ. Product Comparison

aa beginning gauz

e

Exudates Escher

Ground substance

Low protected skin

bb

Moving cell below the dried skin

cc

Cell comes out with gauze

Change gauze

dd

BIOPOL GLOBAL CO., LTD.

Page 7: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Ⅱ. Product Comparison

Comparison Test – Explanation of each graph

1. Absorption Capacity (g/cm3) To measure the water absorptive of sample, pre-weighed dry sample was immersed in distilled water for 24h. After the bulk water was removed by placing the absorbent paper, the weight of wet sample was measured. The procedure was repeated with 5 different pieces of same foam. Then, the water absorptive was determined according to the following equation :

Water absorptive (g/cm3) = {(Ws – Wd) / Wd} X density (g/cm3) where Ws = weight of water absorbed sample Wd = weight of dry sample

2. MVTR (Moisture Vapor Transmission Rate, g/m2/day) ASTM E96-95 (CaCl2 or Desiccant Method) was used to determine MVTR by measuring the rate of change of mass in a CaCl2 filled test dish on which the dressing was mounted. The test dishes (maximum of five) were placed on a platform within an incubator set at 37±0.5℃ and maintained at a relative humidity of 85±2% using a water. Periodic weightings determine the rate of water vapor movement through the specimen into the desiccant. MVTR was calculated at a given time interval by the following method.MVTR = {( m / Δt ) X 24} / A (g/m2/day) where m = mass of water absorbing over the specified time interval (g) Δt = time interval (h) and A = the effective transfer area.

3. Price The price of the products, except MEDIFOAM, was investigated from “Yahoo Shopping” site. All of the price based on 10cmX10cm size product and divided from standard price, MEDIFOAM.

BIOPOL GLOBAL CO., LTD.

Page 8: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

2.4

0.8

1.5 1.5

0

0.5

1

1.5

2

2.5

g/cm

3

Medifoam Allevyn Biatain Seasorb

1.Absorption Capacity

1200

1400

770

1200

0

500

1000

1500

g/m2

/day

Medifoam Allevyn Biatain Seasorb

2.MVTR

Comparison Test

Ⅱ. Product Comparison

BIOPOL GLOBAL CO., LTD.

Page 9: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

0.33

0.25

0.120.18

0

0.1

0.2

0.3

0.4

kgf/c

m2

Medifoam Allevyn Biatain Seasorb

4.Tensile Strength

1.00

1.33 1.26

0.97

0.00

0.50

1.00

1.50

Medifoam Allevyn Biatain Seasorb

3.Price (10cmX10cm)

Comparison Test

Ⅱ. Product Comparison

BIOPOL GLOBAL CO., LTD.

Page 10: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Product Line-Up – Foam type Dressing

Products Product Names Structure of Product Indications

Medifoa

Series

(Foam

Dressing)

Medifoam

Thickness : 1, 2, 3, 5mmSize : 13 classes(5cmX5cm, 10cmX10cm, 10cmX20cm, 20cmX20cm, 5cmX7cm etc)

• Wide and large amount exudates • Superficial second degree burns• Ulcers • Abrasions• Donor site• Skin graft site or general wound

Medifoam B

Thickness : 3, 5, 7, 10mmSize : 12 classes(5cmX5cm, 5cmX10cm, 10cmX10cm, 10cmX20cm, 10cmX30cm etc)

• Over full thickness second degree burns– Antibiosis and debridment

• Absorption of excessive exudates and blood

Medifoam F

Thickness : 1∼2 mmSize : variable• Adhesive film attached to

Medifoam N

• Relatively small site and exudate wound

• Surgical wound

Medifoam C

Thickness : 1∼2 mmSize : various size• Adhesive non-woven fabric attached to Medifoam

Ⅲ. Product Information

BIOPOL GLOBAL CO., LTD.

Page 11: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Products Product Names Structure of Product Indications

Medifoa

Series

(Foam

Dressing)

Medifoam T

Thickness : 2, 3, 5mm Size : 2 classes (5×5㎝ , 10×10㎝ )• Modified of Medifoam

• Catheter and tube fixation, and protection of drainage hole

Medifoam D Thickness : 3∼5 mm Size : various size • Modified of Medifoam A

•Used for absorbing exudates from connecting parts of inner and outer body due to pore and preventing bacterial infection

• Used with Ilizarov, used with catheter and tubes

Medifoam A

Thickness : 1∼3 mm Size : various size• Spread adhesive on MEDIFOAM

• Pressure sore• Surgical wound• Skin graft site

BIOPOL GLOBAL CO., LTD.

Product Line-Up – Foam type Dressing

Ⅲ. Product Information

Page 12: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Products Product Names Structure of Product Indications

Epicare ( Film

Dressing )

Epicare ‘N’Thickness : 45㎛Size : various size

• Wounds with little exudates• Wounds which need observation • 1st and 2nd pressure sore

Epicare ‘S’

Thickness : 55 ㎛Size : various size • High absorbency

Epicare ‘N’

• Wounds with little exudates• Wounds which need observation• 1st and 2nd pressure sore

Epicare ‘IV’Thickness : 40㎛Size : various size

• IV fixation

Ultrasorb ( Non-woven fabric

Dressing )

Ultrasorb Thickness : 1∼5 mm • Suitable for all kinds of wounds

Product Line-Up – Other type dressing

Ⅲ. Product Information

BIOPOL GLOBAL CO., LTD.

Page 13: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Products Product Names Structure of Product Indications

Other Applicati

on

Non-sticking to wound Dressing

Thickness : 1∼3mm• Moist Dressing, No scars

• Minor abrasion

Wounds Sealing Adhesive Dressing

Thickness : 1∼3 mm Size : Expected• Antibacterial,Enhancing effectiveness of wound healing, Added adhesiveness, Able to absorb exudates,Sealing,Non-sticking to wound

• Fixing catheter• Sealing Ilizarov• Sealing other wounds

Dressingwith

Chitin/Chitosan

Thickness : 1∼5 mm• Antibacterial, Enhancing effectiveness of wound healing

• Bedsore and ulcer

BIOPOL GLOBAL CO., LTD.

Product Line-Up – Other type dressing

Ⅲ. Product Information

Page 14: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

MEDIFOAM

MEDIFOAM is an advanced wound dressing made by highly absorbent MEDIFOAM is an advanced wound dressing made by highly absorbent

polyurethane which has very unique structure. It provides the best polyurethane which has very unique structure. It provides the best

moisture wound healing environment resulted from both excellent moisture wound healing environment resulted from both excellent

absorption capability and moisture permeability for exudates. And it is absorption capability and moisture permeability for exudates. And it is

never non-adherent on the wound surface.never non-adherent on the wound surface.

The protection layer is made by PU film which has minimal micro pore The protection layer is made by PU film which has minimal micro pore

structure. structure.

This structure protects bacterial invasion and maintain the optimal This structure protects bacterial invasion and maintain the optimal

MVTR and releases the absorbed exudates properly. MVTR and releases the absorbed exudates properly.

The absorption layer is composed of PU foam which has higher The absorption layer is composed of PU foam which has higher

absorption capability as almost 1,000%. It makes to absorb and hold absorption capability as almost 1,000%. It makes to absorb and hold

the exudates from wound surface. MEDIFOAM absorption capability is the exudates from wound surface. MEDIFOAM absorption capability is

far superior than other dressings. far superior than other dressings.

Especially, It provides perfect moisture wound environment Especially, It provides perfect moisture wound environment

continuously by holding the absorbed exudates. continuously by holding the absorbed exudates.

The wound contact layer is PU membrane which supports to absorb the The wound contact layer is PU membrane which supports to absorb the

exudates smoothly and it prevents adherence of dressing on wound exudates smoothly and it prevents adherence of dressing on wound

surface.surface.

Ⅲ. Product Information

BIOPOL GLOBAL CO., LTD.

Page 15: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

BIOPOL GLOBAL CO., LTD.

Medifoam Medifoam Medifoam Medifoam

Thickness : 1, 2, 3, 5mm

Size : 13 classes• Wide and exudative wounds

• Superficial second degree burns

• Ulcers

• Abrasions

• Donor site

• Skin graft and general wounds

Medifoam BMedifoam BMedifoam BMedifoam B

Absorption LayerAbsorption Layer

Thickness : 3, 5, 7, 10mm

Size : 12 classes

• Over full thickness second degree

burns

– Antibiosis and debridment

• wounds which need high

absorbency

• Pocket and cavity wounds

Medifoam AMedifoam AMedifoam AMedifoam A

Thickness : 1∼3 mm

Size : Various size

• Adhesive coated type of

Medifoam

• Ulcers

• Pressure sores

• Surgical wounds

• Donor site

• Skin graft and general wounds

Protection LayerProtection Layer

Absorption LayerAbsorption Layer

Wound Contact LayerWound Contact Layer

Protection LayerProtection Layer

Absorption LayerAbsorption Layer

Adhesive Coated LayerAdhesive Coated Layer

Ⅲ. Product Information

Page 16: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Let the absorbed exudate out and protects the wound surface from possible infection.

MVTR : 800~1,200g/㎡ /day

Protection Layer

Absorption Layer

Has the high absorbency (Swelling ratio :1,000∼1,500%) and maintaining the best environment for wound healing

Wound Contact Layer

Absorbing exudates and maintains the

moist wound healing environment, and

does not stick to wound surface.

MEDIFOAM’s Structure & Characteristics

BIOPOL GLOBAL CO., LTD.

Ⅲ. Product Information

Page 17: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Body Temperature(

℃)*

Swelling Ratio(%)**

MVTR(g/㎡ /day)

Characteristics

Hydrocolloid Type

30 ∼ 32℃ 90 0

1. It keeps moist environment and maintains healing environment of low acidity.

- Stimulates granulation and epithelialization

2. Not suitable for infected wounds

Film Type 30 ∼ 32℃ 0 480

1. Visibility – eases viewing of wounds

2. It keeps moist environment.3. Prevents bedsore, used for

protecting the skin.4. Not suitable for infected

wounds

Hydrogel Type

30 ∼ 32℃ 400 300

1. It keeps moist environment .2. Its mechanical property

weakens after absorbing exudates.

Properties of MEDIFOAM

Ⅲ. Product Information

BIOPOL GLOBAL CO., LTD.

Page 18: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Body Temperature(

℃)*

Swelling Ratio(%)**

MVTR(g/㎡ /day)

Characteristics

Polyurethane Foam

Type33 ∼ 35℃ 710 1,800

a. It can be used for wounds with excessive exudates

b. It sticks to the wound if it is applied for more than 3 days.

MEDIFOAM 33 ∼ 35℃1,000 ∼ 1,500

1,000 ∼ 2,500

a. It keeps moist environment.b. It prevents forming of scars

and facilitates epitheialization.c. It can be used for wounds with

excessive exudates.d. It doesn’t stick to the wound

surfacee. It provides the ideal healing

environment

※ Note) - Pig skin experiment results by Lock, - Calculation : Swelling Ratio (%) = (Ws-Wd)/Wd ×100

- Moisture Vapor Transfer Rate(MVTR) : Tested according to the KS M – 6886 testing method,

37℃ - 85% RHBIOPOL GLOBAL CO., LTD.

Properties of MEDIFOAM

Ⅲ. Product Information

Page 19: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

ProgressTime

Control ( x 104)

Dressing

MEDIFOAMVariants(U

.K)

1 day 25.75 92% 4%

2 days 25.3 81% 0%

3 days 24.5 64% -

5 days 7.63 72% -

※ Note) - The test was performed by using the ISO 10993-5 Test method

and % indicates live cells.

- Initial seeding(3T3 cell) was set as 2x104/cm2

Cell Toxicity Test

BIOPOL GLOBAL CO., LTD.

Ⅲ. Product Information

Page 20: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Clinical Test (1)

(1) Seoul National University Hospital (Prof. Min, K. W.) – refer to photos and

appendix1

※ Half Side Test between MEDIFOAM and ALLEVYN (Smith & Nephew) was

performed.

※ 32 patients participated.

※ Average age : 41.7Contents Unit Medifoam ALLEVYN Remarks

Period Days 9.37 12.62

Healing effect Points 5.37 4.16 Maximum scale of 6 pointsTechnical

evaluation

Points 4.84 4.16

Side effect Times 1 7

Infection Times 0 0

Scar Marks Minor Severe

Validation Superior Inferior

BIOPOL GLOBAL CO., LTD.

Ⅲ. Product Information

Page 21: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Test 1) Femoral region : Wound surface applied and the result 7days later

(Left: Smith & Nephew’s ALLEVYN Right : MEDIFOAM)

Test 2) Femoral region : Donor site applied and the result 4days later

(Above : Medifoam, Below : Smith & Nephew’s ALLEVYN )

BIOPOL GLOBAL CO., LTD.

7days later

4days later

Ⅲ. Product Information

Page 22: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

(2) Hankang Sungshim Hospital (Prof. Kim,J.H) – refer to photos and appendix2

※ Comparison test between Medifoam and Vaseline gauze was performed.

※ 70 patients participated.

Clinical Test (2)

Contents Unit Medifoam Vaseline Gauze Remarks

Period

Scar marks

Sharp pains

Infection

Validation

Day

Person

9.7

Minor

Non

0

Superior

14.5

Severe

Severe

7

Inferior

BIOPOL GLOBAL CO., LTD.

Ⅲ. Product Information

Page 23: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Test 1) The femoral region : Wound Surface applied and the result as time passed

(Above : Medifoam, Below : Vaseline gauze)

BIOPOL GLOBAL CO., LTD.

Ⅲ. Product Information

Page 24: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Test 2) The femoral region : Wound Surface applied and the result as time passed

(Above : Medifoam, Below : Vaseline gauze)

BIOPOL GLOBAL CO., LTD.

Ⅲ. Product Information

Page 25: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Ⅲ. Product Information

Clinical Trials (Seoul National University Hospital)

Ex. 1) Femoral region : Wound Surface & Dressing

(Left: Smith & Nephew’s ALLEVYN , Right : Medifoam-5T)

3 days3 days 7 days(1)7 days(1) 7 days(2)7 days(2)

BIOPOL GLOBAL CO., LTD.

Page 26: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

① ②

③ ④

Ex.2) 2mm thickness MEDIFOAM – Applied on the scar face

6 days6 days 9 days9 days

Clinical Trials (Seoul National University Hospital)

Ⅲ. Product Information

BIOPOL GLOBAL CO., LTD.

Page 27: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Animal Test

Ⅲ. Product Information

BeginningBeginning 1 week later1 week later 2 weeks later2 weeks later

1week The wound has reduced to 55% of the beginning

2weeks The wound has reduced to 25% of the beginning

2weeks The

wound has

reduced to 50%

of the

beginning

BIOPOL GLOBAL CO., LTD.

Page 28: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

BIOPOL GLOBAL CO., LTD.

Ⅲ. Product Information

MEDIFOAM B is a porous, single layered and hydrophilic polyurethane foaMEDIFOAM B is a porous, single layered and hydrophilic polyurethane foa

m dressing which fulfill many requirements. m dressing which fulfill many requirements.

It has higher handling capacity(~ 1,500%) and provide perfect moisture woIt has higher handling capacity(~ 1,500%) and provide perfect moisture wo

und healing environment by not allowing maceration of the wound or the peund healing environment by not allowing maceration of the wound or the pe

ri-skin. ri-skin.

It does not adhere to the wound surface and it does not release any particlIt does not adhere to the wound surface and it does not release any particl

e or toxic component into the wound site.e or toxic component into the wound site.

MEDIFOAM B is very comfortable on the skin and provides both excellent cMEDIFOAM B is very comfortable on the skin and provides both excellent c

ushioning and protecting effects on the wound surface.ushioning and protecting effects on the wound surface.

MEDIFOAM B

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Ⅲ. Product Information

▶ Easy to apply and conform to body

contours and flexes with movement

▶ Leave no particles on the wound

surface due to the great mechanical

properties

▶ High absorption and retention of

body fluid and blood

Absorption Layer

Ex.1) Clinical trials of MEDIFOAM B

MEDIFOAM B

BIOPOL GLOBAL CO., LTD.

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① Disinfect the wound site ② Cover with MEDIFOAM B

③ Fix the MEDIFOAM B with the secondary dressing

② Fill the MEDIFOAM B in the cavity

③ Cover and fix with the secondary

dressing over the wound

① Disinfect the wound site

Ⅲ. Product Information

MEDIFOAM B

2) Filling Usage (Cavity 2) Filling Usage (Cavity wound)wound)

1) Covering Usage 1) Covering Usage (Burns)(Burns)

† † UsageUsage

BIOPOL GLOBAL CO., LTD.

Page 31: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

† † Physical Physical PropertiesProperties

MEDIFOAM B

Ⅲ. Product Information

BIOPOL GLOBAL CO., LTD.

Page 32: Hydrophilic PU foam BIOPOL GLOBAL CO., LTD.. Vision Ⅰ. Company Overview We pursue the innovative technology based society for human. We pursue the person

Ⅳ. Appendix

THE EFFECTS OF MEDIFOAM(HYDROPHILIC POLYURETHANE FOAM)

DRESSING IN SPLIT THICKNESS SKIN DONOR SITE

By Young oh Park, M.D., Kyung won Min, M.D.

Department of Plastic and Reconstruction

Surgery, College of Medicine, Seoul

National University, Seoul, Korea

The purpose of our study is to evaluate the effects of occlusive wet dressing by using hydrophilic polyurethane foam, MEDIFOAM ®, in the management of donor sites of split thickness skin graft.

The outer layer of MEDIFOAM ® is made of a polyurethane film, which is impermeable to water and microorganisms. It provides moist wound environment and effective bacterial barrier. The middle layer is polyurethane foam, absorption layer. It’s swelling ratio is 1020% and the layer contains wound healing promoters. Inner layer is polyurethane film, which has micro pores whose size are below 20㎛ . It protects to epithelial growth into the pore.

Appendix 1

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We perform half side test to compare MEDIFOAM ® to Allevyn(the hydrocellular dressing materials). We parted STSG donor site into Allevyn ® dressing site, and MEDIFOAM ® dressing site in random fashion. This study was performed in Seoul National University Hospital from April 2001 till August 2001 with 32 patients, who need to skin graft.

We investigated about pain, comfort, healing, and time for complete healing.

The MEDIFOAM ® dressed site had less pain, more comfortable, easier handling and more rapid wound healing. The average healing time of MEDIFOAM is 9.3751.930 days and AHD is 12.625 1.862 days(p<0.001)

So we conclude that occlusive dressing with MEDIFOAM ® is an effective dressing method in split thickness skin graft donor site, and we expect that it is also effective dressing material in many other wounds.

BIOPOL GLOBAL CO., LTD.

Ⅳ. Appendix

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Appendix 2

THE TREATMENT OF DONOR SITES WOUND

USING FOAM DRESSING MATERIAL

By Jong hyun Kim, M.D., Youb nam Koong, M.D.,

Dong kun Kim, M.D., Yoon kyu Park, M.D.

Department of Surgery, College of Medicine,

Hallym University, Seoul, Korea

Backgrounds ; Foam dressings are nonlinting and absorbent. They vary in thickness and have a non-adherent layer that provides nontraumatic removal. Foams creates a moist environment and provide thermal insulation to the wound. General characteristics of dressings include ; nonadherent, may repel contaminants, easy to apply and remove, absorb light to heavy amounts of exudates, and may be used under compression. Foam dressings may be used as primary and secondary dressings for wounds with minimal moderate: or heavy drainage : as a primary dressing to provide adsorption and insulation; or as a secondary dressing for wounds with packing. They also may be used to absorb drainage around tubes. Foams may not be effective for wounds with dry Escher. They may macerate peri-wound skin if they become saturated. The purpose of this clinical study was to evaluate its efficacy as a donor-site dressing for thermally injured patients.

Ⅳ. Appendix

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Methods ; We have analyzed 80 burned patients requiring split-skin graft. We covered one side of each donor site with hydrophilic polyurethane foam dressing. Medifoam® (Treatment group), the other half with Vaseline gauze (control group). All grafts were removed using a Zimmer dermatome set to cut at a thickness 0.005-0.010 inches. After hemostasis had been obtained, each donor site was covered with the polyurethane foam dressing and the Vaseline gauze. At 2 days postoperatively, the dressing were removed (first opening) and then the donor sites was observed daily until epithlization was complete, or until a complication developed that required discontinuance of the study. We examined donor site about epithelization, discharge, infection, scar formation, color and pain.

Results ; Eighty patients had their donor sites heal without severe complication in a mean time (for complete healing) of 9.7 days for polyurethane foam areas, and 14.5 days for fine mesh Vaseline gauze dressings. In seven cases, superficial wound infection occurred in control group. Treatment group had more clean wound surface because of absorption of discharge, no hematoma, no infection, no pain. Treatment group were healed with evenly, homogenously, and hypopigmentation compared with control group.

Conclusion ; Polyurethane foam dressing improved epidermal wound healing by providing a moist environment for enhanced epidermal cell migration and shortened the donor site healing time.

BIOPOL GLOBAL CO., LTD.

Ⅳ. Appendix

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Appendix 3

CE Mark EN 46001 ISO 9001

Ⅳ. Appendix

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AwardAwardss

Korea Prime Minister (Gold) awarding in INOtech-Korea Prime Minister (Gold) awarding in INOtech-Show2002Show2002

The Best of the Leading Venture The Best of the Leading Venture CompanyCompany

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Comparison Test

Comparison Test – Explanation of each graph1) Fluid Handing Test (Water absorptivity (% or g/ ㎤ ))

- To measure the water absorption capability of sample, pre-weighed dry sample was immersed in distilled water for 24h.

After the bulk water was removed by placing the absorbent paper, the weight of wet sample was measured.

The procedure was repeated with 5 different pieces of same foam. Then, the water absorptivity was determined

according to the following equation:

Water absorptivity (%) = (WS - Wo) / Wo × 100

Water absorptivity (g/cm3) = (Ws - Wo)/Wo density (g/cmⅩ 3)

Where Ws = weight of water absorbed sample

Wo = weight of dry sample

2) MVTR (Moisture Vapor Transmission Rate, g/ ㎡ /day)

- A ASTM E96-95 method (CaCl2 or Desiccant Method ) was used to determine MVTR by measuring the rate of

change of mass in a CaCl2 filled test dish on which the dressing was mounted. The test dishes (maximum of five) were

placed on a platform within an incubator set at 37±0.5 and maintained at a relative humidity of 85±2% using a ℃ water. Periodic weightings determine the rate of water vapor movement through the specimen into the desiccant.

MVTR was calculated at a given time interval by the following method.

MVTR = ( m / t) · 24 / A (g/△ ㎡ /day)

Where m = mass of water absorbing over the specified time interval (g)

△t = time interval (h) and A = the effective transfer area.

- MVTR were determined according to the ASTM Method E96-90, Procedure D (Inverted Cup Method). Evaporation

of water through the test sample was monitored by measurement of loss of weight of the cup. The condition on the

incubator were approximately 35±0.5 and 50±5% RH. ℃BIOPOL GLOBAL CO., LTD.

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3) Vertical wicking rate (minutes)

- The vertical wicking rate test measures the time taken for a colored test liquid from a reservoir to wick a vertical

distance of 5cm through a test strip of foam of specified size when the test is performed at 37 .℃

4) Vertical wicking absorbent distance (cm)

- The vertical wicking absorbent distance test is carried out in conjunction with the vertical wicking rate test. Vertical

wicking absorbent distance measures the vertical distance that is wicked to vertical section of the same standard size

foam sample used in the vertical wicking rate test. Such a determination is generally made after the sample has been

allowed to vertically wick test fluid to equilibrium.

5) Surface water absorbing rate in wound contact layer (sec)

- Time for drop wetting (sec).

Comparison Test

Comparison Test - Explanation of each graph

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Comparison TestComparison Test (1) - Absorption Capability

0

0.5

1

1.5

2

2.5

Med

ifoa

m

Med

ifoa

m B

Alle

vyn

Bia

tain

Cur

asor

b

Seas

orb

Duo

Der

m

Com

feel

Bio

film

IV30

00

Teg

ader

m

Op

Site

Gau

ze

Abs

orp

tivi

ty(g

/cm

2 )

BIOPOL GLOBAL CO., LTD.

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Comparison Test

Comparison Test (2) - MTVR (= Moisture Vapor Transmission Rate, g/㎡ /day)

0

1000

2000

3000

4000

5000

Med

ifoa

m

Med

ifoa

m B

Alle

vyn

Bia

tain

Cur

asor

b

Kal

tost

at

Seas

orb

Duo

Der

m

Com

feel

IV30

00

Teg

ader

m

Op

Site

MV

TR

(g/m

2 /day

)

BIOPOL GLOBAL CO., LTD.

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Comparison TestComparison Test (3) - Vertical wicking rate

(minutes)

0

20

40

60

Med

ifoa

m

Med

ifoa

mB

Alle

vyn

Bia

tain

Cur

asor

b

Kal

tost

at

Seas

orb

Bio

film

Gau

ze

Ver

tica

l Wic

king

Rat

e(m

in)

BIOPOL GLOBAL CO., LTD.

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Comparison TestComparison Test (4) - Vertical wicking absorbent

distance (cm)

0

5

10

15

Med

ifoa

m

Med

ifoa

mB

Alle

vyn

Bia

tain

Cur

asor

b

Kal

tost

at

Seas

orb

Bio

film

Gau

zeVer

tica

l Wic

kin

g A

bsor

bent

Dis

tanc

e(cm

)

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0

100

200

300

400

500

Med

ifoa

m

Med

ifoa

m B

Alle

vyn

Bia

tain

Cur

asor

b

Kal

tost

at

Seas

orb

Duo

Der

m

Com

feel

Bio

film

IV30

00

Teg

ader

m

Op

Site

Gau

ze

Max

imum

Per

cent

Str

ain(

%)

Comparison TestComparison Test (5) – Maximum Percent Strain

(%)

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Comparison TestComparison Test (6) – Absorbing Rate in Wound Contact Layer (Sec)

Med

ifo

am

Med

ifo

am

B

Allevyn

Bia

tain

Cu

raso

rb

Kalt

osta

t

Seaso

rb

Gau

ze

0

10

20

30

40

560

580

600

Ab

so

rbin

g R

ate

in

Wo

un

d C

on

tact

Layer

(sec)

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Comparison TestComparison Test (7) – Tensile Strength (kgf/2gm)

Med

ifo

am

Med

ifo

am

B

Allevyn

Bia

tain

Cu

raso

rb

Kalt

osta

t

Seaso

rb

Du

oD

ER

M

Co

mfe

el

Bio

film

IV3000

Teg

ad

erm

Op

sit

e

Gau

ze0

1

2

3

4

5

6

12

13

Ten

sile S

tren

gth

(kg

f/cm

2 )

BIOPOL GLOBAL CO., LTD.

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BIOPOL GLOBAL CO., LTD

Add.: 1409, Hanseo Building, 11-11, Yeoido-dong, Yeongdeungpo-gu, Seoul, Korea 150-746Tel. : 822 785 7270 Fax : 822 785 7279H/page : http://www.biopolglobal.com E-mail : [email protected] (H.C.Hong / President) [email protected](Jetaro, Assist Man. In Overseas Sales ) [email protected] (S.Young / Assist Man. In Overseas Sales )

Here and Now, We create the future !!BIOPOL GLOBAL CO., LTD.