A.M.I. Infusion Ports

Market Potential?Why is this type of business important to ALL of us?

Walter Egle

………..sorry, but I really will keep on bothering you till I get the feeling, that my message has reached all of you!

……….please, do no longer delay the launch / the work with these products in your markets!

……….we / you will need this business in future, and

……….the future needs to be created now!

A.M.I. Infusion Ports Business

Again, why is this business a strategic cornerstone for the future of all our companies?

Again, why should I spend money and time to enter a highly competitive , mature, price driven market?

Again, why will a customer buy A.M.I. Ports?

A.M.I. Infusion Ports Market PotentialWhy should I spend money and time to enter a highly competitive , mature, price driven market?

2011 2012 Trend 2013

A.M.I. CPS Ports Unit SalesHere comes the reason?

Why not joining a growing business?

By all means, we can prove that we are able to break into this mature established market and that this business will become a growth driver for us and hopefully for all our partners!

A.M.I. Infusion Ports Market PotentialWhy should I spend money and time to enter a highly competitive , mature, price driven market?

Here comes the very simple reason?Why not joining a growing business / a growing market?

The infusion port line broadens our presence in the specialty surgical device market with a product line that is growing at a rate of 15 percent annually world wide.

The expected sales contribution of our Infusion Ports to your overall business may be minimal in the first 2 years of putting efforts behind, but let’s look forward to future growth in this growing 1 billion USD market."

By all means, we can prove that we are able to break into this mature established market and that this business will become a growth driver for ALL of us!!

B.BRAUN MedicalBARDDistriclassSmith MedicalPerouseVYGONHelioscopyAngio Dynamicsetc……are they all stupid when fighting for market shares in this business?

A.M.I. Infusion Ports Market Potential

Why will a customer buy A.M.I. Ports?

Covidien Chemosite Port

Bard Ti Port – low pressure

Bard Power Port

Smith Medical – new EasyViewing Port – Productfamily of Port-a-Cath Ports

Districath PortVaxcel Port / Navileast Inc……former Boston Scientific

Braun Celsite Ports

A.M.I. Infusion Ports Market Potential

Why will a customer buy A.M.I. Ports?

Covidien Chemosite Port

Bard Ti Port – low pressure

Bard Power Port

Smith Medical – new EasyViewing Port – Productfamily of Port-a-Cath Ports

Districath PortVaxcel Port / Navileast Inc……former Boston Scientific

Braun Celsite Ports

A

B

C

D

They are pretty much the same, aren’t they?

What would you tell your customers, why to change from Covidien to Bard, from Bard to Smith Medical…etc…

What specific patient benefits do these products offer?

If you would have to sell one of these PORTS tomorrow….What would you tell your customers? Why should your surgeon change from A to B to C to D…

Why A.M.I. Ports?

A.M.I. Infusion Ports Market Potential

Why will a customer buy A.M.I. Ports?

A.M.I. VarioPort……..proprietary A.M.I. Technology!• pre-attached catheter

eliminates intra-operative cath-port connectioneliminates the risk of air embolism provides perfect catheter tip placement shortens implantation time by 50%small 5F catheter provides required flow of 5ml/sec. and reduces risk of thrombosis

- Patented Clip-a-Port Base eliminates port fixation sutures- Safety edge – to prevent deep needle punctures- Low Profile Port – cyclon chamber for perfect port flushing- Perfect Port for long term applications, because of secure placement / tissue ingrowth

in side chambers.

What do we have others cannot provide?

A.M.I. Infusion Ports Market Potential

Why will a customer buy A.M.I. Vario Ports?What do we have others cannot offer?

A.M.I. VarioPort!

- Who else can show and discuss the features and benefits of such kind of port with surgeons?

- Any other company out there offering something similar?- Pricing? Versus competition?- Covidien Chemosite Ports / Germany / low price sellers

via the internet: 450,- EURO / Unit.- A.M.I. Vario Ports: suggested retail price, 300,- EURO /

Unit.

You may not be able to sell this State of the Art Product to every customer,butto present yourself as a Technology Providerandit gives you a perfect opportunity, to present the next level of our A.M.I. Port technology………which is.....our Clip-a-Port Family!

A.M.I. Infusion Ports Market Potential

Why will a customer buy A.M.I. Clip-a-Ports?What do we have, others cannot provide?

A.M.I. Clip-a-Port ……..proprietary A.M.I. Technology!- Patented Clip-a-Port Base

eliminates port fixation sutures shortens implantation time

- X-large Port Base Plateprevent tilting of Port

- Safety edge to prevent deep needle punctures

- High Pressure Infusion approved – like all A.M.I. Ports

- Highest Gripper Needle Pull Back force – to prevent unwanted needle removal during infusion,

- caused by patient movements, a very important safety feature!

A.M.I. Clip-a-Port Products….success story?

Why not enjoying a +32% growth rate like in the BENELUX in 2013!Why not enjoying a 12% market share as we do already in Austria? If we can do – you can do it!

A.M.I. Infusion Ports Market PotentialWhy will a customer buy A.M.I. Eco Ports / Compact Ports?What do we have, others cannot provide?

A.M.I. Eco Port / Compact Port?- X-large Port Base Plate

prevent tilting of Port- Safety edge

to prevent deep needle punctures- High Pressure Infusion approved –

like all A.M.I. Ports- Soft Tip Catheter Technology

enhances safety of catheter tip placement in superior vena cava.

- Highest Gripper Needle Pull Back force – to prevent unwanted needle removal during infusion, caused by patient movements, an important safety feature!

……….and finally, this Product comes for a very competitive price, which allows our partners to participate successfully in public tenders!

A.M.I. Infusion Ports Market Potential

Why is this business a strategic cornerstone for the futureof all our companies?

1.) Participating in a mature, lasting, high potential market will provide an ongoing stream of revenue to your company …….. and secure the long term success, while success in other type of high margin implant business might be short term only!Aren’t we all looking for an ongoing stream of income for our companies ? For ourselves as sales people?

2.) A.M.I. offers top notch technology available in this market (IP protected) and at the low end, a state of the art technology which allows us to be competitive in this price sensitive business!

3.) It requires extra efforts to break in, once you are part of the tender business and just imagine the tender will call for the Clip-a-Port feature ….. daily sales efforts do come down to a minimum ……. it becomes a back bone business to your company.Just imagine, you are able to put the VarioPort or Clip-a-Port Technology on public tenders , in 2 or 3 years from now! What could that mean to your income?

A.M.I. Infusion Ports Market PotentialPort Units placed / year

Price range / unit for TI Ports.

Market volume in EURO (average)

Germany 65.000 140,- to 240,- 10.400.000,-

France 60.000 90,- to 160,- 9.000.000,-

UK 45.000 140,- to 240,- 8.100.000,-

Italy 40.000 160,- to 300,- 8.000.000,-

Benelux 25.000 120,- to 260,- 4.000.000,-

Scandinavia 16.000 140,- to 240,- 2.880.000,-

Switzerland 9.500 180,- to 300,- 1.900.000,-

Austria 8.500 120,- to 180,- 1.275.000,-

Czech 5.000 90,- to 160,- 700.000.-

A.M.I. Infusion Ports Market PotentialExample: BrazilThe vascular access device market in Brazil was valued in 2012 at nearly 59 Mio. $ and growing!The vascular access device market in Brazil includes peripherally inserted catheters (PICC’s), central venous catheters (CVC’s), implantable ports, port or Huber needles, dialyses catheters, syringes and needles.

The PICC, dialysis catheter and total implantable port market are the fastest growing!

In 2012, approximately half of the oncology patients in Brazil were treated through the public system. The Unified Health System in Brazil is very strong in the oncology market, where products like implantable ports are commonly used.

Market leaders such as Teleflex/Arrow, BARD and Becton Dickinson are currently leading Brazil’s underpenetrated vascular access market.Overall, vascular delivery device sales are expected to flourish as they meet the needs of a growing population of both, local citizens and tourists, fostering a thriving multimillion market! (Source: iData Research / Global Report 2013)

A.M.I. Infusion Ports Market Potential

1.) Don’t miss the opportunity to improve your PRODUCT MIX sales and to participate in a mature, long lasting, high volume market.

2.) This market keeps on growing in many countries around the worlddue to- aging of population (increase of certain cancer diseases), and- picking up in countries where application number of such implants / Mio. population is still low (e.g. France: 1200 Ports / Mio and Italy: 700 Ports / Mio).

3.) Entering this market is not easy, but it should be done - if we (you) want to create a broad base of steady income for your company! Ports are used day by day, today and even more in 10 years from now!

The first order we received in 2014, was an Austrian Hospital ordering 10 Units of EcoPorts / F6!On our first selling day in 2014, we shipped a total of 31 Ports to customers!What a strong sign for 2014!

A.M.I. Infusion Ports Market Potential

Why should I spend money and time to enter a highly competitive , mature, price driven market?

Because, it is YOU who can present and offer a State of the Art Technology, available from A.M.I. only!Why do you want to leave this business to competition, while you have a technology on hand competition can just dream of?

A.M.I. Vario Port: addressing perfectly the needs of surgeons, most concerned about the safety of their patients!This additional safety margin may cost 200,- EURO / patient ………. for sure, you will find surgeons and patients, who are looking for the very best treatment option (reference: “Catheter tip position as a risk factor for thrombosis associated with the use of subcutaneous infusion ports” / J. Caers, et.al / Univ. of Brussels / 2005). - Perfect catheter TIP placement &- small lumen size of catheterare key to reduce potential failure risks of such port implants!

A.M.I. Infusion Ports Market Potential

Why should I spend money and time to enter a highly competitive , mature, price driven market?

Because, it is you who can present and offer a State of the Art Technology, available from A.M.I. only!

A.M.I. Clip-a- Port Technology:- allows a surgeon to reduce implantation time by at least 5 Minutes?

A.M.I. Eco Port Products:- allows our partners to participate successfully in this mature competitive market- state of the art TI Port – there is no better material available for long term

implants exposed to various mixtures of chemicals, not even yet known at the day of implantation

- state of the art, soft tip Catheter Technology – enhancing safety of catheter insertion and reducing the risk of thrombosis formation.

Wheeler, 1991 Abstract Previous work suggests significant advantages in

the use of polyurethane over silicone in central venous catheters (CVC). We present the first prospective, randomised, controlled trial of a polyurethane CVC, Cuff Cath (Viggo-Spectramed, Swindon, UK), against a silicone CVC, Hickman (Davol, Cranston RI), in children. Forty consecutive patients were randomised into two groups. There was no significant difference in age, sex, weight, nutritional state, preoperative sepsis, venous site, or tunnel length in either group of 20 patients. In the Hickman group, during a total of 2,270 catheter days, mean 113 days (4–321), 3 (15%) were removed because of sepsis and 4 (20%) because of blockage. Four (20%) fell out after a mean of 15 days (4–30) and 2 (10%) fractured. In the Cuff Cath group, during a total of 3,047 catheter days, mean 152 (30–364), 2 (10%) were removed because of sepsis and 1 (5%) because of blockage. None fell out or fractured. This represented a significant (P <0.001) reduction in blockage, breakage, and dislodgement. We conclude that polyurethane has significant advantages over silicone as a material for the manufacture of paediatric CVCs.

……….which catheter material is best?

Volkow, 2003: Polyurethane catheter as long-indwelling intravenous catheter in patients with cancer

Abstract Background: Silicone has been the standard material for indwelling devices to date. Polyurethane

exhibits properties that makes it suitable as a component of long-indwelling vascular access, with the added advantage of low cost. Objective: To describe the experience of an intravenous therapy team with 206 Polyurethane catheters used as long-indwelling vascular access in patients with cancer. Materials and Methods: All polyurethane single- and double-lumen catheters implanted between January 1, 1994, and March 15, 1995, were analyzed, including time of stay and type and rate of infectious and noninfectious complications. Results: A total of 206 catheters were placed-164 single-lumen and 42 double-lumen catheters-in 190 patients; average stay was 101 days (range, 1-445 days). The infection incidence rate was 0.66 per 1000 catheter-days for single-lumen catheters and 1.6 per 1000 catheter-days for double-lumen catheters. Noninfectious complications included 1 thrombosis (incidence rate, 0.06 per 1000 catheter-days for single-lumen and none for double-lumen catheters), 5 catheter ruptures (2.4%), and 1 pneumothorax (0.48%). Twelve catheters (8.3%) were removed because of complications; only 1 was infectious. The remaining 17 infectious episodes (94.4%) were resolved without catheter removal. Our complication rate with single-lumen catheters in this series was similar to our previous experience with a nontunneled silicone catheter. Conclusions: Our findings indicate that polyurethane catheters have proven useful and safe as long-indwelling vascular access in patients with cancer at our hospital at a considerably lower cost.

……….which catheter material is best?

Sartori, 2003: Longevity of silicone and polyurethane catheters in long-term enteral feeding via percutaneous endoscopic gastrostomy

Background: As percutaneous endoscopic gastrostomy (PEG) is often used for many months or years, the longevity of the feeding tubes plays an important role in the global outcome and costs of PEG.

Aim: A retrospective study to evaluate the longevity of silicone and polyurethane PEG catheters. Methods: The records of 297 patients who were fed via PEG for over 90 days were evaluated. The

material of the PEG catheter, duration of follow-up, local complications, need to remove PEG because of tube deterioration or local complications and time from PEG placement to PEG removal were recorded and compared.

Results: Two hundred and twenty-eight patients had polyurethane and 69 had silicone PEG catheters. The follow-up ranged from 116 to 3207 days for the polyurethane group and from 98 to 1861 days for the silicone group. No differences were observed in either local complications or PEG removal because of local complications. Tube deterioration causing PEG removal occurred in 36 of the 228 polyurethane PEG catheters and in 25 of the 69 silicone PEG catheters (P = 0.0005). Tube deterioration occurred significantly earlier in the 25 silicone catheters than in the 36 polyurethane catheters. The mean time from PEG placement to PEG removal was 287 days (95% confidence interval, 239–335) for silicone tubes and 573.9 days (95% confidence interval, 425–723) for polyurethane tubes (P = 0.0024).

Conclusion: Polyurethane PEG catheters seem to be more resistant to deterioration than silicone PEG catheters, and at present they should be preferred for long-term enteral feeding via PEG.

……….which catheter material is best?

Catheter tip position as a risk factor for thrombosis associated with the useof subcutaneous infusion ports (Jo Caers, Christel Fontaine et. al /2005)

Abstract Aims: The use of subcutaneous infusion ports has become standard practice to provide aLong term venous access in oncological patients. The aim of this retrospective study was to assessthe different complications of infusion ports in our population and to identify predisposing factors.Patients and methods:We reviewed the medical records of 437 patients who were followed at the Oncology/HaematologyDepartment of our hospital. Of these patients, there were 370 (84.4%) with solid tumours and 58(13.2%) with haematological disease. The position of the catheter tip was evaluated by reviewing theavailable chest radiographsor phlebographies. Main results: Analysis of the recordsshowed that 346 patients (79.17%) had no complications. The most common complications afterImplantation were thrombosis (8.46%), catheter dysfunction (4.8%) and infections (4.4%). Univariateand multivariate analysis showed that catheter tip positioning was the most important predisposing riskfactor for thrombosis. Catheter tips positioned in the brachiocephalic vein or in the cranial part of thesuperior vena cava were associated with a high risk of thrombosis. Other significant risk factors weregender and initial diagnosis. Female patients and patients with lung cancer also had an elevatedrisk of developing a thrombosis.Conclusions: Compared to other reports, we noted a higher rate of thrombosis and portdysfunction. Since catheter tip position was a predisposing factor for developing a thrombosis,Correct Catheter Position has to be ensured during placement. Prophylactic antithrombotictreatment might be beneficial in the event of failure to position the catheter correctly.

……….about the importance of proper catheter tip placement?

A.M.I. Infusion Ports Market Potential

Why should I spend money and time to enter a highly competitive , mature, price driven market?

In simply words

because it is worth it and

we would be stupid not to take advantage of the technology we can provide and to leave this mature business to competition

the market is there, we do have a state of the art product on hand, competitively priced………

……….isn’t this an exciting challenge for every sales person?

Happy Selling! 5 to 10% % market share in 2015 in all our partner markets....this should be our shared target!