next generation live cell bone graft - extremity medical...2.4 biofuse viable bone matrix...
TRANSCRIPT
-
Next Generation Live Cell Bone GraftScientific Advancements in Processing Enhance
the Three Key Components Needed for Bone Regeneration
OSTEOCONDUCTIVIT
Y
OSTE
OINDUCTIVITY OSTEO
GENESIS
-
Pro
lifer
atio
n R
ate
(fold
incr
ease
)
2X Faster Rate of Cell Proliferation
Days in Culture*
6
5
4
3
2
1
00 1 2 3 4 5 6 7
TraditionallyProcessed Live
Cell Graft
BioFuse™
Increased Osteogenesis
Proprietary Processing Delivers;More Metabolically Active Live CellsDecreases the Exposure to Harmful Stressors Reduces Apoptosis by 50% (Programmed Cell Death)
• 1 million viable cells/cc, 100% Mesenchymal Stem Cells and/or Osteoprogenitor Cells*
• 2X faster rate of cell proliferation
• Increased production of the 3 essential proteins needed for bone formation
50% Less Apoptosis
Ap
opto
sis
Ind
ex 3.0
2.5
1.5
1.0
0.5
0
Mor
e D
ying
Cel
ls
Analysis of Caspase Levels via Luminescense
1.0
Control
2.4
BioFuse™ ViableBone Matrix
Osteopontin
1.5
CollagenType-1
1.4
Greater Osteogenic Potentialvs. Traditionally Processed Live Cell Graft
Ost
eoge
nic
Ind
ex
Osteocalcin
1.2
2.0
1.5
1.0
0.5
0
Osteocalcin: Most Abundant non-collagenous protein of bone matrix Osteopontin: Glycoprotein secreted by osteoblasts important in
bone remodelingCollagen Type-1: Major ECM protein in bone matrix produced
by osteoblasts
1 million viable cells
* Extensive invitro testing of manufactured lots (n=20) demonstrated an average of just over 1 million cells/cc.
BioFuse™ delivers a complete bone formation solution for challenging patient conditions
-
Enhanced Osteoinductivity
Proprietary Processing Increases; Amounts of Bone Formation Factors for Cell Signaling
• Higher amounts of BMPs-2 and BMPS-7
• Greater amounts of bone remodeling factors, more cell proliferation, and increased amounts of angiogenesis stimulators
Optimized OsteoinductivityBioFuse™ process yields 9-fold higher BMP-2
Ost
eoin
duc
tivity
Ind
ex
BMP-2
9.1
BMP-7
3.8
109876543210
BMP-2: Induces differentiation of uncommitted progenitor cells.BMP-7: Induces differentiation during endochondral and primary bone
formation. Up-regulates ALP and osteocalcin.
TGF-ß1: Regulation of bone remodeling IGF-1: Stimulates proliferation and function, and survival of osteoblasts.
Maintain skeletal homeostasis during bone remodeling bFGF: Stimulates angiogenesis, endosteal and
endochondral bone formation
IGF-1
6.8
bFGF
10.3
Beyond BMPs:Increases Bone Formation Factors
Gro
wth
Fac
tor
Ind
ex
TGF-ß1
7.9
12
10
8
6
4
2
0
Unique Osteoconductivity
Proprietary Processing Produces; Unique Scaffold that Unlocks Higher Levels of Bone Formation Factors
• Cortical bone is demineralized to a level that safely exposes more growth factors
• Growth factors are more bioavailable; they are protected by the matrix, without being trapped in the matrix
BioFuse™ delivers a complete bone formation solution for challenging patient conditions
-
300 Interpace ParkwaySuite 410Parsippany, NJ 07054Phone: 973.588.8980Customer Service: 888.499.0079Fax: 888.499.0542www.extremitymedical.com
Extremity Medical and BioFuse are trademarks of Extremity Medical, LLC.
©Extremity Medical, LLC. 2017. All rights reserved.LBL-145-99105 -EN 08/2017
Fast Preparation and Easy Malleability
Proprietary Processing Yields an OR Friendly Graft• Thaws within 5-15 minutes, no decanting required
• Molds, forms, and packs into any shape
Part # Description
145-10000 BioFuse Viable Bone Matrix 1cc
145-20000 BioFuse Viable Bone Matrix 2cc
145-50000 BioFuse Viable Bone Matrix 5cc
BioFuse™ Viable Bone Matrix
Refer to the package insert supplied with product for
specific information on indications for use, contraindications, warnings, precautions, and
adverse reaction information