IRMA TRUpoint Creatinine Cartridge Field Launch

Business Confidential Product Description The IRMA TRUpoint Creatinine (CR) Cartridge is a point-of-care test for the direct measurement of creatinine in whole blood. Each CR Cartridge is pre-packaged with a liquid calibrant in the luer cap. Similar to the Glucose and H4 calibration cap. February 9, 2006 Business Confidential

CR Cartridge Specifications Methodology: Enzymatic reaction (Substrate Specific Electrode) Typical Precision (Blood): Level 1 Level 2 Mean: 1.5 8.2 SD: 0.09 0.46 %CV 6.1% 5.6% Range 0.2 - 12 mg/dL Shelf life: Maximum: 8 weeks Average international dating: (4-7 weeks) Storage: Shipped overnight with cool packs, pre-cleared thru customs Requires refrigeration (2-8) upon arrival February 9, 2006 Business Confidential

Business Confidential Creatinine Controls 6 syringes per box 3 – Level 1 3 – Level 2 1.5 mL LQC per syringe Refrigerate (2 - 8 C) Shelf life: Maximum - 3 months Average international field dating: 5-10 weeks February 9, 2006 Business Confidential

Business Confidential Why Test Creatinine? More than 10% of hospital-acquired renal failure is contrast-media induced.1 Contrast induced renal failure (nephropathy) is a common complication of radiographic procedures. Elimination of contrast media in renal compromised patients is prolonged. This leads to longer exposure of the kidneys to contrast agents. G. Merten, MD; et al. Prevention of Contrast-Induced Nephropathy with Sodium Bicarbonate. JAMA.2004;291;2328-2334. February 9, 2006 Business Confidential

Business Confidential Why Test Creatinine? To minimize risk of nephropathy many hospitals: Prescreen patients Perform a creatinine test Administer prophylactic treatment February 9, 2006 Business Confidential

Why Test Creatinine at the POC? Obtain immediate results at the bedside Intercede in therapy sooner Potentially improve patient throughput and satisfaction Potentially reduce hospital costs February 9, 2006 Business Confidential

CR Cartridge Value Proposition The IRMA TRUpoint Creatinine Cartridge provides timely results which can enable earlier interventions resulting in improved patient care, utilization of resources and patient triage. February 9, 2006 Business Confidential

Business Confidential Target Market ED or Radiology Department: Clinical decision making for injecting contrast during radiological procedures Critical in low end (<2 mg/dL ) due to potential for ATN- Acute Tubular Necrosis Diagnostic and Interventional Catheterization Lab Oncology Units Potentially anywhere that contrast media is administered. February 9, 2006 Business Confidential

IRMA TRUpoint Performance Clinical trials were held at 3 US sites, the following were observations from these studies: IRMA TRUpoint had: Excellent agreement with reference methodologies Intra-lot consistency Was clinically acceptable and met requirements for a POC device. The IRMA TRUpoint Creatinine showed 80-99% clinical agreement vs other methodologies. i-STAT, VITROS, Beckman, Jaffe Creatinine, Enzymatic Creatinine February 9, 2006 Business Confidential

Business Confidential Performance-Betas Data from Betas comparing IRMA to other methods Excellent correlation to reference method Customer correlation features makes it even better February 9, 2006 Business Confidential

Business Confidential Competition Laboratory Chemistry Analyzers (Many manufacturers) VITROS, Beckman, Abbott, Olympus, Hitachi most common Systems have different methodologies Jaffe Kinetic Jaffe Rate Blank Jaffe Substrate Specific Electrode (SSE) Near Patient Nova Bedside i-STAT February 9, 2006 Business Confidential

Competition-Key Differences i-STAT Calibration after sample is added Sample port is open/biohazards Instrument is not self contained No print out or direct download capabilities Interferences Lack of custom correlation factor NOVA High acquisition cost for a dedicated unit Maintenance associated with bench tops May have issues with high CV’s CAP surveys February 9, 2006 Business Confidential

Comparison ITC vs i-STAT i-STAT and ITC dating is similar While i-STAT may have some advantages with test time and storage, the beta sites indicated that ITC’s performance was superior! Additionally, IRMA TRUpoint has the custom correlation feature which enables correlation to the laboratory reference method. February 9, 2006 Business Confidential

Competitive Differences i-STAT lists the following as creatinine assay interferences: Sarcosine N-acetylcysteine These drugs have been tested and found NOT to effect on the IRMA TRUpoint creatinine assay. N-Acetylcysteine is administered to patients who require imaging contrast media and who have borderline renal function. Binds the contrast material to inhibit the nephrotoxicity. February 9, 2006 Business Confidential

Creatinine Product Additions The following are new product additions to the IRMA TRUpoint price list: Product Creatinine Cartridge Creatinine Controls Creatinine AMR Solution (linearity solution) IRMA TRUpoint Creatinine Ready Units Creatinine Upgrade February 9, 2006 Business Confidential

IRMA Creatinine Product Codes February 9, 2006 Business Confidential

Business Confidential Sales Brochure February 9, 2006 Business Confidential

Creatinine Cartridge Procedure 1 2 3 4 Insert cartridge When instructed, press Cal cap to dispense calibration solution Remove finger After successful calibration, remove Cal cap and inject sample February 9, 2006 Business Confidential

Temperature Requirements Storage Refrigerate upon arrival (2-8C) Not shipped refrigerated Remove from refrigerator prior to use 15 minutes to 8 hours Use within 15 minutes of opening package If removed from refrigerator for 8 hours and not used, discard, do not re-refrigerate February 9, 2006 Business Confidential

Business Confidential Implementation Linearity Kit Troubleshooting Hardware/Software Other cartridge changes February 9, 2006 Business Confidential

Business Confidential Linearity Analytical Measurement Range Testing ITC Creatinine AMR kit and protocol 3 mL vial of 500 mg/dL creatinine spiking solution Product Code 083000 Instructions provided with bottle CMS (CLIA) and CAP requirements Implementation Every 6 month February 9, 2006 Business Confidential

Troubleshooting Erroneous Results High Air bubble Insufficient sample volume Issues causing an abnormally low Hct Low Clot within sample Issues causing an abnormally high Hct February 9, 2006 Business Confidential

Creatinine Edge Connector New “Creatinine” edge connector required for all Creatinine customers. Creatinine edge connector labeling on the interior upper side of the edge connector. Cr edge connector must be matched with new hardware (board) and new v 6.2 software for compatibility. Not backward compatible. February 9, 2006 Business Confidential

Temperature Card Non-Creatinine Temperature Card P/N 432001 February 9, 2006 Business Confidential

Business Confidential Software Information New units will have IRMA 6.2 Software Customers upgrading units: Results and settings do not transfer Lose all your settings. Use DeviceSet 1.2.3, product code 464218 to save settings and restore them. February 9, 2006 Business Confidential

Business Confidential ITC Field Upgrade Form Completed Upgrade Form and sign Send to customer service with po. Form must be received by Customer Services before RMA is issued. February 9, 2006 Business Confidential

Business Confidential To be discussed/added Upgrade program process Riming Forms Promotions???? Pull/leverage into current capital promo Expectations/managing inventory with refrigeration February 9, 2006 Business Confidential