TIGR Matrix Synthetic Long Term Resorbable Surgical mesh

CORPORATE - timeline
MEDICAL SYSTEMSRadiPlast
1978
1979
1980
1981
1982
1983
1984
1985
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1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
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1998
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2009
2010
2011
RadiPlast founded
on the basis of using
intelligent plastic
mouldings to avoid
injuries to children.
Later the company
turns its’hand to
selling catheter kits.
RadiPlast sold to to CR Bard.
RadiPlast becomes
agent for ACS (Advanced
Catheter Systems).
PressureWire® (Radi Sensor)
concept conceived.
First PressureWire® sold.
First FemoStop® sold.
PressureWire® methodology‘Fractional Flow Reserve’(FFR) conceived.
Radi grows it’s international presence globally with nine regional offices.
Employees around the world swell to 350.
First Femoseal® sold.
Radi acquired by St Jude Medical Inc.
Novus Scientific founded.
Polymer research starts in earnest at
the Radi research facility in Uppsala.
The history of Novus Scientific - a journey of innovation
Radi Medical Systems AB founded.
Work starts on TIGR™ project.
TIGR®
available
in USA.
TIGR®
available
in EU.
1978
Engstrom runs radiology product company RadiPlast AB.
1982
Engstrom secures distribution rights to Advanced Cardiovascular Systems Inc. (ACS > Guidant Inc).
1988
Engstrom sells RadiPlast AB to CR Bard Inc. and founds Radi Medical Systems AB.
1988 – 2008
Radi pioneers some of the world’s leading devices for interventional cardiology, hemostasis management, and radiology.
1999
Engstrom sets up a resorbable biomaterials R&D department in Sweden.
2003
Engstrom invests heavily in clean room production facilities on the island of Phuket.
2004
Resorbable polymer matrix project group established - 1st patent filed for what would become TIGR®
Matrix Surgical Mesh.
2005
Engstrom honored at Ernst and Young ’World Entrepreneur of the Year’awards.
2008
Radi Medical Systems sold to St Jude. Inc. / Novus Scientific founded and established into 2009.
2010
TIGR®
Matrix Surgical Mesh launched in the United States.
2011
TIGR®
Matrix Surgical Mesh launched in selected European countries.

TIGR® Matrix Surgical Mesh - indications for use
TIGR® Matrix Surgical Mesh
for use in reinforcement of soft tissue where weakness exists
In January 2010 the US Food and Drug Administration (FDA) gave the company 510(k) clearance to market TIGR® Matrix Surgical
Mesh for use in reinforcement of soft tissue where weakness exists.
In July 2011 Novus Scientific’s Quality Management System was certified by BSI to ISO 13485:2003 for the following scope:
Design, control of manufacture and supply of sterile resorbable synthetic surgical mesh for reinforcement of soft tissue.
In August 2011 Novus Scientific received CE Mark approval for TIGR® Matrix Surgical Mesh in Europe.

PRODUCT - key features
FAST
SLOW
dual-stage resorption
increasing mechanical compliance
wound healing phase remodeling phase
DECREASING MECHANICAL STRENGTH
INCREASING MECHANICAL COMPLIANCE
long-term absorbable
100% synthetic
0 10 20 30 40 50 60
100
50
* TIGR Matrix Surgical Mesh
** Polyglactin 910
*** GTMC
®
WEEKS
% Strength Retention
* Novus Scientific, Data on File.
** Chu, C. C. A comparison of the effect of pH on the biodegradation of two synthetic absorbable sutures.
Annals of Surgery 1982;195(1):55-59
*** Katz et al. New synthetic monofilament absorbable suture made from polytrimethylene carbonate.
Surgery, Gynecology & Obstetrics 1985;161(3):213-222.
strong when you need it gone when you don’t
®
S U R G I C A L M E S H

PRODUCT - design
®
Unique, patented dual-fiber construction (dual-stage mechanics)
Strong in the acute wound healing phase
Gradually increasing mechanical compliance over time
Pore size of approx. 1mm at time of implantation increasing to approx 1 x 2mm at 4 months
Warp knitted to prevent unravelling
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PRODUCT - materials
0 days 6 months 3 years
Fast-resorbing fiber = copolymer of glycolide, lactide and trimethylene carbonate.
strong for 1-2 weeks, gone in 4 months
Slow-resorbing fiber = copolymer of lactide and trimethylene carbonate.
strong for 6-9 months, gone in 3 years

PRODUCT - strength comparison
For six months TIGR® Matrix Surgical Mesh maintains mechanical integrity equivalent to a
lightweight polypropylene mesh and initially is twice that strong.
High strength is crucial in the initial wound healing phase. Beyond that the increasing mechanical
compliance of TIGR® Matrix is designed to promote remodelling of native tissue.
Physiomechanical Properties of Permanent Meshescompared to TIGR® Matrix
Deeken CR, et al. J Am Col Surg. 2011;212:68-79.
Deeken CR, et al. Surg Endosc. 2011;25:1541-52.
Data on file: Novus Scientific
Physiomechanical Properties of Permanent Meshes compared to TIGR® Matrix
10
Product
Burst
strength
(N/cm)
Strain at
16N/cm
(%)
Suture retention
strength,
parallel/perpendicular
(N)
Tear resistance,
parallel/perpendicular
(N)
Thickness
(mm)
TIGR®
Matrix
86.5 7.0 45.8 / 59.0 32.0 / 33.3 0.51
Physiologic
requirement
32 15-25 ? - -
Ultrapro™ 35.5 16.2 15.1 / 16.7 10.5 / 5.1 0.50
Parietex
Composite
™
38.9 6.5 28.2 / 36.3 19.7 / 16.2 0.76
C-Qur™
Lite “Small”
50.5 13.2 22.3 / 33.8 19.4 / 18.35 0.28
Proceed™ 52.6 7.25 34.1 / 41.6 19.8 / 20.2 0.57
Gore
Dualmesh™
97.8 10.2 65.2 / 73.0 30.5 / 41.3 1.20
Parietex
Flat Sheet
TEC™
112.9 3.5 51.4 / 58.4 32.7 / 28.6 0.52
Prolene™ 156.6 5.3 61.2 / 70.5 33.7 / 39.3 0.53
Bard
Mesh™
157.7 10.8 50.8 / 66.8 46.8 / 38.4 0.73

-
10

PRODUCT - strength retention comparison
Biomechanical Characteristics of Biologic Meshes
89.6

253

317

30

37
35

20
14

23

0

50

100

150

200

250

300

350

Veritas™
Alloderm™
Permacol™

Max
Force
(N)

0
Months
1-‐12
Months
max
1-‐12
Months
min

TIGR® Matrix Surgical Mesh is stronger for much longer than other synthetic absorbable
meshes and is designed to have gradually increasing mechanical compliance.
VicrylTM
(Polyglactin 910) for example degrades in a matter of 2-3 weeks. The long-term
resorption of TIGR® Matrix gives the recipient tissue time to respond to the increasing
mechanical load.
0 10 20 30 40 50 60
100
50
* TIGR Matrix Surgical Mesh
** Polyglactin 910
*** GTMC
®
WEEKS
% Strength Retention
* Novus Scientific, Data on File.
** Chu, C. C. A comparison of the effect of pH on the biodegradation of two synthetic absorbable sutures.
Annals of Surgery 1982;195(1):55-59
*** Katz et al. New synthetic monofilament absorbable suture made from polytrimethylene carbonate.
Surgery, Gynecology & Obstetrics 1985;161(3):213-222.
TIGR® Matrix Strength Retention compared to other Resorbable Synthetics
TIGR® Matrix Surgical Mesh retains 50% of its mechanical strength for at least 6 months.
Deeken CR, et al .J Am Coll Surg 2011;212:880-888

THE CONCEPT of mechanotransduction*
“collagen networks are
mechanosensitive in that they are
stabilized by mechanical strain.”
Muscles and tendons become stronger in response to repetitive loading.
“Tendons adapt to changes in
mechanical loading, and numerous
animal studies show that immobilization
of a healing tendon is detrimental to the
healing process.”
*mechanotransduction is the physiological process where cells sense and respond to mechanical loads
Br J Sports Med 2009;43:247-252 doi:10.1136/bjsm.2008.054239

PRODUCT - time dependent mechanical characteristics
TIGR® Matrix Surgical Mesh was developed
based on the hypothesis that soft tissue
positively remodels in response to the
stimulus of increased mechanical load.
The increasing mechanical compliance results in a
gradual transition of load from the mesh to the patient.
7
15
19
20
16.2
6.5
13.2
7.3
10.2
3.5
5.3
10.8
DAY 0
7
15
19
20
16.2
6.5
13.2
7.3
10.2
3.5
5.3
10.8
DAY 0
Physiomechanical Properties of Permanent Meshes compared to TIGR® Matrix
Junge K, et al. Hernia (2001) 5: 113-118.
Data on file: Novus Scientific.
TIGR®Matrix
TIGR®Matrix(day28)
TIGR®Matrix(day182)
TIGR®Matrix(day277)
Ultrapro
ParietexComposite
C-QurLiteSmall
Proceed
GoreDualmesh
ParietexFlatSheetTEC
Prolene
Bard
Strainat16N/cm(%)
required physiological elasticity in vertical stretching (25 ± 7 %)
(day0)
The elasticity of TIGR® Matrix Surgical Mesh
increases over time, reaching normal
physiological levels after 6 months.

PRODUCT - why long-term resorbable /absorbable?
Wound healing is a long-term process. In particular, the time taken to regain 50% of
normal tissue strength is typically 3 months, after which about 80% of normal tissue
strengthisultimatelyachieved.Thetimescalecanbesignificantlylongerinsomepatients.
Approximate times of the different phases of wound healing, with faded intervals
marking substantial variation, depending mainly on wound size and healing
conditions.
(Image does not include major impairments that cause chronic wounds.)

PRODUCT - benefits
TIGR® Matrix Surgical Mesh is: 100% resorbable / absorbable
100% synthetic
Strong for 6 months, gone in 3 years (dual-stage mechanics)
Easy to handle
CE marked
0 days 6 months 3 years
strong
when
you
need it
gone
when
you
don’t
for 6 months in 3 years

DEFCET CREATION - 3 year sheep study
Creation of a 4x4 cm full thickness
defect (peritoneum left intact) in the
abdominal wall of a sheep.
TIGR®MatrixSurgicalMesh
Mesh repair of the defect performed
as onlay using TIGR® Matrix Surgical
Mesh trimmed to 8x8 cm secured with
interrupted permanent sutures.
This is a summary of the results
from a 3 year implantation study
of TIGR® Matrix SurgicalMesh in the
abdominal wall of sheep.
®

HISTOLOGY GUIDE
Macrophage
Fibroblasts (F)
Blood vessel (V)
Organized (layered)
fibroconnective tissue
Collagen (C)
Foreign body granuloma
Polypropylene fiber
(monofilament)
TIGR® Matrix multifilament
bundle
Individual filaments in the
multifilament bundle
TIGR® Matrix filament
engulfed by giant cell (G)
phagocytosis
Visible signs of TIGR®
Matrix fiber degradation
Note: regarding foreign body reaction
The foreign body reaction begins as wound healing, including accumulation of exudate at the site of injury,
infiltration of inflammatory cells to debride the area, and the formation of granulation tissue.
However,thepersistentpresenceofabiomedicalimplant,splinter,particulates,orotherforeignbodiesinhibits
full healing. Rather than the resorption and reconstruction that occurs in wound healing, the foreign body
reaction is characterized by the formation of foreign body giant cells, encapsulation of the foreign object, and
chronic inflammation.

PRECLINICAL - neovascularization at 4 months
NEOVASCULARIZATION
The formation of new blood
vessels can clearly be seen
within the connective
tissue in the vicinity of the
implanted mesh fibers.

KEY
V - blood vessel
KEY
V - blood vessel
V

PRECLINICAL - 4 & 6 months
INTEGRATION
Excellent tissue integration
of TIGR® Matrix with a
well organized, regenerated
fibroconnective tissue at 4
months.
mesh fiber bundle
mesh fiber bundle
(bottom left)
TISSUE INGROWTH
Connective tissue infiltrating the
synthetic filaments of TIGR® Matrix.
(bottom right)
MACROPOROSITY
TIGR® Matrix fibers
under plane polarized
light following 6 months
implantation.
TIGR® Matrix is well
integrated into abdominal
wall with abundant
fibroconnective tissue.
TIGR®MatrixSurgicalMeshTIGR®MatrixSurgicalMesh

PRECLINICAL - 9 months
TISSUE GENERATION
Staining for collagen type I (orange) and III (green) in TIGR®
Matrix (A-B)
and Polypropylene (C-D) meshes following 9 months implantation.
A
C
TIGR®
PP PP
TIGR®
B
TIGR®
Fibers
TYPE I
TYPE I
TYPE III
PP
Fibers
TYPE I
TYPE III
PP
FIBER
TIGR®
Fibers
TYPE I TYPE III
D

FULL THICKNESS REPAIR
TIGR® Matrix showing
excellent tissue integration
and thick repair tissue as
compared to polypropylene
control mesh.
TIGR® Matrix Surgical MeshControl Mesh
(bottom left)
CONTROL
Polypropylene fibers of the
control mesh surrounded
by granulomas and
collagen (the quantity
of collagen is lower and
typically ingrowth between
fibers is not seen to the
same extent). G
V
KEY
V - blood vessel
G - giant cell
KEY
V - blood vessel
G - giant cell
ControlMesh
(bottom right)
ABUNDANT COLLAGEN
Ordered connective tissue
ingrowth (C) between two
TIGR® Matrix multifilament
bundles.
Collagen is abundant and the
inflammatory response is low.
C
KEY
C - collagen
KEY
C - collagen

SEM - TIGR® Matrix
Full thickness abdominal wall with TIGR® Matrix well integrated within a
thick surrounding fibroconnective tissue.
SEM - POLYPROPYLENE CONTROL
Full thickness abdominal wall with polypropylene fibers integrated within a
thin surrounding fibroadipose tissue.
Regenerated
connective
tissue
Fibro-
adipose
tissue
ControlMeshTIGR®MatrixSurgicalMesh

DEGRADATION
TIGR® Matrix filaments surrounded
by giant cells which have engulfed
fibers, indicating an ongoing process of
degradation.
Collagen fibers are infiltrating the mesh.
Sections of degrading filament
C
KEY
C - collagen
G - giant cell
KEY
C - collagen
G - giant cell
G
TISSUE REGENERATED
TIGR® Matrix after two
years of implantation.
Repair tissue is thick
and well vascularized.
Only the permanent
sutures reveal the
original location of the
mesh and defect.

TISSUE RESTORED
Three years after the surgery, results
show a nicely restored abdominal wall
without signs of the original defect
(view from the peritoneal side).
COLLAGEN FORMATION
TIGR® Matrix is absorbed and replaced by
abundant collagen.
Few inflammatory cells remaining and no
foreign body reaction can be seen.
Fibroblasts distributed within well
organized connective tissue.

data on file Novus Scientific
TIGR®
Matrix macroscopically invisible 3 years post
implant. Only permanent sutures remain and are visible.
TIGR®
Matrix has been completely replaced by
thicker, healthy connective tissue (neo-fascia).
ComparisonbetweenTIGR®Matrix&polypropyleneasseenina3yearsheepmodel
Polypropylene mesh encapsulated and
delaminated from tissue after 3 years. (clearly visible).
At 36 months Polypropylene mesh still elicits an
inflammatory response.

TIGR® Matrix - published evidence
As stated in the publication:
“As the resorbable test mesh gradually degraded it was replaced by a newly formed collagen matrix with
an increasing ratio of collagen type I/III, indicating a continuous remodeling of the collagen towards a
strong connective tissue.” Furthermore: “The general connective tissue layer formed was thicker around
the test mesh compared to the control.”
Hjort H, Mathisen T, Alves A, et al. (2011) Three-year results from a preclinical implantation study of a long-term resorbable surgical
mesh with time-dependent mechanical characteristics. Hernia. doi: 10.1007/s10029-011-0885-y
A B
Fig. B - Collagen type I/III ratio as a function of time
following implantation.
(symbols mean values, bars standard deviation).
Fig. A - Total collagen content as a function of time following implantation.
(symbols mean values, bars standard deviation).

TIGR® Matrix - first in man
40 patients with primary inguinal hernias.
Enrolled in 2 Swedish hospitals March-Dec 2009.
Clinical outcome assessed 0.5, 1, 3, 6 & 12 months.
Preliminary follow-up presented March 2009, AHS, Orlando.
All patients followed a normal postoperative course.
No serious adverse events and only one recurrence after 12 months.
Three patients experienced mild pain (VAS<10) after 12 months.
Only 4 patients could feel the presence of a mesh in their groin after 12 months.
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INGUINAL HERNIA
World Cup Speedsurfer
and TIGR® Matrix
recipient (Dec 2009)
Martin Lamm was back
on his board after 12
weeks and competing
within 5 months.
Gothenburg, Sweden

TIGR® Matrix - in action
54 year old male. Necrotizing pancreatitis in 2009. Multiple abdominal
operations resulted in open abdomen necessitating skin graft over
bowel. Presented one year later with large ventral hernia defect and
obvious skin graft deformity.
TIGR® Matrix Surgical Mesh was used as an alternative to permanent
synthetic mesh because permanent synthetic mesh can require mesh
removal in the setting of a post operative wound infection.
TIGR® Matrix Surgical Mesh performed well with excellent short-term
outcomes in a complex patient with high risk of wound complications.
SURGEON HOSPITAL LOCATION
BRUCE RAMSHAW, MD, FACS Halifax Health Daytona Beach, FL USA
PROCEDURE
Endoscopic bilateral component separation
enforced with TIGR® Matrix Surgical Mesh

TIGR® Matrix - in action
In December 2010 a 50 year-old female executive was diagnosed with
leftbreastcarcinoma.Shesubsequentlyunderwentanelectiveleftskin
sparing mastectomy and reconstruction with an ipsilateral transverse
rectus abdominis myocutaneous (TRAM) flap.
Following elevation of the TRAM flap, the abdominal donor site is
closed primarily with PDS 1 suture. A TIGR® Matrix Surgical Mesh is
used as an onlay mesh to reinforce the closure. It is anchored with a
PDS 2/0 and 3/0 continuous stitches.
Conclusion:
Being fully resorbable, there is a potential benefit of reduced long
term complication associated with permanent implants.
SURGEON HOSPITAL LOCATION
YAN LIN YAP, MBBS, FAMS National University Hospital Singapore
PROCEDURE
The use of TIGR® Matrix Surgical Mesh for
closure of abdominal donor site following
transverse rectus abdominis myocutaneous
flap for breast reconstruction.
Primary repair with PDS1 Onlay TIGR® Matrix.
TIGR® Matrix used to reinforce primary repair of rectus sheath

TIGR® Matrix - contraindications
Not suitable for reconstruction of cardiovascular defects.
TIGR® Matrix Surgical Mesh must always be separated from the abdominal cavity by peritoneum.
Not for use following planned intra-operative or accidental opening of the gastrointestinal tract.
Use in these cases may result in contamination of the mesh, which may lead to infection.
RX ONLY - Read Instructions for Use which accompany the product for indications, contraindications,
warnings and precautions.
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TIGR® Matrix - summary of preclinical testing
Test Standard / Method Conclusion
Cytotoxicity ISO 10993/USP MEM elution method Passed. No evidence of causing cell lysis or toxicity. Grade: 0.
Delayed dermal contact
sensitization
ISO 10993/Maximization method Passed. No delayed sensitization in guinea pig. Grade:0.
Intracutaneous irritation ISO 10993/Intracutaneous injection in rabbit Passed. The irritation index: 0 for the 0.9% NaCl extract; 0.08 for
the sesame oil extract (lower than 1)
Acute systemic toxicity ISO 10993/Injection in mouse Passed. No evidence of significant systemic toxicity or mortality.
Genotoxicity ISO 10993/Ames test Passed. Test article extracts were not toxic or mutagenic.
Genotoxicity ISO 10993/Chromosomal aberrations
induction in human cells
Passed. Test article extract did not induce chromosomal
aberrations in human lymphocytes.
Pyrogenicity USP 30-NF25 Passed. Non-pyrogenic.
Implantation study in rats;
1, 3 & 6 months follow-up
ISO 10993 Passed. Good local tolerance.
Implantation study in
sheep; 4, 9, 15, 24, & 36
months follow-up
ISO 10993 Passed. Good overall biocompatibility.

2C
25C
TYVEK
TYVEK
NON
STERILE
ON OUTSIDE
STERILIZE
2
RX ONLY – Before usingTIGR® Matrix Surgical Mesh read the instructions for use which accompany the product for indications, contraindications, warnings and precautions.
INDICATIONS FOR USE
TIGR® Matrix Surgical Mesh is intended for use in reinforcement of soft tissue where weakness exists.
CONTRAINDICATIONS
Not suitable for reconstruction of cardiovascular defects. TIGR® Matrix Surgical Mesh must always be separated from the abdominal cavity by peritoneum. Not for use following
planned intra-operative or accidental opening of the gastrointestinal tract. Use in these cases may result in contamination of the mesh, which may lead to infection.
063M-03

TIGR Matrix Synthetic Long Term Resorbable Surgical mesh

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