Deltex Medical Regulatory News (DEMG)

Deltex Medical Group plc

("Deltex Medical" or "the Company")

First results presented from Premier Burden of Illness study

19 December 2013 - Deltex Medical Group plc, the global leader in oesophageal Doppler monitoring ("ODM"), announces the first presentation of results from a key phase of its collaboration with Premier Inc.

The results showed wide variation in amounts of fluids given to patients during and after surgery in colorectal and orthopaedic surgery. Such variation strongly indicates a major opportunity to improve fluid management during surgery using ODM as well as to improve post-operative fluid management using wider enhanced recovery principles.

Julie Thacker MD, a colorectal surgeon, the medical director of the Enhanced Recovery Program at Duke University Hospital, North Carolina and an expert member of the Premier collaboration research faculty presented results from a burden of illness study at the Postgraduate Assembly in Anesthesiology ('PGA') meeting held in New York City between 13 and 17 December 2013. The study involved an interrogation of Premier's database of hospital data.

There were a total of 84,722 colon and 54,526 primary hip/knee replacement patients included in the study population originating from 524 US hospitals. Day of surgery total fluids ranged from 1,700 ml in the lowest quartile to 5,010 ml in the third quartile for colon patients and from 1,250 ml in the first quartile to 4,100 ml in the third quartile for hip/knee patients. There was also wide variation in post-operative fluids with amounts administered to colon patients ranging from 3,150 ml in the first quartile to 11,000 ml in the third quartile.

Further analyses arising from this dataset will become publicly available when presented at other major clinical meetings in 2014.

Ewan Phillips, Chief Executive of Deltex Medical, commented:

"We are pleased that we can now start to incorporate this data into our US sales and marketing activity. It demonstrates to a wider audience in the USA that there is a massive disparity in fluids given without any measurement basis, which ODM would provide. The level of variation in intravenous fluids given to patients was considerably greater than we had expected and may create opportunities for us to grow our business in the USA more rapidly than hitherto. We expect to be in a position to update shareholders on this and on progress with the Premier project early in 2014."

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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.