www.megen.co.kr MEGEN The Value of Choice for Health
THE VALUE OF CHOICE FOR HEALTH 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. 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 distributors 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 customers 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, innovative, 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 CEO 02 MEGEN The value of choice for health Youn, Young The value of choice for health MEGEN 03
The 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 pre-formed 3-D eptfe facial implant will help surgeons to save time and reduce inconvenience procedure such as Pre-formed 3-D eptfe Facial Implant carving blocks. Products - Curved Asian Nasal - Straight Asian Nasal - Top - Carved Nasal - Asian Para-Nasal Implants - Malar Implants - Chin Implants Benefits - 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 FDA/ KFDA/ CFDA 04 MEGEN The value of choice for health The value of choice for health MEGEN 05
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. eptfe Sheets & Carvable Blocks facial implant material eptfe Sheet As a sheet type (soft strength) medical device provided up to 3mm thickness and used for facial cosmetic surgeries. eptfe Block As a block type (medium strength) medical device provided with 6mm, 10mm thicknesses and used for facial cosmetic surgeries. Applications (Utilization) Rhinoplasty Mentoplasty Maxilloplasty Malarplasty FDA/ KFDA/ CFDA 06 MEGEN The value of choice for health The value of choice for health MEGEN 07
Nasal Implants Round Nasal 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 Curved Asian Nasal 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 Point Nasal 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 Straight Asian Nasal Top-Carved Nasal 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 4NDSR 49.5 10.0 4.0 6AND02 50.0 10.0 8.0 6.0 5NDSR 49.5 10.0 5.0 7AND02 60.0 11.0 9.0 7.0 6NDSR 49.5 10.0 6.0 08 MEGEN The value of choice for health The value of choice for health MEGEN 09
Other Products Sheets & Carvable Blocks Asian Para-Nasal Implants Sheets & Blocks Blocks (Duro : Medium) 4PN01 20.0 18.0 4.0 SFAM601 50.0 60.0 6.0 5PN01 20.0 18.0 5.0 SFAM602 100.0 60.0 6.0 6PN01 21.0 19.0 6.0 SFAM801 50.0 60.0 8.0 SFAM802 100.0 60.0 8.0 Chin Implants SFAM1001 50.0 60.0 10.0 SFAM1002 100.0 60.0 10.0 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 Sheets (Duro : Soft) esh-371 30.0 70.0 1.0 esh-771 70.0 70.0 1.0 esh-7141 70.0 140.0 1.0 Malar Implants esh-372 30.0 70.0 2.0 esh-772 70.0 70.0 2.0 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 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 10 MEGEN The value of choice for health The value of choice for health MEGEN 11
Nasal Implant Comparison Rate of Contraction 0% Silicone Existing eptfe (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 afterimplantation) Approval related facts Anatomical advantage (The concave bottom is ideally suited to the Nasal Bone) Silicone Existing eptfe 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). Stable Stable 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. v 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. Stable Stable Finished Item Biocompatibility Manufacturing accuracy & Design -Manufactured 3-D Type Items by Foreign Country -Carved & injection Molded items provided in local -Provided Non-sterile Lack of biocompatibility : The skin is hardened easily and redness or extrusion can occur caused by capsulation -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 -Provided carved items in local (Infection can occur in the prosthesis during the carving & the distributing in loacal). -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) -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 -Manufactured 3-D Type Finished items by USA. Also Provides sterile. -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) -The correct size & perfect bilateral symmetry by precise manufacturing procedure of the only Surgical Technology Laboratories, Inc. in USA Shearing Force Country of origin South Korea & USA etc., USA & China USA 12 MEGEN The value of choice for health The value of choice for health MEGEN 13
HEXAPLAST-Splint HEXAPLAST-Splint Megen Limited. ISO13485:2012 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. Instructions for use Products - 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) Benefits - 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. 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) 14 MEGEN The value of choice for health The value of choice for health MEGEN 15
No.305 Deawoong Bd., 228 Apgujeong-ro(617-2 Shinsa-Dong), Gangnam-gu, Seoul, KOREA Tel _ 82. 2. 3443. 7200 Fax _ 82. 2. 6442. 5101 www.megen.co.kr 24 July 2015 Published