Deltex Medical Regulatory News (DEMG)

Deltex Medical Group plc

("Deltex Medical" or "the Company")

New positive study from St Thomas's hospital using CardioQ-ODM after surgery in awake patients

First formal UK dedicated trainer in place; probe sales doubled

4 July 2013 - Deltex Medical Group plc (AIM: DEMG), the global leader in oesophageal Doppler monitoring ("ODM"), which measures blood flow in real time enabling fluid level optimisation to enhance recovery after surgery and in intensive care, announces that doctors from St Thomas's hospital in London have presented positive results from the first trial to use CardioQ-ODM after major surgery in awake patients.

84 higher risk patients undergoing major elective colorectal surgery within an established enhanced recovery programme, with planned post-operative critical care admission were included in the trial. Both study and control groups had their vascular fluids managed intra-operatively with CardioQ-ODM and the study group had their fluids managed using ODM for stroke volume optimisation for a further sixteen hours post-operatively. The post-operative ODM group was found to benefit from earlier return of gastro-intestinal function (two days v four days) and had two day shorter lengths of hospital stay (11 days v 13 days).

Since the start of 2013, the anaesthetists at St Thomas's have agreed and implemented fluid management protocols for certain types of major surgery as a result of which, use of CardioQ-ODM probes has increased from around 55 patients a months to over 120 patients a month. Deltex Medical has supported this expansion by deploying a dedicated clinical trainer to work in the hospital for an average of two and a half days a week.

Ewan Phillips, Deltex Medical's Chief Executive, commented:

"These are excellent results from a world renowned London Teaching Hospital. This trial expands the evidence base for CardioQ-ODM: it shows ODM delivering additional benefit post-operatively in high risk patients in whom it has already been used during surgery. It confirms the benefits of ODM within an established enhanced recovery programme; and it shows the clinical utility and effectiveness of ODM in awake patients.

"The growth in use of our products at St Thomas's Hospital so far in 2013 means it has become one of our largest UK customers. It was one of the first hospitals to install our new CardioQ-ODM+ monitors in its operating theatres, as well as the first UK hospital in which we have formally implemented our dedicated trainer programme. "

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Notes for Editors

Deltex Medical manufactures and markets CardioQ-ODMÔ Oesophageal Doppler Monitoring ('ODM') systems. 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 technology 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 intermediate risk 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 supports its use.

Subsequent to the NICE guidance, the NHS in England announced its selection of ODM as a high impact innovation to be rolled out across the system fully, at pace and scale with significant financial penalties starting in the NHS 2013/14 financial year ending 31 March 2014.

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 2012 launch of the CardioQ-ODM+, Deltex Medical has added the Pulse Pressure Waveform Analysis ('PPWA') approach to monitoring cardiac output to ODM functionality. Doing this has improved Deltex Medical's offer for monitoring applications as well as providing doctors and nurses with a choice of clinical strategies appropriate to individual patients in different clinical settings.

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 2,800 CardioQ-ODM systems in use in hospitals worldwide. Distribution arrangements are in place in over 30 countries.