1. IRMA TRUpoint Creatinine Cartridge Field Launch

2. 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

3. CR Cartridge Specifications
Methodology:
Enzymatic reaction (Substrate Specific Electrode)
Typical Precision (Blood):
Level 1 Level 2
Mean:
SD:
%CV 6.1% %
Range
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

4. 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: weeks
February 9, 2006
Business Confidential

5. 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;
February 9, 2006
Business Confidential

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. IRMA Creatinine Product Codes
February 9, 2006
Business Confidential

18. Business Confidential
Sales Brochure
February 9, 2006
Business Confidential

19. Creatinine Cartridge Procedure
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

20. 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

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

22. 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
Instructions provided with bottle CMS (CLIA) and CAP requirements
Implementation
Every 6 month
February 9, 2006
Business Confidential

23. 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

24. 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

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

26. 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 to save settings and restore them.
February 9, 2006
Business Confidential

27. 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

28. 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