Reimbursement Coverage in USA

Deltex Medical Group PLC 27 February 2007 Deltex Medical Group plc Oesophageal Doppler Monitoring recommended for reimbursement coverage in USA 27 February 2007 Deltex Medical Group plc ('Deltex Medical' or the 'Company'), the UK's leading haemodynamic monitoring company, today announces that oesophageal Doppler monitoring has been recommended for reimbursement coverage in the United States. The Deltex Medical CardioQ system is the most widely used oesophageal Doppler monitor in the world. The Centers for Medicare & Medicaid Services (CMS), the government body responsible for determining coverage for the reimbursement of medical technologies in the USA, yesterday published a favourable draft decision memo based on an application originally submitted by Deltex Medical in mid-2006. This application sought to reverse an existing national non-coverage determination that oesophageal Doppler monitoring had no proven clinical benefit. This determination was made before Deltex Medical's CardioQ technology and the clinical evidence supporting its use was available. This pre-existing determination effectively precluded any reimbursement for the use of the CardioQ in the USA. The draft decision memo is available for review at: www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=196 Under its due process CMS is obliged to publish the final decision memo not more than sixty days after a thirty-day public consultation period that started 26 February. Only after this period will the process of negotiating the level of reimbursement begin that, when complete, will enable hospitals and physicians to make formal reimbursement claims. If a technology is 'covered' it is possible for hospitals to receive a payment (reimbursement) that covers the costs associated with the purchase and use of that technology. In some cases coverage will also allow a physician to be personally reimbursed for the time and skill required to use a particular technology. While a positive coverage determination does not absolutely guarantee that reimbursement will be granted or, if it is, that it will be at an adequate level, it is all but impossible for reimbursement to be granted without a positive coverage determination being in place. Deltex Medical's chief executive, Andy Hill, commented: 'This draft decision represents an important milestone in the development of our US business. Securing reimbursement for a new medical technology is the single most important step in establishing it as a standard of care in the world's largest market for medical equipment. The decision was based on a CMS-commissioned Technology Assessment - an extensive, independently conducted analysis of the existing body of clinical data related to the use of oesophageal Doppler monitoring. All the data reviewed in the Technology Assessment was from clinical trials undertaken using Deltex Medical's products. The assessment states that using the CardioQ 'during surgery effectively reduces total complications and length of hospital stay'.' For further information, please contact:- Deltex Medical Group plc 01243 774 837 Nigel Keen, Chairman njk@deltexmedical.com Andy Hill, Chief Executive ahill@deltexmedical.com Ewan Phillips, Finance Director eap@deltexmedical.com Gavin Anderson & Company 0207 554 1400 Deborah Walter dwalter@gavinanderson.co.uk Robert Speed rspeed@gavinanderson.co.uk Charles Stanley Securities 020 7149 6457 Philip Davies philip.davies@csysecurities.com Notes for Editors Deltex Medical manufactures and markets the CardioQ monitor, which uses disposable ultra-sound probes inserted into the oesophagus to determine the amount of blood being pumped around the body - 'circulating blood volume'. Reduced circulating blood volume is known as hypovolaemia, which leads to insufficient oxygen being delivered to the organs. This causes medical complications including peripheral and major organ failure which can lead to death. Hypovolaemia, which is akin to severe dehydration, affects virtually every patient having surgery because of the combined effects of pre-operative starvation, the impact of the anaesthetic agents and trauma from the surgery itself. Using fluids and drugs, guided by the CardioQ, to optimise the amount of circulating blood significantly reduces post-operative complications allowing patients to make a faster, more complete recovery and return home earlier. The CardioQ incorporates the Company's proprietary software and a small diameter, easy-to-use, minimally invasive, disposable oesophageal probe that is used for transmitting and receiving an ultra-sound signal. By using this technology, the CardioQ provides clinicians with the ability to haemodynamically optimise critically ill patients and those undergoing routine moderate to major surgery through the controlled administration of fluid and drugs. Haemodynamic optimisation has been scientifically proven to improve the speed and quality of patient recovery and reduce hospital stay. There are already over 1,250 CardioQs currently in use in hospitals worldwide and distribution arrangements are in place in over 30 countries. In addition, there are currently more than 90 clinical publications on the use of the CardioQ which 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 probe held 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 for taking snapshots or monitoring over short periods. This information is provided by RNS The company news service from the London Stock Exchange
UK 100

Latest directors dealings