1. BIP Central Venous Catheter (BIP CVC)

2. To prevent device related healthcare associated infections:
Bactiguard’s mission
To prevent device related healthcare associated infections:
Reduce healthcare cost
Reduce the use of antibiotics – to prevent spread of multi-resistant bacteria
Save lives

3. CLABSI/CRBSI Prevalence and cost of complications due to CVCs
Catheter related blood stream infection (CRBSI) is the most frequent complication and risk associated with the use of CVCs
Prevalence ranges from 4-6% and a mortality between 12 to 25%
One case of CRBSI costs in average dollar
Morbidity and Mortality Weekly Report (MMWR), Vital Signs: Central Line--Associated Blood Stream Infections --- United States, 2001, 2008, and 2009, CDC
Wolf HH, et all; Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO). Central venous catheter-related infections in hematology and oncology : guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO). Ann Hematol Nov;87(11): [Warren DK, Quadir WW, Hollenbeak CS, Elward AM, Cox MJ, Fraser VJ .Attributable cost of catheter-associated bloodstream infections among intensivecare patients in a nonteaching hospital. Crit Care Med Aug;34
CLABSI Central Line Associated Blood Stream Infection
CRBSI Catheter Related Blood Stream Infection

4. Prevention of microbial adhesion and biofilm formation
Our mechanism of action
Microbes adhere and multiply.
When enough have developed, they form a biofilm.
Uncoated surface
Less microbes adhere to and colonize on the surface, preventing biofilm formation and subsequent infection.
Bactiguard
coated surface

5. How does it work? The galvanic effect – effective and safe Bactiguard
coated surface
Bactiguard
coated surface
Release of substances, such as silver ions, chlorhexidine or antibiotics, killing microbes.
Short effect due to release
Potential harm to tissue
Releasing coatings
The Bactiguard Infection Protection (BIP) technology is based on applying an extremely thin noble metal coating, consisting of gold, silver and palladium, to medical devices. The Bactiguard® coating is firmly bound to the
surface of the device and reduces the adhesion and growth of microbes.
The three noble metals in the Bactiguard coating – gold, silver and palladium, cause a galvanic effect which leads to a micro current that prevent the bacteria to adhere to the surface.
The solution is unique. As opposed to coating technologies, which depend on the release of toxic substances e.g. silver ions or antibiotics, the Bactiguard coating is non-toxic and non-pharmacologic. To date, more than130 million Bactiguard® coated urinary catheters have been sold for patient use, with no reported adverse events related to the coating.
The noble metals Au, Ag and Pd cause a galvanic effect when in contact with fluid. The micro current on the surface create an unfavorable environment for microbial adhesion.
No toxic release of antimicrobial agents
Tissuefriendly
Biocompatible

6. In vitro data BIP CVC
Average % reduction
In vitro data 3 relevant microbial strains reduction of bacterial adhesion BIP CVC compared to uncoated CVC

7. Clinical evidence BIP CVC
Goldschmidt et al.
Reduction in catheter related infections
No patients
236
Patient type
Haematologic and oncologic diseases
Median time for catheterization : 13,3/12,7 days
Design
Prospective, randomized
Site
University of Heidelberg, Germany
Primary outcome
Catheter related infection
Other
Local catheter infection
Catheter related bacteremia
Additionally
The risk for thrombosis was evaluated by Harter et al who found no increased risk in the Bactiguard group
52%
50%
44%
Goldschmidt et al at the University Hospital in Heidelberg Germany, compared the infections rates on oncology and hematology patients using a CVC. During the 17 month study time, 233 CVCs were evaluated of which 113 were standard (uncoated) and 120 were coated with Bactiguard coating. They found that patients with the Bactiguard coated CVC only developed half has many infections as the uncoated CVC group.
In an analysis by Harter et al, it was also concluded that the Bactiguard coated group (1 case) had no increased risk of trombosis vs the standard group ( 3 cases), but the cases were to few for statisitcal significance.
To summarize, the Bactiguard coated catheter showed a decreased risk for infection, while no increased risk for trombosis.
Goldschmidt H, et al. Prevention of catheter-related infections by silver coated central venous catheters in oncological patients. Zentralbl Bakteriol. 1995
Dec;283(2):
Harter et al Catheter-related infection and thrombosis of the internal jugular vein in hematologic-oncologic patients undergoing chemotherapy: A prospective comparison of silver-coated and uncoated catheters. Cancer. 94 (1): (2002).
Goldschmidt H.et al., Zbl. Bakt.1995; 233:

8. Catheter related thrombosis has the same prevalence as CLABSI and is life threatening4%
CLABSI 4-6%
Mortality
12-25%
3 terms:
pro-thrombotic – create clots and gives risk of thrombosis (all devices inserted into blood are pro-thrombotic)
Non-thrombotic – do not create clots, do not give risk for thrombosis
Anti-thrombotic – dissolves present clots, decrease risk for thrombosis
Morbidity and Mortality Weekly Report (MMWR), Vital Signs: Central Line--Associated Blood Stream Infections --- United States, 2001, 2008, and 2009, CDC
Wolf HH, et all; Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO). Central venous catheter-related infections in hematology and oncology : guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO). Ann Hematol Nov;87(11):
[Warren DK, Quadir WW, Hollenbeak CS, Elward AM, Cox MJ, Fraser VJ .Attributable cost of catheter-associated bloodstream infections among intensivecare patients in a nonteaching hospital. Crit Care Med Aug;34

9. Clinical evidence BIP CVC: Risk of thrombosis
Harter et al
Results- Catheter Related Thrombosis
No patients
236
Patient type
Haematologic oncologic diseases
Median time for catheterization : 13,3/12,7 days
Design
Prospective, randomized
Site
University of Heidelberg, Germany
Primary outcome
Thrombosis prevalence
Harter et al, Cancer 94(1): (2002)

10. Thrombosis- TAT as surrogate markers in clinical study
Trombin-Antitrombin complex (TAT)
 Increased TAT formation is correlated to activation of coagulation and are surrogate markers for thrombosis
Thrombosis is when a blood clot is formed in a vein. This is a serious condition, since the bloood clot can seal of the vessel. The blood clot can break apart, travel throughout the body, and cause blockages in the heart, brain, or lungs, leading to heart attack, stroke, or pulmonary embolism depending on where it ends up. To evaluate the blood compatible properties in the lab, we measure TAT, which is a surrogate marker for thrombosis.

11. BIP CVC: Ex Vivo assessment of Blood Compatibility
Vafa Homann et al. 2015
Problem
Catheter related Thrombosis – develops in around 4% of the patients and forms life threatening blood clots
Methods
Blood from 23 healthy volunteers was examined for compatibility with BIP CVC and standard catheter in the Chandlers- loop model
Primary outcome
BIP CVC showed less TAT = less activation of coagulation = lower thrombotic risk than non-coated CVC
Other
BIP CVC showed no hemolysis, while another anti-infective CVC* showed extensive hemolysis. Thus, BIP CVC is unique being both anti-infective and tissue-friendly.
*Chlorhexidine Silver Sulfadiazine CVC
Tendency to less thrombosis has been seen in vitro, using surrogate marker TAT, and visually
Hydrocath Assure – BD Medical
Careflow – BD Medical
The results of the study revealed that the Bactiguard noble metal alloy coating used for the BIP CVC has potentially improved blood compatibility properties of the catheter in terms of risk of thrombosis compared to a standard uncoated product. The BIP CVC was also superior to the other coated CVC with respect of non-hemolytic properties. This, together with prevention of microbial adhesion and biofilm formation on the catheter, suggests that the Bactiguard coating can be a key approach to battle healthcare associated infections in general and bloodstream infections in particular, in a tissue friendly way.
”Tendency
to less Thrombosis”
*TAT= Thrombin–Anti-Thrombin complex, depends on activation of coagulation and is used as marker for thrombotic risk
Vafa Homann et al Improved Ex vivo blood compatibility of Central Venous Catheters with noble metal coating. J of Biomaterial Research Karolinska Institutet, Danderyd Hospital, Bactiguard

12. Soft tip
The superior geometric soft tip design couple with unique soft blended bio-compatible material make insertion safe and easy.

13. Needles Straight Y valve
The BIP CVC kits are available with either straight or the more specialized Y-Valve needle which allows for easy guide-wire insertion while minimizing air embolism and backflow of blood as you can leave the syringe in one of the needle insertion sites while using the other one for the guidewire. It is a very popular and rare feature, often much appreciated by doctors.
Straight
Y valve

14. Kink resistant guidewire
The guidewire of the BIP CVC has a Nitinol core, preventing it from kinking. If you bend it and then release, it will return to its original shape. This prevents it from getting stuck in the catheter during the insertion procedure.

15. High flow catheter 703 - Lumen Size is 16G/18G/18G
Distal = 16G (1.041 mm)
Middle = 18G
Proximal = 18G
713 - Lumen Size is 14G/18G/18G
Distal = 14G (1.20 mm)
14G > 16G
Gauge
A special article amongst the BIP CVC products in the product 713 which just as the 703 is a 7 French catheter with 3 lumen. It has however a larger distal lumen, 14G instead of 16G, allowing for more rapid and high volume of fluids & Medication Administration. It is our high flow catheter and very popular.
This should not be confused with a high pressure catheter, which is something else and not available in the BIP CVC range of products today.

16. BIP CVC features Short term (<30 day) use
Polyurethane with Bactiguard coating on the outside
Y- and straight valve needle options
No increased risk for thrombosis
Tissue friendly and safe for patient use
Catheter size
French
(Fr/Ch)
Lumen Gauge (G)
Length
(cm)
4 Fr 1 lumen
4 Fr 18
16, 20
4 Fr 2 lumen
22/22
6, 10, 16
5 Fr 1 lumen
5 Fr 16
5 Fr 2 lumen
5,5 Fr
18/18
10, 16, 20
5 Fr 3 lumen
20/20/22
8, 13, 30
7 Fr 1 lumen
7 Fr 14
7 Fr 2 lumen
16/16
16, 20, 30
7 Fr 3 lumen
16/18/18
10, 16, 20, 30
14/18/18
8,5 Fr 2 lumen
8,5 Fr
14/16/16
8,5 Fr 3 lumen
8,5 Fr 4 lumen
14/16/18/18
The BIP CVC is approved for use up to 30 days and available in several sizes. 5FR 3 lumen and kinkresistent guidewire will be launched during 2016.

17. Bactiguard Infection Protection
Effective prevention of healthcare associated infections, through reduction of microbial adherence and growth to medical devices.
Reduces the need for antibiotics, and can so limit the spread of multiresistant bacteria.
The Bactiguard coating is proven to be a tissue friendly and safe technology.
To summarize our offer:
- Effective prevention of healthcare associated infections, through reduction of microbial adherence and growth to medical devices.
- Reduces the need for antibiotics, and can so limit the spread of multiresistant bacteria.
- The Bactiguard coating is proven to be a tissue friendly and safe technology.