Download Delivering more than just the matrix

Delivering more
than just the matrix
...Delivering Innate Integrity
Many disease states and postoperative complications are the direct result of inflammation
and the body’s consequent inability to restore a normal state of function. It is known that
regenerative healing occurs in the fetal environment due to an inherent ability to modulate
inflammation.8 Research has shown that this occurs because the fetal tissues, particularly
the Amniotic Membrane and Umbilical Cord, have innate regenerative properties. More
important, these properties can be preserved and transplanted to other environments.
Our Mission . . .
AMNIOX Medical is dedicated to using its proprietary technology to preserve the structural
and functional integrity of fetal tissues and to deliver the benefits of this biology to patients.
AMNIOX Medical is the only restorative therapy company built on the innate integrity
of its advanced science, select product, sound ethics and service model.
Innate Integrity in Product
An innovative and unique restorative matrix
• The only provider of a matrix composed of human Amniotic Membrane (AM) and
Umbilical Cord (UC)
• AM/UC comprises higher levels of key proteins, cytokines and growth factors that have been
shown to modulate inflammation and promote regeneration of normal tissue1-6 – significantly
more than Amniotic Membrane alone
Biological Content:
CRYOTEK Processed Human AM/UC vs.
Dehydrated Human Amniochorion Matrix (dHACM)7
®
6.3x
9.1x
50x
.08x
EGF
KGF
CRYOTEK AM/UC
IL-6
HA
dHACM
EGF – Epidermal Growth Factor – promotes cellular differentiation, proliferation and survival
KGF – Keratinocyte Growth Factor – promotes epithelialization phase of wound healing
IL-6 – Interleukin-6 – strongly promotes a local inflammatory response
HA – Hyaluronic Acid – regulates inflammation and aids in cell proliferation and migration
Innate Integrity in Process
Proprietary CRYOTEK technology
• Cryopreservation maintains the innate biological and structural integrity of the natural tissue
• Protects, preserves, and delivers the restorative properties of the AM/UC matrix
1. Fresh AM/UC
2. CRYOTEK AM/UC
3. Fresh HACM
4. Dehydrated HACM
Cryopreservation (2) effectively maintains the structural integrity of fresh tissue (1) as demonstrated by the comparable
tissue morphology. Dehydrated amniochorion sections (4) demonstrate significant changes to tissue morphology
as evidenced by dramatic compaction of extracellular matrix in contrast to fresh tissue (3).7
5. Fresh AM/UC
6. CRYOTEK AM/UC
7. Fresh HACM
8. Dehydrated HACM
The glycosaminoglycan Hyaluronic Acid (HA) and its proteoglycan derivative, heavy chain HA, are key signaling factors
present in AM and UC. Immunofluorescence staining using HA binding protein demonstrates strong positive staining
(green) throughout fresh AM/UC (5) and cryopreserved AM/UC (6), but sporadic staining in dHACM (8) in contrast
to fresh tissue (7).7
*Magnification = 10x in all images.
Innate Integrity in Performance
• More than 25 years of NIH-sponsored research pioneering the characterization and
preservation of human AM/UC
• More than 130,000 transplants to date
• Unparalleled pre-clinical and clinical experience documented
in more than 300 peer-reviewed publications
Cryopreserved Human Amniotic Membrane and Umbilical Cord
CLARIX®CORD 1K Regenerative Matrix
NEOX®CORD 1K Wound Matrix
CR-10-1515...............................1.5 x 1.5 cm
CR-10-2525...............................2.5 x 2.5 cm
CR-10-4030...............................4.0 x 3.0 cm
CR-10-6030...............................6.0 x 3.0 cm
CR-10-8030*..............................8.0 x 3.0 cm
NX-10-1515...............................1.5 x 1.5 cm
NX-10-2525...............................2.5 x 2.5 cm
NX-10-4030...............................4.0 x 3.0 cm
NX-10-6030...............................6.0 x 3.0 cm
NX-10-8030*..............................8.0 x 3.0 cm
Catalog #
Dimensions
Catalog #
Dimensions
Cryopreserved Human Amniotic Membrane
CLARIX®100 Regenerative Matrix
NEOX®100 Wound Matrix
CR-02-2020...............................2.0 x 2.0 cm
NX-02-2020...............................2.0 x 2.0 cm
Catalog #
Dimensions
CR-02-4040...............................4.0 x 4.0 cm
CR-02-7070...............................7.0 x 7.0 cm
Catalog #
Dimensions
NX-02-4040...............................4.0 x 4.0 cm
NX-02-7070...............................7.0 x 7.0 cm
Particulate Human Amniotic Membrane and Umbilical Cord
CLARIX®FLO Regenerative Matrix
Catalog #
Size
CR-FL-25MG.......................................25 mg
CR-FL-50MG.......................................50 mg
CR-FL-100MG...................................100 mg
NEOX®FLO Wound Matrix
Catalog #
Size
NX-FL-25MG.......................................25 mg
NX-FL-50MG.......................................50 mg
NX-FL-100MG...................................100 mg
NX-FL-150MG*..................................150 mg
*Available on request
INNATE INTEGRITY
The products offered by AMNIOX® Medical are processed and cryopreserved human Amniotic Membrane and
Umbilical Cord. They are designated (and thus regulated) as a Human Cell, Tissue, and Cellular and TissueBased Product (HCT/P) by the U.S. Food and Drug Administration, are minimally manipulated and are
produced in accordance with the FDA regulations for Good Tissue Practices (21 CFR 1270, 1271).
The tissue procured by AMNIOX Medical is collected during live birth via Cesarean section. AMNIOX Medical
procures all tissue through voluntary donation within the United States. Donor mothers are informed and
consent to the procedure in advance of giving birth. The tissue is collected after the placenta has been
removed from the mother’s body, so there are no risks to the patient as a result of the collection process.
Our procurement process, including donor suitability, selection, and testing, meets the stringent requirements
established by the Food and Drug Administration (FDA) and American Association of Tissue Banks (AATB).
Donor mothers are screened at delivery for infectious, malignant, neurological and auto-immune diseases and
other exposures or social habits to determine the suitability for human transplantation. Serological blood tests
are performed to rule out the potential for infectious disease transmission. All tissue is processed aseptically
and is tested for bacterial and fungal organisms by an independent laboratory.
References
1. Liu J, et al. Expert Rev Ophthalmol (2010). 2. Chen W, et al. Wound Rep Reg (1999). 3. Koh T, et al. Expert
Rev Mol Med (2011). 4. Jiang D, et al. Physiol Rev (2011). 5. Stern R. Eur J Cell (2004). 6. He H, et al. J Biol
Chem (2013). 7. Data on file, Amniox Medical, Inc. 8. Namazi M, Int J Dermatol, (2011).
AMNIOX Medical, CLARIX, and NEOX are registered trademarks of AMNIOX Medical, Inc. CRYOTEK is a
registered trademark of TissueTech, Inc.
AMNIOX Medical, Inc. – 2849 Paces Ferry Road, Atlanta, GA 30339 – 888.709.2140 – amnioxmedical.com
Copyright © 2014. AMNIOX Medical, Inc.
EDU-014, Rev.A