Deltex Medical Regulatory News (DEMG)

3 May 2007 10:25

Deltex Medical Group PLC03 May 2007 Deltex Medical Group plc ('Deltex Medical' / 'Company') Results of Annual General Meeting/Trading Update 3 May 2007: Deltex Medical Group plc ('Deltex Medical' or the 'Company'), theUK's leading haemodynamic monitoring company today held its Annual GeneralMeeting. All resolutions put to shareholders at the meeting were passed. Thefollowing is the text of a statement made at the meeting by the Company'schairman, Nigel Keen. "Progress in the first four months of 2007 has continued to reflect the growinginterest from anaesthetists, surgeons and hospital managers to establish use ofDeltex Medical's CardioQ(TM) oesophageal Doppler monitor (ODM) as a standard ofcare in the treatment of patients undergoing major surgery or in intensive care.Sales in both our major direct markets, the UK and the USA, were ahead of lastyear in both the first quarter and in April. It is particularly encouraging thatthere have been early but clear signs that the growth rate from our US businesshas increased. Sales through our distributor partners into International marketsare also growing satisfactorily. As expected, growth in all our markets isquickest in the operating theatre where ODM is the only intra-operativehaemodynamic monitoring technology demonstrated in randomised controlled trialsto reduce post-operative complications and consequently shorten lengths ofhospital stay. Fast-track or enhanced recovery surgical programmes that aim to incorporateevidence-based medicine into clearly defined treatment protocols are beingestablished in continental Europe, the UK and the USA. The CardioQ has a centralrole to play in delivering the goals of these programmes. In April, UniversityCollege London Hospital (UCLH) announced that it had embarked on theimplementation of its Enhanced Surgical Treatment and Recovery Programme(ESTREP). This programme, initially targeted at patients undergoing bowelsurgery, is planned to become standard clinical practice for all patientsundergoing major surgery at UCLH. Use of the CardioQ as a standard of care forTargeted Volume Management is a key component in this programme. Other influential teaching hospitals, as well as a number of District GeneralHospitals, throughout the UK are at various stages of planning or actualimplementation of similar programmes, again with an initial focus mainly onbowel surgery. It is increasingly well recognised that adoption of the CardioQis an essential step in the successful introduction of these programmes. The aimof these new surgical care programmes is to improve outcomes and reduce lengthof hospital stay for all patients undergoing major surgery, and establish newstandards of care that are centred on evidence-based best practice. In February in the USA the Centers for Medicare & Medicaid Services (CMS), thebody responsible for healthcare provision to the elderly and poor, published aproposed recommendation that ODM be covered for reimbursement when used in theMedicare and Medicaid patient population. Insurers and other healthcare paymentorganisations generally follow CMS's lead and are likely to provide coverage indue course. A final decision is due to be published within the next month. Whilecoverage does not absolutely guarantee reimbursement to the physician for thetime and skill required to manage patients using ODM, it is most unlikely thatsuch reimbursement would be granted in the absence of a positive coveragedetermination. The CMS draft decision is a major step on the path toestablishing ODM as a standard of care in the USA. The CMS decision was based on a health technology assessment commissioned fromthe US Government Agency for Healthcare Research and Quality (AHRQ). This healthtechnology assessment undertook a detailed and rigorous review of the publishedliterature concerning ODM and the unique body of randomised, controlled clinicaltrial data associated with ODM technology. The assessment concluded that 'Doppler-guided fluid replacement during surgeryleads to a clinically significant reduction in major complications'; that'Doppler-guided fluid replacement during surgery leads to a clinicallysignificant reduction in the total number of complications'; and that'Doppler-monitored fluid replacement leads to a reduction in hospital stay'.AHRQ assessed the evidence for these conclusions to be strong - in this context,'strong' means that 'it is highly unlikely that new evidence will lead to achange in this conclusion'. Early in 2007 we reported that the US military were to embark on an evaluationof the CardioQ in wounded soldiers being treated at a combat support hospital inIraq. We can confirm that patients have begun to be treated using ODM and thatvaluable information on optimal fluid therapy in this environment has alreadybeen gained. We are currently working with a number of US hospitals, including twoinstitutions rated as among the top 10 US hospitals*, to support theimplementation of routine use of the CardioQ in major surgery. These projectsinvolve multi-disciplinary teams developing protocols to ensure consistentpatient care and represent the establishment of Targeted Volume Management as astandard of care in the US. In our International business, we are seeing clear benefits from therestructuring of our trading relationships with our key European distributors inthe first half of 2006. Our sales of probes to distributors are now much moreclosely linked to underlying usage rates in hospitals. Increased adoption of theCardioQ in many individual countries is feeding through to steady growth in oursales. In Germany, at the Charite Hospital in Berlin, doctors have been working withthe CardioQ in their fast-track colorectal surgery programme and in patientsundergoing spinal surgery. We are currently working with the hospital to developand support an implementation programme for wide-scale usage in all majorsurgery. As well as being one of Germany's leading teaching hospitals, theCharite is also closely involved in setting the standards for intra-operativecare for a leading multi-site pan-European fast-track surgery programme. Our new product development activities are centred on broadening the markets forour technology by making it more suitable for use in awake patients and outsidecritical care wards and operating theatres. We have passed important developmentmilestones with both the wholly non-invasive SupraQO monitor and an enhancedoesophageal probe. The board looks forward to continued progress throughout the remainder of 2007and beyond". End *U.S. News & World Report list of the United States' best hospitals, as preparedby the National Opinion Research Center at the University of Chicago For further information, please contact:- Deltex Medical Group plc 01243 774 837Nigel Keen, Chairman njk@deltexmedical.comAndy Hill, Chief Executive ahill@deltexmedical.comEwan Phillips, Finance Director eap@deltexmedical.com Gavin Anderson & Company 020 7554 1400Deborah Walter dwalter@gavinanderson.co.ukRobert Speed rspeed@gavinanderson.co.uk Charles Stanley Securities 020 7149 6457Philip Davies philip.davies@csysecurities.comRussell Cook russell.cook@csysecurities.com Notes for Editors Deltex Medical manufactures and markets the CardioQ(TM) 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(TM) 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