P-15 vs rhBMP-2
Cellular Signals & Migration: Haptotaxis vs Chemotaxis
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Understanding the different ways of inducing osteoblasts to form bone
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ML-0538 09/18
Peptide vs
Protein: INFUSE® Bone Graft (rhBMP-2/ACS)
Evidence-Based
Decisions:
Striking Similarities & Balancing Safety,
Unique Differences Haptotaxis Chemotaxis Efficacy, and Economics
GRAFT CATEGORY P-15/ABM rhBMP-2/ACS
Bone formation is the Local Signal Broad Signal Class III Drug/Device

goal of any spinal
fusion procedure.
Commercial Products Available:
There are hundreds of bone grafts
on the market. Each works differently.
Fewer than 1% have proven safety &
From Greek hapto “touch, fasten” and taxis From Greek chemo “chemical” and taxis Active Drug Component
MSC Differentiation
“arrangement.” Leverages the local biologic “arrangement.” Stimulates the body’s
Osteoblast Proliferation
environment to induce fusion and enhance normal healing process to induce fusion
the body’s natural bone healing process. chemically. Chemotaxis is activity away SAFETY/EFFICACY
Haptotaxis is activity at the surface from the surface and the implant site. PMA Approved
Large Pivotal IDE Study
of the implant.
Level-1 Clinical Data
Predictable Cell Migration

efficacy. Only two bone grafts are Controlled Environment Diffused Environment ECONOMICS
proven as a stand alone therapy. Recruits local cells into the ABM Recruits cells from a distance (surrounding Published Econ Data
implantation site by P-15 attachment sites. bone, blood, and soft tissue) to the ACS Cost Benefit Ratio
What are Proteins and Peptides? These cells use these anchoring sites to implantation site by a chemical signal Value Creation

Amino acids are the building blocks
of protein. A protein is a large molecule
comprised of a number of amino acid
residues in a 3-dimensional structure.
A peptide is a small molecule consisting
of a linear string of amino acids.
PMA Approved, Class III Drug/Device:
Supported by level-1 clinical evidence,
only two bone grafts have been PMA
approved for use in spinal fusion:
» i-FACTOR™ Peptide Enhanced Bone Graft (P-15/ABM)
» INFUSE® Bone Graft (rhBMP-2/ACS)
move along the surface of the material
encouraging migration 3-dimensionally
across and throughout the carrier.
Directed Migration
Natural bone regeneration via cells
that is directional and predictable.
Cellular activity follows along the
P-15 coated surface of the carrier.
from the diffusion of BMP away from
the implantation site. BMP can initiate Mechanism of Action:
differentiation of cells along numerous i-FACTORTM (P-15/ABM)
pathways, under the right conditions
ATTRACT
this will be toward osteoblasts.
Random Migration
Superphysiologic recruitment of cells
independent of a guiding surface, i.e.
random migration. Hyperactive cellular
activity in response to chemical stimulus
and potential for unwanted differentiation
ATTACH
pathway such as toward osteoclasts.

Mechanism of Action (MOA):

P-15 peptide & rhBMP-2 induce osteoblast
cell proliferation and differentiation
to accelerate new bone formation.
However, they differ in terms of how
they work through unique differences
in cellular signaling, migration, and
activation which may have an impact
on clinical safety and performance.
Predictable Activation Variable Activation
Directed cell migration and activation is Random cell migration and activation is
at the core of healthy predictable bone associated with uncontrolled diffusion ACTIVATE
formation and guided wound healing. which can lead to inflammation, edema, and
undesired cellular differentiation pathways.
Key
- Mesenchymal stem cell; Pre-osteoblast
- Osteoblast
- Osteoclast
- Inflammation
- Bone