Bone Grafting, Naturally™
Accell. A Technological Leap. A New Standard.
The Accell Process
DBM
B
Lot Division
Lot Division
Each donor lot of DBM is divided in two. Half is
reserved for the final formulation.
Solubilization
Solubilization
The remaining half undergoes the Accell
process which results in flowable carrier with
osteoinductive potential.
Soluble DBM
Final Formulation
Final Formulation
The flowable carrier is then combined with the
DBM particles consisting of two components with
osteoinductive potential.
Accell
DBM
Final Product Configuration
E-Beam Sterilization
IsoTis terminally sterilizes every lot of Accell
product with a low-dose electron beam, a process
that has been demonstrated to preserve the
osteoinductive potential of bone growth factors.
Bone Grafting, Naturally
Sterilization
TM
A
The critical role of BMPs and growth factors in bone formation and healing
Bone contains natural BMPs and growth factors which have been shown to be a
critical component in bone formation and healing. 1, 4, 5, 6
The body’s natural response to traumatic injury is to initiate healing through a
complex and highly regulated series of events:
• Stem cell and osteoblast recruitment (chemotaxis)
• Blood vessel establishment (angiogenesis)
• Cell replication (mitogenesis)
• Stem cell differentiation into osteoblasts (osteoinduction)
The Accell advantage
• Skeletally mature sheep model.
• Cylindrical 5 mm metatarsal defect
created in tibial diaphysis.
• Results after 4 weeks.
Control - Empty
1st Generation DBM
Accell
Minimal bone regeneration observed at 4
weeks. Healing limited to area adjacent to
host bone.
Bone regeneration occurs throughout
the defect, caused by the presence of
osteoinductive DBM particles. The inert
carrier has been metabolized.
(DynaGraft II®)
Significantly more bone formation is
evident immediately adjacent to the bone
repair surfaces and within the interior of
the defect. We believe this occurs because
of the immediate access to the BMPs in
the Accell products.
(Accell 100™)
Note: Sections stained for quantitative assessment of bone healing.
Accell. A Technological Leap. A New Standard.
Accell 100
™
Incorporates
Incorporates
– Accell Technology
– IsoTis Processed DBM
– 0% Inert Carrier
– Validated Osteoinductive Potential
– Moldable and easy to pack into defects
– Ready to use
“… Naturally derived bone mixtures of BMPs may contain molecules
with higher specific activities than any single rhBMP.” 1
Available in 1 cc, 5 cc and 10 cc prefilled syringes
Accell Connexus
®
Incorporates
– Accell Technology
– IsoTis Processed DBM
– 30% Poloxamer Reverse Phase Medium Carrier (RPM)
Benefits
– Validated Osteoinductive Potential
– Poloxamer Reverse Phase Medium
– Thickens at body temperature
– Resists irrigation allowing for better graft containment
– Is inert, biocompatible and safe 2
Accell is manufactured by:
– Moldable and easy to pack into virtually any size or shape defect
– Ready to use
“… poloxamer… had a superior ability to deliver… human
bone morphogenetic protein to tissue.” 3
Distributed by:
Available in 0.5 cc, 1 cc, 2.5 cc, 5 cc and 10 cc prefilled syringes
References
1. Wozney J.: Overview of bone morphogenetic proteins. Spine 27(16S), 2002
2. Li C, et al: Disposition of poloxamer 407 in rats following a single intraperitoneal injection assessed using a simplified calorimetric assay. J Pharm
Biomed Anal 1996;14:659-665.
3. Clokie ML, Urist MR: Bone morphogenetic protein excipients: Comparative observations on poloxamer. Plastic & Reconstructive Surgery 2000;
105(2): 628-637.
4. Cheng H, et al: Osteogenic activity of the fourteen types of human bone morphogenetic proteins (BMPs). J Bone and Joint Surgery 2003; 85-A(8):
1544-1552
5. Urist ML: Bone: Formation by autoinduction. Science 1965;150:893-899.
6. Blum B, et al: Measurement of bone morphogenetic proteins and other growth factors in demineralized bone matrix. Orthopedics, January 2004
(Supplement): 161-165.
1105 Autoroute Chomedey Laval, Qc CANADA T 877-243-6724 F 888-258-0760
GP-7024.0 (11/07)
Accell, Accell 100 and Accell Connexus are trademarks of Isotis Inc., a wholly owned subsidiary of Integra Lifesciences