Dermabind TL
A Superior Triple Layer Amniotic Membrane Allograft
640 Proteins • More Collagen • More Fibrin • Better Elastin • More Cytokines • More Growth Factors •
640 Proteins • More Collagen • More Fibrin • Better Elastin • More Cytokines • More Growth Factors •
ASP:Dermabind TL
$1493 - FL
$1537 - the rest of the US
EOB: Proof of Medicare Payment
AGREEMENT OPTIONs
Option 1
Medicare Approved Discount Rate Agreement
6% Medicare Approved Rate
Option 2
Standard Agreement
30% Discount
Option 3
Marketing & Development Agreement
Fair Market Value based on Provider Collaboration
Dermabind: Triple Layer Amniotic Membrane Allograft
Dehydrated, intact placental wound cover.
No separation of the amnion, intermediate and chorion layers
Preserved intermediate layer
Greatest concentration of proteins, cytokines, collagens, and glycoproteins
Dermabind : Natural Biologic Barrier
Terminally Sterilized using Gamma Irradiation
Never Frozen
Completely Free of Preservatives
Non-Immunogenic
Maintains Membrane Shape
Protects Membrane Protein
Enhance Function as Biologic Dressing
Dermabind: Preserved Natural State of the Placenta
Minimally Manipulated
No chemicals during dehydration
No antibiotics during processing
Eliminates risk of antibiotic-resistant bacteria
Eliminates risk of residual irritants
Eliminates risk of chemical denaturation of protein.
Superior Processing Creates a Superior Product
FDA 361 DESIGNATED PRODUCT Dermabind TLTM Allograft
Approved for a 3 year Shelf-life
Dermabind: Thickest Homologous Allograft
1000 microns/1 mm
1000 microns/1 mm
Single layer is 150 microns thin = 1/6 of a triple layer
Dual Layer is 300-400 microns thin:
A single layer that is folded back onto itself
Amnion and chorion layers.
DermaBind Triple Layer
Goo
Can be applied in layers
Holds sutures well
Easy to handle
By not disrupt the natural state of the placental tissue in our manufacturing process, we deliver an allograft option that is intact from its original state. The DermaBind TL allograft product is the closest to the original state of the biomaterial and the original intent of the 361-product description for minimal manipulation and homologous use. This is also reinforced by our manufacturing process.
Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue Based Products: Minimal Manipulation and Homologous Use
21 CFR Part 1271.10(a):
Quality Assurance
DermaBind TL is manufactured under cGMP, cGTP, and ISO 13485 requirements and is processed from donors with normal, full-term pregnancies.
Each donor is carefully screened for comprehensive medical and social histories and is tested according to FDA requirements for Relevant Communicable Diseases.
Most placenta donors reside in Salt Lake City with higher statistics of healthier lifestyles and a very
Clean Processing
We don’t use antibiotics or harsh chemicals.
Our aseptic process takes care of this in the cleaning
stage.
No soaps or chemicals used to clean the product,
therefore no need to remove these later.
Drying Process
By using an Evaporative Dryer, we are able to keep the structure of the membrane and provide space.
We fluff up the intermediate layer and dry it so the body can use the scaffolding and space for better use in the patient’s treatment regimen.
Other allografts do not have this space
Radiation Process
The DermaBind radiation process is much less harsh due to our first steps for cleaning.
We use 17.5 kilogray, others can be known to use 25 kilogray.
The protein structure of the biomaterial can be negatively affected due to the use of that much radiation.
“The remarkable advantage I’ve discovered with the DermaBind TL Allograft is the elimination of the need for skin grafts, significantly expediting the healing process by tenfold or more. It’s truly transformative. DermaBind TL is healing even better than the dual layer I have used in the past.
David Fertel, DO
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