Medisys announces that Hypoguard has received notification from the US Food and Drug Administration (the "FDA") that the Dart blood glucose monitoring system has been cleared for marketing. Dart, which has been trademarked under the Hypoguard Advance name, is the first of the Group’s family of next generation, biosensor based blood glucose monitoring systems. The 510(k) application for Dart was submitted for FDA review in December 2001.

Hypoguard develops and distributes diagnostic products for the worldwide diabetes monitoring market, which is estimated to be worth more than $3.5 billion per annum. The company’s research and development efforts have been focused on developing innovative monitoring systems, designed to promote the ease with which a diabetic can monitor his or her condition, based upon Hypoguard’s own proprietary biosensor. The biosensor at the heart of these next generation blood glucose systems delivers significant advantages to the patient in terms of rapid read time, small blood sample size and convenience.

The Advance glucose monitoring system utilises the latest in 16-bit technology, a convenient meter design incorporating a large, easily read digital display and date and time stamping. The meter also features a data management capability which can store up to 100 test readings, 14 day test averaging and a computer download capability. Market launch of the Advance system is expected to take place before the end of the Group’s current financial year.

In line with Hypoguard’s strategy, the family of next generation blood glucose monitoring products, which includes Advance and the Flight and Quiver products detailed below, will be targeted at the retail sector and private label opportunities with leading US retailers.

The Advance meter and biosensor strips will be produced by sub contract manufacturers based in the Far East and in the UK respectively. Both manufacturing partners have been selected based upon their demonstrated ability to achieve high volume production and consistently high quality standards.

Progress continues to be made on the development of Flight, the 100-test disposable glucose monitoring product, which uses the same biosensor as that used in the Advance system. Flight is a fully integrated glucose testing system which does not require the user to handle the test strips, a process which can be difficult as diabetics often have limited dexterity. Additionally, Flight does not require the test strips to be calibrated against the testing meter, again making the product more user friendly. Flight is directed towards the growing population of Type II diabetics, who test less frequently, but represent the highest growth segment of the market. Development of the Quiver system, which combines a high functionality re-usable meter utilising biosensor strips packed in convenient clip-in disposable cartridges, is also progressing well. Marketing opportunities for the Flight and Quiver systems are already being actively pursued. The Group believes that the Flight and Quiver products offer unique attributes in terms of their functionality making them particularly attractive to the retail and private label sectors.

David Wong, Chief Executive Officer, commented: "US market clearance for our Advance product is a milestone in the development of our Hypoguard business. I believe that we have now validated our in-house developed biosensor, which is the core technology used for our family of next generation products including Flight and Quiver. We look forward to an early market launch of Advance in the retail sector. The launch represents the first stage of our strategy of introducing our new products into the US market, which is the largest glucose monitoring market in the world."

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