DIALYSIS SOLUTIONS INC.PCRRT ConferenceOrlando, FL

June 20th, 2008

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

Bicarbonate( n = 61)

Lactate( n = 56)

P value

Plasma Bicarbonate (mmol/l)

23.7 + 0.4 21.8 + 0.5 < 0.01

Blood Lactate (mg/dl)

17.4 + 8.5 28.7 + 10.4 < 0.05

IV Bicarb given over 24 hrs

13 + 7 68 + 39 < 0.01

CVVH: Bicarb vs LactateBarenbrock M et al, Kid Int 58:1951-1957, 2000

Dark bar = Bicarb Light bar = lactate

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.

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

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

Therapy Evolution

• Diffusion based dialysis requiring device or combination product approved solutions

• Citrate • Hemofiltration dialysis requiring drug approved

solutions• Volume

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

Normocarb HF

•Dialysate vs. Hemofiltration Solution

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

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

Normocarb HF

• Simple Preparation• Maximum Flexibility

– Potassium can be added.– Calcium can be added– Dextrose can be added