Presentation on theme: "1 IRMA TRUpoint Creatinine Cartridge Field Launch."— Presentation transcript:
1 IRMA TRUpoint Creatinine Cartridge Field Launch
February 9, 2006Business ConfidentialPage 2 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. Product Description
February 9, 2006Business ConfidentialPage 3 Methodology: –Enzymatic reaction (Substrate Specific Electrode) Typical Precision (Blood): Level 1Level 2 Mean: SD: %CV 6.1% 5.6% 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 CR Cartridge Specifications
February 9, 2006Business ConfidentialPage 4 Creatinine Controls 6 syringes per box 3 – Level 1 3 – Level mL LQC per syringe Refrigerate (2 - 8 C) Shelf life: Maximum - 3 months Average international field dating: 5-10 weeks
February 9, 2006Business ConfidentialPage 5 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. 1.G. Merten, MD; et al. Prevention of Contrast-Induced Nephropathy with Sodium Bicarbonate. JAMA.2004;291;
February 9, 2006Business ConfidentialPage 6 Why Test Creatinine? To minimize risk of nephropathy many hospitals: –Prescreen patients –Perform a creatinine test –Administer prophylactic treatment
February 9, 2006Business ConfidentialPage 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, 2006Business ConfidentialPage 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, 2006Business ConfidentialPage 9 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, 2006Business ConfidentialPage 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, 2006Business ConfidentialPage 11 Performance-Betas Data from Betas comparing IRMA to other methods Excellent correlation to reference method Customer correlation features makes it even better
February 9, 2006Business ConfidentialPage 12 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, 2006Business ConfidentialPage 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 CVs CAP surveys
February 9, 2006Business ConfidentialPage 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 ITCs performance was superior! Additionally, IRMA TRUpoint has the custom correlation feature which enables correlation to the laboratory reference method.
February 9, 2006Business ConfidentialPage 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, 2006Business ConfidentialPage 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, 2006Business ConfidentialPage 17 IRMA Creatinine Product Codes
February 9, 2006Business ConfidentialPage 18 Sales Brochure
February 9, 2006Business ConfidentialPage 19 Creatinine Cartridge Procedure 1.Insert cartridge 2.When instructed, press Cal cap to dispense calibration solution 3.Remove finger 4.After successful calibration, remove Cal cap and inject sample
February 9, 2006Business ConfidentialPage 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, 2006Business ConfidentialPage 21 Implementation Linearity Kit Troubleshooting Hardware/Software Other cartridge changes
February 9, 2006Business ConfidentialPage 22 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, 2006Business ConfidentialPage 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, 2006Business ConfidentialPage 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, 2006Business ConfidentialPage 25 Temperature Card Non-Creatinine Temperature Card P/N Creatinine Temperature Card P/N
February 9, 2006Business ConfidentialPage 26 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, 2006Business ConfidentialPage 27 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, 2006Business ConfidentialPage 28 To be discussed/added Upgrade program process –Riming –Forms Promotions???? –Pull/leverage into current capital promo Expectations/managing inventory with refrigeration