Nexus Medical TKO-6P Hi Visibility Anti Reflux Technology

Blood Reflux Protection 24/7!™ You deserve a partner at both ends of your catheter!

Products & Solutions Infusion Therapy Nexus TKO^®(To Keep Open) Nexus NIS^®(Nexus Injection Site)

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Nexus TKO^®-6PHV provides the same Anti-Reflux protection with the added value of a highly visible bright green band which was specifically designed to meet the special needs of Home Infusion Patients. The bright green color easily allows Home Infusion Patients to visually distinguish the Extension Set and the TKO! This safe and practical solution assists care providers in patient and family training procedure.

Nexus TKO^®-6P Hi-Visibility Anti-Reflux Technology Overview

Catheter occlusions are difficult to avoid and create unwanted complications • 25% of all central venous catheter (CVC) develop partial or full occlusions^16,17,18 • Blood can inadvertently reflux into a catheter in multiple ways • Current needle free injection sites do not effectively address the many causes of blood reflux • Blood reflux may lead to several unintended IV complications, including the following: - occlusions - infiltrations - phlebitis - costly catheter restarts - catheter-related bloodstream infections (CRBSIs) Blood reflux is the main cause of occluded catheters • Occlusions may result in delayed therapy,¹³ • Occlusions increases the risk of CRBSI’s, ^{1,2,3,4,17,18} • Occlusions created the need for catheter replacement or exchange,¹³ • Occlusions prevent blood sample from CVC/PICC catheter • When blood refluxes into a catheter there is the potential for the Clinician to force the syringe plunger forward when flushing and damage the intima of the vein wall, which may end in a complication resembling an IV infiltration. ¹⁰ Clotted Catheters are known contributors to catheter-related bloodstream infections (CRBSIs)^1,2,3,4, • 87% percentage of all bloodstream infections involve some type of IV device²¹ • Catheter occlusions lead to catheter replacement, increased risk of complications, added patient stress and risk of infection¹³ • CRBSIs are the most costly and life threatening of all healthcare-acquired infections¹³ • CRBSIs cost up to $35,000 per episode, with more than 250,000-500,000 episodes per year in the US¹³ • “Centers for Medicare and Medicaid Services (CMS) no longer reimburse hospitals for vascular catheter- associated infections (initiated October 2008)”²⁰

How The Nexus TKO^®-6P Hi-Visibility Anti-Reflux Diaphragm Works

Nexus TKO^®-6P Hi-Visibility Anti-Reflux Technology Provides Blood Reflux Protection 24/7!™ The Nexus TKO^®-6PHV Anti-Reflux diaphragm automatically opens and closes based upon fluid pressure. The TKO diaphragm opens towards the patient with fluid pressure from sources such as IV pump, syringe pump, IV bag, flushing or medication syringe are used. When the fluid pressure drops the TKO diaphragm instantly and automatically closes preventing blood reflux into the catheters.

No clamping sequence required: The Nexus TKO^® Anti-Reflux technology requires NO CHANGE in practice or clamping sequence, the device automatically provides Blood Reflux Protection 24/7!™

Our patented Tri-Seal™ design with Slit-Lock™ technology is designed into all of our Needle free devices. The Nexus TKO^®Tri-Seal™ design provides Microbial Barrier Protection 24/7!™ The Nexus TKO^®-6PHV Tri-Seal™ design with Slit-Lock™ technology has been validated with 4-separate bacteria (S. aureus, S. epidermis, E. coli, and P. aeruginosa) by an outside GLP laboratory using a 96-activation protocol over the course of 4 days.

First Level of Protection: Second Level of Protection: Third Level of Protection:

A 360° compressed seal proven to provide a safe and effective microbial barrier protection between the septum and the needle-free connector housing

A smooth, easy to disinfect septum surface, promotes a safe and effective microbial barrier.

The Slit-Lock™ septum protects the internal fluid path from microbial ingress while luer is activating

References:

“Theoretically, Blood Reflux into either the IV catheter or the needleless connector increases both the risk of occlusion and biofilm formation.” William R. Jarvis MD

Nexus TKO^®-6PHV with Power Injectable Kink-Free Microbore Tubing

Bi-Directional Flow Control 24/7!™ DOME SHAPED TKO™ Diaphragm Single Piece-Crystal Clear 3-Position

NOTE: Dome Shaped TKO Diaphragm shown in Green for Contrast & Clarity

1. Timisit JF, Missett b, Carlet J, et al. Central vein catheter-related thrombosis in intensive care patients, risk factors, and relationships with catheter-related sepsis. Chest. 1998:114(1):207-213. 2. Mehall JR, Saltzman DA, Jackson RJ, Smith SD, Fibrin sheath enhances central venous infection. Critical Care Med. 202:30(4); 908-912. 3. Raad II, Luna M, Khalil SM, Costerton JW, Lam C, Bodey GP, 4. Nakazama N. Infectious and thrombotic complications of central venous catheters. Semin Oncology Nurse, 2010:26(2) 121-131. 5. Lordick F, Hentrich M, Decker T, et al, Ultrasound screening for internal jugular vein thrombosis aids the detection of central venous catheter-related infections in patients with haemato-oncological diseases: a prospective observational study. Br J Haematol 2003;120:1073-1078. 6. Moureau N, Catheter-related infections and thrombosis: A proven relationship, Arrow, Teleflex, White Paper 2013, 7.Jasinsky RN BSN, J Wurster RN MSN, “Occlusions Reduction and Heparin Elimination Trial using an Anti-Reflux Device on Peripheral and Central Intravenous Lines”, Intravenous Nurses Society 8. S Mitch RN CRNI, B Brandmeyer RN BSN, “PICC and Midline Catheter Occlusion Rates: A Prospective Study Comparing the Interlink Split Septum Device versus Nexus TKO Split Septum Pressure Activated Anti-Reflux Diaphragm”. 9. GLP-Study, Nexus TKO^®, 96-Activation Microbial Barrier Performance Study, on file at Nexus Medical LLC, 10. Lab results on file at Nexus Medical, LLC, 11. Jarvis,W. Choosing the best design for the Intravenous needleless connection to prevent HA-BSI’s. Infection Control Today, 2010 Aug. 13. Hadaway L. Reopen the pipeline for IV therapy. Nursing. 2005; 35(8):54-61. 14. O’Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the prevention of intravascular catheter-related infections. MMWR Recomm Rep. 2002;51(RR-10):1-26. 15. Haire WD, Atkinson JB, Stephen LC, Kotulak GD, et al. Urokinase versus recombinant tissue plasminogen activator in thrombosed central venous catheters: a double- blinded, randomized trial. Thromb Haemost. 1994;72(4):543-7. 16. Deitcher S, et al. Safety and efficacy of alteplase for restoring function in occluded central venous catheters: results of the cardiovascular thrombolytic to open occluded lines trial. J Clin Oncol. 2002;20(1): 317-24. 17. Timoney JP, Malkin MG, Leone DM, Groeger JS, Heaney ML, Keefe DL, Klang M, Lucarelli CD, Muller RJ, Eng SL, Connor M, Small TN, Brown AE, Saltz LB. Safe and cost effective use of alteplase for the clearance of occluded central venous access devices, JCO. Apr 1, 2002:1918-1922; DOI:10.1200/JCO.2002.07.131. 18. Ponec D, Irwin D, Haire WD, Hill PA, Li X, McCluskey ER; COOL Investigators. Recombinant tissue plasminogen activator (alteplase) for restoration of flow in occluded central venous access devices: a double-blind placebo-controlled trial—the Cardiovascular Thrombolytic to Open Occluded Lines (COOL) efficacy trial. J Vasc Interv Radiol. 2001 Aug;12(8):951-5. 19. Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc 2006; 81:1159-71. 20. US Department of Health & Human Services, CMS Centers for Medicare & Medicaid Services. Hospital-acquired conditions (present on admission indicator). http://www.cms.hhs.gov/HospitalAcqCond/06_Hospital-Acquired%20Conditions.asp. Accessed January 10, 2008. 21. Ryder, M. Catheter-related infections: It’s all about biofilm. Topics Adv. Practice of Nursing Journal.2005 5(3)

Nexus TKO^®-6P Hi-Visibility Anti-Reflux Technology

The Nexus TKO^® (To Keep Open) Anti-Reflux technology is designed to deliver I.V. Catheter Patency 24/7!™

• Nexus TKO^® Hi-Visibility provides Blood Reflux Protection 24/7!™ • Nexus TKO^®Hi-Visibility is proven to reduce central line occlusions by up to 85%⁸ • Nexus TKO^®Hi-Visibility substantially reduces the cost of tPA (Cathflo^®) and Heparin⁸ • Nexus TKO^®Hi-Visibility diminishes the need for expensive drugs to declot PICC/CVC catheter⁸

Nexus TKO^®-6P Hi-Visibility is your proven Solution in providing IV Catheter Patency 24/7!™

Infusion Flow Rate at 40 inches 4500mL/Hour

Nexus TKO^®-6P Hi-Visibility Provides Microbial Barrier Protection 24/7!™

Nexus TKO^® technology is designed to protect both ends of your catheter. First, our TKO technology reduces blood reflux from the tip of the catheter. Second, our TKO technology provides microbial barrier protection which has been validated to 96-activations without microbial growth.

• Nexus TKO^® Anti-Reflux Technology provides protection against the costly risk of blood reflux^.7,8,9,10,11 • Nexus TKO^® is proven to reduce central line occlusions by up to 85% and at the same time eliminate Heparin flushing from the formulary.⁸ • Nexus TKO^® with its patented Tri-Seal™ design provides proven microbial barrier protection against bacterial transfer and colonization.^9,10