BIP Foley Catheter

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

Do you recognize any of this? The catheters needs to be changed earlier than expected due to problems? Cloudy urine? Recurring UTIs with certain patients? The staff needs to rinse the catheter? Do you recognize these challenges? What problems do you mostly see with your patients? Smelly urine? Crystals on the catheter? Clogging catheters?

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

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

In vitro data BIP Foley Catheter This is the most recent in vitro data, showing that BIP Foley catheters reduce ESBL producing Klebsiella bacteria. *MRSA tested for Silicone only

Reduction of biofilm in clinical use 37 long term catheterized urological-surgical patients (>30 days) 58% reduction of biofilm occurrence on BIP Foleys BIP Foley Catheter Standard Foley No of patients 18 19 Biofilm 6 (33%) 15 (79%) Mazzoli S.*, Meacci F.*, Cai T.§, Bartoletti R. *STDs Center, Santa Maria Annunziata Hospital, ASL 10 Florence, Italy Urology Unit, Santa Maria Annunziata Hospital, University of Florence, Florence, Italy Poster, “Eurobiofilms 2009” conference, Rome (Sept 02-05, 2009).

Clinical evidence BIP Foley Catheter Author (year) Type of study Number of patients Site # days catheterized Incidence-reduction (p value) Aljohi A (2016) RCT 60 ICU, Saudi Arabia 3 90% (p=0.006) Hidalgo F (2015) 116 Cardiology, Spain 4 mean 38% (p=0.037) Lederer (2014) Before-after 853 7 hospitals, hospital-wide, US 8 mean 58% (p<0.0001) Pickard (2012) 1224* 24 hospitals, surgical care, UK 3-10 days* 19%* (p=0.157) Seymour (2006) 117 One acute general hospital, UK > 2 days 71% Gentry (2005) 133 Medical and surgical wards, US 7-10 days 34% Newton (2002) 1757 Burn unit ICU, US 5-8 days 32% (p=0.029) These are the 6 studies that give the weighted average of 36%. They have been selected by us in colloboration with KOLS as they comply with the stricter critera from CDC since 2009: Peer-reviewed studies Measure symptomatic CAUTI (sCAUTI) specifically, not a mix of asymptomatic and symptomatic >2 days catheterization time in majority of patients As you can see there is a spread, so dependent on study design, baseline of infection incidence and patient population amongs other things you may get different results. * 4241 in total, including patients catheterized for 1-2 days Weighted average 36% These peer-reviewed studies: Measure symptomatic CAUTI (sCAUTI), not bacteriuria Majority of patients >2 days catheterized Aljohi AA, et al, Urol Ann 2016;8:423-9. Hidalgo F et al, Enferm Intensiva 2015; 26(2):54-62 Lederer JW et al, J WOCN 2014; 41(5):1-8 Pickard et al, The Lancet, Nov 5, 2012 Seymour C, British Journal of Nursing, 2006; 15(11): 598-603 Gentry H et al, Nursing Standard. 2005; 19, 50, 51-54 NewtonT et al, Infection Control and Hospital Epidemiology; 2002; 23(1): 217-8

Clinical evidence Foleys 150 million Foley catheters have been used since 1995 No adverse events have been reported, associated with the coating 36% of weighted average reduction is proven in clincial studies of symptomatic CAUTI (catheter associated urinary tract infections), but in some studies up to 90% Permanent catheter Several reports of successful patient cases with permanently catheterized patients As Bactiguard coated Foleys have been used since 1995 in the USA, the products are well documented and studied. In fact approximately 50% of all Foley catheters used in the USA today are coated with Bactiguard. 130 millions of those have been sold since 1995. A large amount of clinical test and studies have been performed involving over 100 000 patients. No adverse events have been reported related to the coating. Most studies related to Bactiguard coating are made with Foleys, where you can see an weighted average reduction of 33%. But on certain patient groups, the reduction can be up to 70%. The studies we have used to calculate this average are the more high qualitative studies meaning they are peer-reviewed, they look specifically at symptomatic CAUTI (in line with the CDC guidelines updated in 2009 to disregard bacteremia since it is not treated) and include majority of patients having a catheter more than 2 days (which corresponds to our recommendation on which patient to use it on). In addition to this, the largest study on 28 000 patients showed a reduciton of 32% in both symptomatic and asymptomatic CAUTI and reduction of urosepsis by 44% Even though the BIP technolgoy is primarily a preventive method, there are also patient cases on permantly catheterized patients that have been ”cured” from their UTI (during the study period) when using a BIP Foley. One case as been publised (Estores, USA) and a second case from Sweden will be published shortly.

Cost savings with BIP Foley Catheter BIP Foley Catheter has been shown to reduce CAUTI in a cost effective way. The costs savings are present in a wide variety of reimbursement systems1,2,3. Several health economic evaluations have been conducted in Europe and USA12,16,17. In one of these, a large, prospective, randomized study of almost 28 000 patients, Bactiguard coated catheters were shown to offer significant annual cost savings when considering the excess cost of CAUTI1. In another 2-year prospective surveillance study of 10 patient care units, the introduction of a Bactiguard coated urinary catheter was associated with a significant decline in CAUTI and led to reduced costs2. BIP Foley Catheters are associated with lower length of hospital stay costs, treatment costs and improved patient quality of life1. The graph to the right is based on a Bactiguard health economy model using Saint et al. 20003. 1. Karchmer TB et al, Arch Intern Med. 2000 Nov 27;160(21):3294–8 2. Rupp ME et al. AJIC. 2004; 32(8):445-450 3. Saint S. et al. Arch Intern Med. 2000; 160:2670-2675 Saint S. et al. Arch Intern Med. 2000; 160:2670-2675

BIP Foley Catheter features Bactiguard coating inside and outside Hydrophilic coating for less friction at insertion Approved for up to 90 days use Material: Latex or Silicone core Transurethral or suprapubic use Tissue friendly and safe for patient use 2-way and 3-way catheters The BIP Foley Catheter is approved for use during 90 days, and is available in a range of sizes in both latex and silicone. Except for the Bactiguard coating they are also coated with a hydrophilic coating to ease insertion. The BIP technology is proven tissue friendly and safe for patient use, due to its low levels of metals and its mechanism of action. Hydrophilic coating Bactiguard-coating Latex/Silicone material

Pre-wetting BIP Foley Catheter 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. Pre-wett the catheter with sterile water or NaCI before inserting the catheter

BIP Foley Catheter patient segments The risk of CAUTI increases with every day the patient has a catheter BIP Foley Catheter is recommended for patients who require a catheter >2 days Such patient segments include, but is not exclusive to: ICU patients – critically ill Neurological patients Stroke Dementia Spinal cord injured Urology patients Prostate cancer Bladder cancer, BPH/TURP Other chronically catheterized patients Immunosuppressed patients As the risk for infections increase with every day the patients carries the catheter, and biofilm formation takes at least approximately 48 hours – we recommende BIP Foley Catheters for patients expected to have the catheter for more than two days. Which patient segements in your care unit has a Foley >2 days? These are some patient segments that we have identfied through published date, expert interviews with over 60 doctors and data from the Swedish healthcare system considering prevalence of UTI, average catherization time and sensibility to infections.

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