Profile: Home Diagnostics, Inc. (HDIX.O)

Home Diagnostics, Inc. (HDI), incorporated in 1985, develops, manufactures and markets of blood glucose monitoring systems and disposable supplies for people with diabetes worldwide. HDI partners with food and drug retailers, mass merchandisers, distributors, mail service providers and third-party payors in the United States and internationally to deliver its products to people with diabetes. The Company markets its products under its own brands, including TRUEresult, TRUE2go, TRUEtest, TRUEtrack, Sidekick, TRUEread and Prestige IQ, and under a co-branded format through which HDI adds its customers’ store brand name to its brand name products. HDI also markets its products to managed care organizations including health plans and pharmacy benefits managers (PBMs) for inclusion on formularies, which are lists of approved products from which the insured or member and their physicians can choose, and granting of preferred product status by health plans.

Blood Glucose Monitoring Systems

The TRUEresult, which was introduced in September 2008, is a no-coding system that offers one of the challenges for blood glucose testers is the calibration of test strips to the blood glucose monitor being used. Calibration is required to ensure that the monitor provides an accurate reading, but can be time consuming and cumbersome for patients with limited dexterity. The Company has developed its own on-strip coding technology, (TRUEtest on-strip coding technology) to provide the user convenience and testing accuracy.

The TRUE2go monitor uses TRUEtest strips and automatically calibrates the system, which makes testing easier and faster for users. TRUE2go requires a blood sample of 0.5 microliters and provides results in four seconds. The TRUE2go has a 99 test memory and provides alternate site testing.

The TRUEtrack blood glucose monitoring system has a memory system capable of storing 365 test results. It also has data uploading capability, a display and capillary action test strips. An audible fill detection sensor lets the user know when enough blood has been drawn. Test results are provided in 10 seconds. TRUEtrack requires only a 1.0 microliter blood sample size and can be used on an alternate testing site.

The Sidekick is HDI's all-in-one, disposable blood glucose monitoring system that combines a vial of 50 test strips with a blood glucose monitor. The design of the Sidekick features the monitor built into the flip-top cap of the strip vial. Its microchip was developed exclusively for HDI by Texas Instruments. The system is portable and can be discarded when the last test strip is used. The Sidekick is pre-coded and requires no user coding procedure, uses 1.0 microliters of blood, and can be used on an alternate testing site. The Sidekick capillary action test strips feature a chemical formulation that provides test results in less than 10 seconds. A fill detection sensor lets the user know when enough blood has been drawn.

The TRUEread blood glucose monitoring system was launched in March of 2007. TRUEread has a 1.0 microliter blood sample requirement and provides test results in 10 seconds. In addition, the meter can hold up to 200 tests in its memory and has uploading data management capabilities. An audible fill detection sensor lets the user know when enough blood has been drawn and can be used on an alternate test site. TRUEread is exclusively available to Medicare and Medicaid customers in the mail service and distribution channels.

Prestige IQ offers a large display with test strips. Given its features, the Prestige IQ is suitable for patients with dexterity or visual limitations. The test strip requires a 4.0 microliter blood sample size. The Prestige IQ offers a 365 test memory and data uploading capabilities.

Other Products

HDI's other products include TrackRecordDMS, Gentle Draw lancing device, single-use sterile lancet, and disposable ketone urinary test strips. TrackRecordDMS, for diabetes management, is a stand-alone optional data management software accessory supplied in compact disc (CD) format for use with the TRUEtrack, TRUEread and Prestige IQ Smart System meters. The software is installed onto a personal computer (PC) and the blood glucose meter is connected to the PC via a data cable. When used with TRUEtrack, TRUEread or Prestige IQ meters, TrackRecord DMS permits the management of blood glucose data transferred from the meter memory to the computer for enhanced data management capability. Software application features include data management for single at-home patient use and multiple-patient use for the healthcare professional in the clinical setting. Users can input patient healthcare and identification (ID) information, and select date range, glucose units, target glucose ranges, and meal time blocks.

The Gentle Draw lancing device enables people with diabetes to obtain a blood sample for a blood glucose test. It features five depth settings to ensure optimum skin penetration. It is lightweight, portable and easy to use and features quick lancet insertion and disposal. HDI markets this product through its distribution partners in a co-branded format.

The sterile lancet fits most lancing devices and is easy to use. Its lancet cap provides safe disposal after use and its performance is comparable to that of repeat usage lancets. HDI markets this product through its partners in a co-branded format.

HDI's disposable urinary test strips are used to test ketone levels in urine. People with diabetes monitor ketone levels because high ketone measurements can lead to a complication called ketoacidosis, which can result in coma. The Company sells ketone test strips in 50 or 100 strip count packages. The test features a 15 second test time.

HDI competes with Bayer Corp., LifeScan, Inc., a division of Johnson & Johnson, the MediSense, Inc. and TheraSense, Inc. divisions of Abbott Laboratories and Roche Ltd.