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DIALYSIS SOLUTIONS INC.

DIALYSIS SOLUTIONS INC. PCRRT Conference Orlando, FL. June 20th, 2008. CVVH: Bicarbonate vs Lactate Barenbrock M et al, Kid Int 58:1951-1957, 2000. CVVH: Bicarb vs Lactate Barenbrock M et al, Kid Int 58:1951-1957, 2000. Dark bar = Bicarb. Light bar = lactate. Normocarb HF.

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DIALYSIS SOLUTIONS INC.

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  1. DIALYSIS SOLUTIONS INC. PCRRT Conference Orlando, FL June 20th, 2008

  2. CVVH: Bicarbonate vs LactateBarenbrock M et al, Kid Int 58:1951-1957, 2000

  3. CVVH: Bicarb vs LactateBarenbrock M et al, Kid Int 58:1951-1957, 2000 Dark bar = Bicarb Light bar = lactate

  4. Normocarb HF • CRRT SHOULD FIX METABOLIC DISTURBANCES, NOT CAUSE THEM. • Normocarb is the right formulation to provide key electrolytes in the physiologically correct concentrations with no unnecessary components and maximum flexibility.

  5. DSI Milestones • 1999 – Original Patent for NC35 applied for • 2001July – Walter O’Rourke joins as consultant • 2001 December – Normocarb receives FDA 510K approval as device • 2002January – DSI records first US sales of Normocarb • 2002 June – Pediatric Nephrology: Pediatric Hemofiltration: Normocarb Dialysate Solution with Citrate Anticoagulation; Bunchman • 2002 June – BBraun agreement signed • 2002 July – Normocarb receives Canadian DIN • 2003 June – Journal of Critical Care: A Novel Regional Citrate Anticoagulation Protocol for CRRT Using Only Commercially Available Solutions; Tobe

  6. DSI Milestones • 2003 December – AJKD: Pediatric Convective Hemofiltration: Normocarb Replacement and Citrate Anticoagulation; Bunchman • 2005 August – FDA grants Orphan Drug Status to the CRRT indication based on DSI’s application • 2006 January – FDA 510K Approval for NC25 • 2006 May – Canadian Patent issued on NC25 • 2006 July – DSI receives an NDA for NC25HF/NC35HF • 2006 November – DSI launches HF Products • 2007 August – DSI receives US patent for 25 bicarb products

  7. Therapy Evolution • Diffusion based dialysis requiring device or combination product approved solutions • Citrate • Hemofiltration dialysis requiring drug approved solutions • Volume

  8. Solution Evolution • Lactate Buffered – PD Solutions – Dialysate • Pharmacy Made – Calcium Containing – Bicarbonate Solutions – Dialysate • Citrate • Pharmacy Made – Calcium Free – Bicarbonate Solutions – Dialysate • Add Mixture Pharmacy Solutions – Calcium Free – Bicarbonate – Dialysate • Normocarb – Calcium Free – Dialysate • Normocarb NDA as hemofiltration solution for direct infusion

  9. Normocarb HF • Dialysate vs. Hemofiltration Solution

  10. Normocarb 35 HF • NC 35 HF • mEq/L • Sodium (Na) 140 • Magnesium (Mg) 1.5 • Chloride (Cl) 106.5 • Bicarbonate (HCO3) 35 • Potassium (K) 0 • Calcium (Ca) 0

  11. Normocarb 25 HF • NC 25 HF • mEq/L • Sodium (Na) 140 • Magnesium (Mg) 1.5 • Chloride (Cl) 116.5 • Bicarbonate (HCO3) 25 • Potassium (K) 0 • Calcium (Ca) 0

  12. Normocarb HF • Simple Preparation • Maximum Flexibility • Potassium can be added. • Calcium can be added • Dextrose can be added

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