www.megen.co.kr

MEGENThe Value of Choice for Health

02 03MEGEN | The value of choice for health The value of choice for health | MEGEN

Under the motto: The value of choice for health and happiness, our corporation Megen was

established in 2008 based on tens of years of medical experience of skin care and cosmetic

surgeries. As the corporation responsible for distribution of STL’s SFAM® and Pureform®

including ePTFE Facial Implants in Asian markets, Megen has agencies and sole distribu-

tors in Korea, Japan, China, Taiwan, Philippines, and Vietnam and has exclusive rights to

select and nominate dealers and agencies throughout Asia.

In addition, Megen acquired KGMP of HEXAPLAST-Splint in 2011, and certification of

CE&ISO13485 in early 2014. so it is getting really good reviews in the overseas market. Our

corporation Megen tries our best to carefully select safe and excellent products that cus-

tomers find necessary and offer them at a reasonable price. We will continue our endeavor

to increase the quality of your health and life by supplying and developing of diverse, in-

novative, and state-of-the-art products with excellent partners and provide you with the

products and services of highest quality to become a small, yet powerful and essential

business partner of yours

THE VALUE OF CHOICE FOR HEALTH

CEO Youn, Young

“As the business partner is small in everybody but in order for certainly is strong to become the partner who is necessary, will do a best.”

SurgiformThe value of choice for health_ MEGEN

The value of choice for health_ MEGEN

04 MEGEN | The value of choice for health

Surgiform

Benefits

Products

- Pre-Formed 3-D Shapes (Chin, Nasal, Para-Nasal and Malar)

- Biocompatibility

- Multiple Designs and Sizes

- Predictable tissue response and augmentation

- Micro-porous surface stabilizes the implant reducing migration

- Provided sterile

- Easily carved for a custom fit

- Curved Asian Nasal Dorsum Implants

- Straight Asian Nasal Dorsum Implants

- Top - Carved Nasal Dorsum Implants

- Asian Para-Nasal Implants

- Malar Implants

- Chin Implants

SurgiformThe Surgiform Facial Implant is an expanded polymer implant device intended for

augmentation or repair of the soft tissues of the facial area. The device is offered in

pre- formed nasal, chin and malar shapes. The Surgiform pre-formed 3-D ePTFE facial

implant will help surgeons to save time and reduce inconvenience procedure such as

carving blocks.

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FDA/ KFDA/ CFDA

Pre-formed 3-D ePTFE Facial Implant

The value of choice for health_ MEGEN

06 MEGEN | The value of choice for health

Surgiform

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Applications (Utilization)

ePTFE Block

ePTFE Sheet

As a block type (medium strength) medical device provided with 6mm,

10mm thicknesses and used for facial cosmetic surgeries.

As a sheet type (soft strength) medical device provided up to 3mm

thickness and used for facial cosmetic surgeries.

Surgiform Facial Augmentation Material is a biocompatible high density

ePTFE(Expanded Polytetrafluoroethylene) device (by CTI technology) intend for

cosmetic & augmentation of the soft tissue of facial area (Nasal, Chin, Malar,

Para-Nasal), also can be carved or trimmed to desired size & shape by surgeons.

Rhinoplasty

Maxilloplasty

Mentoplasty

Malarplasty

Surgiform

FDA/ KFDA/ CFDA

ePTFE Sheets & Carvable Blocks facial implant material

The value of choice for health_ MEGEN

08 09MEGEN | The value of choice for health The value of choice for health | MEGEN

Surgiform

Surgiform Nasal Implants

Curved Asian Nasal Dorsum Implants

Round Nasal Dorsum Implants

Straight Asian Nasal Dorsum Implants

Point Nasal Dorsum Implants

Top-Carved Nasal Dorsum Implants

Catalog Number A B C D

4AND01 50.0 9.5 7.5 4.0

4AND02 50.0 10.0 8.0 4.0

5AND01 50.0 9.5 7.5 5.0

6AND01 50.0 10.0 8.0 6.0

7AND01 55.0 10.5 8.0 7.0

Catalog Number A B C D

2NDR01 37.4 9.6 13.0 2.2

2NDR02 49.0 12.7 17.2 2.2

3NDR01 37.4 10.0 15.7 3.2

3NDR02 49.0 12.7 20.0 3.2

Catalog Number A B C D

2NDP01 37.5 3.6 12.4 2.2

2NDP02 49.1 4.7 16.5 2.2

3NDP01 37.3 3.5 15.0 3.2

3NDP02 49.0 5.4 19.3 3.2

Catalog Number A B C

4NDSR 49.5 10.0 4.0

5NDSR 49.5 10.0 5.0

6NDSR 49.5 10.0 6.0

Catalog Number A B C D

4AND03 50.0 9.5 7.5 4.0

4AND04 50.0 10.0 8.0 4.0

5AND02 50.0 9.5 7.5 5.0

6AND02 50.0 10.0 8.0 6.0

7AND02 60.0 11.0 9.0 7.0

(mm)

(mm)

(mm)

(mm)

(mm)

The value of choice for health_ MEGEN

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Surgiform

SurgiformSheets & Carvable Blocks

Surgiform Other Products

Malar Implants

Catalog Number A B C D

1EC01 52.9 38.1 7.7 13.5

1EC02 59.3 42.9 8.2 14.8

1EC03 66.0 47.4 9.5 16.9

Asian Para-Nasal Implants

Chin Implants

Catalog Number A B C

4PN01 20.0 18.0 4.0

5PN01 20.0 18.0 5.0

6PN01 21.0 19.0 6.0

Catalog Number A B C

1ML01 35.0 18.0 3.5

1ML02 45.4 23.0 5.0

1ML03 49.4 24.0 5.7

1ML04 55.0 27.1 5.8

Blocks (Duro : Medium)

Sheets (Duro : Soft)

Catalog Number A B C

SFAM601 50.0 60.0 6.0

SFAM602 100.0 60.0 6.0

SFAM801 50.0 60.0 8.0

SFAM802 100.0 60.0 8.0

SFAM1001 50.0 60.0 10.0

SFAM1002 100.0 60.0 10.0

Catalog Number A B C

eSH-371 30.0 70.0 1.0

eSH-771 70.0 70.0 1.0

eSH-7141 70.0 140.0 1.0

eSH-372 30.0 70.0 2.0

eSH-772 70.0 70.0 2.0

eSH-7142 70.0 140.0 2.0

eSH-373 30.0 70.0 3.0

eSH-773 70.0 70.0 3.0

eSH-7143 70.0 140.0 3.0

SFAM035 190.0 170.0 0.35

SFAM035C 190.0 170.0 0.35

Sheets & Blocks

(mm)(mm)

(mm)

(mm)

(mm)

The value of choice for health_ MEGEN

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Surgiform

ComparisonNasal Implant

Silicone Existing ePTFE Surgiform

Approval related facts

FDA & KFDA Approved:-Acquired import approval of approved Silicone Blocks by the FDA.-Acquired import approval of approved Silicone 3-D Molded items by the FDA

KFDA Approved:-Acquired manufacturing approval including the carving process with import approved Sillicone Blocks.-Acquired manufacturing approval including the Extruding process with Liquid Silicone Rubber(LSR).

KFDA Approved:-Acquired Import approval of approved ePTFE-Sheets & Blocks by FDA.-Acquired Manufacturing approval including the simple carving process with import approved ePTFE-Sheets & Blocks-Acquired Import approval of approved ePTFE-Sheets / Blocks & 3-D type items by SFDA.

FDA Approved:-Approved 3-D ePTFE type finished items by FDA.

KFDA Approved:-Acquired Import approval of approved 3-D ePTFE type finished items by the FDA.

Anatomical advantage

(The concave bottom is ideally

suited to the Nasal Bone)

Stable

v

Stable

Shearing Force

Stable Stable

Silicone Existing ePTFE Surgiform

Rate of Contraction

0%(No contraction, but depending on the durometer, changes the Elongation & Tensile Strength, also lower durometer, silicone has more flexible properties)

35~40%(During the carving or operation and after-implantation, by the possible external force, it can be contracted)

Below the 5%(There is little contraction after operation and after-implantation)

Finished Item

-Manufactured 3-D Type Items by Foreign Country-Carved & injection Molded items provided in local-Provided Non-sterile

-Provided carved items in local (Infection can occur in the prosthesis during the carving & the distributing in loacal).

-Manufactured 3-D Type Finished items by USA. Also Provides sterile.

Biocompatibility

Lack of biocompatibility : The skin is hardened easily and redness or extrusion can occur caused by capsulation

-Micro-Pore exists: Biocompatibility excellent-Anatomical adhesion is good to nasal bone-As the shearing force, malformation happens-As the deviation between tissue and prosthesis, hematoma occurs, (See the 2, 3 Particle)

-Micro-Pore exists: Biocompatibility excellent-Anatomical adhesion is good to nasal bone (The concave bottom is ideally suited to the nasal bone, see 2, 3 particles)

Manufacturing accuracy & Design

-Hand Carving: There are many different kinds of types, but the symmetry discordance or wrong sized items can occur-Molded: Manufacturing accuracy is excellent, but products types are limited & anatomical advantage is low

-Hand Carving: As carving is difficult, product types are limited, and symmetry discordance & wrong sized items can occur due to poor manufacturing accuracy. Also infection can occur in the prosthesis during the carving in local

-The correct size & perfect bilateral symmetry by precise manufacturing procedure of the only Surgical Technology Laboratories, Inc. in USA

Country of origin South Korea & USA etc., USA & China USA

The value of choice for health_ MEGEN

14 15MEGEN | The value of choice for health The value of choice for health | MEGEN

HEXAPLAST-Splint

Instructions for use

Products

HEXAPLAST-Splint

HEXAPLAST-LITE is a product applied after nasal surgeries for recovery purposes such

as recovering from external and congenital malformation. When applied after softening

with warm water and modifying to fit the affected area, it is hardened while maintaining

the shape of the affected area and supports the affected area as the temperature

decreases.

Megen Limited.

- The Hexagonal hole of HEXAPLAST-LITE is more stable than the other nasal splints.

- Because the contact surface of HEXAPLAST-LITE is 11% larger than

other nasal splints, it becomes soft faster when soaked in warm water,

and also hardens faster when the temperature is lowered.

Benefits

- Prepare a glass of warm water around 70oC ~ 80oC(160oF ~180oF).

- Put the HEXAPLAST ® - LITE into warm water for about 10 ~15 seconds

until the color becomes clear.

- Soaked HEXAPLAST® - LITE get a ductility which allows it to be curved

by a little force, while maintaining a steady elasticty.

- After taking HEXAPLAST® - LITE away from water, use dry towel to

remove moisture.

* Notice : Hot water must be removed before placing HEXAPLAST® -

LITE on patient’s skin to avoid possible burns.

- After applying HEXAPLAST®- LITE to the nose, cover with gauze then

press gently to fold around the nasal bone.

- HEXAPLAST® - LITE is powerful, slim light, very moldable and easy to

apply, while it allows for passage of air and moisture.

- Once the HEXAPLAST® - LITE is applied, keep it in place with dressing

tape. Leave HEXAPLAST® - LITE in place for seven to ten days before

removing and discarding it afterwards.

HEXAPLAST® - LITE Custom Nasal(HLCN-1)Size : 6.0cm x 4.0cm x 5.0cm T(1.7mm)

HEXAPLAST® - LITE 767617(HL767617)Size : 7.6cm x 7.6cm T(1.7mm)

HEXAPLAST® - LITE 453017(HL453017)Size : 45.0cm x 30.0cm T(1.7mm)

ISO13485:2012

No.305 Deawoong Bd., 228 Apgujeong-ro(617-2 Shinsa-Dong), Gangnam-gu, Seoul, KOREA

24 July 2015 Published

Tel _ 82. 2. 3443. 7200Fax _ 82. 2. 6442. 5101

www.megen.co.kr