Biologics competition Flashcards
Scaffold 1
Synthetics
Scaffold and Signal 4
DBM putty
DBM fiber
OsteoAMP
Peptides
Signal 1
BMP
Signal and Cells 3
BMA
PRP
Amniotic
Cells Scaffold and Signal 2
Autograft
Cellular Allograft
Tissue processors
AlloSource MTF Musculoskeletal Transplant Foundation RTI Biologics LifeNet Health LifeLink Tissue Bank MTB
Companies
Medtronic OsteoTefch OrthoFix Depuy Synthes Zimmer Biomet Stryker NuVasive
Products
Allostem Infuse Trinity Elite ViviGen Osteocel Bio4 OsteoAMP
Autograft
Historically requires additional surgical site
Spinous processes are limited in quantity and often require extender
Autograft still considered gold standard
Patient’s own bone is better but what about smoker/diabetic/osteoporotic
DBM Putty
2 ingredients - Demineralized bone (particles or fibers) and carrier that improves handling characteristics
510k required as result of added carrier compound
Offered in putty or injectable paste
Room temperature
2 year shelf life
Grafton (Osteotech/Medtronic)- glycerol carrier
DBX (Depuy) cannot be irrigated will wash away
NO Cells - still need osteogenic component
DBF (Demineralized Bone Fibers)
Long fibers that have been demineralized
Entangle and become similar to putty
100% bone - no carrier
room temp
2 year shelf life
Theory is cells prefer to grow along a liniar scaffold as opposed to jumping particle to particle
Relatively new - not many competitors
No Cells - still need osteogenic component
Handling characteristics close, but still not like putty
DBM cancellous shapes
100% human demineralized cancellous bone Elastic compressible handling characteristics conductive and inductive Room temp 5 year shelf life Radiolucent OsteoSponge (Bacterin) Conform (DePuy) Indux (Zimmer/Biomet) Grafton Matrix PLF
No cells - still needs osteogenic component
DBM (Enhanced?)
Allograft bone with increased levels of BMP
Added from processed bone-marrow
Granules, putty, compressible sponge and structural allografts
Claim 500-1000 times the BMP of native autograft or any allograft derived biologic on the market
No cells - still needs ostoegenic component
Expensive - targeting infuse
First generation synthetics
Osteoconductive scaffold only Calcium phosphate ceramic Hydroxyapatite & Tri-calcium phosphage Calcium sulfate (Plaster or Paris) Polymer-based (Collagen) Combination of several
Recommend combining PRP/BMA
Not dominant in marketplace
Typically only in deformity cases
Low price point
Vitoss (stryker)
Mastergraft (Medtronic)
Chronos/Healous (Depuy)
Synthetic Bioglass
Dominated by bio-active glass or bioglass products
Claim osteopromotive or osteostimulative capacity in addition to osteoconductive scaffold
Recommend combining with PRP/BMA
Vitoss BA (Stryker)
Actifuse (Baxter)
NovaBone (Nova Bone)
Synthetic Peptides
I-Factor (Cerapedics) is only product on market
On a collagen molecule there are segments (peptide - 15 that grab onto osteoblasts
I-Factor is anorganic bone mineral (ABM) that has synthetic P-15 cound to it
The ABM is bone derived calcium phosphate particles
BMP
Infuse - rhBMP-2
recombinant human bone morphogenic protein type 2
Single protein - aka Growth Factor, inherent in natural bone
Osteoinductive - signal only
BMP is 1,000,000 greater than native human levels
Intra-operatively combined wiht collagen spone carrier (20 minutes)
Recruits MSCs to site and signals them to change to osteoblasts
Was declining, now stabilizing
2010 900m 2015 400m
Expensive $1000/cc
Amnion
?
BMA
Primary purpose is to extract stem cells from a boney site such as the sternum or iliac crest.
Machine utilizes centrifugation to separate cell types
For spine, multiple pulls are taken from ilium
15 min of spinning to separate
Needs to be combined with allograft or synthetic scaffold (adds to overall cost)
High variability with respet to platelet concentration and residual leukocyte content
Low numbers of cells has been reported
Magellan (Arteriocyte)
SmartPReP 2 (Terumo/Harbest)
Biomet BioCue
PRP
extract platelets rich in growth factors
Often same machine as BMA
High variability with respect to platelet concentration and residual leukocyte content
Science is not great on promotion of bone
Science is better on soft tissue side
Cellular Allograft Products
NuVasive
Osteocel Plus
Osteocel Pro
Orthofix
Trinity Evolution
Trinity Elite
Zimmer/Biomet
Cennentra
Stryker
Bio4
DePuy/Synthes
Vivigen
RTI/Pioneer
Map3
Miami Tissue Bank
Amendia
Nuvasive
Ground Bone - then cleaned
Contains scaffold signal cells
Cell portion of product is NOT demineralized 20% of demin bone particles added to final product
Why did they add this? probably a flaw in their original formulation
Cell Characteristics
Claim 3m cells but %MSCs unknown
Contains cells other than that related to bone formation
MSC count variable and completely based on donor
Morserlized 1cc 5cc 10cc 15cc
OsteoCel Plus 1st generation
poor handling less expensive
OsteoCel Pro 2nd generation
Stickey, stays together better, premium price
Trinity Elite
Made by MTF
Scaffold, signal, cell
MSC count completely based on donor variables
Contains sells other than bone forming
Trinity Evolution 1st gen
is NOT demineralized - 20% demineralized bone particles added
Contains minimum of 250,000 cells/cc 50,000 of which are validated to be MSCs
Morselized only 1cc, 5cc, 10cc 15cc
Trinity Elite 2nd generation
Improved handling
More cells
Allogenic bone with cortical fibers - like brillo pad
Claim 500,000 cells 100,000 of which MSCs or osteoprogenitor
Noe demineralized - some demin added
Priced higher but coming down due to contracting
BioMet Spine
not demineralized, some demin added 250,000 cell/cc MSC unknown MSC count based on donor Morselized only limited clinical data sells other than bone forming Distributed by biomet reps only
Stryker Bio4
Made by Osiris
600,000 cells
Endogenous bone forming cells including MSCs, OPCs and OBlasts
Vascular Endothelial Growth Factor(VEGF) is important to angiogenisis
MSCs are rich with VEFG as with blood
MSCs based on donor
Ready to use out of package - no decanting
thaws 15min
Vivigen Depuy Synthes
Made by LifeNet
Cell count unconfirmed
They play down stem cell rhetoric
OP and OB attached to ground bone substrate
Linage of cell further along towards becoming bone
Linage cells are committed unlike MSCs
1 form only
MSC count based on donor
Delivery system gotten high praise from surgeons
No known data
Map3 RTI Biologics
Made by RTI
Demineralized cortical cancellous bone chips are scaffold and signal
Cryogenically preserved, viable multipotent adult progenitor - class cells are packaged separately
Osteoprogenitor cells suspended in liquid and cryogenically preserved
Interoperatively combined with provided substrate - chips or strips -HOW many actually stick?
Lineage cells already committed - no replication
Cell count completely variable
Limited forms
Questionable handling
Extra prep time required to combine cells and substrate
Not enough time for cells to adhere
Allostem All-in-one solutions
Designed to mimic autograft
3 necessary ingredients to grow bone - scaffold, signal, cells
Each component connected to each other
Cells are already attached to cancellous scaffold
BMPs are proteins found in the scaffold that are exposed during demin process
AlloStem can be irrigated and won’t wash away - others combined intra-operatively combined with synthetics don’t have enough bonding time. Can be irrigated away.
When RFPs come out, are all costs considered?
Allostem Purer Cell Product
Our patented process ensures a consistent and reproducible cell count each time regardless of donor
Process provides knowable reproducible and consistent population of living, viable MSCs 66,250/cc
Only living viable MSCs attach to substrate
MSCs self select with natural ability to adhere to substrates while other immunogenic cells types wash away
MSCs are non-immunogenic
MSCs proved to multiply and differentiate into osteoprogenitor and osteoblasts
Allostem Handling/Configuration
Allostem is an all in one fusion solution that is easy to use - thaw, rinse, implant
can irrigate in situ
Morsilized
Multiple sizing options to fill in cages or bone voids including MIS applications
Intact
Multiple shape options to fill cages or voids
Compressible and sponge like allowing for mushrooming out of cages to bridge endplates in disc space
