Deltex Medical Regulatory News (DEMG)

12 Jan 2006 07:00

Deltex Medical Group PLC12 January 2006 Deltex Medical Group plc Pre-close update on the year ended 31 December 2005 12 January 2006 Deltex Medical Group plc ('Deltex Medical' or the 'Company'),the AIM listed haemodynamic monitoring company, today announces an update onprogress in the year ended 31 December 2005. During 2005 the Company made significant progress towards its goal ofestablishing the use of its CardioQTM system as a standard of care in themonitoring and management of patients undergoing major surgery. As a result, thedirectors anticipate that sales for the year will be in excess of £3.0 millionwhich is within the range of market expectations. In the UK, the number of doctors wanting to use Deltex Medical's technologycontinued to grow rapidly as did the number of clinical settings in which theCardioQ system has been shown to be both cost effective and clinicallybeneficial to the patients doctors are treating. Sales continued to growsteadily in the UK, although at a far slower rate than clinical demand duemostly to the very difficult financial management challenges facing many NHShospitals. Over 80% of the growth in UK sales came from probe sales andmaintenance cover. In the middle of the year, and somewhat later than originally anticipated, theImproving Surgical Outcomes Group (ISOG) published a pamphlet outlining a rangeof proposals for improving surgical patient care in the UK that have at theirheart the routine use of haemodynamic optimisation to reduce complications andhospital stay. ISOG, an independent group of leading anaesthetists, intensivistsand surgeons, enjoys widespread support and is working with policy makers,health service managers and industry to achieve its aims. The Company has been working closely with a group of surgeons in northern Europeand the UK who are leading the world in improving the quality of large bowelsurgery, primarily in cancer patients, through the Enhanced Recovery AfterSurgery (ERAS) project. A number of surgeons that follow the ERAS approach haveasked that their patients be treated using the CardioQ following presentation ofexcellent results in these patients by surgeons from the Freeman Hospital inNewcastle. It is hoped that haemodynamic optimisation will become established asa standard element of the ERAS approach in the future. In the US, sales of CardioQ monitors were significantly ahead of prior years andincluded the purchase of four units by the William Beaumont Army Hospital in ElPaso, Texas for use in the intensive care unit and in patients undergoingelective or emergency surgery in the operating room. These sales and theincreasing awareness of the need for better, earlier and safer haemodynamicmonitoring in the US perhaps represent the first signs of real growth in thismarket. In Europe, the Company has been working with a leading French doctor to developthe protocol for the first multi-centred, randomised clinical trial into theeffects of haemodynamic optimisation, using the CardioQ, in patients undergoingsurgery for repair of a fractured hip. This clinical trial, which has beenapproved by the French authorities, will be the first to treat sufficientpatients to show an impact on death rates. Patient enrolment is scheduled tostart in the second quarter of 2006. The sale of three of the Company's wholly non-invasive monitor, the SupraQTM,to the Medway Hospital in Gillingham marks the successful completion of thefirst phase of this research and development project. The Company will beworking closely with doctors at the Medway Hospital to undertake furtherclinical research using these devices and as part of the second phase ofdevelopment work that will lead to a second-generation system for mass-marketuse. Actual cash consumption in the second half of the year was, as expected,significantly lower than at any time in the Company's history. The Directorsbelieve that the Company has sufficient cash resources to see it through toprofitability. Nigel Keen, Deltex Medical's Chairman, commented: "Early in 2005 we configured the Company to ensure that we would have sufficientcash resources available to reach profitability, irrespective of the ability ofdoctors in our home market to secure the funding they need to purchase ourproducts. Given the situation facing the UK NHS, that decision has proved to beprudent. Nevertheless, we have seen good progress this year, with those doctorsthat have ready access to CardioQs using them on more and more patients as userconfidence and experience grows. "There are early and encouraging signs real progress in a number of Europeancountries where we have not long had a presence and in the US market too. I lookforward to seeing further progress towards our goals in 2006." For further information, please contact:- Deltex Medical Group plc 01243 774 837Nigel Keen, Chairman nigel.keen@deltexmedical.comAndy Hill, Chief Executive andy.hill@deltexmedical.comEwan Phillips, Finance Director ewan.phillips@deltexmedical.com Financial Dynamics 0207 831 3113David Yates david.Yates@fd.comJohn Gilbert john.gilbert@fd.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 amountof circulating 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. This information is provided by RNS The company news service from the London Stock Exchange