Deltex Medical Regulatory News (DEMG)

Deltex Medical Group plc

("Deltex Medical" or "the Company")

New clinical guidelines for anaesthetists issued for fluid management in France

30 May 2013 - Deltex Medical Group plc (AIM: DEMG), the global leader in oesophageal Doppler monitoring ("ODM"), today announces that the professional body for anaesthetists in France - Société Française d'Anesthésie et de Réanimation ('SFAR') has published new guidelines setting out recommended fluid management best practice for its members.

The SFAR guidelines make it clear that ODM-guided fluid management should be used in all high risk surgery in France. This is estimated to cover circa 750,000 patients a year, of which only about one percent are currently treated with ODM despite it being a market leading technology for IOFM in France. In France clinical guidelines such as these are the key driver behind wide scale changes in clinical practice and, therefore, accelerated adoption of medical technologies. The Company's distributor in France has expanded its clinical training team this year and established an additional hospital training centre. Deltex Medical is providing further support in the South of France from its Spanish office.

The key recommendations in respect of Intra-Operative Fluid Management ('IOFM') monitoring are:

1. Titration of fluids guided by measuring stroke volume ('SV') in order to reduce post operative morbidity and length of hospital stay

2. stop filling if SV does not increase

3. reassess SV regularly and its response to a fluid challenge especially during periods of haemodynamic instability

All of these recommendations are graded in the highest category '1+', meaning that SFAR members are expected to comply because the evidence level is high, and that future evidence is unlikely to change the conclusions from the current evidence. In France clinical guidelines from professional societies determine the standards expected of their members based on clinical benefit.

The recommendations are based on the oesophageal Doppler monitoring ("ODM") evidence and the guidelines make it clear that this evidence should not be assumed to apply to alternative technologies.

The recommendations apply to all high risk surgery, defined as surgery with an increased risk of post-operative complications due to either the health of the patient or the nature of the surgery, typically this excludes minor day-case surgery and surgery lasting less than two hours with low levels of post-operative complication.

See http://www.sfar.org/_docs/articles/RFEremplissage-SFAR2012.pdf 

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

"This is significant news for Deltex Medical as we are the global leader in oesophageal Doppler monitoringand follows on from further significant developments for Deltex Medical in recent weeks: the NHS in England has started the first year of a programme to implement ODM at pace and scale; the Centers for Medicare and Medicaid Services in the US have issued a specific procedure code for ODM thereby setting a national rate for physician payment for using ODM and is expected shortly to issue formal payment instructions. Now the use of ODM to guide fluid management has been established as a care standard in France. Each of these is expected to lead to sustainable growth in sales of our products and to encourage the more rapid recognition of ODM as a standard of care in other health economies."

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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.