Homosense, Inc., incorporated in March 1997, develops, manufactures and sells hand-held blood coagulation monitoring systems for use by patients and healthcare professionals in the management of warfarin medication. The Company's product, the INRatio System, measures the patient's blood clotting time to ensure that patients with a propensity to form clots are maintained within the therapeutic range with the proper dosage of oral anticoagulant therapy. The INRatio System consists of a small, hand-held meter and disposable test strips with integrated, laboratory-like quality control tests that are designed to assure the accuracy of prothrombin time/international normalized ratio (PT/INR) test results. Homosense's system is cleared by the United States Food and Drug Administration (FDA) for use by healthcare professionals, as well as for patient self testing. The INRatio System is targeted to both the professional, or point-of-care market, as well as the patient self-testing market. INRatio Meter The INRatio meter contains a heater, digital user interface and electronic components that measure the changes in resistance or impedance in a blood sample during the coagulation process. The INRatio meter performs a series of self-diagnostic tests every time the device is turned on to ensure the proper functioning of its components. The meter has three buttons that control all of its functions and has a screen, on which instructions and results are clearly displayed. The meter has the ability to store up to 60 PT/INR test results and contains a data port for interfacing with an optional printer. The meter is powered by four AA batteries and has an optional external air conditioning (A/C) adapter. The user can choose to display messages in any of 10 languages programmed into the meter. INRatio Disposable Test Strips, INRatio Accessories The INRatio disposable test strips use the Company's electrochemical technology to measure a patient's PT/INR value and perform two laboratory-like quality control tests on a single test strip with a single drop, or approximately 15 microliters, of blood. The two quality control tests confirm standard PT/INR readings for the normal lower range, or low control, and the therapeutic upper range, or high control. This helps ensure that the meter and test strip are functioning properly and that the patient's PT/INR test result will be accurate. The meter and a single test strip automatically perform all three tests each time a patient's blood sample is applied to a test strip that has been inserted into the meter. When the INRatio meter detects an unacceptable quality control test result, it does not display a potentially incorrect PT/INR test result, but rather alerts the user to the error. Homosense designed its test strips with on-board quality control tests and its meter with built-in electronic diagnostic tests to help ensure the accuracy of test results and to simplify the process by eliminating the need to use specialized control test liquids and additional test strips to obtain quality control test measurements. INRatio test strips can only be used with the INRatio meter. The Company includes all accessories needed for the use of the INRatio System in the patient self testing and point-of-care environments, such as lancets. Homosense competes with Roche Diagnostics and International Technidyne Corporation.

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