Deltex Medical Regulatory News (DEMG)

Deltex Medical Group plc

Enhanced Recovery Partnership backs wide adoption of CardioQ-ODM

3 July 2012 - Deltex Medical Group plc, the global leader in oesophageal Doppler monitoring (ODM), announces the publication of a consensus statement by the doctors leading the NHS enhanced recovery approach to major surgery on the importance of peri-operative fluid management.

The statement is based on the unanimous agreement of the eight authors who comprise the National Clinical Leads of and Specialist Advisors to the UK Government's Enhanced Recovery Partnership ('ERP') and is published in the launch edition of the journal Perioperative Medicine1.

The authors state that "Perioperative fluid management is at the heart of Enhanced Recovery and the use of intra-operative fluid management technology, such as Oesophageal Doppler, is supported by the ERP in line with the National Institute of Clinical Excellence (NICE) Guidance (MTG3 [CardioQ-ODM oesophageal Doppler monitor]), the NHS Operating Framework 2012-13 and the Department of Health Innovation Health and Wealth Review of 2011." The Innovation Review committed to "launch a national drive to get full implementation of ODM, or similar fluid management monitoring technology, into practice across the NHS".

The statement goes on to set out clear recommendations:

·; That local guidelines for intra-operative fluid management should be developed in line with national guidelines, the Innovation Health and Wealth Review and the NICE recommendations on CardioQ-ODM;

·; For identifying those cases where intra-operative fluid management technologies should be used from the outset;

·; That all anaesthetists caring for patients undergoing intermediate or major surgery should have equipment immediately available and be trained to use it; and

·; That perceived lack of resources is not a viable excuse as the NICE guidance on CardioQ-ODM "concluded that we can't afford NOT to use intra-operative fluid management technologies where indicated".

1 www.perioperativemedicinejournal.com/content/pdf/2047-0525-1-2.pdf

Ewan Phillips, Chief Executive of Deltex Medical, commented:

"Strong clinical advocacy has always been a prerequisite for changing standards of care and the Enhanced Recovery Partnership consensus statement provides it. Such robust recommendations for the system wide uptake of intra-operative fluid management monitoring technology can be made only because of the robust evidence base supporting ODM and CardioQ-ODM is the only fluid management monitoring technology recommended by NICE."

For further information, please contact:-

Deltex Medical Group plc 01243 774 837

Nigel Keen, Chairman njk@deltexmedical.com

Ewan Phillips, Chief Executive eap@deltexmedical.com

Paul Mitchell, Finance Director pjm@deltexmedical.com

Nominated Adviser & Broker

Arden Partners plc 020 7614 5900

Chris Hardie chris.hardie@arden-partners.com

Jamie Cameron jamie.cameron@arden-partners.com

Kreab Gavin Anderson 020 7074 1800

Robert Speed rspeed@kreabgavinanderson.com

Deborah Walter dwalter@kreabgavinanderson.com

Notes for Editors

Deltex Medical manufactures and markets the CardioQ-ODMÔ system. Oesophageal Doppler monitoring using the CardioQ-ODM is the only therapy to measure blood flow in the central circulation in real time. Minimally invasive, easy to set up and quick to focus, the device generates a low-frequency ultrasound signal, which is highly sensitive to changes in flow and measures them immediately. Randomised, controlled trials using Doppler have demonstrated that early fluid management intervention will reduce post-operative complications, reduce intensive care admissions, and reduce the length of hospital stay.

The CardioQ-ODM has two distinct established clinical applications: firstly, to guide fluid management during surgery and secondly, to monitor cardiac output in critical care settings.

Surgical market

In March 2011 the National Institute for Health & Clinical Excellence ('NICE') recommended that CardioQ-ODM be considered for use in patients undergoing major and high risk surgery and in high risk patients undergoing major surgery. NICE estimated the applicable number of such patients in the NHS in England alone to be over 800,000 each year. CardioQ-ODM has been shown to be effective in both elective and emergency surgery and with both general and regional anaesthetics. This recommendation was specific to CardioQ-ODM and was based on the robust evidence base that it enjoys.

The NICE evaluation and recommendation confirms that the potential global market for CardioQ-ODM in surgery includes tens of millions of patients, even if confined to developed health economies: the most conservative estimate of the potential value of the market opportunity Deltex Medical has created is in excess of £1 billion per annum. The Company's core focus is on building market leading positions in this surgical market, both geographically and by type of surgery.

Critical care market

In critical care settings, well-equipped hospitals will often have more than one cardiac output monitoring technology available. In this environment, ODM's strengths are that it is quick to set up, easy to use, safe, low cost and the ideal technology for a patient in crisis requiring rapid or frequent intervention. The potential market for cardiac output monitoring in critical care is a fraction of the size of that for intra-operative fluid management.

Through the recent launch of the CardioQ-ODM+, Deltex Medical has incorporated pulse pressure variation, the best validated parameter from the Pulse Pressure Waveform Analysis ('PPWA') approach to monitoring cardiac output. Note that, in surgery, adding PPWA parameters does not expand per se the market potential of ODM, the Company's clinical and market research indicates that it may help accelerate some clinicians' acceptance of the value of ODM measured flow variables.

Company goal

Our goal is to make oesophageal Doppler monitoring (ODM) a standard of care for patients in both these markets. We believe that, in most modern health systems, it is essential to have a robust evidence base of both clinical benefit and cost effectiveness in order to achieve system-wide adoption of a new medical technology. Deltex Medical is one of the very first medical technology companies to have completed the investment necessary to build such an evidence base: as a result, use of ODM during surgery has the proven potential to deliver both clinical and economic benefits that are material at each of patient, hospital and system level.

The Company is currently in the implementation phase of achieving this goal in a number of territories worldwide and there are already over 2,500 CardioQ-ODMs currently in use in hospitals worldwide and distribution arrangements are in place in over 30 countries.