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