1. BIP Endotracheal Tube (ETT)

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. Consequences of VAP
Ventilator associated pneumonia, caused by endotracheal tubes
The relative risk of VAP in a ventilated patient is up to 25 %1-3
VAP adds a estimated cost of more than $40,000 to a typical hospital admission
30-50%
The mortality is between 30–50% 4-5.
BIP ETT is a new product and the clinical data is limited. I will guide you through why we belive that BIP ETT will have great potential to reduce VAP and the clinical data we have availble right now.
1. Ibrahim EH et al. Chest. 2001;120(2):
2. Craven DE et al. Infect. 1996;11(1):32-53.
3. Rello J et al. Chest. 2002;122(6):
4. Kollef MH et al. Chest. 2005; 128 (6):
5. Stijn Blot et al. Critcal Care Medicine, March (2014) 42:3

4. Bacteria causing VAP and longer stay
Early onset <4 days Community acquired bacteria
Late onset >4 days Antibiotic – resistant nosocomial organisms (gram negative, aerobes)
If the symptoms start before 4 days it is probably a community acquired bacteria
If it starts after 4 days it is probably a nosocomial infection by antibiotic-resistent organisms, often gram negative aerobes.
Some authors use the cut off point 2 days, and some use 4 days.
VAP is associated with increasing the number of days the patients’ needs to stay in the ICU. Studies show that patients ventilated more than 5 days, stay up to 22 days in the ICU and in the hospital in general up to 25 days longer.

5. Reduce micro aspiration (=subglottic secretion drainage)
VAP Prevention
Keep the head of the patient’s bed raised
Check the patient’s ability to breathe on his or her own
Hand hygiene
Clean the inside of the patient’s mouth on a regular basis.
Reduce micro aspiration (=subglottic secretion drainage)
Limit bacterial colonization
So what can be done to prevent VAP. These are common guidelines to prevent it:
To keep the patients head high.
Extubate if possible
Hand hygiene; if the health care professional touches the ETT, bacteria can move down the tube.
Routine cleaning of patients mouth.
Reduce micro aspiration, meaning removing fluid or mucose that is stuck above the cuff. This is usually done through a suction lumen, a feature that Bactiguard offers through the BIP ETT Evac – Evac being short for evacuation lumen. This feature is often also called subglottic secretion drainage.
Another important way is to limit bacterial growth and biofilm formation – which we are adressing with our coating.

6. 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

7. 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

8. BIP ETT Evac- A dual approach to VAP prevention
Bactiguard coating preventing infections through less microbial adhesion
Subglottic secretion drainage (SSD)
Reducing VAP by 67%2
Reducing VAP by 50%1
The solution – A dual approach with BIP Endotracheal Tube Evac
It has been specifically designed to reduce ventilator associated pneumonia (VAP). It combines the known VAP reducing feature of subglottic secretion drainage with the clinically proven ability to reduce microbial adhesion and prevention of biofilm formation of the Bactiguard noble metal alloy coating.
It is still to be proven in clinical studies what the reduction of the combination of these two features can bring, but I think you can agree with me it looks very promising.
1 Haas CF et al. Respir Care. 2014; Jun; 59(6):933-52
2 Tincu R et al. Poster Euroanasthesia June (2015) 32

9. In vitro data BIP ETT
Average % reduction
The table shows In vitro data for 5 relevant bacterial strains and their reduction compared to uncoated ETT.
1. Data on file

10. Clinical evidence, BIP ETT
Bucharest Clinical Emergency Hospital, University of Medicine and Pharmacy “Carol Davila”, Critical Care Toxicology Unit, Bucharest, Romania
Clinical evidence, BIP ETT
Tincu et al (Poster, Euroanasthesia 2015)
No of patients
100
Patient type
Come due to drug poisoning
Design
Prospective, randomized, controlled, independent, cross-over
Site
Bucharest, Rumania
Primary outcome
VAP rates, length of stay
Other outcomes
Microbiological findings, Antibiotic use
67%
“ ~70% less antibiotics per VAP case (p=0.05)”
50 patients randomized into either standard or BIP group

11. BIP ETT Evac features Approved for 30 day use For oral intubation
High volume, low pressure cuff
PVC with Bactiguard coating on both inside and outside
Reduces bacterial growth in vitro by >90%1
Tissue friendly and safe for patient use
The BIP ETT Evac is approved for oral intubation up to 30 days. It is available in the most commonly used sizes from 6Fr to 9Fr.
It has a high volume, low pressure cuff – I will come back to this in a couple of slides. ’
The tube itself is made out of PVC with Bactiguard coating on both inside and outside, which has proved to reduce bacterial adhesion by over 90% in vitro.
The tube is also proven to be perfectly safe for patient use.
1. Data on file

12. BIP ETT features Approved for 30 day use
For both oral/nasal intubation
High volume, low pressure cuff
PVC with Bactiguard coating on both inside and outside
Reduces bacterial growth in vitro by >90%1
Tissue friendly and safe for patient use
The BIP ETT is approved for use up to 30 days and available in a broad range of sizes, from pediatric 3Fr up to 10Fr.
It can be used for wither oral or nasal intubation and has a high volume, low pressure cuff.
The tube itself is made out of PVC with Bactiguard coating on both inside and outside, which has proved to reduce bacterial adhesion by over 90% in vitro.
The tube is also proven to be perfectly safe for patient use.
1. Data on file

13. 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.