Deltex Medical Regulatory News (DEMG)

15 Jan 2007 09:31

Deltex Medical Group PLC15 January 2007 Deltex Medical Group plc First sales of SupraQTM and CardioQTM monitors into maternity units 15 January 2007 Deltex Medical Group plc ('Deltex Medical' or the 'Company'),the UK's leading haemodynamic monitoring company, today announces the firstsales of its SupraQ and CardioQ monitors into maternity units. The monitors were acquired by five hospitals in London and the South-East ofEngland. They are to be used to develop protocols for their usage on mothers andtheir babies before, during and after birth. Following an evaluation phase, aseries of randomised controlled clinical trials will be undertaken using thedevices. The project is being coordinated by the team at the Royal Free Hospitalin London which has successfully used the SupraQ as a research tool in a numberof important trials in an obstetric setting over the last four years. The maternity applications for which the CardioQ and SupraQ monitors are beingevaluated include: • caesarean sections; there are about 120,000 caesareans each year in the NHS in England and Wales and nearly one in six of these involve complications. The doctors plan to test the role of the SupraQ as a routine monitor for all these patients and determine which patients should have a CardioQ oesophageal probe placed and at what stage. • post-operative monitoring of mothers in critical care; a small but significant proportion of mothers end up in critical care after giving birth having suffered heavy blood loss and are likely to benefit from minimally or non-invasive monitoring of their circulating blood volume. • neo-natal intensive care monitoring; the CardioQ's KDP probes are currently labelled for use on babies of 3kg or over and this project will determine the clinical need to develop the probes for use on smaller (premature) babies. • monitoring of mothers in labour; assessment of the SupraQ for both higher risk patients (pre-eclampsia etc) and as a basic standard of care (for example as an earlier indicator of risk to the baby than provided by foetal heart rate monitoring). Deltex Medical's chief executive, Andy Hill, commented: "These contracts represent the first use of our monitoring technology in theobstetrics market and our largest commercial sales to date of the SupraQmonitor. The SupraQ is entirely non-invasive, ideal for use on awake patientsand allows doctors to make early interventions. We expect the SupraQ tosignificantly expand the routine clinical applications of flow-basedhaemodynamic monitoring. Concluding these sales in the year just ended was an important development inits own right. The related evaluation and research projects are a majordevelopment as they have the potential to significantly expand over time theexisting market for the CardioQ and to establish a clearly defined market forthe entirely non-invasive SupraQ. Our approach to this new market is designed tomove as quickly as possible from proof of concept to establishing our technologyas a standard of care for a large population of patients." For further information, please contact:- Deltex Medical Group plc 01243 774 837 Nigel Keen, Chairman nk@deltexmedical.comAndy Hill, Chief Executive ah@deltexmedical.comEwan Phillips, Finance Director ep@deltexmedical.com Gavin Anderson & Company 0207 554 1400 Deborah Walter dwalter@gavinanderson.co.ukRobert Speed rspeed@gavinanderson.co.uk Charles Stanley Securities 020 7149 6457Philip Davies philip.davies@csysecurities.com Notes for Editors Deltex Medical manufactures and markets the CardioQ monitor, which usesdisposable ultra-sound probes inserted into the oesophagus to determine theamount of blood being pumped around the body - 'circulating blood volume'.Reduced circulating blood volume is known as hypovolaemia, which leads toinsufficient oxygen being delivered to the organs. This causes medicalcomplications including peripheral and major organ failure which can lead todeath. Hypovolaemia, which is akin to severe dehydration, affects virtuallyevery patient having surgery because of the combined effects of pre-operativestarvation, the impact of the anaesthetic agents and trauma from the surgeryitself. Using fluids and drugs, guided by the CardioQ, to optimise the amount ofcirculating blood significantly reduces post-operative complications allowingpatients to make a faster, more complete recovery and return home earlier. The CardioQ incorporates the Company's proprietary software and a smalldiameter, easy-to-use, minimally invasive, disposable oesophageal probe that isused for transmitting and receiving an ultra-sound signal. By using thistechnology, the CardioQ provides clinicians with the ability to haemodynamicallyoptimise critically ill patients and those undergoing routine moderate to majorsurgery through the controlled administration of fluid and drugs. Haemodynamicoptimisation has been scientifically proven to improve the speed and quality ofpatient recovery and reduce hospital stay. There are already over 1,250 CardioQs currently in use in hospitals worldwideand distribution arrangements are in place in over 30 countries. In addition,there are currently more than 90 clinical publications on the use of the CardioQwhich have repeatedly:- • Validated the results of the Monitor against known standards for measuring cardiac output, demonstrating that the technology works • Proved that the CardioQ works in a wide range of surgical procedures • Demonstrated that the Company's technology provides significant health and economic benefits by helping to reduce post-operative complications and length of hospital stays by an average of 30 to 40 per cent for a wide range of patients. The SupraQ is an entirely non-invasive device which uses an ultrasound probeheld at the base of the patient's neck to track the flow of blood in the aorta;it presents the same data as the CardioQ in a similar format and is used fortaking snapshots or monitoring over short periods. This information is provided by RNS The company news service from the London Stock Exchange