Deltex Medical Regulatory News (DEMG)

5 Jun 2007 07:02

Deltex Medical Group PLC05 June 2007 Deltex Medical Group plc Further update on US reimbursement coverage for oesophageal Doppler 5 June 2007 - Deltex Medical Group plc ("Deltex Medical" or "Company"), the UK'sleading haemodynamic monitoring company, today announces further details of thereimbursement status of oesophageal Doppler monitoring (ODM) and its CardioQ (TM) ODM products in the USA. The Company has confirmed with the Centers for Medicare & Medicaid Services(CMS) that, with effect from 22 May 2007, any doctor treating a CMS patient isentitled to claim reimbursement (payment for professional services) if they useoesophageal Doppler monitoring (ODM) to guide fluid delivery: • in patients in intensive care whose breathing is assisted by a ventilator; or • in patients undergoing surgery who require fluid management. CMS reached its decision because it considers using ODM on these groups ofpatients to be both "reasonable and necessary". The Company's clinical advisers have confirmed both that a significantproportion of patients treated in intensive care units in the USA are placed ona ventilator at some stage and that there is growing clinical consensus that allpatients undergoing moderate and major surgery are exposed to the sorts of fluidshifts requiring ODM-led fluid therapy; furthermore they have indicated thatthere is increasing evidence that such fluid shifts are seen in all patientsundergoing surgery of any kind under general, spinal or large regionalanaesthetic. Reimbursement rates have not yet been formalised: the process to do so typicallytakes up to 18 months. In the meantime users will individually negotiate rates. In addition to reimbursement for the treatment of elderly and poor patients, whomake up the majority of the more than 40 million people falling into theMedicare and Medicaid population, the Company expects, as is usual practice,that private insurance groups will follow CMS's lead and also agree to reimbursephysicians for the use of ODM. CMS's Acting Administer Leslie V. Norwalk commented: "(This) decision reflects CMS' commitment to using evidence-based approaches toprovide Medicare beneficiaries with reasonable and necessary medicaltechnologies as they evolve through innovation in the marketplace. As wedeveloped this decision, we used the best available medical evidence-in the formof randomized controlled clinical trials-to re-evaluate our position on thisimportant non-invasive method of caring for patients in intensive caresituations." CMS's press release on 22 May 2007 also noted that: 'In contrast to other techniques for measuring cardiac output, the probe of theesophageal Doppler can be inserted within minutes, requires minimal technicalskill, and is not associated with major complications.' Deltex Medical's Chief Executive, Andy Hill commented: "Over five million patients in the USA every year could benefit from the use ofthe CardioQ. CMS's ruling is based on overwhelming clinical evidence and clearlyconfirms that ODM should be the standard of care for guiding fluid delivery inthese patients. This decision paves the way for the USA to turn evidence-based medicine intoevidence-based practice in by making use of Deltex Medical's CardioQ routine forhaemodynamic management." 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 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