Introduction
Product Description
TissueMend® is a strong, suturable, porous collagen
biomembrane that is derived from fetal bovine dermis.
Through a proprietary process, the producers of TissueMend® remove
all cellular components from this dermal layer, leaving nothing but
intact, non-denatured collagen fibers.
The TissueMend® collagen fibers function as a foundation for cellular
growth, essentailly providing a scaffold within which the patient’s
cells populate, grow and mature.
Composition: What is Collagen?
Collagen is the body’s plastic, a naturally occurring protein
biopolymer, that gives strength and structure to skin, tendon, bone,
and other connective tissues.
Like all other multi-cellular organisms, the human body uses
collagen fibers as the predominant building material for tissues and
organs, serving as the scaffold within which cells grow and mature.
The body’s cells not only produce
collagen but are continually remodeling
this structural material in a continuous
process of breakdown and renewal.
The natural, undamaged, collagen
fibers seen to the right, make up
TissueMend®.
Composition: Collagen Types
Under normal circumstances,
collagen fibers develop when
individual molecules of collagen
called fibrils “spin” together
with other collagen molecules to
form a thicker, more substantial
collagen structure.
This process continues again and again, resulting in a wide
array of dense collagen fibers. The composition of these
fibers are ultimately determined by the different
combinations of collagen that spin together throughout the
process.
Composition: Collagen Types
The primary composition of the TissueMend® product is:
• Type I collagen (approximately 70-80%)
• Type III collagen (approximately 18-25%)
• Type V collagen (approximately 5-10%).
These are the same collagen types that make up a number of
tissues within our body. Examples within our body include:
• Tendons of the rotator cuff are composed primarily of type I and III.
• Articular cartilage is composed primarily of type II collagen
• ACL and Patellar Tendon are composed primarily of types I and III.
• Articular Capsule is composed primarily of type I and III.
• Periostium is composed primarily of type I and III.
Composition: Collagen
A biomaterial for surgical procedures
• In many of today’s most common surgical procedures, the
surgeon routinely takes a piece of collagen tissue, e.g.,
fascia, and transplants it into a living, but damaged area.
• The allograft/autograft collagenous tissues that are taken
from one part of the body and subsequently transferred to
another, serve as the foundation for new tissue growth and
development.
• Although allograft/autograft tissues can function as adequate
growth foundations, supply and donor site morbidity often
limit usage.
Why TissueMend® Works
• Remodeling
The patient’s cells do not try to encapsulate the implant and
rapidly break it down, like they would a foreign body. Rather,
the implant is accepted and gradually replaced by new collagen
fibers produced by the patient’s cells to provide a permanent
repair, not a permanent implant.
Why TissueMend® Works
• Tissue Building
The TissueMend® product is microporous, encouraging rapid
ingrowth of the patient’s blood vessels and cells to
reconstitute and bring life back to the implant.
Why TissueMend® Works
• Natural Biomaterial
TissueMend® is made of an intertwined network of natural,
undamaged collagen fibers, the same strong, structural
biomaterial that makes up all dense soft tissues such as
tendons, ligaments, articular capsules, periosteum, and
fascia.
Why TissueMend® Works
• The Gold Standard
The TissueMend® product handles, behaves, and interacts much
the same as the autograft/allograft collagen tissues used
effectively everyday in the operating room.
Applications
• Generally indicated for surgical procedures to reinforce and
repair soft tissue where weakness exists.
• Generally indicated for surgical procedures to reinforce and
repair damaged or ruptured soft tissue membranes
• Specifically indicated for repair of the Supraspinatus of the
rotator cuff.
Product Strengths
Biocompatibility:
The TissueMend® product elicits no foreign
body response1, allowing for rapid cell infiltration.
Remodeling:
The TissueMend® product provides a scaffold for cellular
growth, allowing for gradual remodeling over time.
Physical and Handling Characteristics:
The TissueMend® product exhibits superior handling
characteristics and physical features, allowing for obvious
competitive Advantages.
Biocompatibility
Biocompatibility is defined as an object’s ability to exist along side living things
without harming them.
This image illustrates TissueMend® biocompatibility. The image is a histological
look at the TissueMend® patch implanted between muscle bellies of a rat. As you
can see, TissueMend® readily integrates into the muscle fibers. Furthermore, after
only three months, numerous cell nuclei (dark circles inside inner band) have
populated the implanted matrix, free of any type of inflammatory response.
Biocompatibility
Surgical Facts
TissueMend®
Muscle
• The TissueMend® product
is reconstituted with host
cells within days1
• Does NOT elicit significant
foreign body reaction1
• Independent lab classified
the TissueMend® product as
a “nonirritant”1
3 mo rat intramuscular implant (NAMSA)
Muscle
Biocompatibility
A Reason Other Collagen Implants Fail:
Inflammatory Response
A common problem associated with tissue implants of the past
is that the material placed within a defect is recognized as a
foreign body and a severe inflammatory response ensues.
An inflammatory response is
illustrated by the image to the left.
Inflammatory cells (depicted in red)
have infiltrated the collagen matrix
and are rapidly degrading the collagen
fibers (blue). The clinical results of
this process are unpredictable.
Biocompatibility
Why TissueMend® Succeeds
In contrast, gradual remodeling of the TissueMend® matrix is
seen in the image below. Cells and blood vessels (red)
have migrated into the porous
collagen fibers (blue), where they
can begin to gradually mature and
transform the implanted,
TissueMend® matrix into native
host tissue.
Remodeling
Remodeling is defined as a process by which collagen
maintains a dynamic steady state, through sequential
resorption and formation of small amounts of collagen at
the same site.
Therefore, through the gradual process of remodeling, the
implanted TissueMend® collagen fibers are slowly
reconstituted and simultaneously replaced by new
collagen fibers that are native to the area of implantation.
Remodeling
3 Weeks
9 Months
• TissueMend® product used in the surgical repair of incisional hernia
• Implanted TissueMend® product fully remodeled and replaced by host
tissue in 9 month period
• No significant inflammatory response or scar tissue formation evident
• No herniation; defect is healed
Physical and Handling Characteristics
Hydration:
The TissueMend® product hydrates in only
30 seconds, allowing for on-the-spot,
intraoperative decisions.
Strength:
The TissueMend® product is extremely
strong and is designed to withstand the
stresses associated with physical
movements.
Physical and Handling Characteristics
Refrigeration:
The TissueMend® product does not require
refrigeration, which allows hospitals to readily
stock the product on their shelves.
Size and Thickness:
The TissueMend® product is nominally 1mm thick
and is available in a 5cm x 6cm rectangle.
Chemical Crosslinkers:
The TissueMend® product is composed of natural,
non-denatured collagen fibers, free from any form
of chemical crosslinkers.
The Competition
Available Collagen Implants
TissueMend®
Restore®
Graftjacket™
CuffPatch™
The Competition
The Restore® Orthobiologic Implant
• The Restore® Orthobiologic Implant is produced by J&J DePuy.
• The collagen fibers used in the Restore® Orthobiologic Implant
are derived from porcine small intestine submucosa (SIS)2,
essentially the inner lining of a pig’s small intestine.
• The Restore® Orthobiologic Implant is comprised of
approximately 10 layers of SIS, laminated together to form a
single implant2.
• The Restore® Orthobiologic Implant is
0.3mm thick and is available in a 6 cm
circle2.
Competitive Advantages
The Restore® Orthobiologic Implant
Strength
The TissueMend® patch can withstand 4x greater force
than the Restore® orthobiologic implant1
Layering
The TissueMend® collagen matrix is a single layer and
cannot delaminate. The Restore® Orthobiologic Implant
has multiple layers and can delaminate2
Thickness
The TissueMend® patch is nominally 1 mm thick. The
Restore® Orthobiologic Implant is 0.3 mm thick2
Hydration
The TissueMend® patch rapidly hydrates in under a
minute. The Restore® orthobiologic implant requires
7-10 minutes to hydrate and will delaminate if hydrated
for more than 30 minutes2
Storage
The TissueMend® patch is stored at room temperature.
The Restore® Orthobiologic implant must be refrigerated2
The Competition
Graftjacket™
• Graftjacket™ is produced by LifeCell and is marketed and
distributed by Wright Medical.
• The collagen fibers used in the Graftjacket™ implant are
derived from a single layer of adult human cadaveric tissue3.
• The Graftjacket™ Implant is available in 2 sizes:
•5cm x 5cm square
•5cm x 10cm rectangle
Competitive Advantages
Graftjacket™
Strength
TissueMend® is derived from fetal bovine skins, which
contain neither hair nor follicles. Graftjacket™ is derived
from adult tissues, which contain both hairs and hair follicles3.
The disruption of the human collagen layer by imperfections
such as hair and hair follicles may compromise the overall
strength of the implant.
Layering
Hydration
Storage
Both the TissueMend® collagen matrix and Graftjacket™
are comprised of a single layer and cannot delaminate3.
The TissueMend® patch rapidly hydrates in under a
minute. Graftjacket™ is “rehydrated” in 10 minutes3.
The TissueMend® patch is always stored at room
temperature. Graftjacket™ must be refrigerated3.
The Competition
CuffPatch™
• CuffPatch™ is produced by Arthrotek and is marketed
and distributed by Biomet.
• The collagen fibers used in the CuffPatch™ implant are
derived from Porcine small intestine submucosa (SIS)4.
• The CuffPatch™ Implant is comprised of eight layers of
Porcine SIS, each of which is crosslinked4.
• The CuffPatch™ Implant is available in 1 size4:
• 6.5cm x 9cm
Competitive Advantages
CuffPatch™
Integration
Remodeling
Strength
Layering
Hydration
As a result of the acellular nature of TissueMend® collagen
fibers, it is classified as a non-irritant and therefore does not
illicit a foreign body response1. CuffPatch™ collagen is
crosslinked and derived from SIS material. Examination of SIS
implants have revealed a foreign body reaction in the area of
graft placement5.
TissueMend® collagen fibers are infiltrated and remodeled
by host tissue. CuffPatch™ is crosslinked4. Crosslinked
materials will persist as a permanent implant.
TissueMend® is derived from a single layer of thick, durable
bovine dermis that does not require artificial crosslinking to
enhance strength. CuffPatch™ collagen is derived from thinner
SIS material and, as a result, requires chemical crosslinking to
achieve desired strength4.
TissueMend® is composed of a single layer. CuffPatch™ is
composed of 8 separate layers4.
CuffPatch™ offers no true competitive advantage because
the TissueMend® patch rapidly hydrates in under a minute,
allowing for quick intraoperative decision making.
Safety
TissueMend® is a biological, collagen membrane derived from
bovine dermis.
In view of the bovine spongiform encephalopathy (BSE) (“mad
cow disease”) epidemic in the U.K, a number of safety measures
have been taken by TEI Biosciences.
Safety
TEI Biosciences has adopted a series of five effective methods known by
the World Health Organization (WHO), the Food and Drug Administration
(FDA) and the Commission of European Communities reduce BSE risks:
• source materials are traceable to herds having no known incidences of
BSE
• source materials are from animals certified fit for human consumption
• all source materials are exposed to sodium hydroxide, a recognized prion
inactivant
• the source material is of fetal origin; per the World Health Organization,
infectious BSE agents have not been identified in any fetal bovine tissues
• the source material is bovine dermis, a Category IV WHO designated
tissue indicating no detectable BSE infectivity of the tissue source