4

01. Advanced Fiber type DBM...2012/09/21  · 01. Advanced Fiber type DBM The trabecular structure of DBM Fiber provides excellent osteoconductive potential and handling properties

  • Upload
    others

  • View
    2

  • Download
    0

Embed Size (px)

Citation preview

Page 1: 01. Advanced Fiber type DBM...2012/09/21  · 01. Advanced Fiber type DBM The trabecular structure of DBM Fiber provides excellent osteoconductive potential and handling properties
Page 2: 01. Advanced Fiber type DBM...2012/09/21  · 01. Advanced Fiber type DBM The trabecular structure of DBM Fiber provides excellent osteoconductive potential and handling properties

01. Advanced Fiber type DBMThe trabecular structure of DBM Fiber provides excellent osteoconductive potential

and handling properties.

02. Superior Hemostatic EffectThe BongenerTM carrier acts as a physical barrier providing a platform for clot formation,

which results in excellent bone bleeding control.

03. Superb Graft Containment in Defect Site Due to high viscosity of BongenerTM carrier the DBM product can maintain its

shape and be efficiently contained at the bone defect after its insertion, regardless

of the body fluids of the bone environment.

Compared to the particle type DBM, the fiber network structure of BongenerTM gives excellent

osteoconductive potential by ingrowth of bone formation cells.

Bongener is available in two convenient size syringes and with a Terminal sterilization procedure

utilizing Gamma-Irradiation.

and with a Terminal sterilization procedure

Double-packed by blister packaging

Page 3: 01. Advanced Fiber type DBM...2012/09/21  · 01. Advanced Fiber type DBM The trabecular structure of DBM Fiber provides excellent osteoconductive potential and handling properties

A. Micro CT Findings: The radiopacities (arrows)

indicates new bone formation observed at the

8th post-operative week.

B. Bone Histologic Findings: The osteoblasts

can be observed surrounding the new bone,

while the osteocites are trapped in lacunae

and surrounded by bone matrix. (H & E, x20).

A. Micro CT Findings

DBX Putty DBX Putty

B. Bone Histologic Findings

37 Distilledwater for

60 Minutes

Property Low viscosity

Subject to Mixing, Molding, Injection

High viscosity

Resistant to Irrigation & SuctionHandling

Room Temp ( ) In Body ( )

Confirmed Osteoinductivity in-vivoOsteoinductivity confirmed after 8 weeks of follow up in abdominal muscle pouch of

an anthymic nude rat.

Bongener thickens at body temperature and resists irrigation and remains contained at the surgical site.

Page 4: 01. Advanced Fiber type DBM...2012/09/21  · 01. Advanced Fiber type DBM The trabecular structure of DBM Fiber provides excellent osteoconductive potential and handling properties

Daewoong Pharmaceutical Bldg., Samseong 1-dong, Gangnam-gu, Seoul, KoreaTel : +82-2-550-8094 / Fax : +82-2-550-8616 / E-mail : [email protected]

Best facilities, best technology to provide “tissue” of high quality

SOPM & Program satisfy criteria established by KFDA/ KATB/ FDA/ EATB

Facilities Equipment

rehtOOIB GC

World-classfacitlities and labs &

water-for-injection (WFI)production facility

Organized andwell equipped

Barcode system

U.S. FDA deretsigeRderetsigeR

Traceability elbaecart yllaitraPtcudorp laniFwaR

Facility 001 ssalC001 ssalC

Microbiology Total 3 times (Pre, post and after sterilization) Once after sterilization

Terminal Sterilization citpesA ro maeB-EnoitaidarrI-ammaG

Experts

Tissue Processing byEATB member

Medical ConsultatonAdvice from medical professional

groups with knowledge &experience in transplantation:

Orthopedics, General, Neurological,Cosmetic Surgery, Dentistry, etc.