FDA submission completed for CardioQ-ODM+

RNS Number : 6290H

Deltex Medical Group PLC

24 June 2013

 



Deltex Medical Group plc

("Deltex Medical" or "the Company")

FDA submission completed for CardioQ-ODM+

US launch anticipated in H2

24 June 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 it has completed its submission to the US Food & Drug Administration ('FDA') in respect of the CardioQ-ODM+ and therefore anticipates regulatory approval to launch this device in the USA in the second half of 2013.

The CardioQ-ODM+ was launched initially in Europe in the first half of 2012 and substantially upgraded in December 2012. The FDA submission covers the upgraded version together with a further software upgrade. Assuming no undue delays with the FDA approval process, Deltex Medical anticipates launching the CardioQ-ODM+ in the USA during the second half of the current financial year. In accordance with its usual practice on launch of new products, the Company plans to establish a number of research sites in the USA for CardioQ-ODM+ under barter arrangements. The Company notes that £0.4m of such sales in 2012 were made in the first half of the year following the European launch and that comparable barter sales in 2013 will only be made in the second half.

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

"We have been pleased by the response to the CardioQ-ODM+ in the UK and Europe amongst both medical academics and practising clinicians. We believe that its launch in the USA will help us to establish routine use of our products in more hospitals. We are encouraged by the high calibre of hospitals and medical opinion leaders who have already expressed interest in working with the CardioQ-ODM+ after it has been granted US regulatory approval."

For further information, please contact:-

Deltex Medical Group plc	01243 774 837 [e-mail]
Nigel Keen, Chairman
Ewan Phillips, Chief Executive
Paul Mitchell, Finance Director
Nominated Adviser & Broker
Arden Partners plc	020 7614 5900
Chris Hardie
Financial Public Relations
Newgate Threadneedle	020 7653 9850
Graham Herring
Caroline Evans-Jones
Heather Armstrong

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.

 

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