Q1 – 2014 / Area Manager Meeting / WE 1 A.M.I. ™HexaPro Mesh What a market? What an opportunity...

Q1 – 2014 / Area Manager Meeting / WE

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A.M.I. ™HexaPro Mesh

What a market?What an opportunity on hand?


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• An estimated 1,5 Million abdominal hernia repairs are performed each year in Europe

• An estimated 75% of which are inguinal hernia repairs.• The lifetime prevalence of inguinal hernias is between 10% and 15% for

men and 2% for women.• The landscape of hernia repair techniques and prosthetics has expanded

over the past 2 decades and continues to evolve.• Surgeons have a wide variety of open and laparoscopic techniques at

their disposal.• Ninety percent of procedures now use mesh prosthesis (as opposed to

primary tissue repair with sutures).• At this time, no operative technique has emerged as the clear choice for

all inguinal hernias.


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A.M.I. ™HexaPro MeshWorldwide Synthetic Mesh Market

US Market Research / Published 2012 by PolyPro Mesh !2013 2014 2015

Current Global Hernia Mesh Repair Mesh Units 5.688.000 5.976.000 6.288.000

Current Global Groin Hernia Mesh Repair Average Selling Price US$ / Unit

121 123 124

Current Global Groin Hernia Mesh repair Mesh Market US$

688.414.000 733.126.000 781.125.000

Other type of hernias….

Current Global Paraumbilical Hernia Mesh Repair Units 950.000 1.000.000 1.050.000

Current Global Epigastric Hernia Mesh Repair Units 320.000 330.000 350.000

Current Global Other Hernia Mesh Repair Units 320.000 330.000 350.000

Current Global Incisional Hernia Mesh Repair Units 2.145.00 2.227.500 2.313.100

I guess it is obvious, why more than 50 companies in the world, do provide hernia mesh implants!

The market is huge……….

and still keeps on growing rapidly in many parts of the world!

What can we offer, others don’t have?


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A.M.I. ™HexaPro MeshWorldwide Synthetic Mesh Market

US Market Research / Published 2012 by PolyPro Mesh !

GoreCovidienEthiconBardOthers

9%

13%

33%41%

4%

287 Mio. USD

230 Mio. USD

91 Mio. USD


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A.M.I. ™HexaPro MeshDespite the low recurrence rates found with placement of large prosthetic in

the pre-peritoneal space, • less than 30% of all inguinal hernias are repaired laparoscopically in

EUROPE, and • even less than 25% in the ROW, including the US!

However, in many instances• recurrent hernia, • bilateral hernias, etc…the laparoscopic approach is viewed as ideal!

Techniques currently used for laparoscopic repair of inguinal hernia • TAPP & TEP Procedurewere developed in the early 1990s……..thus 20 years ago!


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A.M.I. ™HexaPro MeshWhat are the most common laparoscopic inguinal hernia repair procedures?

TEP:

In the TEP approach, the pre-peritoneal space is accessed via an infra-umbilical incision.

TEP approach may not be possible in patients who have peritoneal scarring from previous surgery.

TEP: if large tears in the peritoneum occur, conversion to TAPP approach is necessary.


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A.M.I. ™HexaPro MeshWhat are the most common laparoscopic inguinal hernia repair procedures?

TAPP: The peritoneal (abdominal) cavity is entered via an incision at the umbilicus, where a 10mm (why not a 5mm?) trocar is placed. Two 5mm (why not 3 mm?) trocars are placed on each side of the abdomen, just lateral to the epigastric vessels. The peritoneum is incised several centimeters above the hernia defect. The peritoneum is bluntly (Bluntdissect – DLU!!) stripped down from the abdominal wall proceeding medially until Cooper’s Ligament is identified. A large 12x15 or 15x15 cm A.M.I. HEXAPRO MESH is placed in the pre-peritoneal space and secured to Cooper’s Ligament with tacks, glue or sutures. The peritoneum is then closed back over the mesh, using tacks, glue or sutures.


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A.M.I. ™HexaPro MeshMost common non laparoscopic inguinal hernia repair procedure by means of a mesh?

LICHTENSTEIN Procedure: This is the most commonly performed inguinal herniaraphy.A.M.I. HEXAPRO Mesh is used to bridge the defect in the inguinal floor, it is not necessary to approximate tissues that are not naturally in apposition (tension free repair)!

FYI:More than 70 named hernia repair approaches have been described in the literature. Many are relatively minor modifications of other approaches. You may run into procedures names, such as: Plug&Patch, Read_Rives, Wantz, Stoppa, Kugel, McVay, Ugahary and others…..just keep in mind………all these procedure do play a very minor role in the treatment hernias.


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A.M.I. ™HexaPro MeshCommonly Used Methods for Inguinal Hernia Repair

Name Year Description

Mesh-Free Approaches

Bassini 1890 Open anterior approach, fixation of the m. obliquus internus, m. transversus abdominus and the fascia transversalis to the inguinal ligament

McVay Cooper Lig. Repair 1942 Open anterior approach, Fixation of the m. Obliquus internus, m. transversus abdominus and the fascia transversalis to the Cooper’s ligament.

Shouldice Operation 1945 Open anterior approach, doubling running suture of the fascia transversalis and doubling suture of the M. obliquus internus to the inguinal ligament.

Mesh –Based Approaches

Rives 1965 Open posterior approach, trans-inguinal preperitoneal meshplasty

Stoppa 1968 Open posterior approach with mesh, bilateral hernias

Lichtenstein 1970 Open anterior approach with mesh, implantation of mesh behind the aponeurosis of the m. obliquus externus (onlay patch)!

Wantz 1989 Open posterior approach with mesh; unilateral hernia

TAPP 1991 Laparoscopic posterior approach with mesh, transabdominal preperitoneal meshplasty

TEP 1991 Laparoscopic posterior approach, total extraperitoneal meshplasty


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2012 Data available from the German Hernia Society:Germany: 82 Mio. PopulationTotal Inguinal Hernia Repairs: 275.000 cases / year (approx. 3.350 Cases / Mio. Pop.)

Percentage of recurrency procedures: 10 to 15%

Total Number of lap. hernia repair: 77.000 cases / year 28% of cases, ( growing…..)

Most common performed procedures:

Primary Repair% of all cases

Recurrency Repair% of all cases

Bassini 0,3 0,4

Shouldice 3,9 3,3

Hernia Sack Closure 0,1 0,2

Plug 4,6 6,4

Lichtenstein 23,4 31,2

Gilbert und TIPP 3,9 4,4

TAPP 38,5 34,8

TEP 22,3 16,2

Others 3,0 3,2

HexaPro Mesh perfect for 84,2% of all laparoscopic conducted inguinal hernia repairs in Germany!

HexaPro Mesh perfect for 83,2% of all laparoscopic conducted inguinal hernia recurrency repairs in Germany!


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2012 Data available from the German Hernia Society:

Germany: 82 Mio. PopulationTotal Inguinal Hernia Repairs: 275.000 cases / year (approx. 3.350 Cases / Mio. Pop.)

Percentage of recurrency procedures: 10 to 15%

Total Number of lap. hernia repair: 77.000 TAPP & TEP procedures / year 28% of cases, ( growing…..)

Total Number of Lichtenstein : 82.500 procedures / year!

HexaPro Business Potential in Germany 2012:

160.000 Cases / year160.000 HexaPro Multisze Meshes per year!

or approx.5.600.000 EURO in sales

(assuming a low retail price of 35,- EURO / Unit).

Germany; HexaPro Mesh 15 x 15cm; business potential : 68.000,- EURO / Mio. Pop.


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Which material, which mesh is best?• The use of synthetic mesh for both inguinal and ventral hernia repairs has

gained nearly universal acceptance among surgeons.• Modern mesh products were first introduced in 1958 (Usher, et.al); today,

the abundance of mesh products available makes it difficult for surgeons to understand the advantages, disadvantages and

indications for each of the available options!• A multitude of animal studies have been published evaluating synthetic

mesh products for abdominal wall reconstruction. Drawing any firm conclusions as to the superiority of one product over another is not possible, as authors use various models with little clarity as to the definitions of the outcome measured (from literature surgeons

cannot learn, which product is best)!• Today, POLYPROPYLENE-based meshes are the most commonly

used prosthetics worldwide for the repair of inguinal hernia!


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A.M.I. ™HexaPro MeshCommonly Used Polypropylene and/or Composite Mesh Systems for

Inguinal Hernia RepairBrand Names Vendor Density of

Polypropylene in Mesh

Average Knitting Pore Size

Interstitial Pore Size

Implant Thickness

Surgipro Covidien 110 g/m2 < 1mm unknown 0,57 mm

Prolene (preshaped / precut) Ethicon 105 g/m2 1-1,6mm unknown 0,55 mm

Bard Mesh / Bard Soft Mesh/Marlex / 3DMax / Visilex

Davol / Bard 80 – 95 g/m2 0,1 – 0,8 mm

unknown 0,66 – 1,5mm

C-Qur (O3FA-absorbable tissue coating)

Atrium 85 g/m2 0,8mm unknown 0,48 mm

ProLite (preshaped, self forming plugs)

Atrium 85 g/m2 0,8 mm unknown 0,48 mm

ProLite Ultra Atrium 50 g/m2 0,75 mm unknown 0,41 mm

Prolene Soft Ethicon 45 g/m2 3 – 4mm unknown 0,41mm

Ultrapro (partially absorbable) Ethicon 28 g/m2 3 – 4mm unknown 0,5 mm

Ti Mesh GFE 16 g/m2 < 1mm unknown 0,2 mm

HexaPro A.M.I. 21 g / m2 2 mm 100 -150 micrometer

0, 3 mm


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A.M.I. ™HexaPro MeshCommonly Used Polypropylene and/or Composite Mesh Systems for

Inguinal Hernia Repair

US Market Trends:

• Surgeons prefer macroporous mesh over conventional microporous mesh

• Bilogics are unreliable and surgeons are tending back to macroporous polypropylene mesh, including those patients with pre-existing infections.

• Surgeons are suspect of ePTFE and Polyester Meshes for infection risk patients, they prefer polypropylene of biologics for these patients.

• FDA is focused on the incidence of chronic pain and device biocompatibility


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A.M.I. ™HexaPro MeshComplications?

Recovery Time & Postoperative Pain!• Studies have demonstrated that postoperative recovery following inguinal

hernia repair is faster and postoperative pain is reduced when laparoscopic approaches and ultralight mesh implants are used.

• Patients receiving a light weight mesh for inguinal hernia repair have less sensation of a foreign body in the groin and may feel less

discomfort on exertion and active physical exercise!• Can you imagine, how patients can benefit from our ultra light

A.M.I. HexaPro Mesh, with it’s unique ISOELASTICITY, when implanted in the groin area?

• Persistent postop pain that fails to resolve 3 month post-surgery is classified as chronic pain.

• Two large studies from Sweden have investigated the incidence of long-term pain after inguinal hernia repair.

• Mild to moderate pain can occur in about 30% of patients, whereas severe pain that interferes with activities of daily living occurs in 3 to 6

% of patients!

A surgeon carries - 3 to 6 % very unhappy, and- up to 30 % complaining patients hernia patients in his records!

Can we help hernia surgeons to reduce such numbers?

What a great opportunity for us to come up with some excellent selling probes in our next session……selling probes, which do open the door for our sellers, when asking for an appointment to sell “another type mesh”!


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What else is needed to succeed in this battle for market share in this highly competitive market?

What do we have on hand?• A technological State of the Art Mesh Implant for use in inguinal hernia

repair!• Very competitive in price!• Unique packaging, designed to support cost saving efforts of hospital

administration!

How to make it happen?

Q1 – 2014 / Area Manager Meeting / WE 1 A.M.I. ™HexaPro Mesh What a market? What an opportunity...

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