Deltex Medical Regulatory News (DEMG)

15 Apr 2008 07:01

Deltex Medical Group PLC15 April 2008 Deltex Medical Group plc UK NHS's Centre for Evidence-based Purchasing publishes evidence review and economic assessment of oesophageal Doppler monitoring 15 April 2008 - Deltex Medical Group plc ("Deltex Medical"), the UK's leadinghaemodynamic monitoring company, today announces the results of a new report onthe CardioQ(TM) technology of oesophageal Doppler monitoring (ODM). The report is an Evidence Review by the Centre for Evidence-based Purchasing('CEP'), which is part of the Policy and Innovation Directorate of the NHSPurchasing and Supply Agency. The report is "based on evidence contained in ahigh-quality 2007 systematic review of ODM in patients during surgery andpost-operatively from the US Agency for Healthcare Research and Quality (AHRQ)":the Company notes that this is the same AHRQ review which drove the decision ofthe Centers for Medicare and Medicaid Services to cover ODM for reimbursementnationally across the USA. In respect of use during surgery, the Company's key target market for theCardioQ, the CEP report concludes: "In patients undergoing high-risk surgery, addition of ODM-guided fluidadministration to CVP monitoring plus conventional clinical assessment(comparison 1) is likely to result in fewer deaths, fewer complications, and ashorter length of hospital stay. The costs of ODM are likely to be offset byreductions in both complications and length of hospital stay (although the costsof treatments prompted by monitoring are uncertain)". The economic analysis associated with this conclusion calculates a range of perpatient equipment costs of between £65.60 per patient and £214.15 per patient(dependent on probe variant and frequency of use of the monitor). It alsocalculated a range of savings per patient from using the CardioQ of between £642and £4,441. Comparing the highest cost above with the lowest saving indicatesthat the NHS saves at least £3.00 for every £1.00 it spends on the CardioQ: thesaving rises to £67.00 for every £1.00 spent on the CardioQ if the lowest costper patient is compared to the highest benefit. CEP gives one of four verdicts to health technologies based on its evidencereviews ranging from "recommended" to "not recommended". In respect of ODM itsverdict is "significant potential", although the Company notes that CEP hasnever given any technology a higher verdict than "significant potential". The CEP report provides an early synopsis of a technology assessment reportcommissioned by the National Coordinating Centre for Health TechnologyAssessment and which is due to be published in October 2008. The CEP report isavailable at www.pasa.nhs.uk/PASAWeb/NHSprocurement/CEP. Deltex Medical's Chief Executive, Andy Hill commented: "The CEP report confirms once again the strong evidence that the CardioQsignificantly improves outcomes for large numbers of patients undergoingsurgery. This is the first UK Government commissioned economic analysis of thepotential impact of the CardioQ across the NHS and the results are stunning,with savings identified of up £4,441 per patient. This report will make itharder than ever before for the NHS to deny funding to those clinicians wishingto use the CardioQ. "We will be seeking to work closely with the report's authors over the comingmonths to provide them with whatever extra information they feel they need inorder to recommend the CardioQ be formally recognised as a standard of care for a significant proportion of the 3,000,000 NHS patients who undergo surgeryevery year." 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 0207 554 1400Deborah Walter dwalter@gavinanderson.co.ukRobert Speed rspeed@gavinanderson.co.ukStuart Macaulay smacaulay@gavinanderson.co.uk Charles Stanley Securities 020 7149 6000(Nominated Adviser)Philip 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 around 1,500 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