NovaFlux Inc CleanFlow CIP™ “The Profound Solution to Ultrapure Dialysate”

Two-Phase Flow (TPF) -- “The New Standard” TPF uses a high-velocity mixture of gas and liquid to clean narrow tubes and lumens. TPF creates shear forces 1,000 times higher than conventional liquid flow. TPF treatment Bacterial biofilm on lumen of a narrow tube Impact of TPF cleaning

Optimal Two-Phase Cleaning Liquid to Gas Ratio Velocity/Turbulence Condition of Boundary Layer and Interface Droplet Formation/Reformation Liquid Surface Tension Optimal Surface Chemistry Shear Stresses Mass Transfer Rate

Dialysate Quality Standards in Europe and USA Bacteria Count (CFU/ml) Endotoxin Level (EU/ml) AAMI Old Standard2000None AAMI New Standard*2002 ERA Current Standard** ERA Ultrapure< 0.1< 0.03 AAMI is the American Association for the Advancement of Medical Instrumentation ERA is the European Renal Association * Will be very difficult to meet in the US ** Will be extremely difficult to meet in the US

Current Construction Materials of DCWS in the United States Material of ConstructionPercentage of Dialysis Clinics (1)PVC – Schedule 80 *, ** (2) PVDF and Steel *** ~ 95 % < 5 % * PVC is not suitable for hot-water disinfection. ** PVC is attacked by O 3 at recommended treatment dose concentrations. *** PVDF and steel are suitable for hot-water pasteurization/disinfection.

Limitations of Existing Technologies (1) Current Manual Maintenance Protocols (2) Ozone Disinfection (3) Hot-water Pasteurization/Disinfection

Microbiological Results Baseline Two-phase SuccessTotalPercentSuccessTotalPercentLog oddsP value ROTO % % ROTR % % BiTO % % BiTR % % ROM % % BiM % % Dial % %

Endotoxin Concentrations BaselineTwo-phase SuccessTotalPercentSuccessTotalPercentLog oddsP value ROTR % % BiTO % % BiTR % % Dial % %

Scanning Electron Microscopy (SEM) Results Biofilm Density During Conventional Protocol (CFU/cm 2 ) Percentage Removal by TPF 6.16 x 10 7 ± 3.02 x %

CleanFlow TM CIP CleanFlow TM Clean-in-Place (CIP) System Components: – CleanFlow TM CIP Device – Oil-less Compressor – Chemicals : Peracetic Acid, Acetic Acid, and CleanFlow TM Cleaning Solution. Application: CleanFlow TM cleans and disinfects the central dialysis water system, including: RO Loop, Bicarbonate Loop, Central Dialysate Loop and Connection Tubing to Dialysis Machines. Fully Automated: Cleaning/Disinfection in about 1-2 hours Eliminates: Biofilm, Endotoxin, and Planktonic Bacteria Proven to deliver Ultra-Pure Fluid for Dialysis Patients

CleanFlow TM CIP Features Reduces Labor and Maintenance Costs Eradicates biofilm and bacteria Eliminates endotoxin Cleans all water system internal surfaces Fully-automated Process Usable with all piping materials: PVC, PVDF, and Stainless Steel Can deliver Ultrapure Dialysate

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NovaFlux Inc CleanFlow CIP™ “The Profound Solution to Ultrapure Dialysate”