Deltex Medical Regulatory News (DEMG)

Deltex Medical Group plc

("Deltex Medical" or the "Company")

Evidence Update

Multiple studies highlight the benefits of IOFM and demonstrate that such benefits are achievable only with ODM

11 September 2014 - Deltex Medical Group plc, the global leader in oesophageal Doppler monitoring ("ODM"), announces an update on clinical evidence reinforcing the unique advantages of ODM.

1. Spanish trial pilot results

A major government funded multi-centre randomised controlled trial of ODM in surgery in Spain has been completed and results are due to be submitted for publication before the end of 2014. Results from the first 121 of the c500 patients in the trial show statistically significant reductions in: total hospital stay (9.2 v 10.9 days); post-operative intensive care stay (1.9 v 3.6 days); duration of surgery (181 v 240 minutes); return to oral diet (1.7 v 3.1 days) and return to walking (2.5 v 4.2 days).1

2. Introduction of ODM into an enhanced recovery programme in Ireland

In an 80 patient audit of the introduction of ODM into an enhanced recovery laparoscopic colorectal surgery programme in a leading Dublin teaching hospital, doctors found statistically significant improvements in outcomes: reduced critical care admission (1 v 6 patients); lower average post-operative morbidity score on the day after surgery (2 v 4); fewer post-operative complications (14 v 20 patients); reduced time to return to oral diet (2.3 v 3.8 days). 2

3. ODM within an enhanced recovery programme in the USA

Doctors from Duke University Hospital in North Carolina have published the results of introducing an enhanced recovery programme which included protocolised use of ODM to guide fluid management during surgery. They reported statistically significant reductions in: length of hospital stay for both of laparoscopic surgery (4 v 6 days) and open surgery (6 v 7 days) with an overall two day reduction; urinary tract infections (13% v 24% of patients); and readmissions within 30 days (9.8% v 24%). 3

Note: data on 137 of these 142 patients were included within the pilot Premier study data the Company announced 19 June 2013. In this slightly larger group an unspecified small number of patients were treated using an alternative IOFM technology contrary to the protocol. The Company notes that the outcomes in the Premier dataset were marginally better than in this larger population.

4. Meta-analysis confirms superiority of ODM outcomes

The Company has started to publish and regularly update a meta-analysis report analysing the cumulative published clinical evidence for intra-operative fluid management ('IOFM'). This focuses on the technique of stroke volume optimisation developed with ODM to exploit its unique ability to detect precisely, reliably and in real time small changes in the rate of blood flows around the body.

The meta-analysis shows that stroke volume optimisation during surgery only reduces complications or length of hospital stay if ODM guided. In respect of complication reductions the ODM evidence base is sufficiently strong to carry all other technologies despite their inability, in multiple individual trials or overall, to deliver positive results. 4

Ewan Phillips, Chief Executive of Deltex Medical, commented:

"Clinical evidence is vitally important in the era of evidence based medicine and is a key driver behind Deltex Medical's growth. These studies will help clinicians understand both the benefits of IOFM within the most modern and advanced approaches to surgery and that such benefits are achievable only with ODM. In the USA many of the hospitals who have been introduced to the concept of IOFM are reaching out to Deltex Medical once they have investigated the evidence base."

References

1. Calvo J.M., et al. Efficacy of intraoperatory optimisation of fluids guided with transoesophageal doppler monitorisation: a multicentre randomised controlled trial. 1AP3-10. European Journal of Anaesthesiology: Volume 31 e-supplement 52: 2014

2. McKenny, M., et al., Introduction of oesophageal Doppler-guided fluid management in a laparoscopic colorectal surgery enhanced recovery programme: an audit of effect on patient outcome. Ir Med J, 2014. 107(5): p. 135-8.

3. Miller T., et al. Reduced Length of Hospital Stay in Colorectal Surgery after Implementation of an Enhanced Recovery Protocol. Anesthesia & Analagesia 2014: 118(5)

4. Murrell C. Intraoperative Fluid Management (IOFM) technologies and patient outcome: a meta-analysis. http://www.deltexmedical.com/wp-content/uploads/2014/07/Meta_analysis-7_14-web.pdf

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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.

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 3,000 CardioQ-ODM systems in use in hospitals worldwide. Distribution arrangements are in place in over 30 countries.