Bactiguard Infection Protection

Bactiguard Infection Protection
Introduction training First name Last name, Title RMH147A

The challenge | The solution | The evidence | The cost savings | The product | The conclusion The challenge According to the World Health Organization (WHO): Preventing healthcare associated infections (HAIs) has never been more important Every infection prevented is an antibiotic treatment avoided Infection prevention and control actions can save millions of lives, every year Preventing healthcare associated infections (HAIs) has never been more important. Every infection prevented, is an antibiotic treatment avoided. According to the World Health Organization (WHO), effective infection prevention and control reduces HAIs by at least 30%. Every day, HAIs result in prolonged hospital stays, long-term disability, increased anti-microbial resistance, additional costs for health systems, unnecessary suffering for patients and their families, and unnecessary deaths. References: 1. World Health Organization. (2016). The critical role of infection prevention and control. Retrieved from 2. World Health Organization. (2016). The critical role of infection prevention and control. WHO/HIS/SDS/ World Health Organization

How big is the problem? Healthcare associated infections (HAI)
The challenge | The solution | The evidence | The cost savings | The product | The conclusion How big is the problem? Healthcare associated infections (HAI) Medical devices are accountable for 50 – 60% of HAI cases Nearly 6 million cases in the US and EU annually – causing deaths1 Annual HAI associated costs are estimated to € 7 billion (EU) and $ 6.5 billion (USA)1 70% of the bacteria that cause HAI are resistant to at least one relevant antibiotic2 Leading causes of death Rank Cause of death 1 Cardiovascular diseases incl. stroke 2 Cancer 3 Healthcare Associated Infections Healthcare associated infections (HAI), also referred to as “nosocomial” or “hospital acquired” infections are infections that are acquired in a hospitals or other healthcare facilities when the patient have been admitted for reasons other than the infection. As an example, a patent could be submitted for a hip replacement. During the operation, the patient has a urinary catheter and could get a catheter related urinary tract infection or a surgical wound infection. HAI are acknowledged as the most frequent adverse event in healthcare. Medical devices, for example catheters, account for over 50% of all HAI cases. Apart from the suffering of the patients and enormous cost for the healthcare systems, hospitals are an important breeding ground for the development and spread of antibiotic resistant bacteria. References: 1. World Health Organization Report on the burden of endemic health care-associated infection worldwide : 1. World Health Organization Report on the burden of endemic health care-associated infection worldwide :

Antimicrobial Resistance (AMR)
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Antimicrobial Resistance (AMR) European and Global Challenge by 2050 EU: patients die annually Globally: Could be as high as 2050 > 10 million deaths 392K 317K 4.7M 4.1M 392K AMR is a serious threat to public health: patients die annually in the EU as a result of infections caused by resistant bacteria. Globally this could be as high as million deaths per year are projected by 2050 if current infection and resistance trends continue. An ECDC (European Centre for Disease Prevention and Control) study (2018) estimates that about people die each year as a direct consequence of infections caused by bacteria resistant to antibiotics and that the burden of these infections is comparable to that of influenza, tuberculosis and HIV/AIDS combined. The study, based on data from the European Antimicrobial Resistance Surveillance Network (EARS-Net)from 2015, also shows that 39% of the burden is caused by bacteria resistant to last-line antibiotics such as carbapenems and colistin, which are early stage antibiotics with significant negative side effects. This is an increase from 2007 and worrying since these antibiotics are the last treatment options available. When these are no longer effective, it will be extremely difficult or, in many cases, impossible to treat infections. Link:

Antimicrobial Resistance
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Antimicrobial Resistance The first reported case in the United States where the patient was resistant to all available antibiotics So called “superbugs” can now be found on every continent When people hear about antibiotic resistance creating “superbugs”, they tend to think of new diseases and pandemics spreading out of control. The real threat is less flamboyant, but still serious: existing problems getting worse, sometimes dramatically. Infections acquired in hospital are a prime example. They are already a problem, but with more antibiotic resistance they could become a much worse one. Elective surgery, such as hip replacements, now routine, would come to carry what might be seen as unacceptable risk. So might Caesarean sections. The risks of procedures which suppress the immune system, such as organ transplants and cancer chemotherapies, would increase. It’s the first time this colistin-resistant strain has been found in a person in the United States. Public health officials worldwide reacted with alarm when Chinese and British researchers reported finding the colistin-resistant strain in pigs and raw pork and in a small number of people in China. The deadly strain was later discovered in Europe and elsewhere.

Antimicrobial resistance
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Antimicrobial resistance Selection to resistant bacteria Drug resistance is a consequence of evolution. If you have a population of bacteria where some are resistant, as described in this picture as red bacteria, and you expose them to antibiotics, the non-resistant bacteria (the green) will die. Leaving only resistant bacteria after the antibiotic treatment. So antibiotic use results in antibiotic resistance.

Consequences for common treatments in modern care
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Consequences for common treatments in modern care So why is resistance of such a high concern? Without antibiotics we cannot treat for example cancer or do orthopedic surgeries, like replacing hip joints. Antibiotic resistance can eventually make us go back to how it was before antibiotics was discovered.

Considerable higher rates at Intensive care units
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Considerable higher rates at Intensive care units Compared to hospitals in general Sweden HAI Rates EU HAI Rates Low to mid-income HAI Rates General ICU General ICU General ICU 60-90% 34% 30% 9% 7% 15% Top three HAIs in ICUs: VAP, CAUTI, CRBSI Cost of treating a case of VAP or CRBSI in ICU approx k Euro Additional length of stay up to additional 22 days Mortality for CRBSI and VAP up to 25% and 50% respectively Patients in the ICU are most exposed to HAI of all patients In low- and middle-income countries the frequency of ICU-acquired infection is at least 2─3 fold higher than in high-income countries; Proportion of infected patients in ICUs can be as high as 60-90% - most of these are HAI. High income countries: approximately 30% of patients in ICUs are affected by at least one episode of HAI as compared to an average within the hospital of maybe 7-10% Source: WHO Source costs: Source mortality: 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 intensive care patients in a nonteaching hospital. Crit Care Med Aug;34 Efrati S et al. VAP: current status and future recommendations. J Clin Monit Comput Apr;24(2):161-8 Source: WHO HAI Factsheet, Lakartidningen 2012, CDC

When an infection escalates to sepsis
The challenge | The solution | The evidence | The cost savings | The product | The conclusion When an infection escalates to sepsis “…the body's response to an infection damages its own tissues and organs.” Sepsis arises when the body’s response to an infection injures its own tissues and organs. It may lead to shock, multi-organ failure, and death - especially if not recognized early and treated promptly. Sepsis is the final common pathway to death from most infectious diseases worldwide. The following symptoms might indicate sepsis: Slurred speech or confusion Extreme shivering or muscle pain, fever Passing no urine all day Severe breathlessness It feels like you’re going to die Skin mottled or discolored If you have a confirmed or suspected infection and are experiencing any of these symptoms, please contact your local hospital or physician immediately. 1. Local infection 2. Organ dysfunction 3. Septic shock Source: Global Sepsis Alliance

The global burden of sepsis
The challenge | The solution | The evidence | The cost savings | The product | The conclusion The global burden of sepsis It affects 27 to 30 million people every year, 7 to 9 million die – one death every 3.5 seconds. Depending on country, mortality varies between 15 and more than 50 %. Many surviving patients suffer from the consequences of sepsis for the rest of their lives. Source: Global Sepsis Alliance

Common sources of infections leading to sepsis
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Common sources of infections leading to sepsis UTI, penumonia and catheters Most types of microorganisms can cause sepsis, including bacteria, fungi, viruses, and parasites. However, it may also be caused by infections with seasonal influenza viruses, dengue viruses, and highly transmissible pathogens of public health concern; such as avian and swine influenza viruses, Ebola, and yellow fever viruses. Sepsis often presents as the clinical deterioration of common and preventable infections such as those of the respiratory, gastrointestinal and urinary tract, or of wounds and skin. Sepsis is frequently under-diagnosed at an early stage - when it still is potentially reversible. Common sources of sepsis are urinary tract infections, blood stream infections and pneumonia – infections that we are addressing with the current BIP portfolio. Source: Global Sepsis Alliance

BIP Products (Bactiguard Infection Protection)
The challenge | The solution | The evidence | The cost savings | The product | The conclusion BIP Products (Bactiguard Infection Protection) BIP Foley BIP CVC BIP ETT The green coloured pie charts illustrate the areas in the body most exposed to HAI. The data is from the USA in this chart, but can be applied to most of the developed countries. Catheter associated urinary tract infection, CAUTI, is the most frequent HAI, of which a large proportion is caused by indwelling urinary catheters. The risk for invasion of microbes and subsequent infections increase with every day of catheterization. References: Klevens RM et al. Estimating healthcare associated infections and deaths in U.S. hospitals, 2002 Public Health Rep Mar-Apr;122(2):160-6. Klevens RM et al. Estimating healthcare associated infections and deaths in U.S. hospitals, 2002 Public Health Rep Mar-Apr;122(2):160-6.

Bacterial colonization
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Bacterial colonization Bactiguard mechanism of action A few seconds A few hours A few days A few days A few hours A few seconds Uncoated surface Bactiguard coated surface The surfaces of catheters attract microbes, which colonize it and may develop biofilm. CAUTI occurs when there is an immune response to microbes in the urethra or bladder. Uncoated surface: Bacteria begin to adhere to the surface Bacteria begin multiply Bacteria form a biofilm, when they begin to disperse, there is an increased risk for infection Bactiguard coated surface: 3. Less bacteria adhere to the Bactiguard coated surface compared to an uncoated surface, preventing biofilm formation and subsequent infection. Scanning electron microscopy The reduction of microbial colonization has been observed by scanning electron microscopy (SEM). The pictures show the microbe colonization of bacteria on an uncoated surface versus on a Bactiguard coated surface. Less bacteria colonize the Bactiguard coated surface.

The technology The galvanic effect – effective and safe
The challenge | The solution | The evidence | The cost savings | The product | The conclusion The technology The galvanic effect – effective and safe When in contact with fluids the noble metals create a galvanic effect The different electro potentials of the metals create a micro current Preventing microbial adhesion Non-releasing mechanism The Bactiguard Infection Protection (BIP) technology is based on a very thin noble metal alloy coating, consisting of gold, silver and palladium, firmly attached to medical devices. When in contact with fluids, the noble metals create a galvanic effect. Like in batteries, the different electro potentials of the metals create a microcurrent. Preventing microbial adhesion The galvanic effect creates a micro current that prevents microbial adhesion to the catheter material and subsequently reduces biofilm formation and potential infections. The Bactiguard technology does not use release of antimicrobial substances as its mechanism of action. Watch video

Periodic Table of Elements
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Periodic Table of Elements The three metals in the Bactiguard coating are very close to each other in the periodic system, meaning that between silver and palladium there is only one electron difference to easy to create a galvanic effect.

No release of toxic or pharmacological quantities
The challenge | The solution | The evidence | The cost savings | The product | The conclusion No release of toxic or pharmacological quantities Tissue-friendly and safe The amount of noble metals at the surface is very low No release of any toxic or pharmacological quantities This makes the technology both tissue-friendly and safe Release of substances, such as silver ions, chlorhexidine or antibiotics, killing microbes. Short effect due to release Potential harm to tissue Releasing coatings … as opposed to traditional coating technologies that depend on the release of substances that kill bacteria, e.g. high concentrations of silver ions, chlorhexidine or antibiotics The amount of noble metals at the catheter surface is very low and there is no release of any toxic or pharmacological quantities. This makes the technology both tissue-friendly and safe as opposed to traditional coating technologies that depend on the release of substances that kill bacteria, e.g. high concentrations of silver ions, chlorhexidine or antibiotics. The unique Bactiguard solution is tissue-friendly and safe for patient use while still efficient against infections.

The safety No release of any toxic or pharmacological quantities
The challenge | The solution | The evidence | The cost savings | The product | The conclusion The safety No release of any toxic or pharmacological quantities Silver Ag Palladium Pd Gold Au 3–4 μg 2 μg 0,2–0,3 μg A glass of milk contains equivalent amount A portion of potatoes contains equivalent amount Use of products with Bactiguard® coating, exposes the patient to the equivalent of The amount of noble metals at the surface is very low and there is no release of any toxic or pharmacological quantities. This makes the technology both tissue-friendly and safe as opposed to traditional coating technologies that depend on the release of substances that kill bacteria, e.g. high concentrations of silver ions, chlorhexidine or antibiotics. This slide illustrates the amounts of different noble metals that a patient is exposed to if using a BIP Foley. The levels are normally times below toxicological safety limits at chronic use.

Why Bactiguard should be standard in every ICU
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Why Bactiguard should be standard in every ICU Bactiguard can offer protection against the 3 most common HAIs in the ICU BIP CVC to prevent CLABSI BIP ETT Evac to prevent VAP Subglottic secretion drainage Coating preventing microbial adhesion BIP Foley to prevent CAUTI Bactiguard is unique in our field in being able to address the three most common HAIs in ICUs

BIP Technology for the highly exposed patients
The challenge | The solution | The evidence | The cost savings | The product | The conclusion BIP Technology for the highly exposed patients BIP core potential is when the product is used > 2 days Less microbes adhere to and colonize on the surface, preventing biofilm formation and subsequent infection. Bactiguard coated surface BIP products are primarily meant for the patients with highest exposure to infections, who generally have the products for more than 2 days because of the mechanism of action to prevent biofilm which usually takes around 48h.

Bactiguard’s vision Eliminate healthcare associated infections to
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Bactiguard’s vision Eliminate healthcare associated infections to Save lives Reduce cost Reduce the use of antibiotics We save lives! This is our mission. We do this by developing and providing infection prevention solutions that reduce the risk of health care-associated infections. Our vision Our vision is to eliminate health care-associated infections in order to: 1. save lives 2. reduce healthcare costs 3. reduce the spread of antibiotic resistance Our core values Everything we do in our daily operations is permeated by: • Long-term partnership • Trust and responsibility • Creativity • Responsiveness • Resourcefulness ...and is embraced by empathy, respect and communication. And thereby prevent the spread of multiresistant bacteria

The challenge | The solution | The evidence | The cost savings | The product | The conclusion Bactiguard A Swedish history of innovation Nobel Prize laureate Gustav Dahlén Partnership with C.R. Bard 2005 Bactiguard AB founded 1978 1994/1995 FDA 510K and Patent in the US 2008 Launch of BIP Foley Catheter 1912 1990 Bactiguard – a Swedish history of innovation Bactiguard was founded in 2005, but our technology is almost a hundred years old It stems from the Swedish Nobel Prize laureate in in physics 1912, Gustav Dahlén, the man behind the famous AGA Lighthouse. Gustav Dahlén had an apprentice called Axel Bergström, who developed the technique of applying a thin layer of metals to non-conductive materials. Axel then passed this knowledge on to his apprentice, Billy Södervall. Applying for patents in USA Billy, the innovator behind the Bactiguard technology, refined the technique and in the 1970’s, he started applying the noble metals to medical devices. The results proved very effective and led him to applying for patents on the innovation in the USA. The product quickly proved a resounding success. The company entered into a partnership with US medical device company C.R. Bard. In 1994, the US Food and Drug Administration (FDA) approved the sale of Bardex IC Foley catheters, treated with the Bactiguard infection protection coating. The catheters were launched on the market the following year. Bactiguard AB Bactiguard AB was founded in Sweden in 2005 and acquired the business and technology from the previous owner. Bactiguard is now taking the technology a step further in preventing and fighting healthcare associated infections, reducing the use of antibiotics and combating the spread of multi-resistant bacteria. In 2006, a development and production unit was established in Markaryd, in the south of Sweden, to focus on the further development of the technology. Billy Södervall starts developing the Bactiguard technology

Bactiguard 2014 2018 2013 2016 2019 A Swedish history of innovation
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Bactiguard A Swedish history of innovation CE mark of orthopaedic trauma implants with Bactiguard coating 2019 Launch of BIP ETT & BIP CVC 2013 Launch of BIP ETT Evac 2016 Share Listed on Nasdaq Stockholm/ moved to new Headquarter 2014 2018 Today we are available in over 40 countries on all continents Launch of own product portfolio In 2006, work started on developing a separate product portfolio and 2008 saw the first delivery of Bactiguard coated latex urinary tract catheters, Bactiguard Infection Protection Foley catheter (BIP Foley catheter). Silicone urinary tract catheters were launched the following year. In 2013, Bactiguard coated endotracheal tubes (BIP ETT) and central venous catheters (BIP CVC) were launched. A production unit was established that same year in Malaysia, to manufacture urinary tract catheters for the company. Stock exchange In June 2014, Bactiguard was listed on the NASDAQ OMX Stockholm with the stock symbol Bacti. The aim of the float was to refinance the company and boost continued development and growth. New integrated headquarters In late 2014, Bactiguard relocated to its new-built headquarters on Alfred Nobels Allé in Tullinge, south of Stockholm. The new office enabled all parts of the company such as sales and marketing, research, production and product development to come together under the same roof. Another advantage of being based in the new Karolinska Institute Science Park is proximity to research and development at the Karolinska Institute and the Royal Institute of Technology plus healthcare at Karolinska University Hospital which all facilitate closer cooperation. Expanding the BIP portfolio In 2016 the BIP ETT Evac is launched, which combines Bactiguard's infection protection technology with subglottic secretion drainage. Two years later the BIP Foley catheter is launched in two new variants; Female and Tiemann. At the same time, the BIP CVC range is also expanded with a Raulserson syringe. Bactiguard now operates in over 40 countries and is available on all continents. Launch of BIP Foley Tiemann – Female BIP CVC with Raulerson Syringe

Bactiguard Infection Protection Foley Catheters
BIP Foley Catheters Bactiguard Infection Protection Foley Catheters BIP Foley catheters Designed to: Reduce urinary tract infections Reduce use of antibiotics Reduce healthcare costs

BIP Products (Bactiguard Infection Protection)
The challenge | The solution | The evidence | The cost savings | The product | The conclusion BIP Products (Bactiguard Infection Protection) CAUTI is the most frequent HAI of which up to 90% is caused by indwelling catheters 1-5 % of all CAUTI leads to urosepsis Definition of CAUTI (Centre of Disease Control) Bacteria in urine 105 CFU/ml and clinical symptoms Catheterized for >2 calendar days Symptoms during catheterization OR within 48 hours after withdrawal The green coloured pie charts illustrate the areas in the body, most exposed to HAI. The data is from the USA in this chart, but can be applied to most of the developed countries. Catheter associated urinary tract infection, CAUTI, is the most frequent HAI, of which a large proportion is caused by indwelling urinary catheters. The risk for invasion of microbes and subsequent infections increase with every day of catheterization. To be included in the CAUTI or sCAUTI definition, the “s” standing for symptomatic catheter related urinary tract infections - the patient should have been catheterized for > 2 days and diagnosed during catheterization or within 2 days from the day of catheter removal, and have symptoms of infection in addition to bacteriuria. Klevens RM et al. Estimating healthcare associated infections and deaths in U.S. hospitals, 2002 Public Health Rep Mar-Apr;122(2):160-6.

The challenge | The solution | The evidence | The cost savings | The product | The conclusion Sources of bacteria Exogenous Infections may either arise when we inadvertently insert bacteria into the patient’s urinary tract during catheterization. Or, infections can be caused by bacteria in the urinary tract forming a biofilm on a catheter, which results in an infection. The source of microorganisms causing the infection may either be: endogenous (meatal, rectal or vaginal) i.e. from the patient herself, or exogenous such as contaminated hands of health care personnel during catheter insertion or manipulation. It is roughly as common to get an endogenous as an exogenous infection. This is important to remember when discussing with health care professionals about prevention of CAUTI – only the exogenous can possible be battled through better hygiene routines. Endogenous Urology nurse, Sweden

Problems caused by bacteria
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Problems caused by bacteria Catheter complications The catheters needs to be changed earlier than expected Cloudy urine The staff needs to rinse the catheter Recurring UTIs Smelly urine CAUTI is often caused by indwelling urinary catheters but also other problems related to bacterial colonization, such as for example smell, encrustation or catheter blockage are common. Encrustation Clogging catheters

Process and risks of urinary catheterization
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Process and risks of urinary catheterization Example scenario on hip joint fracture There are many steps during the patients pathway through the hospital that he/she can receive or change catheter. To battle infections one must understand this process, and from a sales perspective you need to know the different milestones to be successful in addressing the account.

The efficacy In vitro data BIP Foley
The challenge | The solution | The evidence | The cost savings | The product | The conclusion The efficacy In vitro data BIP Foley Reduction in microbial adhesion to BIP Foley catheter compared to uncoated standard catheter -98% -95% -93% -66% -58% -61% -69% -94% CFU/cm2 Uncoated surface In vitro test The reduction of microbial adhesion and colonization to device surfaces has been verified for clinically relevant microbial strains using an in vitro test (Ahearn test). It evaluates the adhesion of gram-positive and gram-negative bacteria to device surfaces. You expose pieces of product with and without coating and incubate, then you wash them and count the bacteria that have adhered and compare the results. Bactiguard coated surface *MRSA tested for Silicone only Source: Data on file

Clinical microbiology data
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Clinical microbiology data BIP Foley Catheter E. coli are most abundant, followed by Klebsiella and Enterococcus Fungi common but not so abundant Great variation Bactiguard This slide is looking at all microbiology data from clinical publications, not all studies include reports of microbiological findings but we have summarized the ones who do. In the coloured staples you see the uncoated product vs the green staples the respective Bactiguard product. As you can see there are less patients where each bacteria can be found. Source: Data on file

Targeting BIP Foley Catheter

The challenge | The solution | The evidence | The cost savings | The product | The conclusion Market overview Hospital in-patient care represents ~60 % of total Foley usage Focus for this work 60% % of Foley market Home care 40% High concentration of Foley users 100% 5% ~15%< ~20% ~60% Total Foley usage is split among hospital in-patient care (~60%), out-patient care (~20%), primary care (~15%) and elderly care (~5%) That’s why we will focus on Hospital in patient care given high concentration of patients and limited number of sites. On the other hand, all our patients usually fall within the high risk group of patients. So, this channel may be interesting to explore in some countries. Upside: High Foley use outside hospitals in some prioritized groups can give a positive spill over effect into other care segments expected. Hospital out-patient careHospital out-patient careHospital out-patient care Total Foley marketTotal Foley market Elderly careElderly care Primary carePrimary care Hospital in-patient careHospital in-patient care Elderly patients with retention or incontinence Elderly patients living at home with retention or incontinence Other patients with long-term or permanent catheter, e.g., post stroke treatment More fragmented patient groups; e.g., waiting for prostate surgery, spinal cord patients Entry point for many catheter users Potential to build traction in other patient groups and caregivers / facilities Source: SKL point-prevalence of Foley usage 2013, Socialstyrelsen DRG-database 2013, Karolinska Sjukhuset, Swedish intensive care registry, Läkartidningen 2005, Läkartidningen 2007, M. Petersson – Urinary catheters at two primary care facilities in Jönköping 2013

Hospital BIP Foley Potential
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Hospital BIP Foley Potential Share of in-patient Foley catheters (%) Short catheterization time Low risk patients ~70% 50% of BIP Foley potential identified in target patient groups Of the hospital patients, approximately 30% of patients are at high risk for infections and therefore constitute the BIP core potential ~30% 5% in other Total Foley usageTotal Foley usageTotal Foley usage Low potential segmentsLow potential segmentsLow potential segments BIP Foley potential in target departments BIP Foley potential in target departments BIP Foley potential in target departments BIP Foley potential in target departments Secondary factors in target departmentsSecondary factors in target departmentsSecondary factors in target departmentsSecondary factors in target departments BIP Foley potentialBIP Foley potential1 Other departmentsOther departments 45% of identified potential in 7 prioritized patient groups Hospital BIP Foley potential estimated at 30% of total in-patient Foley usage Socialstyrelsen DRG-database 2013 and ICD database 2013; SKL point-prevalence of Foley usage 2013; Swedish intensive care registry; Survey of US physicians; Expert interviews; Internal interviews

Approach to identify prioritized patient groups
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Approach to identify prioritized patient groups Departments with high Foley usage Large patient groups using Foleys Prioritized patient groups Decision criteria Share of patients using Foley Size of department Key diagnoses using Foleys General By department UTI rates Length of catheterization > 2 days Sensitivity to infections Fragmentation (# of departments) Rationale Limited sales force needs to be targeted in interactions with physicians Provide large sample size for hospital testing, be consistently found in hospitals, and be of importance to physicians Identify patient groups that would benefit the most from reduced infection rates We started which departments that use a large number of Foleys – looking at % Foley users and total number of patients using databases and expert interviews. We then narrowed it down to identifying certain diagnosis that require a Foley, with expert interviews and international guidelines as sources of information. Finally we concluded on prioritized patient groups who are likely to have the catheter for more than 2 days, often develop infections and that are treated within as few departments of the hospital as possible. The last parameter to make it easier for a sales rep work efficiency. Data sources SKL point-prevalence data DRG-database 2013 Expert interviews KS purchasing report US physician survey Expert interviews Guidelines US physician survey Expert interviews

The 7 most exposed patient groups
The challenge | The solution | The evidence | The cost savings | The product | The conclusion The 7 most exposed patient groups Patient group % using Foley % of Foley users in hospital # days with catheter ICU 74% 6.9% 7 Stroke / CVA 44% 4.0% 19 Dementia 25% 0.5% 25 Prostate cancer 27% 13 Bladder cancer 21% 0.4% BPH/TURP 23% 0.3% 17 SCI 0.1% 24 Neurology/Neurosurgery ICU Anesthesia Urology Cardiology (surgery) General surgery Oncology Gynecology Geriatrics Pediatrics These are the 7 priority patient groups for BIP Foley targeting that came out of this exercise. ICU patients, Stroke and dementia patients, urological patients treated for prostate or bladder cancer or benign prostate hyperplasia (BPH) but also chronically catheterized spinal cord injured patients. The table shows from left to right the % of patients within a certain segment that uses a Foley, what % of total Foley users in a hospital it represents, the average number of days the patient is catheterized and in which departments you can find them. Using this as an entry point into the hospital will help you with some quick wins that can be further expanded in the future for larger market share gains. The 7 groups make up approximately of 15% market share. Source: BCG survey of US physicians, Socialstyrelsen DRG-database 2013, SKL point-prevalence of Foley usage 2013, Swedish intensive care registry

Long-term use >30 days
The challenge | The solution | The evidence | The cost savings | The product | The conclusion The patient <2 days Short-term use 2-30 days Long-term use >30 days Use a standard catheter Exception: Consider BIP Foley for patient with ongoing infection Example: Critically ill Geriatric patients Urology patients Surgical patients Example: Spinal cord injured patients Patients with neurological bladder dysfunctions Risk of infections 2 30 BIP Foley Catheters BIP Foley Catheters The patient The BIP Foley catheters reduce the risk of CAUTI through reduction of microbial adhesion and biofilm formation and is intended for patients catheterized for longer than two days. Less than two days usage rarely leads to infection and a standard catheter can then be used. Less than 2 days Use a standard catheter. Exception: If the patient has an ongoing infection, consider a BIP Foley Catheter. Short-term use (2-30 days) Some patients catheterized for longer than two days will use a catheter only for a short term, but still with a high risk of developing infections. E.g. the critically ill, geriatric patients, urology patients, surgical patients or patients with suppressed immune systems. Long-term use (>30 days) The long-term catheterized patients always have a high risk of developing infections and other problems related to bacterial colonization, such as smell or catheter blockage. E.g. spinal cord injured patients or patients with neurological bladder dysfunctions. Days with catheter treatment

The challenge | The solution | The evidence | The cost savings | The product | The conclusion Clinically proven Two different tracks, short term use (>2 days) and long term use (“permanent”) 2 different target groups Short-term use: - Lederer et al. - Newton et al. - Hidalgo Fabrellas et al. 100 % Foley users Long-term use: - Chung et al. - Estores et al. - Magnusson et al. - Patient testimonials When presenting the clinical data, we divide it for short (2-30) and longterm (>30 days) patients. 70 % < 2 days 30 % > 2 days 40 % “Home” 60 % at the hospital

Studies on short-term use (2-30 days)
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Studies on short-term use (2-30 days) Bactiguard coated catheters The efficacy of Bactiguard coated catheters has been assessed in more than 20 studies, published in peer reviewed journals These publications studies the preventive effect of Bactiguard coated catheters Primary endpoint is symptomatic CAUTI Short-term use (2-30 days) The efficacy of Bactiguard coated catheters has been assessed in more than 20 studies, published in peer reviewed journals. The studies below comply with the latest CAUTI definition, measuring only symptomatic infections for patients catheterized longer than 2 days.

Multicenter study, USA Short-term use (2-30 days)
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Multicenter study, USA Short-term use (2-30 days) Reduction of CAUTI incidence Author, year Lederer et al. 2014 Journal Journal of Wound Ostomy & Continence Nursing Number of patients 853 (453 control group, 400 Bactiguard group) Patients Hospitalized patients years Mean catheterization time 8 days Design Multicenter Surveillance study (before-after) Site 7 acute care hospitals, USA Primary endpoint Symptomatic CAUTI, CDC definition Other Antibiotic use Multicenter study, USA Lederer et al conducted a multicenter surveillance study in the US, including 853 patients at 8 hospitals, catheterized for 8 days in average. The incidence of CAUTI infections was reduced by 58% after introduction of Bactiguard coated catheters. Lederer JW et al, J WOCN 2014; 41(5):1–8.

Burn unit ICU patients, USA
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Burn unit ICU patients, USA Short-term use (2-30 days) Reduction of CAUTI incidence Author, year Newton et al. 2002 Journal Infection Control and Hospital Epidemiology Number of patients 1 757 Patients Patients in Burn unit ICU Design Before – After Site Burn centre in Augusta, GA, USA Primary endpoint Symptomatic CAUTI, CDC definition Methodology Urinary culture obtained when medically indicated; medical information and culture data obtained by retrospective chart review OR=2.22,P<0.037 Bactiguard coated catheters standard catheters -39% Burn unit patients, USA Newton et al studied the effect of Bactiguard coated catheters on patients with a 7–8 days mean catheter time in a burn unit in Georgia, US. They found a 32% incidence reduction with Bactiguard coated catheters and a 39% reduction of CAUTI per catheter days. Newton T et al, Infection Control and Hospital Epidemiology; 2002; 23(1):217–8.

Cardiac surgery patients, Spain
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Cardiac surgery patients, Spain Short-term use (2-30 days) Author, year Hidalgo Fabrellas et al. 2015 Journal Enferm Intensiva Number of patients 116 Patients Cardiac surgery post-operative ICU patients Mean catheterization time 4 days Design Prospective randomized (RCT) Site Dr Josep Trueta University Hospital, Spain Primary endpoint CAUTI confirmed by 105 CFU/ml microorganisms in urine Microbiology Most common species were E-coli (30%) and Klebsiella Pneumonia (30%) Health economy The use of BIP Foley Catheter was shown cost effective Urinary tract infection according to catheter Cardiac surgery patients, Spain Hidalgo et al performed a randomized study on 116 post-op cardiology patients in Spain, with a 4 days mean catherization time, and found a 38% incidence reduction of CAUTI. The use of BIP Foley catheters was shown to be cost effective. Hidalgo Fabrellas et al. Enferm Intensiva. 2015; 26(2):54–62.

Critically ill patients, USA
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Critically ill patients, USA Short-term use (2-30 days) Author, year Rupp et al. 2004 Journal American Journal of Infection Control Number of patients 4 400 Patient Critically ill patients Design Prospective surveillance study, historical control data Site Nebraska Medical Center (600 beds), USA Primary endpoint UTI (symptomatic CAUTI and asymptomatic bacteriuria) Additional outcomes Microbial silver resistance, Health economy -57% Adapted from Rupp et al. P =0.002 The impact on CAUTI by changing to Bactiguard-coated urinary catheters were assessed at the Nebraska Medical Center, where historical data from 1999 and 2000 with standard catheters were compared to a similar time period with Bactiguard coated catheters. The rate of UTI declined by on average 57% between the years 2001 and 2002 compared with the rates in 1999 and This is true for symptomatic and asymptomatic CAUTI combined. (The rate of infections for (2.62/1000 catheter-days) was statistically lower than for the period (6.13/1000 catheter-days, P =0.002) - a 57% reduction. ) Out of the patients who were diagnosed with infections, the majority, 57%, were classified as symptomatic CAUTI and the lesser part of 43% as bacteriuria only. 57 % of patients experienced a symptomatic UTI, whereas 43 % were classified as having asymptomatic bacteriuria Rupp et al, Effect of silver-coated urinary catheters: Efficacy, cost-effectiveness, and antimicrobial resistance. American Journal of Infection Control, 2004, vol 32 (8):

Ward randomized study, USA
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Ward randomized study, USA CAUTI reduction with Bactiguard coated catheters Reduction CAUTI incidence Author, year Karchmer et al. 2000 Journal Arch Intern Med. Number of patients 27 878 Patient All hospitalized patients. Wards with infrequent catheter use/low infection rates were excluded. Design Prospective, ward randomized, cross-over Site University Hospital of Virginia, USA Primary endpoint Symptomatic and asymptomatic UTI -21% -32% Karchmer study, published 2000, is of interest since it is the largest study comparing both symptomatic and asymptomatic CAUTI in patients at the University Hospital of Virginia in the USA. It was designed as a prospective, ward randomized cross over study over 12 months. It included patients in total, and compared infectious outcome for standard catheter (siliconized latex) and Bactiguard Foley. The study showed a reduction of CAUTI /100 catheter by 32% and a reduction of CAUTI per 1000 catheter days by 21%, as well as a reduction of urosepsis by 44%. The hospital, as well as many other hospitals in USA, now use Bactiguard catheters as standard. Karchmer TB et al, A randomized crossover study of silver-coated urinary catheters in hospitalized patients. Arch Intern Med Nov 27;160(21):3294-8 -44% Karchmer TB et al, Arch Intern Med Nov 27;160(21):3294-8

Studies on long-term use (>30 days)
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Studies on long-term use (>30 days) Bactiguard coated catheters Long-term catheterized patients are highly exposed to infections, the risk for infection increases by approx. 5% per day Other problems related to bacterial colonization, such as smell, encrustation or catheter blockage are common Things have never been as easy as they are now! I haven’t had any infections, I no longer need take antibiotics and I have definitely regained my joy of life. In addition to the published clinical evidence in the studies above, there are also patient testimonials about other bacterial related problems, such as smell, clogging and encrustation, where the infection prevention technology of Bactiguard coated catheters has improved the quality of life for both patients and their relatives. Elisabeth, BIP Foley user

Medical rehabilitation patients, Hong Kong
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Medical rehabilitation patients, Hong Kong Long-term use (>30 days) Reduction of CAUTI incidence (in group with catheter days) Catheter change interval Author, year Chung et al. 2017 Journal Hong Kong Medical Journal Number of patients 306 Patient Medical rehabilitation patients Design Prospective controlled before-after The catheters were exchanged when problems occurred (infection or blockage) 2 cohorts Long-term users 5 catheters / patient, days Shorter term users 2 catheters / patient, days Site Hong Kong, Kowloon Hospital Endpoints Days until catheter problems occur and catheters had to be exchanged Symptomatic CAUTI, CDC definition 9.3 BIP Foley catheters standard catheters -48% standard catheters 48 BIP Foley catheters Chung et al studied 306 medical rehabilitation patients. They observed a prolonged period of time with the BIP Foley Catheter until complications occurred and a change of catheter was needed: 48 days vs 9.3 days for the patients treated with catheter for days. The average reduction of CAUTI for the sub group treated with catheter for as long as days was 48% with BIP Foley catheters (p=0.027). For the entire study population, the average reduction of CAUTI was 31% (p=0.095). Chung PH et al. Hong Kong Medical Journal.2017;23:Epub.

Patient case, Sweden Long-term use (>30 days)
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Patient case, Sweden Long-term use (>30 days) Author Magnusson et al. Journal Data on file, to be published Number of patients 1 Patient type Permanently catheterized, suprapubic, neurologic bladder dysfunction with urine retention, recurrent UTI every month Design 22 months follow up cross-over (switch to BIP Foley Catheter month 10) Site Centralsjukhuset Karlstad, Sweden Primary endpoint CAUTI Antibiotic use Other endpoints Comfort (patient) Handling properties (nurse) Adapted from Magnusson et al. Patient cases Estores et al (USA)and Magnusson et al (Sweden) both describe cases of permanently catheterized patients with monthly recurring UTIs. After changing to Bactiguard coated catheters, the patients were free from symptomatic infections up to 2 years. Magnusson et al. Unpublished data.

Health economy benefits
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Health economy benefits Difference in payer costs: standard catheters vs. BIP Foley catheters $ Example: With an investment of $800,000 you can save $3,400,000 Patients 100,000 Incidence of infections 10% Treatment cost CAUTI $911 Treatment cost sepsis $2 834 Infection reduction 40% Extra cost per BIP Foley Catheter $8 Cost savings $ $1 MM $3,4 MM $10,5 MM $6,3 MM standard catheters Investing in prevention with BIP Foley catheters has been shown to reduce CAUTI in a cost-effective way. The cost savings are present in a wide variety of reimbursement systems.1,2 Several health economic evaluations have been conducted in Europe and USA.1,2,3 BIP Foley catheters are associated with lower costs related to length of hospital stays, lower treatment costs and improved patient quality of life.1 According to Saint et al2, the estimated average cost for a CAUTI is $ 911 per patient. If it spreads to the blood stream, the estimated cost is $ per patient. Example The example shows that even with an extra investment of $ (higher cost for BIP Foley), you can still save up to $3,4 millions References: 1. Karchmer TB et al, Arch Intern Med Nov 27;160(21):3294–8 2. Saint S. et al. Arch Intern Med. 2000; 160: 3. Hidalgo Fabrellas et al. Enferm Intensiva. 2015; 26(2):54–62. BIP Foley catheters CAUTI: $911 per patient Uro sepsis: $2 834 per patient Source: Saint S. et al. Arch Intern Med. 2000; 160: Karchmer TB et al, Arch Intern Med Nov 27;160(21):3294–8

The challenge | The solution | The evidence | The cost savings | The product | The conclusion Product features Latex or silicone material Bactiguard coating inside and outside Hydrophilic coating reduces friction and increases patient comfort For transurethral or suprapubic use 2-way and 3-way catheters Nelaton or Tiemann tip, Female or full length The BIP Foley catheters are approved for use up to 90 days. After 90 days in urine, up to 99% of the Bactiguard coating is still bound to the surface of the catheters. BIP Foley catheters The BIP Foley catheters are approved for transurethral and suprapubic use for up to 90 days. The Bactiguard coating is environmentally friendly and requires no special procedures for handling, use or disposal. The Bactiguard solution is unique, tissue-friendly and safe for patient use. To date, more than 160 million Bactiguard coated catheters have been sold for patient use, with no reported adverse events related to the coating. 47

3 things to keep in mind! When aming to prevent CAUTI Handling
The challenge | The solution | The evidence | The cost savings | The product | The conclusion 3 things to keep in mind! When aming to prevent CAUTI Handling Material Indication There are three things to keep in mind when aiming to prevent CAUTI: Indication: First of all only to treat the patients that really need a catheter with one, meaning also to remove it as soon as the patient no longer requires it. Handling: Secondly to handle the catheter and patient in the most optimal way, meaning aseptic catheterization and carefully preventing any traumatic event. Bactiguard Infection Protection Clinical Implementation Program, BIP CIP, offers an educational material for healthcare professionals with the aim of increasing the knowledge of proper treatment of patients requiring catheters. The BIP CIP videos can be found on YouTube (or go to slide 30). There is also “A short guide to catheter treatment” created in collaboration with experts from Karolinska University Hospital, Sweden. Material: Last but not least, the choice of material. The Bactiguard coating will help to prevent infection, and its hydrophilic coating will reduce friction and increase the patient comfort.

The challenge | The solution | The evidence | The cost savings | The product | The conclusion BIP CIP Bactiguard Infection Protection Clinical Implementation Program All aspects of catheter treatment Educational material developed with experts from Karolinska University Hospital Seminars, brochures, videos, posters Better knowledge of the proper treatment of patients requiring catheters is one way of reducing catheter related urinary tract infections. With the aim of reducing these infections, Bactiguard has developed an educational material for healthcare professionals; Bactiguard Clinical Implementation Program, BIP CIP in collaboration with experts from Karolinska University Hospital, Sweden. Märta Lauritzen and Helena Thulin, Karolinska University Hospital

The challenge | The solution | The evidence | The cost savings | The product | The conclusion BIP CIP Bactiguard Infection Protection Clinical Implementation Program Catheterization with indwelling catheter – man Catheterization with indwelling catheter – woman Change of suprapubic catheter BIP CIP instructional videos on YouTube

The hydrophilic coating
The challenge | The solution | The evidence | The cost savings | The product | The conclusion The hydrophilic coating Providies more ease of insertion for the health care professional and more comfort for the patient Needs to be pre-wetted before catheter insertion. We recommend: Pre-wetting with sterile water in a tray - preferred Pre-wetting with gel The hydrophilic coating is a premium feature of the Bactiguard Foley catheters, providing more ease of insertion for the health care professional and comfort for the patient. It is important that the hydrophilic coating is pre-wetted before catheter insertion. We recommend the following options: Pre-wetting with sterile water in a tray - preferred Pre-wetting with gel

BIP Foley Tiemann The challenging anatomy of the man Nelaton Tiemann
The challenge | The solution | The evidence | The cost savings | The product | The conclusion BIP Foley Tiemann The challenging anatomy of the man Nelaton Tiemann Urinary catheters are available with different tip designs, of which the most commonly used are the straight Nelaton and the curved Tiemann tip. The most commonly used tip for routine catheterization is the Nelaton tip which is round with two drainage eyes. Due to the challenging curvature of the male urethra, a Tiemann catheter with a curved tip can be used to ease insertion. Also the Tiemann tip is equipped with two drainage eyes. Bactiguard offers both types of tips.

Summary BIP Foley catheters
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Summary BIP Foley catheters 160 million Foley catheters have been used since 1995 No adverse events associated with the coating have been reported Proven efficient against sCAUTI for patients catheterized longer than 2 days As Bactiguard coated Foleys have been used in the USA since 1995, the products are well documented and studied. In fact approximately 50% of all Foley catheters used in the USA today are coated with Bactiguard. More than 160 millions of those have been sold since 1995. A large amount of clinical test and studies have been performed involving over patients. No adverse events have been reported related to the coating.

Biofilm study urological-surgical patients, Italy
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Biofilm study urological-surgical patients, Italy Long-term use (>30 days) Author, year Mazzoli S. et al. 2009 Publication Poster at Eurobiofilms 2009 Number of patients 37 Patient Long-term (>30 days) catheterized urological-surgical patients Design Controlled intervention study, with two parallel groups Site Santa Maria Annunziata Hospital Primary endpoint Biofilm reduction BIP Foley Catheter Standard Foley No. of patients 18 19 Biofilm 6 (33%) 15 (79%) 58% reduction of biofilm occurrence on BIP Foleys, p = 0.008 Reduction of biofilm in clinical use Also the reduction of biofilm has been tested in clinical settings. In this study by Mazzoli, which was presented as a poster at the ”Eurobiofilms 2009” conference in 2009, the reduction of biofilm was 58% in the Bactiguard group compared to patients receiving a standard catheter. Mazzoli S. et al. 2009, Poster at Eurobiofilms 2009

Biofilm study urological-surgical patients, Italy
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Biofilm study urological-surgical patients, Italy Long-term use (>30 days) Author, year Pickard et al. 2012 Journal The Lancet Number of patients 4 241 (2 097 standard Bactiguard coated) Patients Surgical patients in various specialties Catheterization time Short (average 2 days, 70% of patients: > 2 days) Design Prospective randomized, controlled superiority trial Remarks: The study did not follow CDC’s definition of CAUTI 70% of patients were catheterized > 2 days Diagnosis was assessed longer than two days after removal Site 24 acute care hospitals in UK Primary endpoint Self-assessed symptoms of UTI treated with antibiotics up to 6 weeks after inclusion Result Catheterization length Reduction of sCAUTI No of patients (% of total in both groups) Days 1-14 4% (P=0.69) 4 241 Days 3-10 19% (P=0.16) 1 224 (30%) …Duration of catheter use by most participants may have been too short to allow the antimicrobial effect of the tested catheters to become apparent… A large randomized clinical trial was published in 2012 in the Lancet, one of the most prestigious publications with a very high impact factor. At first glance it looked like it showed that the Bactiguard coating did not have any significant effect on infections – only a 4% reduction was announced. However 70% of the patients in the study only had the catheter for 1-2 days and they were also diagnosed through self-assessment up to 6 weeks after inclusion to the study. This means that they cannot be included in the evaluation according to the CDC criteria for the definition of CAUTI. When analyzing the subgroup of patient that had the catheter for more than 2 days, more detailed 3 to 10 days, the reduction was 19% high so significantly higher. This has been pointed out by several leading Swedish and International experts in the urology field and is even mentioned by the authors themselves. They write: “…Duration of catheter use by most participants may have been too short to allow the antimicrobial effect of the tested catheters to become apparent…” Pickard et al. 2012, The Lancet

Bactiguard Infection Protection Central Venous Catheter
BIP CVC Bactiguard Infection Protection Central Venous Catheter BIP CVC Designed to: Reduce CRBSI Reduce use of antibiotics Reduce healthcare costs

Definition of CRBSI (Centre of Disease Control)
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Where does HAI occur? Catheter related blood stream infection (CRBSI) is the most frequent complication and risk associated with the use of CVCs Thrombotic complications are also common and may lead to thrombotic events or obstruction of blood flow and catheter dysfunction Definition of CRBSI (Centre of Disease Control) At least one symptom (fever >38°C, chills, hypotension) Recognized CLABSI pathogen from blood sample Organism is NOT related to infection from other site Patients catheterized for >2 days During catheterization or on the 1st day after withdrawal The green coloured pie charts illustrate the areas in the body, most exposed to HAI, where Bactiguard has a correlating products. The data is from the USA in this chart, but can be applied to most of the developed countries. Catheter related bloodstream infection (CRBSI) is a common complication and one of the most frequent HAIs. Also, thrombotic complications are common during treatment with central venous catheter.

CLABSI and Thrombosis 4-6%1 4%2 Prevalence and consequences Prevalence
The challenge | The solution | The evidence | The cost savings | The product | The conclusion CLABSI and Thrombosis Prevalence and consequences Prevalence Mortality 12-25%3 CLABSI 4-6%1 Thrombosis 4%2 Prevalence of CLABSI ranges from 4-6% with a mortality between 12 to 25%, and one case only is estimated to cost the health care system up to USD4,5 mainly driven by the extra length of stay in the hospital/in the ICU. The second complication, thrombosis, also has a prevalence around 4%. Thrombosis is when a blood clot is formed in a vein. This is a serious condition, since the blood 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. References: 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): Kluger DM, Maki DG. The relative risk of intravascular device related bloodstream infections in adults [Abstract]. In: Abstracts of the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA: American Society for Microbiology, 1999:514 Dimick JB et al. Increased resource use associated with catheter-related bloodstream infection in the surgical intensive care unit. Arch Surg 2001;136: Rello J, Ochagavia A, Sabanes E, et al. Evaluation of outcome of intravenous catheter related infections in critically ill patients. Am J Respir Crit Care Med 2000;162: 1. Morbidity and Mortality Weekly Report (MMWR), Vital Signs: Central Line--Associated Blood Stream Infections --- United States, 2001, 2008, and 2009, CDC. 2. 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): Kluger DM, Maki DG. The relative risk of intravascular device related bloodstream infections in adults [Abstract]. In: Abstracts of the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA: American Society for Microbiology, 1999:514.

The efficacy In vitro data BIP CVC
The challenge | The solution | The evidence | The cost savings | The product | The conclusion The efficacy In vitro data BIP CVC Reduction in microbial adhesion to BIP CVC Uncoated surface The reduction of microbial adhesion to and colonization on the device surfaces has been verified for clinically relevant microbial strains, using an in vitro test (Ahearn test). The test evaluates the adhesion of gram-positive and gram-negative bacteria to the device surfaces. These strains account for a large proportion of CRBSI infections. You expose pieces of product with and without coating and incubate, then you wash them and count the bacteria that have adhered and compare the results. Pseudomonas aeruginosa Coagulase negative Staphylococcus aureus Staphylococcus aureus Klebsiella pneumoniae Bactiguard coated surface Source: Data on file

Randomized Controlled Trial, Germany
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Randomized Controlled Trial, Germany Proven effective against CRBSI, less thrombotic events Frequency of catheter related infections and septicemia1 Author, year Goldschmidt et al, 1995, Journal Zentralblatt für Bakterielogie, Mikrobiologie und Hygiene Number of patients 233 Patients Haematology, oncology Median time for catheterization 13,3 / 12,7 days Design RCT (Prospective, randomized, controlled) Site University Hospital Heidelberg, Germany Primary endpoint Catheter related infections, CRI (Septicemia, Bacteremia and Local infection) Standard CVC Bactiguard coated CVC Factor Standard CVC (n=113) Bactiguard coated CVC (n=120) Visualization of thrombus 3 1 Absence of spontaneous flow 2 Total no. of catheter-related thrombosis Catheter related infections (p=0.011) Catheter related septicaemia (p = 0.304) Randomized Clinical Trial, Germany In the clinical study including 233 haematological oncology patients at the University of Heidelberg, Germany, published by Goldschmidt et al,12 Bactiguard coated CVC has been shown effective against CRBSI. The coating significantly reduced the incidence of infections by 52%. Catheter related infections developed in 21% of patients with the standard catheter, but in only 10% of the patients with the Bactiguard coated catheters. Catheter related septicaemia was also reduced by 40% (p=0.304). Fewer cases of thrombosis In the clinical study on 233 haematological oncology patients, published by Harter et al 10, it was also concluded that the Bactiguard coated CVC group had no increased risk of thrombosis versus the standard CVC group: 1 case of thrombus in 120 patients versus 3 cases of thrombus in 113 patients (see Table below), but the cases were to few for statistical significance. To summarize, the Bactiguard coated catheter showed a decreased risk for infection, while no increased risk for thrombosis. References: Goldschmidt H, et al. Prevention of catheter-related infections by silver coated central venous catheters in oncological patients. Zentralbl Bakteriol 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). Adapted from Harter et al. 2002 1. Goldschmidt H, et al. Prevention of catheter-related infections by silver coated central venous catheters in oncological patients. Zentralbl Bakteriol 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).

Adverse events in RCT, Sweden
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Adverse events in RCT, Sweden Safety confirmed in clinical study from Karolinska University Hospital Author, year Björling et al. 2017 Journal J of Biomedical Research Number of patients 34 Patients Large abdominal surgery Design Prospective RCT Site Karolinska University Hospital, Sweden Primary endpoints Adverse events (infection, thrombosis), antibiotic use In a controlled, randomized pilot study performed at Karolinska University Hospital in Sweden, 34 patients undergoing large abdominal surgery were included. 22 patients received a BIP CVC, and 12 patients received a standard, uncoated CVC. The primary endpoint was safety, assessed by evaluation of adverse events. There were statistically less adverse events in the Bactiguard group compared to the standard group: 4 vs none (Table, 1 adverse event was not related to the catheter). The study has confirmed the safety and shown the coating durability in the bloodstream. References: Björling G et al., J Biomed Mater Res B Appl Biomater Nov 6; (Epub ahead of print). Adverse events Standard CVC (n=12) BIP CVC (n=22) P-value Sepsis (CLABSI) 1 0.35 Thrombo-embolism 2 0.12 All adverse events 4 0.01 Björling G et al., J Biomed Mater Res B Appl Biomater Nov 6; (Epub ahead of print).

Ex vivo study on thrombosis and hemolysis
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Ex vivo study on thrombosis and hemolysis Blood compatibility comparison with standard and CSS-CVC TAT levels relatively to blood control Author, year Vafa Homann et al. 2015 Journal J or Biomaterial Research B: Applied biomaterials Patients 23 healthy volunteers Design Ex vivo Methods Human blood was examined for compatibility parameters with BIP CVC and standard CVC in the Chandlers-loop model Primary outcome TAT formation (surrogate marker for activation of coagulation) Other Platelet count, fibrin deposition, complement system activation, Haemolysis (haemolytic index) *Chlorhexidine Silver Sulfadiazine CVC Standard CVC Bactiguard coated CVC TAT µg/L Excellent blood compatibility shown in ex vivo study The blood compatibility is excellent, with reduced risk for thrombosis compared to standard catheters. Thrombin-Anti-Thrombin (TAT) complex depends on activation of coagulation and was used as a marker for thrombotic risk in the study above. Also, a reduced risk of haemolysis compared to chlorhexidine coated CVCs was observed in this ex vivo study. According to ASTM F standard, haemolytic index 0–2% is classified as “nonhaemolytic” 2–5% as “slightly haemolytic” and >5% as “haemolytic”. Uncoated CVC (n=43) BIP CVC (n=38) *p<0.02 Vafa Homann et al Improved Ex vivo blood compatibility of Central Venous Catheters with noble metal coating. J of Biomaterial Research Karolinska Institute, Danderyd Hospital, Bactiguard

Ex vivo study on thrombosis and hemolysis
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Ex vivo study on thrombosis and hemolysis Blood compatibility comparison with standard and CSS-CVC 2. BIP CVC 3. ARROW 1. Uncoated Haemolytic grades haemolytic >5% slightly haemolytic 2-5% nonhaemolytic 0-2% Uncoated CVC (n=23) BIP CVC (n=29) CSS-CVC (n=3) p<0.001 (CSS-CVC vs uncoated CVC and BIP CVC) Haemolytic index (%) May lead to anemia. Anemia is one of the most commonly encountered abnormal laboratory findings in intensive care unit (ICU) patients, and many ICU patients will receive a blood transfusion during their ICU stay. In the study the Chlorhexidine-Silver-Sulfadiazine coated CVC (CSS-CVC) was found to be haemolytic. 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

Difference in payer costs: standard CVC vs. BIP CVC1
The challenge | The solution | The evidence | The cost savings | The product | The conclusion The cost savings Health economy benefits Difference in payer costs: standard CVC vs. BIP CVC1 One case of CRBSI can cost up to $ to treat2,3 It is important to prevent CRBSI, since it leads to prolonged hospital stays, increased mortality, costs and use of antibiotics. According to the WHO, one case of CRBSI can cost up to USD to treat1,2. The US Centre for Disease Control and Prevention estimates that between 12 and 25% of patients who acquire CRBSI die3. BIP CVC is associated with lower length of hospital stay costs, lower treatment costs and improved patient quality of life4. For local health economic calculations, please contact your Bactiguard representative. References: Saint S. et al. Arch Intern Med. 2000; 160: Dimick JB et al. Increased resource use associated with catheter-related bloodstream infection in the surgical intensive care unit. Arch Surg 2001;136: Rello J, Ochagavia A, Sabanes E, et al. Evaluation of outcome of intravenous catheterrelated infections in critically ill patients. Am J Respir Crit Care Med 2000;162: Kluger DM, Maki DG. The relative risk of intravascular device related bloodstream infections in adults [Abstract]. In: Abstracts of the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA: American Society for Microbiology, 1999:514. 1. Saint S. et al. Arch Intern Med. 2000; 160: Dimick JB et al. Increased resource use associated with catheter-related bloodstream infection in the surgical intensive care unit. Arch Surg 2001;136: Rello J, Ochagavia A, Sabanes E, et al. Evaluation of outcome of intravenous catheter related infections in critically ill patients. Am J Respir Crit Care Med 2000;162: Kluger DM, Maki DG. The relative risk of intravascular device related bloodstream infections in adults [Abstract]. In: Abstracts of the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA: American Society for Microbiology, 1999:514.

The challenge | The solution | The evidence | The cost savings | The product | The conclusion The Product – BIP CVC Bactiguard Infection Protection Central Venous Catheter Used for administration of drugs and intravenous solutions, sample blood and for blood pressure monitoring Coated with the Bactiguard coating Made of polyurethane The Bactiguard coating is environmentally friendly and requires no special procedures for handling, use or disposal The BIP CVC is used for administration of drugs and intravenous solutions, sample blood and for blood pressure monitoring. It is made of polyurethane, coated with the Bactiguard coating and approved for use up to 30 days. The Bactiguard coating is environmentally friendly and requires no special procedures for handling, use or disposal. BIP Central Venous Catheter is coated with the Bactiguard coating and approved for use up to 30 days.

Needles Raulerson syringe Straight needle Y-valve needle
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Needles Raulerson syringe 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 some doctors. The BIP CVC with Raulerson syringe, for easier handling and insertion, is a line extension to the original product. It supports an insertion method used in many countries for example in the middle east, where young doctors are trained using this procedure. Straight needle Y-valve needle

Soft tip and kink resistant guidewire
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Soft tip and kink resistant guidewire The superior geometric soft tip design couple with unique soft blended bio-compatible material make insertion safe and easy.

The challenge | The solution | The evidence | The cost savings | The product | The conclusion BIP CVC kit components 10 9 3 1. Central Venous Catheter 2. J-guidewire (nitinol) sized to catheter 3. Introducer needle (Y-Valve or Straight) 4. Dilator, size appropriate to catheter 5. Scalpel with protective cover 6. Luer-Slip™ syringe or Raulerson syringe 5ml 7. Guidewire advancer, for one hand use 8. Suture wings and staples 9. Injection port 10. Extension line clamps 11. Needle stopper 1 6 4 5 11 8 CVCs are usually sold in different kit configurations, when the necessary components to place the catheter. Here we are looking at the BIP CVC kit containing the catheter itself with 3 injections ports and extension line clamps, a guidewire sized to the catheter, the introducer needle, the dilator sized to the catheter, the scalpel in protective cover, a 5ml syringe, the white curled guidewire advancer, the suture wing fasteners. Also included in the kit is a needle stopper, the square blue cushion like item. 2 7

Catheter lumens and sizes
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Catheter lumens and sizes 1 Lumen Lumen Lumen Lumen 14G > 16G Gauge Central venous catheters in general, but also the BIP CVC, are available with different number of lumens that are surrounded by the catheter itself which is the part that is inserted into the patients blood stream. Multiple lumen catheters hence provide multiple access channels to the central venous circulation through a single insertion site, permitting several functions to be performed simultaneously. Which number of lumen the doctor choses is depending on the specific treatment the individual patient needs. If for example only venous pressure needs to be monitored, a 1-Lumen catheter is enough. If the patient also needs nutrition, blood sampling or administration of medication a multi-lumen catheter is used. At the bottom you can see how the different lumen can be designed within the catheter. The aim for the manufacturer is to have as many lumens as possible within a certain catheter outer diameter, while still allowing the walls to be strong enough to withstand the pressure of fluids going through. The internal diameter is mesured in Gauge which is an inverted unit of measure, meaning that 14G is larger than 16G for example.

The article number reveals the size
The challenge | The solution | The evidence | The cost savings | The product | The conclusion The article number reveals the size Example: CVN 7 French 3 Lumen 20 cm (Length) The article numbers of the products reveal the size, in this example we have a 7 French – 3Lumen- 20 cm long catheter.

CVC Market and competitor overview
The challenge | The solution | The evidence | The cost savings | The product | The conclusion CVC Market and competitor overview Company Product Coating Type Clinical evidence Blood comp. Teleflex Arrow g+ard Blue Arrow g+ard Blue Plus* Chlorhexidine + silver sulphadiazine (*Plus version has coating on inside and outside) Antiseptic Cook Medical Spectrum Glide Minocycline/Rifampin Antibiotic B Braun Certofix Protect Polyhexanide + polyethylene glycol and polymethacrylate Anti-colonization Vygon MultiCath Expert Silver MultiStar+ Rifampicin + Milconazole Bactiguard BIP CVC Noble metal alloy Strong Medium Weak The coating technologies available today are of different kinds, they can either be antiseptic – meaning killing off microbes with different substances such as chlorhexidine, antibiotic coated or have an anticolonization mechanism such as the Bactiguard coating preventing biofilm formation following microbial adhesion. Some products have strong evidence on reducing infections, whereas many others have none at all. In general the published evidence for coated CVCs in battling infections is accepted in the health care professional community and they are commonly used already today. Teleflex with its Arrow g+ard Blue line of products have good evidence on infection reduction, but on the other hand there is data suggesting poor blood compatibility. We will address this more in the advanced course of BIP CVC. Cook Medical is another known producer of antibiotic coated CVCs, that in the short term can show effect on infections. But we know well by now that overuse of antibiotics should be avoided! B Braun and Vygon have hardly any published clinical evidence on infection reduction. B Braun only show in vitro data in their brochures, which is a clear indication of not having any real clinical data. As for Bactiguard you know the evidence available which is of good quality, showing reductions by 52% but the downside is that this study is older. That is why we continue to strive to build our evidence base, and new studies including BIP CVC are already in advanced planning stage. We should however not diminish what we have, a well designed randomized independent study showing great results on infection prevention. And in addition what already now sets Bactiguard apart from the rest, is that we have published data on excellent blood compatibility. Another strong selling point!

Summary BIP CVC No adverse events Designed to reduce CRBSI
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Summary BIP CVC No adverse events associated with the coating have been reported Designed to reduce CRBSI Very good blood compatibility with regards to thrombosis and hemolysis More than 160 millions Bactiguard products have been sold since 1995. A large amount of clinical test and studies have been performed involving over patients. No adverse events have been reported related to the coating.

Arrow g+ard Blue toxicology – kills mice
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Arrow g+ard Blue toxicology – kills mice Edwards Vantex CVC In corresponding ISO test, none of the animals in BIP CVC group shown abnormal clinical signs indicative of toxicity during the 72 hour test BIP CVC Edwards White Paper: Biocompatibility Assessment of Edwards Vantex Central Venous Catheter with Oligon Material vs. Chlorhexidine and Silver Sulfadiazine (Antiseptic) Coated Central Venous Catheter. Vantex CVC Whitepaper 03 Written by: Jeffrey M. Lohre, M.A. Edwards Lifesciences LLC, John W. Sagartz, D.V.M., Diplomate, A.C.V.P.

Arrow g+ard Blue vs BIP CVC
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Arrow g+ard Blue vs BIP CVC Arrow g+ard Blue CVC BIP CVC Chlorhexidine and silver-sulphadiazine Noble metals Releases silver sulphadiazine and chlorhexidine  kills bacteria The effect diminishes with time Surface mechanism preventing bacterial adhesion The effect persistent over time Kills human cells / triggers inflammatory response Potential safety issue Proven safe & tissue friendly Several cases of anaphylactic shock reported Recognized Serious safety issue - MHRA warning6 and FDA warning5 No adverse events related to the coating The table is a side by side comparison to Arrow g+ard Blue, a commonly used CVC with chlorhexidine and silver coating. Jee R, Nel L et al,. Four cases of anaphylaxis to chlorhexidine impregnated central venous catheters: a case cluster or the tip of the iceberg? Br J Anaesth Oct;103(4):614-5 Stephens, R., et al., Two episodes of life-threatening anaphylaxis in the same patient to a chlorhexidine-sulphadiazine-coated central venous catheter. Br J Anaesth, (2): p Oda, T., et al., Anaphylactic shock induced by an antiseptic-coated central venous [correction of nervous] catheter. Anesthesiology, (5): p FDA adverse event database MHRA medical device alert, all medical devices containing chlorohexidine, Weng M et al. Life-threatening anaphylactic shock due to chlorhexidine on the central venous catheter: a case series. Int J Clin Exp Med Dec 15;7(12):5930-6

Bactiguard Infection Protection Endotracheal Tube
BIP ETT & ETT Evac Bactiguard Infection Protection Endotracheal Tube BIP ETT Designed to: Reduce VAP Reduce use of antibiotics Reduce healthcare costs

Definition of Ventilated Associated Pneumonia
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Where does HAI occur? Ventilated Associated Pneumonia (VAP) is the second most common nosocomial infection in the ICU and is estimated to occur in up to 25% of the patients1,2,3 Mortality directly attributable to VAP is estimated to be as high as 30-50%4,5 Definition of Ventilated Associated Pneumonia Intubated >2 days Fever, Leucocytosis, Purulent secretions, Infiltrate on chest x-ray The green coloured pie charts illustrate the areas in the body, most exposed to HAI. The data is from the USA in this chart, but can be applied to most of the developed countries. Despite a limited and relatively short life-sustaining treatment with an ETT, many patients develop an infection in the upper or lower respiratory tract; Ventilator Associated Tracheobronchitis (VAT) or Ventilator Associated Pneumonia (VAP). VAP is a common and very serious HAI of the respiratory tract that can affect intubated patients. It is the second most common nosocomial infection in the ICU and is estimated to occur in up to 25% of the patients. Mortality directly attributable to VAP is estimated to be as high as 30-50%. 1. Ibrahim EH et al. Chest. 2001;120(2): Craven DE et al. Infect. 1996;11(1): Rello J et al. Chest. 2002;122(6): Kollef MH et al. Chest. 2005; 128 (6): Stijn Blot et al. Critcal Care Medicine, March (2014) 42:3.

The challenge | The solution | The evidence | The cost savings | The product | The conclusion Main causes of VAP Intubation with an ETT is by far the most important risk factor to develop a VAP Intubation Impaired clearance of secretions Development of a biofilm Subglottic secretion Intubation During the intubation itself, the risk for microaspiration is high. Impaired clearance of secretions Intubation is a violation of natural defense mechanisms such as the cough reflex, which otherwise protects the lungs from secretions from the upper respiratory tract. Development of a biofilm Microbial adhesion on both the inside and the outside of the tube resulting in biofilm formation. Subglottic secretions Secretions that accumulate above the cuff represent an ideal growth medium for microbes. The contaminated secretions might trickle down the sides of the cuff into the lower respiratory tract

VAP Prevention Keep the head of the patient’s bed raised
The challenge | The solution | The evidence | The cost savings | The product | The conclusion 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 mucosae 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 addressing with our coating.

The efficacy In vitro data BIP ETT In vitro test
The challenge | The solution | The evidence | The cost savings | The product | The conclusion The efficacy In vitro data BIP ETT Uncoated surface In vitro test The reduction of microbial adhesion to and colonization on the device surfaces has been verified for different microbial strains, using an in vitro test. The test evaluates the adhesion of gram-positive and gram-negative bacteria to the device surfaces. These strains encounter for a large proportion of VAP infections. You expose pieces of product with and without coating and incubate, then you wash them and count the bacteria that have adhered and compare the results. Bactiguard coated surface Source: Data on file

Reduced incidence of VAP in RCT
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Reduced incidence of VAP in RCT Author, year Tincu et al. 2015 Journal Poster, Euroanesthesia Number of patients 100 Patients Toxicology ICU (drug-poisoning) Design RCT (Prospective, randomized, controlled, independent) Site Bucharest Clinical Emergency Hospital, Bucharest Primary endpoint VAP Other Microbiology, Antibiotic use, Length of stay -67% In a prospective, randomized and independent clinical study14, Tincu et al. on compared a standard uncoated endotracheal tube with the BIP ETT on 100 patients suffering from drug poisoning. The VAP rate was 24 cases / 1000 ventilation days (6 patients) in the standard group and 8 cases / 1000 ventilation days (2 patients) in BIP ETT group. The incidence of ventilator associated pneumonia was reduced by 67% (p=0.14). Staphylococcus aureus and Pseudomonas aeruginosa were the most frequent causes of infections followed by Acinetobacter baumanii and Klebsiella pneumonia. Tincu R et al.Poster Euroanasthesia June (2015) 32.

Oral in vivo study of bacterial colonization
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Oral in vivo study of bacterial colonization Author Bactiguard Journal Data on file Number of patients 40 Patients Healthy volunteers Design In vivo human study, single-blinded, randomized Site Stockholm, Sweden Primary endpoint Microbial colonization Other Exposure 2h, colonization confirmed by Ahearn test -67% In an in vivo human study on a total of 40 volunteers, an average reduction of 40% in microbial colonization was observed after 2 hours exposure of uncoated ETT and BIP ETT to oral mouth flora (p<0,001 in Wilcoxon Rank Sum test). Data on file

Difference in payer costs: standard ETT vs. BIP ETT1
The challenge | The solution | The evidence | The cost savings | The product | The conclusion The cost savings Health economy benefits Difference in payer costs: standard ETT vs. BIP ETT1 The attributable cost for a VAP infection is estimated to $ per case2,3 On average a patient with VAP stays additional 6.1 days in the ICU and 11.5 days in hospital4 ETT costs Treatment costs (antibiotics + diagnostics) Hospital stay costs Cost savings It is important to prevent CRBSI, since it leads to prolonged hospital stays, increased mortality, costs and use of antibiotics. According to the WHO, one case of CRBSI can cost up to USD to treat1,2. The US Centre for Disease Control and Prevention estimates that between 12 and 25% of patients who acquire CRBSI die3. BIP CVC is associated with lower length of hospital stay costs, lower treatment costs and improved patient quality of life4. For local health economic calculations, please contact your Bactiguard representative. References: 1. Dimick JB et al. Increased resource use associated with catheter-related bloodstream infection in the surgical intensive care unit. Arch Surg 2001;136: Rello J, Ochagavia A, Sabanes E, et al. Evaluation of outcome of intravenous catheter-related infections in critically ill patients. Am J Respir Crit Care Med 2000;162: Kluger DM, Maki DG. The relative risk of intravascular device related bloodstream infections in adults [Abstract]. In: Abstracts of the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA: American Society for Microbiology, 1999: Saint S. et al. Arch Intern Med. 2000; 160: Alpesh Amin. Clinical and Economic Consequences of Ventilator-Associated Pneumonia. Clinical Infectious Diseases 2009; 49:S36–43. Hugonnet S et al. Impact of ventilatorassociated pneumonia on resource utilization and patient outcome.Infection Control and Hospital Epidemiology, 2004, 25:1090–1096. Safdar N et al. Clinical and economic consequences of ventilator-associated pneumonia: a systematic review.Critical Care Medicine, 2005, 33:2184–2193. Rello J, Ollendorf DA, Oster G, et al. Epidemiology and outcomes of ventilator-associated pneumonia in a large US database. Chest 2002;122:2115–21.

BIP ETT product features
The challenge | The solution | The evidence | The cost savings | The product | The conclusion BIP ETT product features Available with or without an evacuation lumen; BIP ETT Evac and BIP ETT Coated with the Bactiguard coating on both the inside and outside of the tube The beveled tip, Murphy Eye and high volume-low pressure cuff are designed to minimize the risk of damages to the trachea and ensure safe usage Free from phthalates (DEHP and others) The BIP ETT Evac combines the VAP reducing feature of subglottic secretion drainage with Bactiguards infection prevention technology BIP ETT is made of phthalate-free PVC and coated with the Bactiguard coating on both the inside and outside of the tube. The beveled tip, Murphy Eye and high volume-low pressure cuff are designed to minimize the risk of damages to the patient’s trachea and ensure safe usage. The Bactiguard coating is environmentally friendly and requires no special procedures for handling, use or disposal. Bactiguard’s endotracheal tube is available with or without an evacuation lumen; BIP ETT Evac and BIP ETT. Bactiguard coating on both the inside and outside of the tube Subglottic secretion drainage (SSD) Meta-analysis of randomized, controlled studies have consequently shown reduction of VAP with approximately 50% when using tubes with subglottic secretion drainage. The BIP ETT Evac combines the known VAP reducing feature of subglottic secretion drainage with the ability of the Bactiguard noble metal alloy coating to reduce microbial adhesion and prevention of biofilm formation.

ETT Competitor Overview
The challenge | The solution | The evidence | The cost savings | The product | The conclusion ETT Competitor Overview Product Company Coated Evacuation lumen Specialty cuff Clinical claims / evidence available? Claims based on own studies? Agento® IC Bard Yes – Silver No VAP was reduced by 36% for those that received the AGENTO® I.C. silver-coated ETT. Yes TaperGuard™ (Evac) Covidien (Mallinckrodt) This technology has been shown to reduce VAP by an average of 50% in multiple studies over the last decade. Yes – (Muscadere et al 2011 systematic review) SACETT™ Smiths Medical (Portex) Continous subglottic secretion has been shown to reduce the incidence of VAP No – based on Mallinckrodt ISIS HVT™ Teleflex (Rusch) Drainage of the subglottic secretions has been demonstrated as an effective strategy in reducing early-onset VAP BIP ETT Bactiguard No – indirectly via bacterial adhesion reduction. One clinical trial available * Tincu et al 2015 This table gives you an overview of the most common competitors – we suggest to download it and make sure you understand your own competitive environment in your country. Strong clinical evidence (large and/or multiple RCT, recent) Weak evidence (few studies, old data) No clinical evidence **One clinical trial available, but Evac proven to work

Summary BIP ETT Proven safe in clinical trials Designed to reduce VAP
The challenge | The solution | The evidence | The cost savings | The product | The conclusion Summary BIP ETT Proven safe in clinical trials Designed to reduce VAP Available with/without subglottic drainage More than 160 millions Bactiguard products have been sold since 1995. A large amount of clinical test and studies have been performed involving over patients. No adverse events have been reported related to the coating.

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