1. The Kalypto Medical NPD 1000 NPWT System - Device andDressing Technology

2. The Kalypto Medical NPD 1000 was designed specifically to address the needs of the mobile wound patient that was underserved by existing technology. 3. Reminder NPWT Operating Principles Wound contact to put in/on wound Adhesive-backed plastic sheet to seal the surface Plastic tubing in dressing to deliver negative pressure and remove exudate Vacuum pump and canister to deliver pressure and hold exudate 4. Why the NPD 1000 is what it is Fact #1: Negative pressure works Fact #2: Negative pressure systems, other than Kalyptos, are not designed for mobility Heavy, with tether to line power Canisters are messy Fact #3: Many synergistic wound therapies, such as compression, are not compatible with most negative pressure dressing technologies 5. Talking about pumps is fine, but from theKalypto perspective NPWT technology startswith the dressing. Literally, the revolutionaryKalypto pumptechnology is madepossible by the dressing. 6. Kalypto Dressing Features from wound up FDA cleared wound contact layer Silverlon Proprietary non-woven absorbent layer Hydrophobic Gore membrane Proprietary hydrogel pressure sealing gasket Semi-occlusive wound cover with non-woven strengthening layer Dressing fill status windows Quick connect pigtail tubing 7. Wound Contact Layer Silverlon is a plated medical nylon Provides a large reservoir of Silver (Ag) ions, that have a bactericidal effect Minimally adherent No other NPWT product on the market has a market-proven silver functionality built-in 8. Proprietary Non Woven Layer Two fiber non-woven pad One fiber is hydrophilic (loves water) The other is super-absorbing Hydrophilic fiber wicks fluid into the pad on the outside of the fiber Super-absorbing fiber molecularly bonds fluid Locked in to the pad Mechanical force will not release fluid 9. Non- Woven contd Pad will swell as fluid is absorbed Pad will not occlude during absorption As long as the fluid output is below the capacity of the dressing, periwound maceration should not be an issue. Thus, the dressing can lay right over the wound 10. Hydrophobic Gore Membrane Similar Gore material to that found in vascular grafts and dialysis filters Keeps fluid in the dressing Keeps bacteria in the dressing Will resist water up to an applied pressure of 380 mmHg 11. Hydrogel Gasket Along with non-woven makes the Kalypto system possible adhesive leaks Creates a seal around the periphery of the wound, flows into ridges on the skin Good dressing application is indicated by a pump ON interval > 1-3 minutes Makes it possible to run the system on AA battery 12. Semi-Occlusive Cover Cover is a laminate 1) semi-occlusive polyurethane (similar other other NPWT drapes) 2)non-woven film for strength and conformability of the dressing Dressing is robust and will deploy like a bandage 13. Dressing Fill Status Windows Three windows near the pressure port to monitor the exudate traveling to the source of pressure When all three are discolored, it is time to change the dressing Ideally the wound should be distal to the port to make maximum use of the absorbing pad 14. Quick Connect Tubing Short tubing allows clinician to apply a compression wrap more easily than would be possible if the tubing were longer Limits fooling around with the pump every dressing change (such as is the case with canister based systems) 15. The Pump Smallest on the Market Operates on 3 AA alkaline batteries Backlit LCD display Pressure settings from 40 125 mmHg Pressure modes Continuous and Intermittent 6 feet of tubing with proprietary dressing connector Pump separable from controller 16. Alarms and Notifications Low battery alarm( -) approximately 30% battery life remaining (or about 1 week of normal use) Pump operational Icon ( ) upper left hand corner of display. If this icon is visible, pump is on and functioning normally. Leak Icon ( ) Indicates that the system has failed to seal for normal operation 17. Setting up a Patient Pump Configuration Expose programming buttons by sliding protective cover down Depress mode and vac simultaneously, then push the power button briefly, the system will beep and the LCD will flash Adjust settings by depressing appropriate buttons Depress power button to exit setup mode 18. Setting up a Patient Applying the Dressing After wound is cleaned and readied, make sure that the clinician cleans and dries the periwound skin, dead skin or dried slough can impact the seal Remove dressing from package and remove clear release liner and attach pigtail tubing Align dressing along wound to achieve least tortuous fit Place pad over wound and apply the center of dressing 19. Setting up a Patient Applying the Dressing Remove side wings to expose adhesive and rest of gasket Deploy carefully to minimize wrinkling of the wound cover Smooth out gasket around the wound to ensure good contact with skin Connect pump to dressing and depress power button 20. Two real world applications -- Kalypto Medical NPD 1000 System 21. Kalypto Patient w/ healed Venous insufficiency ulcer 22. Setup Comparison to Other NPWT Technologies Setup and dressing change takes less than 5 minutes Pain of dressing removal is greatly reduced No protection of periwound area necessary No assembly of custom fabricated parts System is leak-free - so troubleshooting leaks consist of pressing down the gasket, no extra taping 23. Kalyptos Advantages over other NPWT systems Quick and easy application Smaller and lighter (think radio versus laptop) No canister mess and smell contained in dressing not in pump exhaust Bacterial control on board No bacterial cross-talk in two dressing setups Dressing does not need attention in the event of a pump failure Dressing compatible with compression, offloading and other therapeutic interventions