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

3. CVVH: Bicarbonate vs Lactate Barenbrock M et al, Kid Int 58:1951-1957, 2000
P value
Plasma Bicarbonate (mmol/l)
< 0.01
Blood Lactate (mg/dl)
< 0.05
IV Bicarb given over 24 hrs
13 + 7

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

5. 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.

6. DSI Milestones 1999 – Original Patent for NC35 applied for
2001 July – Walter O’Rourke joins as consultant
2001 December – Normocarb receives FDA 510K approval as device
2002 January – 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

7. 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

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

9. 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

10. Dialysate vs. Hemofiltration Solution
Normocarb HF
Dialysate vs. Hemofiltration Solution

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

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

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