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TM
Flow & Membrane
Are you
living with
joint pain?
TM
Nanofactor consists of Amniotic
Membrane with the chorion layer removed,
and is available in a variety of sizes and
volumes, as both a sterile extra cellular
matrix and as a cryopreserved allograft.
www.arthrosurface.com
Why should I consider receiving a
Nanofactor™ Amniotic Tissue Graft?
HLA’s have the potential to cause an immune reaction,
resulting in the body rejecting the graft.
When the body sustains damage from either trauma,
disease or simple wear and tear, it normally results in
the formation of a wound. These wounds can be either
external or internal to the body, affect a specific tissue
or structure, and often result in a void or loss of tissue.
In medicine, wounds are also referred to as lesions,
defects, scars or tears. As part of the body’s normal
healing mechanisms, a biological process begins to
repair the damage. In order to strengthen the body’s
own healing mechanisms, allograft tissue is often used
to cover the wounded area or to fill the tissue void.
This “biological blanket” may help reduce adhesions or
scarring and augment the closure of the wound.
Amniotic tissue has also been shown to be multi-potent
(accelerates healing), anti-microbial (attacks germs) with
anti-adhesion (reduces scar tissue formation) properties.
These properties can aid in wound healing. It also has
the inherent advantage of being unadulterated by the
effects of time, disease or other medications. For many
years, Amniotic membrane has been used in other
disciplines such as ophthalmology and plastic surgery
with widespread success.
What is Amniotic Tissue?
Amniotic tissue is the inner most lining of the placenta
and directly contacts and contains the fluid surrounding
the fetus during pregnancy. Amniotic tissue consists
of 2 layers, the Amnion and Chorion. The Chorion is
the outer layer of the placenta
that lies against the uterus and
makes contact with the mother.
The Amnion is the innermost
layer and makes contact with
the fetus. For Arthrosurface
Nanofactor™ grafts, the Chorion
is separated and removed so
that the Amnion is the only layer
that is utilized. A major benefit
of a Chorion-free graft is that
it eliminates the possibility of
Human Leukocyte Antigens
(HLA’s), which are found in the
Chorion layer of the placenta.
What is Nanofactor™?
Nanofactor™ is a human tissue allograft taken from
amniotic tissue that contains many biological elements.
These elements are widely believed to be involved in
the complex cascade of reactions that occur in tissue
healing. Healthy mothers donate Amniotic tissue
at the time of a live, scheduled, cesarean childbirth.
The donated Amniotic tissue and fluid is harvested,
cryopreserved (frozen) and shipped to an accredited
lab and tissue bank. Throughout their pregnancy, the
donors are meticulously screened. Both mother and
child are tested again prior to the donation. Upon
delivery of the tissue to the tissue bank another full
screening is carried out.
Nanofactor™ is available in two forms: Flow &
Membrane.
What is Nanofactor™ Flow?
Nanofactor™ Flow is a fluid version of the allograft
that can be applied to topical or internal wounds and
is diluted with normal saline to a suitable viscosity for
delivery. It is available in a variety of volumes and can be
administered in-office or used during surgery.
Contents in Each Therapy
What is Nanofactor™ Membrane?
Nanofactor™ Membrane is a chorion-free, pliable, film/
sheet form of the allograft, which can be used to cover
internal or external wounds such as lesions, scars and
soft tissue tears.
How is Nanofactor™ different from
other grafts of cell therapies?
Other cell therapies such as Platelet-Rich Plasma (PRP)
and Bone Marrow Aspirate (BMA) rely on taking blood
or marrow from the patient (patient harvesting) and
then re-injecting it back into the affected area. These
donor cells can be affected by the age and general
health of the patient and may not be as powerful or
plentiful as Amniotic Tissue.
With Nanofactor™, no patient harvesting procedure is
necessary; therefore, delivery time is shortened and a
potential infection site is eliminated. It has also been
shown that a higher density of multi-potent cells exist in
amniotic grafts versus those harvested from marrow.1
1. Chin J Cancer Res. 2011 Mar;23(1):43-8. doi: 10.1007/s11670-011-0043-1.
PRP
BMA
(Platelet Rich Plasma)
Growth Factors
(Bone Marrow Aspirate)
Growth Factors
Multipotent Cells
Nanofactor™
(Amniotic Tissue Graft)
Growth Factors
Multipotent Cells
Scaffold
All three elements are believed to be essential for tissue healing.
Features
Nanofactor
PRP
BMA
Contains all 3
regenerative
elements
Yes
No
No
Contains
multipotent
stem cells
Yes
No
Yes
Off-the-shelf
graft
Yes
No
No
Requires
invasive patient
harvesting
No
Yes
Yes
Cells require
manipulation
to be extracted
No
Yes
Yes
Cells need to
be expanded or
concentrated
No
Yes
Yes
High yield
stem cell source
Yes
No
No
How many treatments will I need?
Each patient and injury is different. Your physician will
advise on the number of treatments recommended
based on their professional assessment of your medical
condition.
What should I avoid after treatment?
Do NOT ice or take any anti-inflammatory medications
such as Advil®, Motrin®, Aleve®, Aspirin, Ibuprofen, etc.
for at least four weeks following treatment. These can
compromise the healing process of the Nanofactor™
graft. Tylenol® or acetaminophen based products can
be used for pain relief. You may resume exercise and
activity in the hours and days after the treatment, as you
are comfortable. Please discuss specific post treatment
care with your physician.
How do I know it’s Safe?
Nanofactor™ is safe based on the extensive amount of
screening and testing completed on the tissue and donor.
An extensive medical review and prenatal evaluation
is completed on the donor prior to the birth. No fetal
sacrifice is involved.
Following medical screening, complete serology is
conducted on the donor inclusive of:
• Hepatitis B
• Surface Antigen
• Hepatitis B Core Antibody
• Hepatitis C Antibody
• HIV Types I, II and O Antibody
• Hepatitis C Virus
• Human Immunodeficiency Virus
• Hepatitis B Virus
• Syphilis
• Human T-lymphotropic V
Extensive testing and analysis of the final harvested
tissue is also conducted.
Communicable disease testing has been performed by
a laboratory registered with the FDA to perform donor
testing and certified to perform such testing on human
specimens in accordance with Clinical Laboratory
Improvement Amendments (CLIA) and 42 CFR Part 493,
or that has equivalent requirements as determined by
the Centers for Medicare and Medicaid Services.
Amniotic tissue has been used as a medical therapy
since the early 1900’s and has had no reported side
effects since its first documented case in 1910.
TM
Flow & Membrane
* Update on Amniotic Membrane Transplantation. Expert Rev.
Ophthalmol. 5(5), 645-661 (2010). Jingbo Liu, Hosam Sheha, Yao
Fu, Lingyi Liang & Scheffer CG Tseng.
Due to its general applicability, do not rely on
information in this brochure to assess any particular
joint condition. Individual results may vary. Seek
professional medical advice for specific personal care.
Do not delay seeking professional medical advice
or disregard professional medical advice because of
something you have read in this brochure.
For more information, visit our website
www.arthrosurface.com
28 Forge Parkway • Franklin, MA 02038
1 508 520 3003
PN 0020-1250 REV C